StemCell Therapy

PARIS--(BUSINESS WIRE)--Regulatory News:

Lysogene (FR0013233475-LYS) (Paris:LYS) held its ordinary annual and extraordinary general meeting of shareholders on June 26, 2020, in closed session, which was chaired by Karen Aiach, Chairman of the Board of directors and chief executive officer, without the physical presence of the shareholders.

With a quorum of 53.64%, the shareholders have adopted all the resolutions recommended by the Board of Directors, including the financial statements for the 2019 financial year, the compensation policy applicable to the Chairman and Chief Executive Officer and the directors, as well as delegations granted to the Board of Directors related to financial transactions.

Shareholders also approved the renewal of Karen Aiach, Philippe Goupit, Peter Lichtlen, David Schilansky, Mathieu Simon and Carole Deffez as Board members.

Details on the vote results will be available on the companys website.

About LysogeneLysogene is a gene therapy company focused on the treatment of orphan diseases of the central nervous system (CNS). The company has built a unique capability to enable a safe and effective delivery of gene therapies to the CNS to treat lysosomal diseases and other genetic disorders of the CNS. A phase 2/3 clinical trial in MPS IIIA in partnership with Sarepta Therapeutics, Inc. is ongoing and a phase 1/3 clinical trial in GM1 gangliosidosis is in preparation. In accordance with the agreements signed between Lysogene and Sarepta Therapeutics, Inc., Sarepta Therapeutics, Inc. will hold exclusive commercial rights to LYS-SAF302 in the United States and markets outside Europe; and Lysogene will maintain commercial exclusivity of LYS-SAF302 in Europe. Lysogene is also collaborating with an academic partner to define the strategy of development for the treatment of Fragile X syndrome, a genetic disease related to autism. http://www.lysogene.com.

Original post:
LYSOGENE Releases the Results From June 26, 2020 Ordinary Annual and Extraordinary General Meeting - Business Wire

Axsome Therapeutics surprise win in a late-stage Alzheimers study, unveiled just two months ago, has registered with regulators. The New York-based biotech has notched a breakthrough therapy designation for AXS-05 for the indication, its second after major depressive disorder.

So whats the big deal here? The drug is an oral agent with multimodal activity consisting of two components: dextromethorphan, an NMDA receptor antagonist, and bupropion whose main purpose is to slow down the metabolism of the former.

In the pivotal Phase II/III ADVANCE-1 study, patients treated with AXS-05 saw their Cohen-Mansfield Agitation Inventory (CMAI) total score decrease in 5 weeks from baseline by 15.4 points on average, compared to 11.5 points for placebo (p=0.010). It was also superior to bupropion alone (p<0.001), proving the necessity of a combo.

The CMAI score measures some of the most visible behaviors as reported by caregivers of Alzheimers patients, including episodes of screaming or hitting.

This FDA Breakthrough Therapy designation is an important milestone in the development of AXS-05 for Alzheimers disease agitation, a serious, prevalent, and debilitating condition for which there is currently no approved therapy, CEO Herriot Tabuteau said in a statement.

Analysts tracking Axsome hadnt been paying much attention to Alzheimers agitation, focusing instead on MDD, where the company is lining up a near-term application with the FDA after reporting upbeat data in one of the toughest fields in R&D.

But after consulting with physicians, Cowen analyst Joseph Thome recently noted that the disease has historically been difficult to treat, and that the results were impressive especially given the placebo group actually performed better than expected.

We expect that AXS-05 will be successfully developed for the indication following another Ph. III study and model $750MM in peak U.S. sales, he wrote, adding to the $2 billion opportunity with MDD.

The fact that no other drug has ever been approved for the specific use, though, can be a double-edged sword. Otsukas Avanir has previously scored a Phase III win for AVP-786 deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate) only to be disappointed in the second.

Axsome seems to have the FDA on its side for now. And that has investors stoked, sending shares up 11.33% to $85.29.

See the original post here:
Presented with upbeat Alzheimer's agitation data, FDA sees another 'breakthrough' in Axsome's AXS-05 - Endpoints News

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Mercks anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. This approval is based on data from the Phase 2 KEYNOTE-629 trial, in which KEYTRUDA demonstrated meaningful efficacy and durability of response, with an objective response rate (ORR) of 34% (95% CI, 25-44), including a complete response rate of 4% and a partial response rate of 31%. Among responding patients, 69% had ongoing responses of six months or longer. After a median follow-up time of 9.5 months, the median duration of response (DOR) had not been reached (range, 2.7 to 13.1+ months).

Cutaneous squamous cell carcinoma is the second most common form of skin cancer, said Dr. Jonathan Cheng, vice president, clinical research, Merck Research Laboratories. In KEYNOTE-629, treatment with KEYTRUDA resulted in clinically meaningful and durable responses. Todays approval is great news for patients with cSCC and further demonstrates our commitment to bringing new treatment options to patients with advanced, difficult-to-treat cancers.

Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see Selected Important Safety Information below.

Data Supporting Approval

The efficacy of KEYTRUDA was investigated in patients with recurrent or metastatic cSCC enrolled in KEYNOTE-629 (NCT03284424), a multi-center, multi-cohort, non-randomized, open-label trial. The trial excluded patients with autoimmune disease or a medical condition that required immunosuppression. The major efficacy outcome measures were ORR and DOR as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ.

Among the 105 patients treated, 87% received one or more prior lines of therapy and 74% received prior radiation therapy. Forty-five percent of patients had locally recurrent only cSCC, 24% had metastatic only cSCC and 31% had both locally recurrent and metastatic cSCC. The study population characteristics were: median age of 72 years (range, 29 to 95); 71% age 65 or older; 76% male; 71% White; 25% race unknown; 34% Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 and 66% ECOG PS of 1.

KEYTRUDA demonstrated an ORR of 34% (95% CI, 25-44) with a complete response rate of 4% and a partial response rate of 31%. Among the 36 responding patients, 69% had ongoing responses of six months or longer. After a median follow-up time of 9.5 months, the median DOR had not been reached (range, 2.7 to 13.1+ months).

Patients received KEYTRUDA 200 mg intravenously every three weeks until documented disease progression, unacceptable toxicity or a maximum of 24 months. Patients with initial radiographic disease progression could receive additional doses of KEYTRUDA during confirmation of progression unless disease progression was symptomatic, rapidly progressive, required urgent intervention, or occurred with a decline in performance status. Assessment of tumor status was performed every six weeks during the first year and every nine weeks during the second year.

Among the 105 patients with cSCC enrolled in KEYNOTE-629, the median duration of exposure to KEYTRUDA was 5.8 months (range, 1 day to 16.1 months). Patients with autoimmune disease or a medical condition that required systemic corticosteroids or other immunosuppressive medications were ineligible. Adverse reactions occurring in patients with cSCC were similar to those occurring in 2,799 patients with melanoma or non-small cell lung cancer (NSCLC) treated with KEYTRUDA as a single agent. Laboratory abnormalities (Grades 3-4) that occurred at a higher incidence included lymphopenia (11%).

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those 1% included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

Go here to see the original:
FDA Approves Merck's KEYTRUDA (pembrolizumab) for the Treatment of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) that...

NEW HAVEN, Conn.--(BUSINESS WIRE)--Simcha Therapeutics, a biotechnology company developing first-in-class biologic drugs that modulate powerful cytokine pathways, launched today with $25 million in Series A financing and a mission to harness the precision and power of the immune system through the use of directed evolution.

Simchas lead program involves a customized variant of interleukin-18 (IL-18), a cytokine with potent antitumor effects, developed in the lab of Scientific Founder Aaron Ring, M.D., Ph.D., Assistant Professor of Immunobiology at the Yale School of Medicine. The biology and preclinical profile of this molecule, which Simcha expects to advance to the clinic in the first half of 2021, is described in detail in a scientific paper published today in the journal Nature.

Cytokine therapies heralded the immuno-oncology revolution more than 30 years ago with the discovery that interleukin-2 (IL-2) could promote rare, but dramatic, responses in melanoma and kidney cancer patients. However, they have not lived up to their promise as a class due to substantial toxicities and limited efficacy. Simcha was founded to overcome those obstacles by using directed evolution to engineer a new generation of cytokines with improved properties relative to those of their native variants. Simchas molecules are purpose-built to control immune cell activation, differentiation and proliferation and to reverse the immunosuppressive tumor microenvironment that is a barrier to effective eradication of the cancer.

Cytokines represent a compelling therapeutic class because they tap into pathways that are hard-wired into immune cells. The challenge is that nature didnt design them to be anti-cancer therapies; theyre signaling molecules, so their activity can be hard to specifically direct, Dr. Ring said. At Simcha, we set out to improve on natures design by engineering custom-built proteins that can precisely activate and expand populations of crucial immune responders, such as natural killer (NK) cells and T cells. Too many cancer patients do not respond to the immunotherapies available today. Were hopeful that our approach will provide new options and potential benefits to these patients.

Evading a Decoy Receptor

Simchas lead asset, ST-067, activates the IL-18 receptor, triggering potent inflammatory signaling in antitumor immune cells of both the adaptive and innate branches of the immune system.

Early efforts by leading pharmaceutical companies to develop IL-18 into a drug failed. Dr. Rings lab broke new ground by identifying the reason for that failure: The tumor microenvironment is teeming with a decoy called IL-18BP, which binds IL-18 and blocks it from activating its receptor. When infused as a drug, IL-18 is drawn to the decoy and fails to reach its true target. As described in the Nature paper, the decoy receptor is a major barrier to IL-18 immunotherapy.

To overcome that barrier, Dr. Rings lab used directed evolution to create a version of the cytokine that would evade the decoy and bind only to the true IL-18 receptor. This was a difficult task, since IL-18 normally binds its decoy 10,000 times tighter than it does to the IL-18 receptor. The designer version of IL-18 made in Rings lab has dramatic alterations in its receptor binding properties, biasing binding towards the IL-18 receptor and away from the decoy by more than one million-fold. This decoy-resistant property enables the custom-built cytokine to work effectively in the immunosuppressive tumor microenvironment.

Potent Single-agent Antitumor Effects

When Rings lab tested the decoy-resistant IL-18 and compared it to natural IL-18 in mice, they found that just as in human patients natural IL-18 had little to no antitumor activity. By contrast, the decoy-resistant IL-18 had potent single-agent activity that inhibited tumor growth and even produced complete tumor regression in many animals, including in tumor types that are refractory to checkpoint inhibitors.

Rings lab also examined the effect of decoy-resistant IL-18 on the tumor microenvironment. A key finding: The engineered IL-18 acted on a crucial population of stem-like T cells within tumors, increasing their numbers over tenfold and skewing their development toward a highly active effector phenotype, as opposed to an exhausted or dysfunctional state. In checkpoint-resistant tumors, the engineered IL-18 also acted on innate NK cells, increasing their numbers and maturation to promote antitumor activity.

