StemCell Therapy

Researchers atAirlangga University (Unair) and the State Intelligence Agency (BIN) released on June 12what appeared to be an encouraging statement:the discovery of five combination drug therapies and two stem cell therapies for treating COVID-19.

The acute respiratory disease caused by the SARS-CoV-2 virus has claimed at least 2,000 lives in Indonesia to date.

The joint statementattributed to Unair andBIN also said that themedicines were ready for distributionin treating COVID-19 patients.

Drug combinations

The five combination therapiesfor COVID-19 are: lopinavir/ritonavir with azithromycin, lopinavir/ritonavir with doxycycline, lopinavir/ritonavir with clarithromycin, hydroxychloroquine with azithromycin, and hydroxychloroquine with doxycycline.

In addition, the statementclaimed that the researchers had identified two types of isolated stemcells that inhibitedSARS-CoV-2 activity:hematopoietic stem cells (HSCs) and natural killer (NK) cells.

Their goodwill to bring an end tothe pandemic should be appreciated. Unfortunately, their conclusions seem premature and could lead to more damaging consequences for the public.

In theory, the drug combinationsrecommended by Unair and BIN have the potentialto inhibit SARS-CoV-2. Lopinavir and ritonavir are protease inhibitors that are currently used to treat people with HIV/AIDS. Hydroxychloroquine is a malarial treatment, while azithromycin, doxycyclineand clarithromycin are antibiotics that can fight secondary bacterial (not viral) infections in COVID-19 patients who have developed pneumonia.

However, theory does not necessarily work inpractice. Noneof these drugs have been provenin any clinical study to bea safe and effective treatmentfor COVID-19. The World Health Organization (WHO) has started clinical trials involving thousands of patients in dozens of countries to test the efficacy and safety of these drugs. So far, there has been no clear indication that these drugs, whether individually or in combination,are effective in treating COVID-19.

In fact, evidence exists that hydroxychloroquine may worsen the condition of patients, which led the WHO to suspend the clinical trial of the drug.

Unair and BIN are correct in conducting in vitro (test tube) experiments to verify the effect and toxicity of the drugs for SARS-CoV-2. Unfortunately, they have not communicated in any clear way on how they designed, executedand analyzed their experiments.

We do not know how they cultured the virus, what kind of negative controls they used, what kind of cells they testedor whether the cells they usedcontained the necessary receptors for SARS-CoV-2 to enter a human cell. More importantly, it is crucial to note thatthe results of in vitro experiments(however encouraging) cannot be assumed to be safe and effectivetreatments for direct use in human patients. For example, the United States Food and Drug Administration (FDA) on averageapprovedless than 10 percent of drugs that performed well in vitroas safe for humanprescription.

The human lungs contain millions of cells comprising dozens of different types that perform intricate interactions. The proposed drugs can also affect other organs in the human body and cause adverse reactions.

Instead of announcing that these five combination therapiesare ready for treating COVID-19, Unair and BIN should first run arandomizedcontrolled trial (RCT) to confirm their findings.Recruiting diverse patient populations is also critical to ensuring thefairness and robustness of the study.

Despite their good intentions, all the drugs that Unair and BIN researchers have proposedare strong medicines, whether individually or in combination, that can potentially cause unwanted sideeffects and even death. Surely none of us want to rush into an unproven treatmentin order to avoid developing even more overwhelming health problems in the future.

Stem cell therapy

Stem cell therapy is another COVID-19treatment that Unair and BIN researchers have proposed. Stem cells are undifferentiated cells thathas the potential to develop into many different types of cells in human body. One type of stem cell they have proposed is hematopoietic stem cells (HSCs), whichdevelop into blood cells, includingimmune cells that help the body fight pathogens and infections.

However, stem cell therapy is still considered very risky, expensiveand limited to treating a few cancers, such as leukemia. No evidence exists that stem cell therapy is efficient in treating viral infections in the human bodysuch asCOVID-19.

As with the drug therapies, the Unair and BIN researchers did not say how they performed their stem cell experiment. We have no information oncrucial aspects likestem cell culturing protocol, the stem cell's differentiation status, tumorigenic potential, proliferation capacity orexcretion patterns, and how they tested stem cell activity against SARS-CoV-2.

Even if the researchersestablished a sound experimentalprotocol for their in vitro experiments, administering stem cell therapy to COVID-19 patients is an extremely dangerous procedure that can result in undesirable costs, such as malignancy, the stem cells attacking other healthy cellsand possibly death.

Injecting stem cells into the human body carries a huge risk of immuno-rejection (think of a blood type A patient receivinga bloodtype B infusion, but witha much more severe reaction). The doctors administering the treatment must isolate autologousstem cells from the individual patient or allogenic stem cells froma separate donor, culture them, and reinject the treated cells into the patient. These processes are extremely laborious, time-consumingand expensive, and there is no clear indication that the treatment will produce a safe and successful outcome against viral infection.

This is hardly a sound strategy to use during a pandemic. Furthermore, thecommon procedureis to administer powerful immunosuppressants to reduce the strength of thepatients immune system, particularly in the allogenic scenario, which would minimizethe risk of immuno-rejection. However, it would be unwise to shut down a COVID-19patient's immune system that is neededto work properly for their body to fight SARS-CoV-2.

Unair and BIN's valiant effortsshould still be applauded, as they are committed to treating COVID-19 and ending the pandemic. The public is waiting impatiently for the health crisis to subside so they canresume their normal lives.

However, everyone should realize that discovering treatments and developing a potential vaccine for a disease that was virtually unknown six months ago takes a lot of time and resources.

Unair and BIN said that they had submitted their research to at least seven peer-reviewed internationaljournals, but this does not mean that their research is validated immediately. It still needs reviewing and questioned by their scientific peers.

It is necessary for the researchers to publish their findings onan open access, preprint repository for biological or medical research papers like BiorXiv or MedrXiv, so that scientists and people around the worldcan scrutinize and engage in healthy scientific discourse.

We absolutely deserve good news during the pandemicon safe medical treatmentsand vaccines. We also deserve complete, clear and transparent public communications from all COVID-19 stakeholders, including researchers and governments, to ensure that all actions are evidence-based, safeand effective.

The writer is a research scientist with a PhD in biochemistryfrom the University of Cambridge, which he earned as a recipient of the 2015-2019 Gates Cambridge Scholarship program.

Disclaimer: The opinions expressed in this article are those of the author and do not reflect the official stance of The Jakarta Post.

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Preventing misleading claim of COVID-19 cure - The Jakarta Post - Jakarta Post

KENILWORTH, N.J.--(BUSINESS WIRE)--Jun 17, 2020--

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Mercks anti-PD-1 therapy, as monotherapy 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.

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.

For the second time, KEYTRUDA monotherapy is now approved based on a biomarker rather than the location in the body where the tumor originated, said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. TMB-H, defined as 10 mutations per megabase or more, can help identify patients most likely to benefit from KEYTRUDA. Were pleased that our collaborative efforts to advance biomarker research have resulted in our ability to provide a new treatment option that addresses a high unmet medical need for these patients with cancer.

As physicians, we are always looking to find new options for patients, especially in the second-line or higher treatment setting, said Roy S. Herbst, M.D., Ph.D., ensign professor of medicine (medical oncology) and professor of pharmacology, Yale School of Medicine; chief of medical oncology, Yale Cancer Center and Smilow Cancer Hospital; and associate cancer center director for translational research, Yale Cancer Center. Its great to see the use of innovative biomarkers and immunotherapy come together with this approval and encouraging that we now have an option for patients with TMB-H tumors across cancer types, including rare cancers.

The FDA also approved FoundationOne CDx test as the companion diagnostic to identify patients with solid tumors that are TMB-H (10 mutations/ megabase) who may benefit from immunotherapy treatment with KEYTRUDA monotherapy.

These approvals stem from years of research into how TMB levels may influence a patients response to immunotherapy, said Brian Alexander, M.D., M.P.H., chief medical officer, Foundation Medicine. Its critical that healthcare professionals have access to a validated genomic test to measure TMB in clinical tumor assessments and pinpoint those who are more likely to respond. Were proud to be collaborating with Merck to help match appropriate patients to this important treatment.

Data Supporting the Approval

The accelerated approval was based on data from a prospectively-planned retrospective analysis of 10 cohorts (A through J) of patients with various previously treated unresectable or metastatic solid tumors with TMB-H, who were enrolled in KEYNOTE-158 (NCT02628067), a multicenter, non-randomized, open-label trial evaluating KEYTRUDA (200 mg every three weeks). The trial excluded patients who previously received an anti-PD-1 or other immune-modulating monoclonal antibody, or who had an autoimmune disease, or a medical condition that required immunosuppression. TMB status was assessed using the FoundationOne CDx assay and pre-specified cutpoints of 10 and 13 mut/Mb, and testing was blinded with respect to clinical outcomes. Tumor response was assessed every nine weeks for the first 12 months and every 12 weeks thereafter. The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR) in the patients who received at least one dose of KEYTRUDA 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.

In KEYNOTE-158, 1,050 patients were included in the efficacy analysis population. TMB was analyzed in the subset of 790 patients with sufficient tissue for testing based on protocol-specified testing requirements. Of the 790 patients, 102 (13%) had tumors identified as TMB-H, defined as TMB 10 mut/Mb. The study population characteristics of these 102 patients were: median age of 61 years (range, 27 to 80); 34% age 65 or older; 34% male; 81% White; and 41% Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 and 58% ECOG PS of 1. Fifty-six percent of patients had at least two prior lines of therapy.

In the 102 patients whose tumors were TMB-H, KEYTRUDA demonstrated an ORR of 29% (95% CI, 21-39), with a complete response rate of 4% and a partial response rate of 25%. After a median follow-up time of 11.1 months, the median DOR had not been reached (range, 2.2+ to 34.8+ months). Among the 30 responding patients, 57% had ongoing responses of 12 months or longer, and 50% had ongoing responses of 24 months or longer.

In a pre-specified analysis of patients with TMB 13 mut/Mb (n=70), KEYTRUDA demonstrated an ORR of 37% (95% CI, 26-50), with a complete response rate of 3% and a partial response rate of 34%. After a median follow-up time of 11.1 months, the median DOR had not been reached (range, 2.2+ to 34.8+ months). Among the 26 responding patients, 58% had ongoing responses of 12 months or longer, and 50% had ongoing responses of 24 months or longer. In an exploratory analysis in 32 patients whose cancer had TMB 10 mut/Mb and <13 mut/Mb, the ORR was 13% (95% CI, 4-29), including two complete responses and two partial responses.

The median duration of exposure to KEYTRUDA was 4.9 months (range, 0.03 to 35.2 months). The most common adverse reactions for KEYTRUDA (reported in 20% of patients) were fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain and abdominal pain.

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.

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.

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FDA Approves Second Biomarker-Based Indication for Merck's KEYTRUDA (pembrolizumab), Regardless of Tumor Type - The Baytown Sun

Americas 66 million (pre-COVID-19) family caregivers people caring for loved ones with complex, chronic and ongoing care needs are thrust into their role with no training, no background and no support infrastructure. Preposterously, most feel like the only one on earth.

Why? Because caregiving is the modern-day mystique.

Betty Friedans classic 1963 book The Feminine Mystique revealed that many homemakers were suffering in silence, weighed down with responsibilities they were expected to love. It sparked a revolution of truth-telling and collective action. Todays COVID-19 crisis might just spark the same revolution with caretaking.

Like the feminine mystique, the caregiver mystique thrives in silence and shame. Family caregivers are socialized to think that caring for aging parents and sick loved ones is a family duty that comes naturally and is filled with love and an abundance of patience.

For families with loved ones who are vulnerable, the coronavirus threat is absolutely terrifying.

I know what its like to be a family caregiver. I was one for my mom for 28 years due to her Multiple Sclerosis. There were many challenging moments, but none harder than a winter weekend in 2016. Stem cell replacement therapy had been my mothers Holy Grail for years and on a chilly Friday afternoon, she got a shot of stem cells directly into her spinal fluid. We could almost hear trumpets.

But at the end of the needle was a tiny droplet of strep infection, likely the result of a nurse or doctor who accidentally spit while chatting with us. It gave my mom bacterial meningitis. When she woke up that Saturday, her body was having convulsions and she was murmuring strange words like she was possessed. Her doctor said I needed to keep her alive for the next 48 hours until I could bring her to the hospital. I did and worked from her side in the hospital on Monday. On Tuesday, I went back to the office and completely downplayed the traumatic experience wed been through.

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My nightmare weekend, and the silence that followed, is a version of what so many family caregivers are experiencing right now.

For families with loved ones who are vulnerable, the coronavirus threat is absolutely terrifying. The family caregivers are responsible for preparing their loved ones with back-up meds and supplies, keeping them safe from the virus and, in the case of diagnosis, scrambling to make the right decisions to keep them alive.

At my caregiving concierge company, Wellthy which grew out of my experience caring for my mom were hearing stories of families navigating hospice decisions, pulling loved ones out of long-term care, and older adults with dementia who think the family is on an extended spring break. (Forgetfulness is bliss in a pandemic!)

But the pandemic is also leading family caregivers to admit that they cant handle all of these responsibilities on their own.