The mechanism of action of decoy-resistant IL-18 is unique and distinct from immunotherapeutic agents that are being developed for other pathways. For this reason, we are hopeful it could be effective in tumors that have not otherwise responded to immune-based treatments, as well as enhance the activity of standard cancer immunotherapies, said Dr. Ring.

Founders Strong Record in IO Drug Discovery

Dr. Ring has a strong track record in immuno-oncology drug discovery. He co-invented the first described CD122-biased IL-2 variant, originally detailed in Nature in 2012, which is now advancing through preclinical studies at Medicenna Therapeutics. He also developed a high-affinity SIRP antagonist, featured in Science in 2013, that is now in clinical development at ALX Oncology as ALX-148. For these and other discoveries, Ring was named to Forbes 30 under 30 list of rising stars in health care in 2016 and has been honored with an NIH Directors Early Independence Award and recognition as a Pew-Stewart Scholar in Cancer Research.

Simcha plans to build out a full executive team as the company prepares to move ST-067 into the clinic next year.

The companys investors include WuXi AppTecs Corporate Venture Fund, Sequoia Capital China and Connecticut Innovations.

About Simcha Therapeutics

Simcha Therapeutics uses directed evolution to engineer novel cytokines designed to unlock the precision and power of the immune system. Simchas lead program, ST-067, is a designer IL-18 cytokine that has shown potent antitumor effects in animal models, both as a monotherapy and when combined with anti-PD-1 checkpoint inhibitors, as described in Nature in June 2020. A Phase 1 trial is expected to be launched in the first half of 2021. Simcha was founded by Aaron Ring, M.D., Ph.D., Assistant Professor of Immunobiology at the Yale School of Medicine. The company has received $25 million in funding to date and is based in New Haven, Conn.

Continued here:
Simcha Therapeutics Launches to Engineer Therapeutic Cytokines to Unlock the Full Potential of the Immune System - Business Wire

Staff and congregants should stay home and not attend service if they have any symptoms like fever, cough or shortness of breath. If you have been diagnosed with COVID-19 infection, you should not leave your home until approved by your medical provider or the health department. If you are on home quarantine for 14 days because you have been in contact with someone with COVID-19 infection, you should not attend in-person worship services.

Screening individuals before they enter place of worship will ensure that individuals who are attending worship service are currently healthy and not experiencing any COVID-19 related symptoms. Asking a few simple questions and taking the temperature of individuals entering is a great step in preventing the spread of COVID-19. Below is what should be asked prior to entering the worship facility:

Have you had close contact (within 6 feet for at least 10 minutes) in the last 14 days with someone diagnosed with COVID-19, or has any health department or health care provider been in contact with you and advised you to quarantine?

Have you experienced any of the following symptoms in the last 72 hours Fever Chills Shortness of breath or difficulty breathing New cough New loss of taste of smell

Have you been diagnosed with COVID-19?

If anyone responds yes to any of the above questions, has symptoms, or has been exposed to COVID-19 they should go home, stay away from other people, and call their doctor.

If you are a senior citizen or have an underlying health condition, you are at high risk for severe disease. Consider asking your pastor to video the service for you. This allows you to view the service from the safety of your home.

Read the original post:
Health department urges COVID-19 preventative measures upon returning to places of worship - Statesville Record & Landmark

This Pride Month,Rewire.Newsrecognizes that celebrating during the pandemic will look very different for many of us, which is why were putting together tools of resistance and hope to help us all survive (and even thrive)Pride 2020.

When pre-exposure prophylaxisbetter known as PrEPhit the market in 2012, it was quickly recognized as a highly effective method for preventing HIV infections. So why isnt the life-saving medication free and accessible for all?

After someshort-lived handwringing that the drug wouldencourage gay men to have condomless sex, PrEP rapidly found a place in public health arsenals around the world. The medication is free or costs a few dollars a month in countries like France, New Zealand, and Kenya, but in the United States, that kind of easy access is elusive. In the worst-case scenario,if a PrEP userhad no insurance, no Medicaid, and lived in, say, rural Indiana (among many other places), they could be on the hook for a little under $2,000 a month (or $64 per pill), plus doctors fees for the prescription.

The group predominantly responsible for that price tag is Gilead Sciences, a pharmaceutical giantthat recorded over $22 billion in total revenue in 2019. Gilead has exclusive rights to produce and sell Truvada and Descovythe only approved forms of PrEP in the United Statesand it has the freedom to set prices wherever it likes.

Want our news sent to you every week?

SUBSCRIBE TODAY!

According to James Krellenstein, co-founder of the advocacy group PrEP4All, PrEPs lofty price tag means that a sizable chunk of government spending on HIV prevention goes directly to the company that sets the price, instead ofother prevention strategies, like community outreach.

All of the resources dont go to addressing [other] barriersthey go to pay off a company like Gilead, Krellenstein told Rewire.News.

Even then, government spending on PrEP is patchy. The most straightforward way to get free PrEP is to be on Medicaid, but low-income, uninsured adults dont meet the eligibility criteria in many states. But some municipalities like New York state and the cities of Atlanta and San Francisco do fund programs to make PrEP freefor lower-income people.

The United States Preventative Service Taskforce (USPSTF), an independent panel of experts in prevention and evidence-based medicine, recommended in 2019 that PrEP be covered fully by all private insurance plans. While the recommendation isnt a legal requirement, the Affordable Care Act (ACA) requires that most private insurance plans, as well as states with expanded Medicaid as part of the ACA, cover the full cost of any preventative service given an A or B rating by the task force. Starting January 2021, these insurance plans will be required to cover PrEP, as well as all lab work and clinic visits, with no co-pays or deductibles, according to the recommendation. (By the way, none of this helpspeople who are uninsured.)

For now, theres private insurance and its myriad co-pays and deductibles. Those left with a bill after insurance kicks in have one more option: asking Gilead for help. The company has a program that covers a chunk of out-of-pocket costs for PrEP ifinsurance already covers it to some degree.

According to Krellenstein, this isnt a particularly philanthropic move from Gileadrather, its a discount on a product that they priced in the first place.

A lot of people rely on that co-pay program, but at the end of the day, it doesnt get around the fact that even with the co-pay program theyre making $10,000 a year on a drug that costs $80 [to make], Krellenstein said, making a rough estimate on the manufacturing cost.

It doesnt seem that this mishmash of corporate and public coverage works: The Center for Disease Control and Prevention (CDC) suggests that out of 1.2 million people in the United States in the high-risk category for contracting HIV, only around 200,000 take PrEP. Plus, infection rates have declined by less than 10 percent since PrEP was approved in 2012. HIV/AIDS is an ongoing, very active epidemic, Krellenstein said.

Meanwhile, countries like Australia have closer to half of their high-risk population on PrEP. And its not because Australia is willing to spend more public moneythey have agenericversionon the market, along witha robust public system that can bargain prices down.

In the United States, Gileads Truvada patent runs out later this year, but only one genericis expected to surface in September, so only a modest price drop should be expected. Gilead is also encouraging PrEP users to switch from Truvada to Descovy, which is billed as safer (but is also patent-protected for longer) to protect its market.

While Gileads nefarious pricing is an obvious and convenient boogeyman in this case, advocates say the federal government also shoulders ashare of the blame.

The U.S. government may have had the ability to force down Gileads high prices, but didnt act on it until 2019, when it filed a series of lawsuits alleging that Gilead infringed on CDC researchers patents in developing Truvada and Descovy; Gilead has in turn claimed that the CDC infringed on its patents. While the status quo still stands, initial hearings have come down on the governments side, prompting advocates to question why the CDC didnt act earlier.

These patents were the CDCs domain they chose to do nothing about it even when they knew about these massive problems with access to the medication, Krellenstein said.

Not only that, aTrump administration program that aims to supply free PrEP to 200,000 people enrolled just 891 people since it began in December.

While the government secured the drug supply for the campaign, it didnt do the necessary outreach, particularly into Black communities where HIV infection rates are higher and PrEP use is lower, said Matthew Rose, director of U.S. policy and advocacy at Health GAP (Global Access Project), an international organization dedicated to ensuring that all people with HIV have access to affordable, life-saving medicines.

Preventative medicine has had a low uptake in these communities, he said. Some of this is due to medical mistrust and racism. It can be hard to get a provider, people may be reluctant to talk to a provider the government has to work to build the trust within those communities.

But even if the government had a flawless outreach program, 200,000 more people with access to PrEP still wouldnt be enough, Rose said. Between Gileads dominance and the high price of medical services, the health-care system simply isnt cut out for free PrEP.

Weve got to get hold of the insurance companies and the drug companiestheres just not enough money and coverage to go around to get people to live their best health outcomes, Rose said.

More here:
If the Government Cared About HIV, PrEP Would Be Free - Rewire.News

A Japanese supercomputer has taken the top prize in a renowned global speed competition for the first time since 2011, beating out the Chinese and American competitors that usually win. Fugaku, as the supercomputer is called, clocked in a score of 415.53 petaflops on the biannual Top500 List.

To put that into context, a system capable of one-petaflop speed can perform one quadrillion "floating point operations," or computer arithmetic calculations. To keep up with a one-petaflop supercomputer, you'd have to perform one calculation every second for 31,688,765 years, according to Indiana University. Multiply that by 415.53 petaflops, and that's one calculation every second for about 13.2 billion years. Phew.

This marks the first time an Advanced Reduced instruction set computing Machine (ARM) supercomputer has taken the lead slot on the Top500 List. Usually, ARM processorswhich require fewer transistors, are cheaper, use less power, and create less heatare relegated to the world of mobile devices like smartphones, tablets, or laptops, making Fugaku's win particularly compelling.

"For Arm, this achievement showcases the power efficiency, performance and scalability of our compute platform, which spans from smartphones to the worlds fastest supercomputer," Rene Haas, president of Arm's IP Products Group, said in a prepared statement. Arm Holdings is the Softbank-owned semiconductor company that first introduced ARM chips.

Fugaku beat out its nearest competitor, Summitan IBM-developed supercomputer that lives at Oak Ridge National Laboratory in Tennesseeby 266.93 petaflops. That supercomputer previously topped the Top500 List in the last round of competition, back in November, when it ranked in at 148.6 petaflops.

The latest ranking included four supercomputers from the U.S., two from Italy, two from China, one from Japan, and one from Switzerland.

Fugaku is installed at the RIKEN Center for Computational Science in Kobe, Japan. The original idea came about back in 2014, and the supercomputer won't even be fully operational until April 2021.