Over the last several weeks, employees have had to come out to their employers as they juggle their work responsibilities with caregiving crises at home.

These families need support. They need solidarity. And they need structural transformation.

Caregiving is really tough. Family caregivers are squeezed, and the health care system expects them to figure it all out. Unlike becoming a parent, there are no step-by-step guides for the introduction into caregiving. Mostly, caregivers fall into their role suddenly. And every caregiving path is long, windy and different.

Caregivers must figure out how to navigate complicated insurance questions, administer medications, lift someone who weighs as much or more than they do, bathe correctly, buy the right equipment and supplies, watch for potentially dangerous symptoms like the development of a pressure wound, and, now, protect loved ones from a global devastating virus.

Sadly, neither the health care system nor our countrys leaders have acknowledged caregivers critical and quiet role behind closed doors, protecting loved ones, avoiding hospitalization and preventing death.

Yet family caregivers are critical in preventing the spread of the virus and improving the spiraling diagnosis and death rate.

This all could be different, though.

Imagine a world where families had a local caregiving agency staffed with warm, informed and empathetic experts to help navigate, advocate and set up the right care for each family based on their unique needs.

Imagine that each state had a robust and well-funded Department of Aging, renamed Department of Caregiving, with a team of social workers supported by a robust software system that tracks and recommends, in real time, local and state resources, services and programs.

Imagine a society in which we prioritized preventative care in the form of proactive support programs like in-home aides, therapists, community groups and social activities to provide physical and emotional stimulation to all our citizens.

Imagine a world where the heartache that people experience over the weekend isnt considered a shame to be swallowed on Monday, but a natural human need to be met and a set of skills to be nurtured.

In the time of a pandemic, especially, lets recognize, celebrate and, most importantly, help our family caregivers.

Lindsay Jurist-Rosner is founder and CEO of Wellthy, a caregiving concierge service supporting families with complex and ongoing care needs.

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OPINION: COVID-19 Reveals the Caregiving Mystique - Next Avenue

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It has been a while since I thought back to that week in 2012 when I received news that three close family members had been diagnosed with cancer two in my household. Newly published figures on how Covid-19 has delayed cancer referrals and treatments brought the memory back. Im grateful those cases didnt arise in the middle of a pandemic, but alarmed at the implications for those fighting cancer now.

New data from the U.K.s National Health Service showed how the focus on Covid-19 has been impacting cancer care. Urgent cancer referrals fell by 60% in April compared with the same month last year. Thats a major concern given how important early diagnosis is to successful treatment and cancer survival rates. This, and other recent data, are a grim reminder that the NHSs much-lauded response to the pandemic has come at a cost.

How this will affect the U.K.s already lagging cancer survival rates depends on how quickly the health-care system can restore capacity and deal with a backlog of cases. But the data suggest we had better brace for bad news.

A study published in April modeled the number of excess deaths likely to occur among people with cancer and other problems during Covid-19; the results suggest that an additional 18,000 people with cancer in the U.K. could die in the next 12 months. The researchers also analyzed data from the U.S. and estimated the country could see 33,890 excess deaths from cancer.

At every stage of what is referred to as a patients cancer pathway, Covid-19 has slowed things. Even among patients who did get a referral, the proportion who were then seen within the two-week target time was at its lowest level ever in April. The median length of time patients waited for treatment was 12.2 weeks, with more than a million patients waiting more than 18 weeks. There was also an 18% decline in the number of people starting cancer treatment following a referral.

Cancer remains the second biggest cause of death globally (after cardiovascular diseases), and cases are rising in many countries. Despite big improvements in prevention, the number of people diagnosed with cancer each year is set to grow rapidly in the U.K. Cancer Research UK, a charity, estimates that one in two of those born after 1960 will get the disease.

Over the past decade, cancer care has been steadily improving in Britain albeit from a low baseline. There is now a national cancer strategy, better data reporting, more investment and greater public awareness. There are targets for the time between a referral and receiving a diagnostic test (two weeks), receiving a diagnosis (28 days) and starting treatment (no more than 62 days from the date of referral).

Even so, the U.K. lags behind almost all other advanced countries in one- and five-year survival rates for most cancers. Now the pandemic threatens to set back cancer care considerably.

We have improved because there has been pretty steadfast focus and support for cancer treatment in this country, but the reality is that Covid will have hit very hard, says Sarah Woolnough, an executive director at Cancer Research UK. Key to Britains progress over the past decade, she notes, was reducing the lag time for diagnostic services; and yet that critical first step on the cancer pathway has been disrupted by Covid-19.

Britain has national screening programs to test for breast, cervical and bowel cancers. These werent officially suspended in England, but the NHS stopped sending out screening invitations, notes Woolnough. Unsurprisingly, there was a 78% drop in breast cancer referrals in April from the year before. Overall, Cancer Research UK estimates 3,800 cancers would have been diagnosed through screening during the first 10 weeks of lockdown. The charity also estimates that during those 10 weeks, 12,750 fewer patients received cancer surgery, 6,000 fewer had chemotherapy treatments and 2,800 missed radiotherapy.

More worryingly, Covid seems to have deterred people with symptoms from seeking help. We spent the last decade saying to people that if you suspect symptoms, please go check it out. Covid has set that effort back, Woolnough says. Some are worried about wasting the doctors time during a crisis; many fear for their safety.

Getting people back to seeking these services will take clearer guidance from the government and a protocol for testing patients and health-care providers for Covid-19. Woolnough estimates that it would take up to 37,000 tests a day for providers to operate safely. So far the government hasnt published guidance on testing cancer patients.

Among the most vulnerable cancer patients are those who receive stem cell transplants because of their highly compromised immune systems. Henny Braund, chief executive of Anthony Nolan a U.K. charity that matches stem cell or bone marrow donors to patients with blood cancers told me theyve seen a 25% reduction in the number of transplants. There needs to be some thought about how that backlog is going to be dealt with, in ensuring weve got the right workforce in place, the right PPE and testing for patients and staff, she says. All three are in short supply.

Even Londons lucrative private hospital market, where a quarter of revenues come from the cancer care, is seeing fewer patients. Robert Marcus, a consultant haematologist with the private provider HCA Healthcare, says the number of patients hes seeing now is a lot lower than six months ago and the chemotherapy units where he works are operating at 50% to 60% capacity. You cant necessarily put the same number of patients on a surgical list or a radiologists list than you did because you cant have the patients mixing in waiting rooms and you have to be even more scrupulous about the cleaning of the various environments, he says.

Treatment plans are also impacted. The big post-Covid change, apart from capacity constraints, is that providers now need to weigh the risk of giving immune-compromised patients treatment that will make them more vulnerable to complications from Covid-19.

There is another potential hit to the U.K.s cancer-fighting effort: a loss of funding. Charities fund 60% of all cancer research in the U.K. and 40% of all medical research; they also provide vital services from nursing to support lines and financial aid for patients.

Cancer Research UK spends more than 400 million pounds ($502 million) a year supporting research at some 90 different institutions. Its income is from private donations and the proceeds of its 600 charity shops, which have been closed in the lockdown. The charity is projecting a 25% drop in income this year and has already made a 44-million pound cut to its research portfolio. Anthony Nolans Braund says it expects a fall of a quarter to a half of gross income this year.

If were looking for silver linings, the Covid crisis seems to have sped up the adoption of more targeted, simplified therapies for a host of cancers, which can mean fewer trips to the hospital or less toxic treatment. It has resulted in some useful partnerships with private hospitals. And many doctors have said private hallelujahs to the way the crisis has cut bureaucracy. There is now an opportunity for a high-level rethink of how health care is delivered; a new NHS Confederation report calls for such a reset.

Not all delays or changes to treatment protocols mean shortened lives, either. Many people can safely have treatment postponed or changed. My father-in-laws prostate cancer in 2012 was treated with radiation; thats generally a slow-moving cancer and waiting out a pandemic may have been fine. However, he died seven years later, after battling a far more aggressive cancer that needed frequent interventions. (The other two cancers in my family were also not ones where waiting was a great option; one treatment was curative and the other bought a couple more quality years of life.)

The virus has undoubtedly set back the U.K.s cancer fighting cause. But some things will make a difficult situation worse: A lack of Covid-19 testing capacity, delays to contact tracing and unclear guidance from the government were repeatedly mentioned to me. The longer it takes to resume services, the greater the chance that Britain will lurch from one health crisis straight into another. Bloomberg

Also read: Lets not forget cancer treatment message from oncology summit held in the shadow of Covid

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Response to Covid has come at the cost of tackling the more fatal cancer - ThePrint

BURLINGAME, Calif.--(BUSINESS WIRE)--Humanigen, Inc., (HGEN) (Humanigen), a clinical stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the companys proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody, announced data on the first clinical use of lenzilumab in 12 COVID-19 patients. The manuscript, titled First Clinical Use of Lenzilumab to Neutralize GM-CSF in Patients with Severe and Critical COVID-19 Pneumonia was published online at medRxiv.org (www.medrxiv.org/content/10.1101/2020.06.08.20125369v1). Patients showed rapid clinical improvement with a median time to recovery of five days, median time to discharge of five days and 100% survival to the data cut-off date. Patients also demonstrated rapid improvement in oxygenation, temperature, inflammatory cytokines and key hematological parameters consistent with improved clinical outcomes.

Dr. Zelalem Temesgen, Professor of Medicine at Mayo Clinic and one of the key authors of the study, said, Lenzilumab use was associated with improved clinical outcomes and oxygen requirement, with no reported mortality. We did not observe any treatment-emergent adverse events attributable to lenzilumab and it was well-tolerated. Based on the pathophysiology of cytokine storm following SARS-CoV-2 infection, along with work conducted at Mayo Clinic on GM-CSF depletion in CAR-T therapy, lenzilumab may offer a rational approach to ameliorate the consequences of cytokine storm in COVID-19.

Dr. Cameron Durrant, chief executive officer of Humanigen, stated, It is extremely encouraging to see this initial group of high-risk patients with severe and critical COVID-19 pneumonia show clinical improvement on lenzilumab, and at the data cut-off point, 11 of them discharged from the hospital. All 12 patients had at least one risk factor associated with poor outcomes, such as age, smoking history, cardiovascular disease, diabetes, chronic kidney disease, chronic lung disease, high BMI, and elevated inflammatory markers, with several patients having multiple such risk factors.

All patients were hospitalized in the Mayo Clinic system and had severe or critical pneumonia as a result of COVID-19. They were also viewed as being at high risk of further disease progression. All patients required oxygen supplementation and had elevation in at least one inflammatory biomarker prior to receiving lenzilumab. All patients had at least one co-morbidity associated with poor outcomes in COVID-19 and several patients had multiple co-morbidities: 58% had diabetes mellitus, 58% had hypertension, 58% had underlying lung diseases, 50% were obese (defined as a BMI greater than 30), 17% had chronic kidney disease and 17% had coronary artery disease. The median age was 65 years.

More details on the companys programs in COVID-19 can be found on the companys website at http://www.humanigen.com under the COVID-19 tab, and details of the Phase III potential registration study can be found at clinicaltrials.gov using ClinicalTrials.gov Identifier NCT04351152.

About COVID-19

COVID-19 is an infectious disease caused by SARS-CoV-2. COVID-19 has become a global pandemic, with almost 8 million confirmed cases and almost 450,000 deaths reported to date. Patients with severe cases of COVID-19 experience severe viral pneumonia that can progress to acute respiratory distress syndrome (ARDS), respiratory failure and death.

In severe and critical patients with COVID-19, published research suggests GM-CSF as the key link between pathogenic Th1 cells and inflammatory monocytes, which secrete additional GM-CSF1. Lenzilumab is a late clinical-stage, monoclonal antibody targeting GM-CSF, a pro-inflammatory cytokine up-regulated in the serum of COVID-19 patients2. The percentages of certain GM-CSF-expressing cells are significantly higher in the blood of ICU-admitted COVID-19 patients compared with healthy controls and are more pronounced in ICU-admitted COVID-19 patients versus non-ICU patients2.

1. Zhou Y, Fu B, Zheng X, et al. Aberrant pathogenic GM-CSF+ T cells and inflammatory CD14+CD16+ monocytes in severe pulmonary syndrome patients of a new coronavirus. Pre-Print. 2020. https://doi.org/10.1101/2020.02.12.945576.

2. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395(10223):497-506. doi:10.1016/s0140-6736(20)30183-5.

About Humanigen, Inc.

Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of inflammation and cancers via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection as well as the serious and potentially life-threatening CAR-T therapy-related side effects while preserving and potentially improving the efficacy of the CAR-T therapy itself, thereby breaking the efficacy/toxicity linkage. The companys immediate focus is to prevent or minimize the cytokine storm that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection and also in combining FDA-approved and development stage CAR-T therapies with lenzilumab, the companys proprietary Humaneered anti-human-GM-CSF immunotherapy, which is its lead product candidate. A potential registrational Phase III study in COVID-19 patients is currently enrolling. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T- cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). For more information, visit http://www.humanigen.com

Forward-Looking Statements

This release contains forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding our expectations for the Phase III study and the potential future development of lenzilumab to minimize or reduce the severity of lung dysfunction associated with severe and critical COVID-19 infections or to be approved by FDA for such use or to help CAR-T reach its full potential or to deliver benefit in preventing GvHD. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and potential need for additional capital to conduct the Phase III study and grow our business; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in the Company's periodic and other filings with the Securities and Exchange Commission.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.