At RIKEN, around 3,000 researchers use the machine for drug discovery; personalized and preventative medicine; natural disaster simulations; and studies into the fundamental laws of the universe. And on an experimental basis, researchers are even using Fugaku for COVID-19 research into diagnostics, therapeutics, and simulations showing the spread of the virus.

STRGetty Images

"Fugaku was developed based on the idea of achieving high performance on a variety of applications of great public interest...and we are very happy that it has shown itself to be outstanding on all the major supercomputer benchmarks," Satoshi Matsuoka, director of the RIKEN Center, said in the statement. "I hope that the leading-edge IT developed for it will contribute to major advances on difficult social challenges such as COVID-19."

This content is created and maintained by a third party, and imported onto this page to help users provide their email addresses. You may be able to find more information about this and similar content at piano.io

This commenting section is created and maintained by a third party, and imported onto this page. You may be able to find more information on their web site.

Read more:
Meet Fugaku, the New Fastest Computer in the World - Popular Mechanics

On the same Monday in June, two studies emerged challenging most of what everyone thinks we know about the battle against the deadly pandemic SARS-CoV-2 coronavirus, and both suggest a fundamental frailty in the way humans think:

We are prejudiced by a desire to believe in human dominion over nature.

That fundamental belief, the studies suggest, might have prejudiced conclusions that non-pharmaceutical efforts to contain the pandemic have been successful even though the evidence doesnt appear to support that conclusion.

After modeling real-world data from 40 countries, professor Harald Walach from the Poznan University of Medical Sciences in Poland and German health consultant Stefan Hockertz concluded that little of what has been done to battle the disease to date has proven truly effective and some actions might have made things worse.

Interestingly, none of the variables that code for the preparedness of the medical system, for health status or other population parameters were predictive (of lower death rates), they wrote. Of the public health variables, only border closure had the potential of preventing cases and none were predictors for preventing deaths. School closures, likely as a proxy for social distancing, was associated with increased deaths.

The pandemic seems to run its autonomous course and only border closure has the potential to prevent cases. None of them contributes to preventing deaths.

The study was published on the preprint server MedRxiv and has not been peer-reviewed. The authors appeared to concede that, but they werent pulling any punches.

It is interesting to observe that closure of schools emerges as a strong positive predictor for the number of deaths, i.e. school closures are associated with more deaths, they wrote. This could be an indicator for strong social distancing rules in a country which might be counterproductive in preventing deaths, as social distance for very ill and presumably also very old patients, might enhance anxiety and stress and could then become a nocebo.

It could also reflect the fact that countries which saw a rising tendency of deaths closed schools as an emergency measure, and hence school closure is an indicator of fear in a country. But considering the prevention of deaths, none of the public health measures studied are associated with the prevention of deaths.

Conceding that their work contradict(s) new modeling data using time series models that report clear evidence for the effectiveness of non-pharmaceutical interventions, they took direct aim at those findings.

The major shortfall of these models is that they ignore the most likely reason why we find the data we find: immunity in the population and neglecting the strength ofnatural immunity, they write. Thus, a new reliability study of such models shows that they are crucially dependent on assumptions, parameters assumed and the time point at which they capture data. If the wrong assumption about a potential resistance against an infection in a population is made, the results are far off from true values.

Walach and Hockertz are not alone in this thinking. Another study new on the MedRxiv server Monday also concluded that while actions taken to slow the spread of the disease appear to have reduced demand for space in intensive-care units none of the proposed mitigation strategies reduces the predicted total number of deaths below 200,000. Surprisingly, some interventions such as school closures were predicted to increase the projected total number of deaths.

A team of researchers from the University of Edinburgh reached those conclusions after investigating the United Kingdoms response to the pandemic as guided by the advice of the countrys Imperial College against the subsequent trajectory of the disease.

Like Walach and Hockertz, the Edinburgh group led by Professor Ken Rice, an astrophysicist who specializes in modeling, concluded that closing schools actually increased the number of deaths, but the Edinburgh scientists didnt stop there.

We confirm that adding school and university closures to case isolation, household quarantine, and social distancing of those over 70 would lead to more deaths when compared to the equivalent scenario without school and university closures, they write. Similarly, adding general social distancing to a case isolation and household quarantine scenario was also projected to increase the total number of deaths.

Though this conclusion might at first appear counter-intuitive, the logic is sound. As with all viruses, SARS-CoV-2 needs new hosts to infect in order keep spreading. The fewer people it is capable of infecting, the harder it for the disease to travel through a population.

Thus if a large number of young people are infected and subsequently develop antibodies to ward off future infections, the virus has an increasingly harder time finding hosts and the spread of the disease slows.

The qualitative explanation for this is that within all mitigation scenarios in the model, the epidemic ends with herd immunity with a large fraction of the population infected, the Edinburgh researchers wrote. Strategies which minimize deaths involve having theinfected fraction primarily in the low-risk younger age groups. These strategies are different from those aimed at reducing the ICU burden.

Younger people for reasons still not fully clear have far better odds of beating SARS-CoV-2 than old people. Some do get very sick from COVID-19 the disease caused by the coronavirus but overall death rates are relatively low.

The U.S. Centers for Disease Control (CDC) currently estimates a COVID-19 case fatality rate of 0.05 percent for those age 49 and under. It rises to 0.2 percent for those age 49 to 64 and climbs to a deadly 1.3 percent for those 65 and older.

When the data is further broken down, it lays things out even more clearly. The CDC charts a COVID-19 death rate that starts at 3.5 deaths per 100,000 for those aged 5 to 17 and climbs steadily to 535.2 deaths per 100,000 for those age 85 and older.

The chart reflects that those 50 to 64 years old are dying at a rate almost five times greater than those age 18 to 29, and by age 65, the death rate for the 65-and-older group is approaching 10 times that of those under 30.

For comparison sake as to the death rates for younger ages, U.S. drug deaths for those age 18 to 34 (the closest available cohort to the 18 to 29 group for COVID) are 30.9 per 100,000.

A 2009, peer-reviewed meta-analysis of studies of the common flu published in the journal Epidemiology reported that most estimates for that disease fell in the range of 5 to 50 deaths per 100,000, but as with COVID-19 rose monotonically with age, from approximately one death per 100,000 symptomatic cases in children to approximately 1,000 deaths per 100,000 symptomatic cases in the elderly, although with substantial variation in the estimates within each age group.

Other than trying to protect the most vulnerable while growing herd immunity among the less vulnerable, both studies suggest there is not a whole lot that humans can do to change the course of the COVID-19 at this time.

The image that emerges from the data and the attempt to understand their relationship through modeling is that of a largely autonomous development, Walach and Hockertz write. It affects mainly the elderly. Smoking is somewhat protective and border closures is associated with a lower number of cases. But other measures closing of schools and lockdown of whole countries do not contribute to a reduced number of cases or deaths.

The data does indicate, they add, that if suspected cases are tracked and traced fast enough as in Taiwan and Hong Kong containment is possible.(but) once infectionsare in the vulnerable segments of a population, like in hospitals or homes for the elderly,political actions like school closures or country lockdowns do not prevent deaths.

If anything, social distancing seems to be harmful. What might be useful but cannot be seen in our coarse-grained data are special protective measures geared to protect these vulnerable populations, such as protective masks for personnel and visitors in hospitals and old peoples homes, or the wearing of face masks in places with bad ventilation and close proximity of people.

They admit its nice to believe the existing public health measures work, but argue the data just doesnt support that conclusion.

We have pointed out that the peak of the cases had been reached in Wuhan already on January 26th, only three days after the city lockdown, they write. This was surely too short to be an effect of public health measures as cases manifest with a delay of at least five and rather more days. And a careful analysis shows that, if one uses realistic retrodiction (back-tracking of time) of cases, then effects of public health measures cannot be seen.

The Edinburgh study gives more credit to the interventions but concludes that when they are relaxed which must inevitably be done since governments cant hold people in lockdown forever anything that has been gained by the lock down is lost and maybe worse.

The consequence of some interventions, they warn, is that they suppress the first wave so that a second wave, occurring after the interventions have lifted, then leads to a total number of deaths that exceeds the total for the equivalent scenario without this additional intervention.

Both studies argue for protecting the elderly and others most vulnerable while growing herd immunity among younger citizens. If they are right, the U.S. might now be accidentally engaged in this practice given the Black Lives Matter protests that have drawn together large numbers of primarily young demonstrators.

As of this time, there have been no reports of deadly disease outbreaks tied to those protests, but there is no way of knowing how many people might have been infected who are asymptomatic and presymptomatic and destined to show up infections counts in the days ahead.

The Swedes, who have taken a beating for a more liberal response to dealing with the pandemic, generally followed the model suggested in the studies, but did a terrible job of protecting the elderly.

An estimated 90 percent of the 5,100 dead in Sweden are over 70 years old and three-quarters were in nursing homes or receiving home care, according to a report from Barrons magazine.

Swedish national epidemiologist Anders Tegnell described it as a weakness of the nations elderly care.

The Swedish death rate of 507 per 100,0000, according to the Worldometer COVID-19 tracker, is far higher than that of its Scandanavian neighbors, but less than that of Italy (573/100,000) and Spain (606/100,000) two countries that engaged in onerous lockdowns.

Swedens rate is less than a third that of New York (1,607/100,000) and near a third of that of New Jersey (1,467/100,000). A number of studies have flagged population density as a possible contributing factor there, but the latest studies point to age being a bigger issue.

Since being elderly is a risk factor for many diseases, and eventually death, and cannot be changed, political actions in future pandemics would likely need to focus on protecting these members of society first, Walach and Hockertz written. Apparently, closing schools and locking down countries is not the right method to preventdeaths.

The study is sure to be controversial.

Back in March, Dr. David Katz a specialist in preventative medicine and public health, and the founding director of Yale Universitys Yale-Griffin Prevention Research Center wrote an op-ed for the New York Times (NYT) suggesting that idea.

Not long after, Katz appeared on CNN where NYT Science and Health writer Donald McNeil called the op-end an extremely dangerous way of thinking and demanded the doctor take that paper back and apologize for it because I think it provided a scientific underpinning for (President) Donald Trump to say things like the cure is worse than the disease.

McNeil called for a lengthy lockdown to save lives, arguing were not going to be able to think about our 401Ks or take retirement at the time we want to. Were going to have to think about getting enough calories, for perhaps the next year until a vaccine is here.

McNeil seemed wholly unaware of economic realities. And a year-long down lockdown seems even more unrealistic now and then.

After a lockdown of only a couple months, the country has been split by the biggest protests since the Vietnam War as Americans, largely the young, demand racial justice, a noble goal no one is quite sure how to achieve in a society that has become only more tribal in the past decade.