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Mayo Clinic Study of Humanigen's Lenzilumab Shows Rapid Recovery and Discharge in Severe and Critical COVID-19 Patients - Business Wire

The Healthcare Nanotechnology (Nanomedicine) Market research report enhanced worldwide Coronavirus COVID19 impact analysis on the market size (Value, Production and Consumption), splits the breakdown (Data Status 2014-2020 and 6 Year Forecast From 2020 to 2026), by region, manufacturers, type and End User/application. This Healthcare Nanotechnology (Nanomedicine) market report covers the worldwide top manufacturers like (Amgen, Teva Pharmaceuticals, Abbott, UCB, Roche, Celgene, Sanofi, Merck & Co, Biogen, Stryker, Gilead Sciences, Pfizer, 3M Company, Johnson & Johnson, Smith&Nephew, Leadiant Biosciences, Kyowa Hakko Kirin, Shire, Ipsen, Endo International) which including information such as: Capacity, Production, Price, Sales, Revenue, Shipment, Gross, Gross Profit, Import, Export, Interview Record, Business Distribution etc., these data help the consumer know about the Healthcare Nanotechnology (Nanomedicine) market competitors better. It covers Regional Segment Analysis, Type, Application, Major Manufactures, Healthcare Nanotechnology (Nanomedicine) Industry Chain Analysis, Competitive Insights and Macroeconomic Analysis.

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Healthcare Nanotechnology (Nanomedicine) Market report offers comprehensive assessment of 1) Executive Summary, 2) Market Overview, 3) Key Market Trends, 4) Key Success Factors, 5) Healthcare Nanotechnology (Nanomedicine) Market Demand/Consumption (Value or Size in US$ Mn) Analysis, 6) Healthcare Nanotechnology (Nanomedicine) Market Background, 7) Healthcare Nanotechnology (Nanomedicine) industry Analysis & Forecast 20202026 by Type, Application and Region, 8) Healthcare Nanotechnology (Nanomedicine) Market Structure Analysis, 9) Competition Landscape, 10) Company Share and Company Profiles, 11) Assumptions and Acronyms and, 12) Research Methodology etc.

Scope of Healthcare Nanotechnology (Nanomedicine) Market:It is defined as the study of controlling, manipulating and creating systems based on their atomic or molecular specifications. As stated by the US National Science and Technology Council, the essence of nanotechnology is the ability to manipulate matters at atomic, molecular and supra-molecular levels for creation of newer structures and devices. Generally, this science deals with structures sized between 1 to 100 nanometer (nm) in at least one dimension and involves in modulation and fabrication of nanomaterials and nanodevices.

Nanotechnology is becoming a crucial driving force behind innovation in medicine and healthcare, with a range of advances including nanoscale therapeutics, biosensors, implantable devices, drug delivery systems, and imaging technologies.

The classification of Healthcare Nanotechnology includes Nanomedicine, Nano Medical Devices, Nano Diagnosis and Other product. And the sales proportion of Nanomedicine in 2017 is about 86.5%, and the proportion is in increasing trend from 2013 to 2017.

On the basis on the end users/applications,this report focuses on the status and outlook for major applications/end users, shipments, revenue (Million USD), price, and market share and growth rate foreach application.

Anticancer CNS Product Anti-infective Other

On the basis of product type, this report displays the shipments, revenue (Million USD), price, and market share and growth rate of each type.

Nanomedicine Nano Medical Devices Nano Diagnosis Other

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Geographically, the report includes the research on production, consumption, revenue, Healthcare Nanotechnology (Nanomedicine) market share and growth rate, and forecast (2020-2026) of the following regions:

Important Healthcare Nanotechnology (Nanomedicine) Market Data Available In This Report:

Strategic Recommendations, Forecast Growth Areasof the Healthcare Nanotechnology (Nanomedicine) Market.

Challengesfor the New Entrants,TrendsMarketDrivers.

Emerging Opportunities,Competitive Landscape,Revenue Shareof Main Manufacturers.

This Report Discusses the Healthcare Nanotechnology (Nanomedicine) MarketSummary; MarketScopeGives A BriefOutlineof theHealthcare Nanotechnology (Nanomedicine) Market.

Key Performing Regions (APAC, EMEA, Americas) Along With Their Major Countries Are Detailed In This Report.

Company Profiles, Product Analysis,Marketing Strategies, Emerging Market Segments and Comprehensive Analysis of Healthcare Nanotechnology (Nanomedicine) Market.

Healthcare Nanotechnology (Nanomedicine) Market ShareYear-Over-Year Growthof Key Players in Promising Regions.

What is the (North America, South America, Europe, Africa, Middle East, Asia, China, Japan)production, production value, consumption, consumption value, import and exportof Healthcare Nanotechnology (Nanomedicine) market?

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Coronavirus threat to global Healthcare Nanotechnology (Nanomedicine) Market 2020 Industry Share, Size, Consumption, Growth, Top Manufacturers, Type...

Global Nanomedicine Market research report delivers comprehensive analysis of the market structure along with estimations of the various segments and sub-segments of the market. This study also analyzes the market status, market share, growth rate, sales volume, future trends, market drivers, market restraints, revenue generation, opportunities and challenges, risks and entry barriers, sales channels, and distributors. The company profiles of all the chief and dominating market players and brands who are taking steps such as product launches, joint ventures, mergers and acquisitions are mentioned in the report. With the use of SWOT analysis and Porters Five Forces analysis which are two of the standard, prominent and full-proof methods, this Global Nanomedicine Market report is been framed.

To prosper in this competitive market place, businesses consider taking up innovative solutions and market research report is one of them. Analysis and estimations derived through the enormous information gathered in this Global Nanomedicine market analysis report are extremely necessary when it comes to dominating the market or creating a mark in the market as a new emergent. A lot of efforts have been put together and no stone is left unturned while generating this report. This Global Nanomedicine market report represents a professional and all-inclusive study of the industry which focuses on primary and secondary drivers, market share, competitor analysis, leading segments and geographical analysis.

Global nanomedicine marketis registering a healthy CAGR of 15.50% in the forecast period of 2019-2026. This rise in the market value can be attributed to increasing number of applications and wide acceptance of the product globally. There is a significant rise in the number of researches done in this field which accelerate growth of nanomedicine market globally.

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Key Market Competitors

Few of the major market competitors currently working in the global nanomedicine market are Abbott, Invitae Corporation, General Electric Company, Leadiant Biosciences, Inc., Johnson & Johnson Services, Inc., Mallinckrodt, Merck Sharp & Dohme Corp., NanoSphere Health Sciences, Inc., Pfizer Inc., CELGENE CORPORATION, Teva Pharmaceutical Industries Ltd., Gilead Sciences, Inc., Amgen Inc., Bristol-Myers Squibb Company, AbbVie Inc., Novartis AG, F. Hoffmann-La Roche Ltd., Luminex Corporation, Eli Lilly and Company, Nanobiotix, Sanofi, UCB S.A., Ablynx among others.

Competitive Landscape

Global nanomedicine market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of nanomedicine market for global, Europe, North America, Asia-Pacific, South America and Middle East & Africa.

Key Insights in the report:

Complete and distinct analysis of the market drivers and restraints

Key Market players involved in this industry

Detailed analysis of the Market Segmentation

Competitive analysis of the key players involved

Market Drivers are Restraints

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To comprehend Global Nanomedicine market dynamics in the world mainly, the worldwide Nanomedicine market is analyzed across major global regions.

Actual Numbers & In-Depth Analysis, Business opportunities, Market Size Estimation Available in Full Report.

Some of the Major Highlights of TOC covers:

Chapter 1: Methodology & Scope

Definition and forecast parameters

Methodology and forecast parameters

Data Sources

Chapter 2: Executive Summary

Business trends

Regional trends

Product trends

End-use trends

Chapter 3: Industry Insights

Industry segmentation

Industry landscape

Vendor matrix

Technological and innovation landscape

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Nanomedicine Market report effectively provides required features of the global market for the population and for the business looking people for mergers & acquisitions, making investments, new vendors or concerned in searching for the appreciated global market research facilities. It offers sample on the size, offer, and development rate of the market. The Nanomedicine report provides the complete structure and fundamental overview of the industry market.

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Global Nanomedicine Market Analysis 2020 With COVID 19 Impact Analysis| Leading Players, Industry Updates, Future Growth, Business Prospects, In-depth...

New Jersey, United States,- A detailed research study on Healthcare Nanotechnology (Nanomedicine) Market recently published by Market Research Intellect. This is the latest report, which covers the time COVID-19 impact on the market. Pandemic Coronavirus (COVID-19) has affected every aspect of global life. This has brought some changes in market conditions. Rapidly changing market scenario and the initial assessment and the future of this effect is included in the report. Reports put together a brief analysis of the factors affecting the growth of the current business scenarios in various areas. Important information relating to the size of the industry analysis, sharing, application, and statistics summed up in the report to present the ensemble prediction. In addition, this report includes an accurate competitive analysis of major market players and their strategies during the projection period.

This report includes market size estimates for the value (million USD) and volume (K Units). Both top-down and bottom-up approach has been used to estimate the size of the market and validate the Market of Healthcare Nanotechnology (Nanomedicine), to estimate the size of the various submarkets more dependent on the overall market. Key players in the market have been identified through secondary research and their market share has been determined through primary and secondary research. All the shares percentage, split, and the damage have been determined using secondary sources and primary sources verified.

Get Sample Copy with TOC of the Report to understand the structure of the complete report @ https://www.marketresearchintellect.com/download-sample/?rid=210503&utm_source=COD&utm_medium=888

Leading Healthcare Nanotechnology (Nanomedicine) manufacturers/companies operating at both regional and global levels:

Healthcare Nanotechnology (Nanomedicine) Market Competitive Landscape & Company Profiles

Competitor analysis is one of the best sections of the report that compares the progress of leading players based on crucial parameters, including market share, new developments, global reach, local competition, price, and production. From the nature of competition to future changes in the vendor landscape, the report provides in-depth analysis of the competition in the Healthcare Nanotechnology (Nanomedicine) market.

Segmental Analysis

Both developed and emerging regions are deeply studied by the authors of the report. The regional analysis section of the report offers a comprehensive analysis of the global Healthcare Nanotechnology (Nanomedicine) market on the basis of region. Each region is exhaustively researched about so that players can use the analysis to tap into unexplored markets and plan powerful strategies to gain a foothold in lucrative markets.

Healthcare Nanotechnology (Nanomedicine) Market, By Product

Healthcare Nanotechnology (Nanomedicine) Market, By Application

Regions Covered in these Report:

Asia Pacific (China, Japan, India, and Rest of Asia Pacific)Europe (Germany, the UK, France, and Rest of Europe)North America (the US, Mexico, and Canada)Latin America (Brazil and Rest of Latin America)Middle East & Africa (GCC Countries and Rest of Middle East & Africa)

To get Incredible Discounts on this Premium Report, Click Here @ https://www.marketresearchintellect.com/ask-for-discount/?rid=210503&utm_source=COD&utm_medium=888

Healthcare Nanotechnology (Nanomedicine) Market Research Methodology

The research methodology adopted for the analysis of the market involves the consolidation of various research considerations such as subject matter expert advice, primary and secondary research. Primary research involves the extraction of information through various aspects such as numerous telephonic interviews, industry experts, questionnaires and in some cases face-to-face interactions. Primary interviews are usually carried out on a continuous basis with industry experts in order to acquire a topical understanding of the market as well as to be able to substantiate the existing analysis of the data.

Subject matter expertise involves the validation of the key research findings that were attained from primary and secondary research. The subject matter experts that are consulted have extensive experience in the market research industry and the specific requirements of the clients are reviewed by the experts to check for completion of the market study. Secondary research used for the Healthcare Nanotechnology (Nanomedicine) market report includes sources such as press releases, company annual reports, and research papers that are related to the industry. Other sources can include government websites, industry magazines and associations for gathering more meticulous data. These multiple channels of research help to find as well as substantiate research findings.

Table of Content

1 Introduction of Healthcare Nanotechnology (Nanomedicine) Market

1.1 Overview of the Market1.2 Scope of Report1.3 Assumptions

2 Executive Summary

3 Research Methodology

3.1 Data Mining3.2 Validation3.3 Primary Interviews3.4 List of Data Sources

4 Healthcare Nanotechnology (Nanomedicine) Market Outlook

4.1 Overview4.2 Market Dynamics4.2.1 Drivers4.2.2 Restraints4.2.3 Opportunities4.3 Porters Five Force Model4.4 Value Chain Analysis

5 Healthcare Nanotechnology (Nanomedicine) Market, By Deployment Model

5.1 Overview

6 Healthcare Nanotechnology (Nanomedicine) Market, By Solution

6.1 Overview

7 Healthcare Nanotechnology (Nanomedicine) Market, By Vertical

7.1 Overview

8 Healthcare Nanotechnology (Nanomedicine) Market, By Geography

8.1 Overview8.2 North America8.2.1 U.S.8.2.2 Canada8.2.3 Mexico8.3 Europe8.3.1 Germany8.3.2 U.K.8.3.3 France8.3.4 Rest of Europe8.4 Asia Pacific8.4.1 China8.4.2 Japan8.4.3 India8.4.4 Rest of Asia Pacific8.5 Rest of the World8.5.1 Latin America8.5.2 Middle East