Katz, meanwhile, is sticking to his original suggestion for dealing with SARS-CoV-2. He is continuing to call for a risk-based response to the disease.

Currently there is no guidance for what comes after flattening the curve,' he writes. It delays but does not prevent a spike in hospital need and mortality, unless maintained until a vaccine is available.

Everybody back to the world now means a high, unacceptable rate of severe infection and death among those at elevated risk.

Hunker in a bunker until theres a vaccine ignores the potentially massive adverse health effects of social determinants of health as lives, livelihoods, goods, services, and supply chains are disrupted and degraded.

He has been criticized as putting economics ahead of health, but the two new studies would suggest the equation is not that simple.

Like Loading...

Categories: News

Tagged as: #SARS-CoV-2, age gap, assumptions, CDC, COVID-19, deaths, elderly, fear, flatten the curve, flu, german, herd immunity, homes, hospitals, human dominion, Imperial College, intensive care, Katz, lock down, low-risk, medRxiv, models, more deaths, non-pharmaceutical efforts, pandemic, Poland, prejudice, school closures, shortfalls, social distancing, Sweden, United Kingdom, younger

Originally posted here:
Against the tide - craigmedred.news

CHICAGO, June 18, 2020 /PRNewswire/ -- With the COVID-19 pandemic interrupting non-urgent medical care, physicians are concerned that important gains in preventing colorectal cancer could be lost and their patients could miss out on life-saving preventive care or treatment.

Colorectal cancer is the second-leading cause of cancer death, yet it is highly preventable and treatable with screening and early diagnosis, said Laura J. Zimmermann, MD, MS, medical director of Rush's Prevention Center and assistant professor of Preventive Medicine and Internal Medicine at Rush Medical College.

"If it's caught early, it has a really high cure rate, but if by delaying we find something later, it may be harder to treat," she said.

Ad StatisticsTimes Displayed: 102322Times Visited: 691

SRI is a leading Developer, Manufacturer & Supplier of Innovative Portable Imaging Equipment. We offer Lightweight, Agile, Easy to Maneuver Portable X-Ray Systems ideal for maneuvering in tight spaces. Call us at 631-244-8200

While Rush is starting to perform screening colonoscopies again, colorectal surgeon Dana Hayden, MD, MPH, associate professor and chief of the Division of Colon and Rectal Surgery at Rush Medical College, worries that the delay in care will linger and patients who had taken the important step of scheduling a colonoscopy may put off rescheduling and others who are due to be screened won't.

"We really don't know how long the delay could last," Hayden said. "Patients may be focused on more urgent matters than preventative care and may also be nervous about coming to the hospital while the pandemic continues."

That would reverse a positive, lifesaving trend:

The rate of people over age 50 who are up to date on colorectal cancer screening has improved greatly in the past several years, from 38% in 2000 to 66% in 2018, according to the American Cancer Society.

"As the rate of screening has increased in these age groups (over 55 years old), the incidence of colorectal cancer has decreased," Hayden said. And the mortality rate has declined as well.

Delayed screening means people will miss the opportunity to prevent or treat the disease early. That leads to a greater incidence of cancer, which is diagnosed at later stages with more severe symptoms and higher mortality, she said.

While it is impossible to know how much screening will be missed because of the pandemic, a look at the number of new colorectal cancer cases projected for 2020 in the U.S., two months with little or no screening theoretically could postpone diagnosis of cancer in 24,650 patients, among those some 9,860 cancers that may be at an advanced stage already.

Link:
Covid-related delays In colorectal cancer screening jeopardizes preventive care, early treatment - DOTmed HealthCare Business News

Every Married to Medicine cast member is a millionaire but does the newest addition really have a net worth of $500 million? Maybe at least she compared herself to someone with that fortune.

Buffie Purselleis married to a physician but has created her own empire as a personal finance and tax expert. She shared on CNBC in 2017 she built her net worth through a number of businesses shes created. She admits to working up to 12 hours a day and only sleeps a total of 40 hours per week.

Known as Buffie the Tax Heiress Purselle said, Im going to quote Beyonce when she said that she thinks she might be the black Bill Gates. I think I just might be the black, curvy, fabulous Marcus Lemonis-in-the-making. Marcus Lemonis has a net worth of $500 million. Shes undoubtedly a resourceful and powerful entrepreneur. However, other resources put Purselles net worth closer to $1 million.

Toya Bush-Harris and Dr. Heavenly Kimes both have a reported net worth of $4 million each. Kimes runs a successful dental practice in Atlanta who specializes in cosmetic dentistry. She often shares success stories on Instagram and patient transformation photos. Replacing missing teeth can restore your smile to optimal health, function and appearance. Dental implants are a great option for restoring your smile because the implants are designed to look, function and feel just like your natural teeth, and with proper care, they can last a lifetime, she recently shared along with a video.

RELATED: This Is How Much the Stars of Married to Medicine Make in Real Life

Bush-Harris is married to a physician and is a published author. She released the childrens book, SleepyHead Please Go To Bed!Bush-Harris created a tremendous social media following using the hashtag, #MommyChronicles.

Also worth $4 million is Mariah Huq who is a Married to Medicine creator and producer. Huq is married to Dr. Aydin Huq and she often entertains at her lavish home on the series.

Married to Medicine top docs all have a net worth ranging from $3.5 to $3 million. Dr. Simone Whitmore has a net worth of $3.5 million as one of the most sought after OB/GYNs in the Atlanta area. Whitmore is a mother of two and has been with husband Cecil for 23 years. Viewers witnessed the couple experiencing rocky moments throughout the series.

Dr. Jacqueline Walters has a net worth of $3 million is also a highly respected OB/GYN in Atlanta. Walters is a published author and a two-time breast cancer survivor. She also openly discussed her infertility on the series.

RELATED: After Hesitating To Start a Family With Her Ex-Husband, Married To Medicine Star Quad Webb Has Adopted a Daughter

Also, with a net worth of $3 million is Dr. Contessa Metcalfe. Metcalfe focuses her practice on preventative medicine and became friends with Dr. Britten Cole while in the Navy. Metcalfe became the crossover cast member between Married to Medicine and Married to Medicine Los Angeles.

Quad Webb is a millionaire in her own right. With a reported net worth of $1.5 million, Webb was a medical sales representative when she first joined the series. But now owns Picture Perfect Pup, a specialty brand designed for dogs. She was originally married to Dr. Gregory Lunceford but the couple has since divorced. Webb recently adopted a baby.

Continued here:
Does a 'Married to Medicine' Cast Member Have a Net Worth of $500 Million? - Showbiz Cheat Sheet

Photo: Shutterstock

For many residents of the Okanagan, the fatalities caused by illicit drug use may seem a distant problem with little to no impact on your life. However, everyone has a role to play in preventing overdoses.

BC has recorded the highest number of fatal overdoses in a single month, with deaths overtaking those due to COVID-19 in the whole year. During May, 170 individuals lost their lives due to illicit drug overdoses, where COVID-19 has caused 167 deaths in the entirety of 2020.

Of these overdose deaths, 82% involved fentanyl. Fentanyl is a strong opioid painkiller, 100 times stronger than morphine. It is often mixed with heroin or crack cocaine to enhance the effects, not always with the users knowledge.

Despite an initial reduction in overdose related deaths in 2019, fatalities have surged since the start of the pandemic. This is in part due to regular supply chains being cut off, and users having limited access to overdose prevention sites or drug checking services.

Interestingly, there were no deaths at supervised consumption or drug overdose prevention sites across B.C. in May, when these figures were released.

So what can you do?

There are several steps you can take to have a positive impact on the community in Kelowna, in terms of reducing harm caused by illicit drug use.

If you see someone in the street that looks like they could be having an overdose, stop and check theyre OK. If you feel uncomfortable doing this, call RCMP for a wellness check or 911 for an ambulance.

The signs of an overdose include not breathing or breathing very slowly, blue tinged lips or fingertips, an unusual gargling or snoring sound, or that the individual cant be woken and doesnt respond to pain.

If you see someone that could be overdosing, shake the person, shout at them and try to get a response to pain (squeeze their shoulder tightly in your hand). If theres no response, call 911 immediately.

Turn the individual on their side to prevent them from choking, and stay with them until help arrives.

To provide even more help, carrying and understanding how to use a naloxone kit is the best way to prevent deaths from overdose. The kits are free, and available from most pharmacies without a prescription. Carrying a kit in your car is a hugely important step in helping to save someones life; even if you dont feel comfortable using it, someone else at the scene may be able to.

Aside from saving someones life from the immediate effects of an overdose, there are other ways you can help in the bigger picture.

If you know someone that actively uses, support them in seeking help. Connecting with someone in the grips of addiction can be tough, but your support is vital in empowering them to get treatment and stay clean. Offer to accompany them to appointments, and ask them how you can help. Even alcohol addiction can lead to overdosing, so reach out now to anyone you know that is struggling.

Help to reduce the stigma around illicit drug use and overdosing by talking openly with your kids, teenagers and adult children about drug use. Discuss the reasons people use drugs, as well as the risks involved, to help reduce the likelihood of harm and encourage healthy behaviours.

The Okanagan has many supportive housing facilities and centres with drug overdose prevention sites or drug checking facilities. Although you may feel uncomfortable with one of these centres being in your neighbourhood, engage with the staff and residents at the centre to fully understand what it means to be tackling addiction, and how overdose prevention sites are helping. Many centres run community engagement days to help build bridges in the neighbourhood; even if you dont approve, educating yourself is key to understanding the reasons behind these facilities.

Overdoses are common, but they are also preventable. Empower yourself and your family to reduce stigma, help others and ultimately save lives.

Read the original post:
What to do if someone ODs - Health and Happiness - Castanet.net

Jeff Williams, chief operating officer of Apple Inc., speaks during an Apple event at the Steve Jobs Theater at Apple Park on September 12, 2018 in Cupertino, California.

Justin Sullivan | Getty Images News | Getty Images

Apple has grand ambitions to move into the health care field. The company's CEO Tim Cook once referred to health as the company's "greatest contribution to mankind."

In the last five years or so, the company has built up a big internal team staffed with doctors, health coaches, and engineers. It has developed health-focused software and hardware, and even started medical clinics for its own employees.

But with a concrete strategy and a biomedical breakthrough, such as non-invasive blood pressure or blood sugar monitoring, it could do a lot more. Ahead of its World Wide Developer Conference (WWDC) next week, here's what people in the health and technology sector think of Apple's influence and achievements so far -- and where it needs to go next.

Apple has a slew of products and services in health care.