9 Healthcare Nanotechnology (Nanomedicine) Market Competitive Landscape

9.1 Overview9.2 Company Market Ranking9.3 Key Development Strategies

10 Company Profiles

10.1.1 Overview10.1.2 Financial Performance10.1.3 Product Outlook10.1.4 Key Developments

11 Appendix

11.1 Related Research

Customized Research Report Using Corporate Email Id @ https://www.marketresearchintellect.com/need-customization/?rid=210503&utm_source=COD&utm_medium=888

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Market Research Intellect provides syndicated and customized research reports to clients from various industries and organizations with the aim of delivering functional expertise. We provide reports for all industries including Energy, Technology, Manufacturing and Construction, Chemicals and Materials, Food and Beverage and more. These reports deliver an in-depth study of the market with industry analysis, market value for regions and countries and trends that are pertinent to the industry.

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Healthcare Nanotechnology (Nanomedicine) Market Analysis, Top Manufacturers, Share, Growth, Statistics, Opportunities and Forecast To 2026 - Cole of...

New Jersey, United States,- A detailed research study on Nanomedicine Market recently published by Market Research Intellect. This is the latest report, which covers the time COVID-19 impact on the market. Pandemic Coronavirus (COVID-19) has affected every aspect of global life. This has brought some changes in market conditions. Rapidly changing market scenario and the initial assessment and the future of this effect is included in the report. Reports put together a brief analysis of the factors affecting the growth of the current business scenarios in various areas. Important information relating to the size of the industry analysis, sharing, application, and statistics summed up in the report to present the ensemble prediction. In addition, this report includes an accurate competitive analysis of major market players and their strategies during the projection period.

This report includes market size estimates for the value (million USD) and volume (K Units). Both top-down and bottom-up approach has been used to estimate the size of the market and validate the Market of Nanomedicine, to estimate the size of the various submarkets more dependent on the overall market. Key players in the market have been identified through secondary research and their market share has been determined through primary and secondary research. All the shares percentage, split, and the damage have been determined using secondary sources and primary sources verified.

Get Sample Copy with TOC of the Report to understand the structure of the complete report @ https://www.marketresearchintellect.com/download-sample/?rid=201321&utm_source=COD&utm_medium=888

Leading Nanomedicine manufacturers/companies operating at both regional and global levels:

Nanomedicine Market Competitive Landscape & Company Profiles

Competitor analysis is one of the best sections of the report that compares the progress of leading players based on crucial parameters, including market share, new developments, global reach, local competition, price, and production. From the nature of competition to future changes in the vendor landscape, the report provides in-depth analysis of the competition in the Nanomedicine market.

Segmental Analysis

Both developed and emerging regions are deeply studied by the authors of the report. The regional analysis section of the report offers a comprehensive analysis of the global Nanomedicine market on the basis of region. Each region is exhaustively researched about so that players can use the analysis to tap into unexplored markets and plan powerful strategies to gain a foothold in lucrative markets.

Nanomedicine Market, By Product

Nanomedicine Market, By Application

Regions Covered in these Report:

Asia Pacific (China, Japan, India, and Rest of Asia Pacific)Europe (Germany, the UK, France, and Rest of Europe)North America (the US, Mexico, and Canada)Latin America (Brazil and Rest of Latin America)Middle East & Africa (GCC Countries and Rest of Middle East & Africa)

To get Incredible Discounts on this Premium Report, Click Here @ https://www.marketresearchintellect.com/ask-for-discount/?rid=201321&utm_source=COD&utm_medium=888

Nanomedicine Market Research Methodology

The research methodology adopted for the analysis of the market involves the consolidation of various research considerations such as subject matter expert advice, primary and secondary research. Primary research involves the extraction of information through various aspects such as numerous telephonic interviews, industry experts, questionnaires and in some cases face-to-face interactions. Primary interviews are usually carried out on a continuous basis with industry experts in order to acquire a topical understanding of the market as well as to be able to substantiate the existing analysis of the data.

Subject matter expertise involves the validation of the key research findings that were attained from primary and secondary research. The subject matter experts that are consulted have extensive experience in the market research industry and the specific requirements of the clients are reviewed by the experts to check for completion of the market study. Secondary research used for the Nanomedicine market report includes sources such as press releases, company annual reports, and research papers that are related to the industry. Other sources can include government websites, industry magazines and associations for gathering more meticulous data. These multiple channels of research help to find as well as substantiate research findings.

Table of Content

1 Introduction of Nanomedicine Market

1.1 Overview of the Market1.2 Scope of Report1.3 Assumptions

2 Executive Summary

3 Research Methodology

3.1 Data Mining3.2 Validation3.3 Primary Interviews3.4 List of Data Sources

4 Nanomedicine Market Outlook

4.1 Overview4.2 Market Dynamics4.2.1 Drivers4.2.2 Restraints4.2.3 Opportunities4.3 Porters Five Force Model4.4 Value Chain Analysis

5 Nanomedicine Market, By Deployment Model

5.1 Overview

6 Nanomedicine Market, By Solution

6.1 Overview

7 Nanomedicine Market, By Vertical

7.1 Overview

8 Nanomedicine Market, By Geography

8.1 Overview8.2 North America8.2.1 U.S.8.2.2 Canada8.2.3 Mexico8.3 Europe8.3.1 Germany8.3.2 U.K.8.3.3 France8.3.4 Rest of Europe8.4 Asia Pacific8.4.1 China8.4.2 Japan8.4.3 India8.4.4 Rest of Asia Pacific8.5 Rest of the World8.5.1 Latin America8.5.2 Middle East

9 Nanomedicine Market Competitive Landscape

9.1 Overview9.2 Company Market Ranking9.3 Key Development Strategies

10 Company Profiles

10.1.1 Overview10.1.2 Financial Performance10.1.3 Product Outlook10.1.4 Key Developments

11 Appendix

11.1 Related Research

Customized Research Report Using Corporate Email Id @ https://www.marketresearchintellect.com/need-customization/?rid=201321&utm_source=COD&utm_medium=888

About Us:

Market Research Intellect provides syndicated and customized research reports to clients from various industries and organizations with the aim of delivering functional expertise. We provide reports for all industries including Energy, Technology, Manufacturing and Construction, Chemicals and Materials, Food and Beverage and more. These reports deliver an in-depth study of the market with industry analysis, market value for regions and countries and trends that are pertinent to the industry.