Its primary product is the Apple Watch, and health is both a major use case and selling point. Its smartwatch device offers activity tracking, heart rate monitoring, an electrocardiogram to detect irregularities with the heart's rhythm, fall detection alerts, integrations with third-party health apps, and more.

The Apple Watch has other benefits, but overall, "the greatest use case for Apple Watch still remains health," said Ben Bajarin, an analystwith Creative Strategies specializing in consumer technology.

Henrik Berggren, founder of a diabetes-focused virtual medical clinic called Steady Health, said the Apple Watch is most helpful when it comes to tracking exercise and incorporating data from existing blood-sugar tracking devices. Many of Steady Health's patients already have Apple Watches or iPhones, and the group will look at that data in addition to their blood glucose levels and eating habits. "That exercise part they're doing quite well today," he says.

Beyond the Watch, vice president of technology Kevin Lynch is working to let customers bring medical information, including lab results and medical history, to their iPhones. That software, known as Apple Health Records, is continuing to make strides, but is still held back by the fact that consumers have to remember which doctors and hospitals they've been to in recent years and log into those systems separately.

The company has also developed software kits for third-party developers to build health applications. Among the most widely used is ResearchKit, which helps academics recruit people to their clinical trials via mobile devices.

Internally, Apple's California-based employees can use a health-care system known asAC Wellness. The company doesn't speak about it much and hasn't said whether it plans to expand those clinics to consumers more broadly. For now, it likely functions as a way for the health teams to learn about the practice of delivering medicine - and not just building tech.

During the Covid-19 pandemic, Apple teamed up with Google to release contact tracing technology for mobile phones, which public health researchers can use to build apps to track exposure to the virus. The company has seen the most traction for that in Europe and Asia.

Doctors have mixed feelings about the role of consumer health devices, including Apple's.

While some are bullish on their potential, others say that it's highly cumbersome for them to analyze this patient-generated information, and they don't currently get paid for the extra work. Many are simply refusing to look at data from wearable devices.

When John Koetsier, a technology consultant and writer, tried to share his Apple Watch data with a doctor, he was essentially told to keep it to himself. Koetsier had been tracking his food intake, weight and exercise on his own. But his doctor said that he had too many information sources already, and was feeling overwhelmed.

There are also questions about the accuracy of wearable devices when tracking health data.

"I trust Apple's step tracking, but heart rate I'm more concerned about," said Dr. Josh Emdur, a telemedicine doctor with SteadyMD. Emdur said he once admitted a patient into the hospital a few years ago because of an Apple Watch result, but it turned out to be a false alarm. He acknowledges that the data seems to have improved since then, and he's now using Apple Watches as a heart health screening tool. But he'll still recommend a medical device, like a Zio cardiac monitor, as a followup.

"To make the use- generated data actionable from devices like the Apple Watch, it needs to integrate better with electronic health record dashboard so a care team can see trends and it all comes in in a structured way," he said.

New York-based cardiologist Dr. Jeffrey Wessler says the Apple Watch offers more benefits than harms. "It really was a catalyst for the industry because it was the first time a consumer device began to infiltrate the clinical environment in a high volume way," said Wessler, who runs preventative heart health clinics called Heartbeat. "

But he notes that it can be frustrating patients come in with a concerning Apple Watch reading but no risk factors. In that case, there might not be a clear treatment pathway, and they're simply sent back home and told to come in if they develop symptoms.

"That's taking visits and time away from people who really need us," said Wessler.

Apple could make money in health by using it as a way to market and sell more of its devices. But there are much bigger opportunities in the $3.5 trillion health care sector.

The company has already announced partnerships with insurers, like Aetna, where users can "earn off" the cost of a device by engaging in healthy behaviors. It's also talking to some private Medicare plans about subsidizing the cost of the device for seniors.

Imagine if the company could somehow build a body of clinical evidence to get into the business of taking on risk for a population. If it can truly prove that it could improve the quality of care and bring down costs, that would be a huge opportunity. That vision would take many years to achieve, but it would certainly meet Cook's goal of having a major impact on health care.

Another game-changer would be if Apple can introduce more sophisticated sensors, including non-invasive glucose or blood sugar monitoring or a blood-pressure monitor. At that point, its device could reach a much bigger market -- 6 in 10 Americans - with one or more chronic diseases, as well as prevention. More than 1 in 3 Americans, for instance, are at high risk for type 2 diabetes.

"If they came out with a blood sugar or blood pressure monitor that was non-invasive and continuous, it would be a complete game changer," said Berggren. "That's what we dream about for the watch."

"I think there's a lot of opportunity for Apple still in the space," said Bajarin. "For me, it's really hinges on preventative health (as) that really expands the potential of the Apple Watch."

Other experts suggested the following areas where Apple should go next:

Better sleep tracking: "I'd love to see more in that direction," said Dr. CalvinWu, an endocrinologist with Steady Health. "They're just scratching the surface on sleep."

Telemedicine: Wessler, the cardiologist, believes that there needs to be an intermediary layer that helps triage patients. Instead of rushing to the emergency room or to a specialist, Apple could direct patients to an online visit and even offer its own video-based online medicine service.

More women's health focus: Several of the doctors wanted to see more thorough tracking for menstruation, fertility, and reproductive health.

More interoperability and integration with other medical devices: Apple already has close relationships with companies like Dexcom in the diabetes space, but the doctors agreed that it would be helpful to expand on that.

More validated clinical trialswould give Emdur, the telemedicine doctor, more confidence about the medical features in its products, including arrhythmia detection. Apple has done some trials, but it could double down.

Food logging: Helping people track the nutritional content of their food is another opportunity. Imagine snapping a picture of the food and algorithms figure out what's in the food. "It's a really hard problem but if anyone could solve it, that would probably be Apple," said Berggren.

More focus on seniors: The company has a fall-detection feature and many of its heart health features are useful to seniors, but it could do more to make its devices more accessible to older groups.

Apple Pay integrations: Apple could use its expertise in payments to help people navigate their health care bills.

More health features in Airpods: For Bajarin from Creative Strategies, that's an obvious move. It's easier to measure some vitals from the ear, which could make it a powerful health-focused wearable.

What's on your Apple Health wishlist? Let us know at @CNBCTech.

The rest is here:
Apple still has a lot of room to grow in the $3.5 trillion health care sector - CNBC

DURHAM, N.C. -- Speculation that a vaccine for COVID-19 might be widely available by the end of this year is overly optimistic, three Duke experts said Wednesday.

While there may be substantial scientific progress by the end of 2020, there will still be significant manufacturing hurdles to clear before a vaccine is available to most people, the experts said during a briefing for media.

Below are excerpts from the briefing:

David Ridley, health economist

Dr. Fauci is quite optimistic. I think optimism is good. I think optimism has a really important role. We need people within these companies being optimistic. If everyone sits back and talks gloom and doom nothings ever going to get done. So I respect that optimism.

But will you and I get vaccinated this year? No way. Its possible a vaccine will be approved this year. But not at scale. We wont have a lot of doses of this.

We might have some people vaccinated this year. But the average person wont be vaccinated this year.

Thomas Denny, chief operating officer, Duke Human Vaccine Institute

If youre going into a tough game, you need a coach thats getting the team revved up. We may have some good science by the end of the year and think we have some leading candidates. But manufacturing them to have it all administered, thats a tall order to be ready by the beginning of 2021.

Ooi Eng Eong, deputy director, Emerging Infectious Diseases Programme, Duke-NUS Medical School in Singapore

Once we get to the efficacy phase and ask the question of whether this vaccine will work to prevent infection, that depends on how common the infection is at that time. If the situation still goes on as it is, we shouldnt have any problem testing efficacy."

But if for whatever reason the prevalence of the disease goes down, it will take us a much longer time to assess efficacy.

Were not going to get rid of the coronavirus in a hurry. Its going to stay with us. Even if we can vaccinate people, protect them from infection the question is how long will immunity last?

If we think about using vaccines in stages, potentially we could get one, possibly at the soonest to me, about this time next year. Anything sooner than that is extremely optimistic. Others have said we could get it by the end of this year. Im an optimistic person, but Im not that optimistic.

David Ridley

Were preparing to manufacture at scale. Fortunately, some of these vaccine makers are already manufacturing now. Sanofi said theyre going to be able to make 100 million doses this year and a billion doses next year. Thats really unprecedented. Usually youd wait to see if your vaccine is having some success. If you think theres a 1-in-8 chance that youre going to get on the market, and youre already spending tens of millions, hundreds of millions of dollars, thats kind of crazy. But thats the crazy world we live in and I salute them for it.

Usually it takes years to manufacture. You want to be sure you got a good vaccine before you begin making it at scale. Typically this is going to take four or five years. Maybe now we can do it in one or two years. Part of this is going to depend on the appetite of these manufacturers to start building something now that they probably will never use.

My guess is this will take longer than people will assume because there will be a little bit of foot-dragging. If you drag your feet a little bit longer and make sure its a good vaccine, that its going to work before you make the huge investments in manufacturing, you can save a lot of money.

Thomas Denny

The duration of immunity post-vaccination is a major scientific issue were trying to understand. Were also trying to understand right now whats the duration of immunity after natural infection. That will help us probably understand how well or how well not vaccines will work for us.

One of the approaches were taking at the vaccine institute, were also exploring the potential development of a pan-coronavirus vaccine.

If we can develop a vaccine that would cover protection to all types of coronaviruses that may be a threat to us we think that would be a big benefit. Thats a longer-term goal for ours. Its 18 months to two years out. I dont think there are many playing in that space currently. Most are looking at the short-term COVID-19 pathogen and trying to get a rapid vaccine developed for that one.

Ridley

Its very common for the second product, a later product to be better than the first. Lipitor was fifth to market for cholesterol drugs and was arguably better than the previous four.

Its reasonable to expect that later entrants will be better. Assuming the virus is still with us and still a threat, Id expect other companies to continue product development.

Ooi Eng Eong

Obviously theres pressure. Theres pressure from the demand from the public for a solution so they can go back to some level of normality in their lives. Theres pressure from colleagues in the hospitals saying we need to deal with this.

Theres also competition from other groups working on vaccines. I think competition is good. It forces us to think harder to come up with better, more innovative ways of doing things. There is pressure but I think at some level of pressure is good to really push the boundaries.

Ridley

We need a lot of materials in this process. Some are very simple. Gowns and masks are pretty simple things. Swabs for diagnostics are pretty simple things. Rubber stoppers, medical glass sound pretty simple. But we really have a high standard for those because anytime we have something coming into contact with the vaccine thats going to go straight into your blood stream, we have a really high standard for sterility.

Sterile water always seems to be in shortage. Water should be easy to make. But it has to be sterile because its going straight into the bloodstream. We cant underestimate the importance of all these products along the line.

We might be a little concerned about hoarding. Theres cost to scaling up PPE. Theres cost to scaling up medical glass and rubber stoppers. Someone might hoard those. One of the vaccine manufacturers, one of the hospitals might try to grab those materials. Theres all sorts of parts in this process and if one of them breaks down, it slows the process of getting the vaccine to people."

Ridley

None of the major vaccine manufacturers will charge ridiculous prices. Theyre in this game to try to do good, to try to impress their employees, to try to impress their shareholders. Theyre not going to do that by charging ridiculous prices.

Ooi Eng Eong

Were testing (our vaccine) as a preventative vaccine. But is an intriguing possibility. Our fight against the virus relies on the body to recognize first of all its infected with the virus. It triggers a series of processes. So it is entirely possibly theoretically that because were using an RNA vaccine, the vaccine will trigger the processes that will allow the (body) to fight an RNA pathogen.

Weve only had this virus for seven months now. Theres a lot we dont know about this virus.

Think about it like a thief breaking into your house. If this person is very skilled at overcoming your alarm, they will be able to break into your house. If you have another system that can activate the alarm while the break-in is in process, you would actually trap the thief. So it is something that is possible.

Denny

Those with underlying medical conditions, and first-line responders. Hospital workers, theyre the highest priority. If we cant keep those folks going, were in trouble.

Faculty participants

Thomas N. DennyThomas Dennyis chief operating officer of the Duke Human Vaccine Institute, a professor of medicine and an affiliate member of the Duke Global Health Institute. His administrative oversight includes a research portfolio of more than $400 million. Denny has served on numerous committees for the NIH over the last two decades.thomas.denny@duke.edu

Ooi Eng EongOoi Eng Eongis a professor of medicine and deputy director of the Emerging Infectious Diseases Programme at Duke-NUS Medical School in Singapore. He also co-directs the Viral Research and Experimental Medicine Centre at the SingHealth Duke-NUS Academic Medical Centre (ViREMiCS), which studies therapies and vaccines against viral infections.engeong.ooi@duke-nus.edu.sg

David RidleyDavid Ridleyis a professor of the practice at Dukes Fuqua School of Business, where he is faculty director of the Health Sector Management program.He was lead author of the paper proposing a review program to encourage development of drugs for neglected diseases that became U.S. law in 2007.david.ridley@duke.edu

---Duke experts on a variety of other topics related the coronavirus pandemic can be found here.

Go here to read the rest:
COVID-19 Vaccine in 2020 Highly Unlikely, Experts Caution - Duke Today

Where have all the patients gone? Thats what doctors in our West Virginia University hospitals began asking as the coronavirus pandemic spread.

We were prepared for a rise in COVID-19 patients, but we didnt expect the sharp decline we saw in everyday cases. Our emergency department visits fell by half in early April, a time when we would normally see growth as flu season overlaps with an increase in trauma as the weather improves. Inpatient stays fell by nearly two-thirds during the same time period.

Did the population of a state that ranks in the bottom of most health indicators suddenly get better? Did their lung disease, heart disease and vascular disease improve?

In the emergency room, we heard the reason: I thought I could wait this out, patients told us.

Delaying treatment for acute and chronic conditions comes at a cost, both human and financial.

In hospitals across the U.S. andEurope, people fearing contracting COVID-19 have been choosing not to seek the emergency treatment they need. One survey conducted in April found thatnearly a third of U.S. adults had delayed medical careor avoided seeking care because they were concerned about getting COVID-19.

The numbers reported by hospitals seem to bear that out. U.S. emergency room trips for heart attacks fell 24% in the 10 weeks after the government declared a national emergency, according todata released June 22by the Centers for Disease Control and Prevention. Visits for strokes were down 20%, and visits for hyperglycemia, or uncontrolled high blood sugar, were down 10%.Childrens vaccinations also dropped offsignificantly, according to CDC data, raising new concerns after last yearsmeasles outbreak.

This has certainly been our experience as physicians and faculty at the West Virginia University School of Medicine. The patients we saw in the emergency room this spring were a lot sicker, and the proportion of emergency room patients who needed hospitalization increased.

Delaying treatment for acute and chronic conditions comes at a cost, both human and financial.

A patient with appendicitis who gets treatment early will usually undergo laparoscopic surgery, using small incisions and a camera, and can go home two days later. If the same patient waits too long, however, and a pocket of infection known as an abscess forms, that means more complex surgery. We will have to insert a tube for several days to drain the abscess, and the patient will be hospitalized longer, in addition to going on antibiotics. In the worst case, the appendix could burst and lead to diffuse peritonitis and sepsis, a medical emergency with severe abdominal pain and low blood pressure.

Similarly, if a diabetic with a foot infection that is early in the stages of cellulitis, a painful localized skin infection, waits a week to two longer than usual, theres a greater chance the infection has reached the bone, becoming an osteomyelitis that could require amputation.

The ultimate cost for delaying treatment can be loss of life.Data from the CDCshows the U.S. had66,000 more deaths than expectedfrom January through the end of April, with only about half of those linked to COVID-19. In April and May, the U.S. saw about13% more non-COVID-19 deathsthan would have been expected.

In some cases, clinics have tried to balance the risks. For example, many clinics delayed preventative care such as cancer screenings because of the risk of COVID-19. One U.S. study foundan abrupt drop in preventative cancer screeningsof between 86% and 94% through April. Treatments for cancer patients continued, but with hospitals takingextra precautionsto protect patients while their immune systems are compromised.

COVID-19 is not going away anytime soon, nor will heart attacks, strokes or appendicitis.

If you feel you need to see your doctor, go. If you feel you need to go to the emergency department, call 911. Its better than the pain and costs that can come with delay.

COVID-19 is not going away anytime soon, nor will heart attacks, strokes or appendicitis.

Your experiences during hospital visits going forward will definitely be different for a while. People arriving for hospital care that doesnt require staying overnight should expect some kind of screening process to make sure that they are not ill with COVID-19. The health care system will encourage social distancing at check-ins, as well as in the waiting rooms, and everyone will be wearing face masks.

While these unprecedented times have upended our care processes, they also offer patients and health care systems new opportunities.

When we talk to our patients, many of them appreciate the opportunity for virtual visits, especially those at highest risk for complications from COVID-19 infection. The ability to establish virtual urgent care as well as offer many clinical services through virtual visits is here to stay.

The past few weeks have seen very significant changes at all points of patient entry into a hospital or clinic. However, clinical medicines fundamental principle ofprimum non nocere, first do no harm, prevails, and we remain committed to making sure that patients who need care get it on time and do not have to delay their visits or ignore their symptoms.

Arif R. Sarwari, Physician, associate professor of infectious diseases, chair of Department of Medicine, West Virginia University and Christopher Goode, Emergency medicine physician, chair of Emergency Medicine, West Virginia University. This article is republished from The Conversation under a Creative Commons license. Read the original article.

See the rest here:
Fearing coronavirus, patients delayed hospital visits, putting health and lives at risk - Considerable

"The current setting we're in is certainly quite triggering for people who have migraines. People are worried and they're getting more migraine headaches," said Dr. Rachel Colman, director of the Low-Pressure Headache Program at the Icahn School of Medicine at Mount Sinai in New York.

In addition, "many of us have our work-home boundaries blurred right now," said Dr. Merle Diamond, president and managing director of Chicago's Diamond Headache Clinic.

"We're working from home, and oftentimes that makes it harder to have an on-switch and an off-switch," she said. The change in work can be triggering because "migrainers have very sensitized nervous systems that don't like change."

Nor are we getting up and moving, stretching, hydrating or sleeping as we should, which can all be significant triggers, Diamond said. She's the daughter of Dr. Seymour Diamond, who was renowned for shattering common medical assumptions that migraines were psychosomatic, a sign of depression or just an excuse to avoid chores or work.

Is my headache Covid-19?

Of course, in today's reality, the first thing that pops into any headache sufferer's head is: Do I have Covid-19?

Longtime "migrainers" may know the difference, but what if you're a newbie to the world of head pain? From what is known right now, Diamond said, a headache brought on by Covid-19 presents much differently than a migraine.

"You may have fever, you may have persistent coughing and all of those things can predict a headache," said Diamond, who is a National Headache Foundation board member.

"However, the headache of Covid-19 is described as a really tight, sort of squeezing sensation, and typically worsens with coughing and fever," she said.

That sensation happens as our immune system rallys in response to the virus, releasing chemicals called cytokines. Cytokines produce inflammation, which is perceived as pain by the cerebral cortex of the brain.

But a migraine presents much differently, Diamond said, with a throbbing pain that is moderate to severe, and can be accompanied with a sensitivity to light and noise and vomiting.

"The best way to describe a migraine is that it is a sick headache," Diamond said. "Patients describe it as their brain is too big for their skull.

"Then there's the migraine hangover. For a lot of patients the pain part of their headache might last eight hours, 12 hours, 14 hours, but after the headache is gone, they have cognitive clouding," Diamond added.

"They're lethargic, they're irritable, they may still continue to have light sensitivity or nausea. The whole process for some migraines can take several days," she said.

While migraine, tension and cluster headaches are the most common forms, there are hundreds of different subtypes of headaches.

Categories include abdominal, hormonal, caffeine, hypertension, post-traumatic and rebound headaches; allergy, sinus, medication, cough, sex or exercise-induced headaches; as well as headaches defined by symptoms, such as stabbing, thunderclap, ice-pick or exploding head syndrome.

Two severe and dangerous types of headaches are caused by meningitis, where the membranes that cover the brain and spinal cord become swollen or inflamed, and encephalitis, an inflammation of the brain that is caused by viral infection, with neck stiffness and fever.

In Covid-19 cases, the most severe and dangerous headaches seem to be in people who are extremely sick with Covid-19, said Colman, who is a member of the National Headache Foundation Health Care Professionals Leadership Council.

"There's been some really bad headache disorders with Covid-19," Colman said. "it's too early to know for sure, but it does seem like the very ill patients that have very sick lungs and are really struggling in ICU tend to be the ones that are getting the more serious complex neurological complications."

What to do?

Anyone who is suffering from constant or debilitating headaches or migraines should reach out to a headache specialist for help, experts say. Most are seeing patients via telemedicine, and will work with you to get to the root of the problem.

"I'm trying to troubleshoot some of the issues that are happening during isolation," Colman said. "Is it the fact that they're not sleeping, they're not leaving work at work, they're not exercising anymore?

"Or is it the fact that they're very stressed out with worry about financial and personal and family obligations? So trying to kind of find the root cause for why the worsening is to try and work on it," she said.

There are also preventative things you can do to keep headaches at bay.

"Make sure you have good hydration at the place that you're sitting and drink a certain amount every hour," Diamond said. "It's also important to get up, breathe and stretch at least once an hour."

Meditation and relaxation exercises are extremely helpful, as is biofeedback, she suggested.

"I think that's really helpful and it doesn't take a lot of time. You can do it in five to 10 minutes and it just kinda resets, which is what we want to do," Diamond said. "Then making sure you're not skipping meals, and that you're not overworking. You have to have an off to your day if you can."

Go here to read the rest:
Covid-19 or migraine? Here's how to tell and what to do about it - CNN

As we discussed in our last update on the Food and Drug Administrations Comprehensive Regenerative Medicine Policy Framework back in December 2019 (during the much simpler, pre-COVID-19 world), this coming November will conclude the three-year period of enforcement discretion announced by the agency when it first articulated the policies and goals of this comprehensive framework. In particular, under the dual-track program announced in 2017, the Food and Drug Administration (FDA) has been focused on: (1) clarifying the regulatory criteria for product marketing through guidance and providing support to legitimate product developers through formal and informal interactions; and (2) removing unapproved, unproven, and potentially unsafe products from the U.S. market.

None of the COVID-19-related operational updates provided by the FDA generally or by the Center for Biologics Evaluation and Research (CBER) in recent months has suggested that the November 2020 deadline will be extended or otherwise altered as a result of the ongoing public health emergency, even as certain other enforcement discretion policies have been put into place. Additionally, a recent editorial published by agency leadership and a noticeable increase in Warning/Untitled Letters to persons offering unapproved cellular therapy products, taken together, strongly suggest that folks in this industry that are currently operating outside of the applicable regulatory framework should not expect to be given any additional time to come into compliance.

June 2020 JAMA Editorial Strong Language and No Sign of a Deadline Extension

Multiple statements on the topic of regenerative medicine have been issued by the governing FDA Commissioner as well as CBER Director Peter Marks over the past several years, which indicates how important this area is to the agencys broader public health priorities at the start of the 21st century. The most recent salvo from agency leadership came in the form of an editorial published online by JAMA on June 17, 2020, authored by Dr. Marks and Commissioner Stephen Hahn, who has been in his new job for about six months. Their editorial includes some of the strongest language we have seen to date on the topic of unapproved regenerative medicine products. For example, Dr. Marks and Dr. Hahn state that [d]espite assertions by some individuals to the contrary, these products, whether autologous or allogeneic, are not inherently safe and may be associated with serious adverse consequences. They assert that [t]he increasing number of adverse events being reported following the widespread use of unapproved regenerative medicine therapies at hundreds of clinics across the country make it necessary for the FDA to act to prevent harm to individuals receiving them.

Drs. Marks and Hahn briefly highlight some of the enforcement that the agency has undertaken in this space since 2017 and ask for engagement from both clinicians and patients to help to ensure that instead of remaining unintentionally or intentionally hidden, potentially harmful unapproved regenerative medicine therapies are identified and removed from the market. They then provide basic guidelines for patients and caregivers to use when assessing whether a cellular therapy product is being offered in compliance with applicable laws and FDA regulations. Specifically, they recommend the following key considerations for anyone considering treatment with a cellular product:

Nothing in this newly-published editorial suggests that FDA/CBER will be taking its proverbial foot off the pedal to slow down its efforts towards further oversight of the private stem cell clinic industry after November 2020. To the contrary, the piece could represent one of the last informal warnings those businesses get from the agency before they receive a customized Warning or Untitled Letter or become subject to whatever increased enforcement activity the federal government initiates in this area in 2021 and beyond.

Relatively Large Number of Warning Letters Sent Since January 2020

We previously noted that FDA/CBER appeared to have increased the pace of issuing Warning and Untitled Letters to sellers of unapproved stem cell products during the second half of 2019, with many of those letters involving companies that processed and marketed unapproved umbilical cord blood-derived cellular products. We also reported that the agency had issued a Public Safety Notification on Exosome Products on December 6, 2019, informing the public of multiple reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes. That safety alert also described the unscrupulous conduct of sellers of such products in forceful and direct language, similar to the language used by Dr. Marks and Commissioner Hahn in this months editorial piece.

Over the first half of this year, as we get yet closer to the November 2020 deadline for stem cell clinics and medical practitioners to come into compliance with federal law, there has been a more noticeable increase in the Warning/Untitled Letters issues regarding the marketing of unapproved products that put patients at risk. These include at least nine Untitled Letters issued since January 2020 (which can each be accessed from this CBER webpage) and at least two Warning Letters, one from March and one from June. The Warning Letters in particular include charges that the firms in question were violating current good manufacturing practices (CGMPs) and current good tissue practices (CGTPs) for human cells and tissue products, putting patient safety at risk.

Interestingly, the most recent FDA Warning Letter issued on June 4, 2020 not only cites the recipient for marketing unapproved stem cell products and an unapproved exosome product, but it also states that the unapproved exosome product was being marketed for the treatment and prevention of COVID-19 something the June 17 Marks/Hahn JAMA editorial alluded to generally as well. Given that there are currently no FDA-approved products to prevent or treat COVID-19, any such claims will automatically heighten the enforcement risk to a company or physician engaged in the sale of products for those intended uses.

In addition to the work being done by FDA, moreover, the Federal Trade Commission (FTC) has also been monitoring the commercial marketplace closely and taking various actions to protect consumers from fraudulent COVID-19 products, including a few marketed by stem cell clinics. So far this month, FTC announced on June 4, 2020 that it had issued a 35 warning letters and an additional 30 warning letters on June 18, 2020. The first batch of these FTC warning letters notably included one to a stem cell clinic that, among other things, had claimed that stem cells can be administered intravenously and by inhalation through a nebulizer to treat lung damage caused by COVID-19 without scientific evidence to support the efficacy claim, while the second batch included two letters addressed to marketers of stem cell products.

FDA and the FTC coordinate quite closely on consumer protection matters that implicate both agencies primary missions, as is apparent from the large number of COVID-19 Warning Letters that have been jointly issued by the two agencies since March 2020. So they may very well be coordinating more actively now on the monitoring of stem cell clinics and individual physicians offering unapproved cellular therapies to the general public, as the focus shifts to the next phase of the Comprehensive Regenerative Medicine Policy Framework. The next five or six months should offer everyone more insight into what the enforcement landscape is likely to evolve into once the FDAs enforcement discretion period ends in November. As always, well keep our readers apprised of any notable developments.

[View source.]

Read more from the original source:
Update on FDAs Comprehensive Regenerative Medicine Framework: Looming November 2020 Deadline Preceded by a Flurry of Letters from CBER and a New JAMA...

LONDON--(BUSINESS WIRE)--Infiniti Research is the world's leading independent provider of strategic market intelligence solutions. Our market intelligence services are designed to connect your organizations goals with global opportunities. Today's competitive business environment demands in-depth, accurate, and reliable business information to ensure that companies gain a strong foothold in domestic or foreign markets. Our global industry specialist teams ensure the international consistency of our research, enabling powerful access to the real story behind market changes. Request a free brochure for more insights into our solutions portfolio.

Regenerative medicine is currently the hive of innovation in modern science with far-reaching benefits for big pharma, healthcare systems, and patient outcomes. The rapid pace of development is expected in the US regenerative medicine market over the next decade. Some of the key factors fueling demand include the increasing investments in R&D activities and the rising incidence of chronic diseases in the country. Leading vendors have enhanced their R&D investments to develop innovative medical therapies, which is driving the overall growth of the market. Furthermore, M&A and strategic alliances among vendors will have a significant impact on the overall market growth and innovation. Nevertheless, the actual delivery of regenerative medicines has proven to be rather challenging with several roadblocks to commercially viable therapies that are capable of catering to unmet clinical needs.

The promise of regenerative medicines requires an innovative look at the complete product lifecycle, including the development of an efficient distribution network. Planning to venture into this space? Request a free proposal for comprehensive insights about the market.

Experts at Infiniti Research outline some of the most relevant and pressing manufacturing challenges in regenerative medicine products:

Manufacturing expense: Cell therapy manufacturing processes are generally highly expensive. Scaling up from limited laboratory facilities to automated systems for bulk production will largely be based on cost, therefore impeccable financial and time planning become vital.

Design quality: In the case of automation, robots manually reproduce the existing inefficient manual processes due to which the products are often based on obsolete technologies. As a result, the manufacture of regenerative medicines sometimes misses the opportunity to improve their quality by innovating process design.

Biomaterials challenges: Challenges relating to biomaterials are mostly concerned with their selection than the manufacturing process. The trends in material selection will eventually have a major impact on the manufacturing process.

Supply chain challenges: The clinical supply chains required to deliver regenerative medicines therapies are arguably the most complex the industry has seen so far, even more so than for biologic medicine.

Read the complete article for comprehensive insights on the key regenerative medicine manufacturing challenges.

The personalization and unique requirements of regenerative medicines require manufacturers to provide an increased focus on the precision and accuracy of processes. Get in touch with an industry expert from Infiniti research to identify gaps in your existing processes and bridge them with viable business strategies.

About Infiniti Research

Established in 2003, Infiniti Research is a leading market intelligence company providing smart solutions to address your business challenges. Infiniti Research studies markets in more than 100 countries to help analyze competitive activity, see beyond market disruptions, and develop intelligent business strategies. To know more, visit: https://www.infinitiresearch.com/about-us

See the article here:
Regenerative Medicine: The Future of Medicine is Here but Not Without Challenges | Infiniti Research - Business Wire

An online game that lets students learn about stem cells and tissue engineering also offered them information about high school and college internship programs to further spur their interest in regenerative medicine.

Through the game, aimed mainly at seventh graders through high school seniors, students competed in daily challenges to win swag and the chance to meet inventor Dean Kamen (virtually in this pandemic age).

The vision is to help inform young people about all the really cool things that are happening in this space, said Alexander Titus, the freshly minted chief strategy officer at the Advanced Regenerative Manufacturing Institute in Manchesters Millyard.

The game helps to inspire students as they choose their classes, their elective classes in high school and particularly majors in college, Titus said last week.

Nearly 100 students took part in the game, which ended Friday. The content about regenerative medicine will remain online through June.

ARMI, which is working to manufacture human tissue commercially, is working on recruiting tomorrows workforce one cool video at a time.

I think the timing of this couldnt be any better, said Julie Demers, executive director of the New Hampshire Tech Alliance. The pandemic has limited in-person, work-based learning opportunities and interactions with industry professionals. Interactive opportunities to get students interested in and thinking about career opportunities are critical.

Titus said a chief goal is to build a pipeline of future workers.

Its all tied together in attracting students while theyre young to understand the process of what to study along the way to get to college and a job when theyre done, said Titus, who earned a Ph.D. in quantitative biomedical sciences at Dartmouth.

Titus said he expects the game to help ARMI officials learn what draws the interest of students so they can develop other programming they know will garner student interest, he said.

The ARMI challenge, called TEMPtation, featured profiles of businesses from more than a dozen states as well as universities and colleges interested in regenerative medicine.

Arizona State University holds summer camps for middle and high school students that are interested in learning more about science and mathematics, read one profile.

From Georgia Tech in Atlanta: Georgia Tech has a Center for Career Discovery & Development, which offers internships, co-ops, and career services that give students the resources they need to support their search for employment following their graduation.

Formerly employed at the U.S. Department of Defense, Titus returned to New Hampshire to join ARMI.

The mission, he said, is marrying science and manufacturing.

Bring the science to the stage where we can automate it and market the new technologies we couldnt make before, said Titus, previously assistant director for biotechnology within the Office of the Under Secretary of Defense for Research & Engineering.

ARMI features more than 150 partners and more than $300 million in government and private investment committed.

If we want to be able to produce a replacement heart for people who have heart disease, what are the components that go into that? Titus said.

He hopes ARMI can attract startups in the Manchester area, allowing for ARMI to mentor them until they are viable companies.

The idea is for companies to move into New Hampshire and move into our ecosystem if you will, Titus said.

I think especially given now, where were seeing so many people in the cities during COVID have a hard time social distancing, I expect well see some shifting of people out of the cities, said Titus, who speculated some could settle in New Hampshire.

Whats Working, a series exploring solutions for New Hampshires workforce needs, is sponsored by the New Hampshire Solutions Journalism Lab at the Nackey S. Loeb School of Communications and is funded by Eversource, the New Hampshire Charitable Foundation, Dartmouth-Hitchcock Medical Center, the New Hampshire College & University Council, Northeast Delta Dental and the New Hampshire Coalition for Business and Education. Contact reporter Michael Cousineau at mcousineau@unionleader.com. To read stories in the series, visit unionleader.com/whatsworking.

Visit link:
Online game looks to stoke interest in regenerative medicine - The Union Leader

Overview: Regenerative medicine is an interdisciplinary field that applies life science and engineering principles for the regeneration or repair of injured/diseased tissues or organs resulting from various causes including, disease, defects, trauma and aging. The field includes the generation and use of tissue engineering, therapeutic stem cells and the production of artificial organs. It also allows scientists to grow organs or tissues in the lab and implant them in the body safely when the body fails to heal itself. Notably, it has great potential to solve the problem of organ shortage.

Request For Report [emailprotected]https://www.trendsmarketresearch.com/report/sample/9918

According to the estimation of World Health Organization, there is an increasing prevalence of diabetes among adults over the age of 18 years, that has increased to 8.5% in 2014 compared to 4.5% in 1980 across the globe. As per the estimation of Arthritis Foundation, the number of people expected to be diagnosed from arthritis will be more than 78 million, by 2040.

The market for regenerative medicine is driven by increasing prevalence of neuronal disease, cancer and genetic disease, emerging application of regenerative medicine, and advancement in technology. Huge number of ongoing clinical trails and strong product pipeline are providing market growth oppurtunity. High cost of the treatment, regulatory issues and ethical issuesare hampering the market growth.

Market Analysis: The Global Regenerative Medicine market is estimated to witness a CAGR of 16.6% during the forecast period 20182024. The global market is analyzed based on three segments Therapy, Application and regions.

Regional Analysis: The regions covered in the report are the North America, Europe, Asia Pacific, and Rest of the World (ROW). North America is the major shareholder in the global regenerative medicine market, followed by Europe. Asia-Pacific region is expected to have the fastest growth rate with the market growth centered at Japan, China and India. This is mainly due to increasing funding in healthcare research, rising research activities, growing patient pool, flexible regulatory environment for clinical trials, and rising healthcare expenditure.

Get Complete TOC with Tables and [emailprotected]https://www.trendsmarketresearch.com/report/discount/9918

Therapy Analysis:Immunotherapy occupied major market share of global regenerative medicine market in 2017, and is expected to remain same during the forecasted period. Increasing product approvals, emerging technological advancements in cell and gene therapy, flexible regulatory for stem cell based research, and growing awareness regarding the benefits of stem cell therapies.

Application Analysis: The market by application is segmented into cancer, central nervous system, orthopedic and musculoskeletal, diabetes, dermatology, cardiovascular and others. Among various application, dermatology occupied the largest share in 2017 and cancer segment is expected to grow at fastest rate during the forecasted period. Growing aging population, changing lifestyle, increasing disease prevalence makes cancer, the fastest growing application segment during the forecasted period.

Key Players: Allergan plc, Integra lifesciences, Mimedx Group, Inc., Medtronic plc, Organogenesis Inc., Zimmer Biomet, Acelity L.P. Inc., Nuvasive, Inc., Stryker Corporation, Japan Tissue Engineering Co., Ltd. (Fujifilm Holdings Corporation subsidiary), Osiris Therapeutics, Inc., Vericel Corporationand other predominate and niche players.

Competitive Analysis: Currently dermatology segment dominates the global regenerative medicine segment. A lot of researches are going on cancer, CNS, cardiovascular, orthopedic & musculoskeletal applications. The increasing importance of regenerative medicine has resulted in the launch of new products and also increased acquisition, approvals, funding to develop new product.

For instance, in August 2017, Tissue Regenix Group plc completed the acquisition of acquisition of CellRight Technologies, an US based specialist in regenerative osteoinductive bone scaffolds. In April 2018, Roche acquired a program named Inception 5, focused on regenerative therapies for multiple sclerosis. In May 2018, Novartis received second FDA approval for Kymriah, CAR-T cell therapy for B-cell acute lymphoblastic leukemia (ALL)

<<< Get COVID-19 Report Analysis >>>https://www.trendsmarketresearch.com/report/covid-19-analysis/9918

Benefits: The report provides complete details about the usage and adoption rate of regenerative medicine in various therapeutic verticals and regions. With that, key stakeholders can know about the major trends, drivers, investments, and vertical players initiatives. Moreover, the report provides details about the major challenges that are going to impact on the market growth. Additionally, the report gives the complete details about the key business opportunities to key stakeholders to expand their business and capture the revenue in the specific verticals to analyze before investing or expanding the business in this market.

The rest is here:
Regenerative Medicine Market to Record a Robust Growth Rate for the COVID-19 Period - Cole of Duty

he globalstem cell and regenerative medicines marketshould grow from $21.8 billion in 2019 to reach $55.0 billion by 2024 at a compound annual growth rate (CAGR) of 20.4% for the period of 2019-2024.

Report Scope:

The scope of this report is broad and covers various type of product available in the stem cell and regenerative medicines market and potential application sectors across various industries. The current report offers a detailed analysis of the stem cell and regenerative medicines market.

The report highlights the current and future market potential of stem cell and regenerative medicines and provides a detailed analysis of the competitive environment, recent development, merger and acquisition, drivers, restraints, and technology background in the market. The report also covers market projections through 2024.

The report details market shares of stem cell and regenerative medicines based on products, application, and geography. Based on product the market is segmented into therapeutic products, cell banking, tools and reagents. The therapeutics products segments include cell therapy, tissue engineering and gene therapy. By application, the market is segmented into oncology, cardiovascular disorders, dermatology, orthopedic applications, central nervous system disorders, diabetes, others

The market is segmented by geography into the following regions: North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The report presents detailed analyses of major countries such as the U.S., Canada, Mexico, Germany, the U.K. France, Japan, China and India. For market estimates, data is provided for 2018 as the base year, with forecasts for 2019 through 2024. Estimated values are based on product manufacturers total revenues. Projected and forecasted revenue values are in constant U.S. dollars, unadjusted for inflation.

Request for Report Sample:https://www.trendsmarketresearch.com/report/sample/11723

Report Includes:

28 data tables An overview of global markets for stem cell and regenerative medicines Analyses of global market trends, with data from 2018, estimates for 2019, and projections of compound annual growth rates (CAGRs) through 2024 Details of historic background and description of embryonic and adult stem cells Information on stem cell banking and stem cell research A look at the growing research & development activities in regenerative medicine Coverage of ethical issues in stem cell research & regulatory constraints on biopharmaceuticals Comprehensive company profiles of key players in the market, including Aldagen Inc., Caladrius Biosciences Inc., Daiichi Sankyo Co. Ltd., Gamida Cell Ltd. and Novartis AG

Summary

The global market for stem cell and regenerative medicines was valued at REDACTED billion in 2018. The market is expected to grow at a compound annual growth rate (CAGR) of REDACTED to reach approximately REDACTED billion by 2024. Growth of the global market is attributed to the factors such as growingprevalence of cancer, technological advancement in product, growing adoption of novel therapeuticssuch as cell therapy, gene therapy in treatment of chronic diseases and increasing investment fromprivate players in cell-based therapies.

In the global market, North America held the highest market share in 2018. The Asia-Pacific region is anticipated to grow at the highest CAGR during the forecast period. The growing government funding for regenerative medicines in research institutes along with the growing number of clinical trials based on cell-based therapy and investment in R&D activities is expected to supplement the growth of the stem cell and regenerative market in Asia-Pacific region during the forecast period.

Reasons for Doing This Study

Global stem cell and regenerative medicines market comprises of various products for novel therapeutics that are adopted across various applications. New advancement and product launches have influenced the stem cell and regenerative medicines market and it is expected to grow in the near future. The biopharmaceutical companies are investing significantly in cell-based therapeutics. The government organizations are funding research and development activities related to stem cell research. These factors are impacting the stem cell and regenerative medicines market positively and augmenting the demand of stem cell and regenerative therapy among different application segments. The market is impacted through adoption of stem cell therapy. The key players in the market are investing in development of innovative products. The stem cell therapy market is likely to grow during the forecast period owing to growing investment from private companies, increasing in regulatory approval of stem cell-based therapeutics for treatment of chronic diseases and growth in commercial applications of regenerative medicine.

Products based on stem cells do not yet form an established market, but unlike some other potential applications of bioscience, stem cell technology has already produced many significant products in important therapeutic areas. The potential scope of the stem cell market is now becoming clear, and it is appropriate to review the technology, see its current practical applications, evaluate the participating companies and look to its future.

The report provides the reader with a background on stem cell and regenerative therapy, analyzes the current factors influencing the market, provides decision-makers the tools that inform decisions about expansion and penetration in this market.

More Info of Impact[emailprotected]https://www.trendsmarketresearch.com/report/covid-19-analysis/11723

Read more:
Stem Cell And Regenerative Therapy Market : Segmentation, Industry Trends and Development size COVID-19 2024 - 3rd Watch News