Contact Us:

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Market Research Intellect

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Nanomedicine Market Analysis, Top Manufacturers, Share, Growth, Statistics, Opportunities and Forecast To 2026 - Cole of Duty

The introduction of JAKs inhibitors for the treatment of rheumatoid arthritis represents a promising new era in the management of the disease. New compounds under investigation, like upadacitinib, with greater selectivity for JAK1 inhibition have recently been approved for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs.Herein, the authors review the pharmacological data, the therapeutic efficacy, and safety data of upadacitinib before providing the reader with their critical evaluation and future perspectives.Upadacitinib was able to accomplish all the primary and secondary end points in most of the trials, with a safety profile that is similar to the other JAK inhibitors. It has also demonstrated superiority over a tumor necrosis factor inhibitor and data on new indications is also favorable. Upadacitinib is a promising new drug for the treatment of rheumatoid arthritis.Adalimumab: ADA; American College of Rheumatology: ACR; Assessment of Spondylarthritis International Society 40: ASAS40; Ankylosis Spondylitis: AS; Area under the Curve: AUC; Biological Disease-modifying arthritis drugs: bDMARDs; Clinical disease activity index: CDAI; C Reactive Protein: CRP; Conventional Synthetic Disease-modifying arthritis drugs: csDMARDs; Deep Venous Thrombosis: DVT; Disease arthritis score: DAS.

PubMed

Continue reading here:
Evaluating upadacitinib for the treatment of rheumatoid arthritis. - Physician's Weekly

AbbVie (NYSE:ABBV) has a solution for the loss of patent protection on its blockbuster drug Humira: ABBV-3373, a souped-up version of the monoclonal antibody that's quite literally Humira on steroids; it's Humira, an antibody that targets tumor necrosis factor (TNF), connected to a glucocorticoid receptor modulator (GRM) steroid.

In a phase 2a clinical trial, ABBV-3373 reduced the Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) -- a measurement of the severity of rheumatoid arthritis disease -- by 2.65 points, compared to a decline of 2.13 points for patients who were given Humira in other clinical trials. The phase 2a study also had some patients on Humira, and when data from those patients was combined with the historical Humira data, Abbvie calculated that there was a 90% chance that ABBV-3373 was associated with a greater improvement in DAS28-CRP than Humira.

Image source: Getty Images.

Antibody-drug conjugates have been used for decades to treat cancer by using an antibody to target a toxic payload to tumor cells. But AbbVie is using the technology to target a molecule -- the GRM steroid that is anti-inflammatory -- to activated immune cells while still blocking the pro-inflammatory TNF protein. By specifically targeting activated immune cells, the drugmaker hopes to dampen the systemic side effects seen with glucocorticoid steroids.

A few other companies are developing antibody-drug conjugates where the additions aren't the traditional toxic payload. Privately held Bolt Biotherapeutics and Silverback Therapeutics, for instance, are using antibodies to target tumor cells and attaching molecules that can stimulate immune cells to attack the cancerous ones. And Avidity Biosciences, which has filed to go public under the ticker RNA, is attaching oligonucleotides to antibodies in order to target them to specific cells in the body.

Here is the original post:
AbbVie's Humira on Steroids (Literally) Treats Rheumatoid Arthritis Better Than the Original - The Motley Fool

Trusted Business Insights answers what are the scenarios for growth and recovery and whether there will be any lasting structural impact from the unfolding crisis for the Psoriatic Arthritis Therapeutics market.

Trusted Business Insights presents an updated and Latest Study on Psoriatic Arthritis Therapeutics Market 2019-2026. The report contains market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market.The report further elaborates on the micro and macroeconomic aspects including the socio-political landscape that is anticipated to shape the demand of the Psoriatic Arthritis Therapeutics market during the forecast period (2019-2029).It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary, and SWOT analysis.

Get Sample Copy of this Report @ Global Psoriatic Arthritis Therapeutics Market 2020 (Includes Business Impact of COVID-19)

Global Psoriatic Arthritis Therapeutics Market Analysis Trends, Applications, Analysis, Growth, and Forecast to 2028 is a recent report generated by Trusted Business Insights. The global Psoriatic Arthritis Therapeutics market report has been segmented on the basis of drug, diseases type, and region.

Request Covid 19 Impact

Global Psoriatic Arthritis Therapeutics Market: Overview

Psoriatic arthritis (PsA) is a type of chronic disease, characterized by inflammation in the joints and skin. This disease is progressive category of diseases that may worsening over time. If left untreated, this psoriatic arthritis may lead to joint damage permanently. It is characterized by potential involvement of diverse tissues, including, enthesitis, peripheral and axial joints, skin & nail disease, and dactylitis. The treatment of PsA includes the use of a variety of interventions that act as an agent for the treatment of patients with other forms of inflammatory arthritis, such as rheumatoid arthritis (RA), spondyloarthritis and others.

Global Psoriatic Arthritis Therapeutics Market: Dynamics

Increasing number of cases of psoriatic arthritis especially in elderly population is a key factor expected to drive the growth of the global market over the forecast period. In addition, rising awareness about psoriatic arthritis treatment among the healthcare professionals and increasing elderly population. The above mentioned are some of the other factors expected to drive growth revenue of the global market. However, high cost of the drugs and treatment, entry of biosimilar drug in the market, and lack of standardization tools for diagnosis and treatment. These are some of the major factors expected to hamper growth of the target market to a certain extent.

Global Psoriatic Arthritis Therapeutics Market: Segment Analysis

Among the drug type segments, Nonsteroidal anti-inflammatory drug is estimated to account for majority of revenue share in the global market. This is due to, rising prescribing of NSAID drugs for patients, in order to pain and morning stiffness, controlling swelling, and to improve range of motion to joints.

Among the diseases type segments, symmetric psoriatic arthritis is estimated to hold highest revenue and register highest CAGR over the forecast period, due to increasing number of cases of affecting several joints in pairs on both sides of your body. It may damage joints over time, that can lead to limited movement and function of body.

Global Psoriatic Arthritis Therapeutics Market: Trends

The established players are adopting various growth strategies such as partnership, collaboration, mergers, new product launch etc., in order to cater the growing demand for Psoriatic Arthritis Therapeutics globally. In addition, the prominent players are collaborating with local player in order to form string value and supply chain. The aforementioned are some of the current key trend witnessed in the target market.

Global Psoriatic Arthritis Therapeutics Market: Regional Analysis

In 2019, the markets in North America estimated to account for highest market revenue share in the target market over the forecast period. This is primarily attributed to, increasing incidences of psoriatic arthritis. According to RheumatoidArthritis.org, which is a non-profit team of healthcare professionals around 85% of individuals living with psoriatic arthritis in US. The markets in Asia Pacific accounted for highest CAGR over the forecast period, owing to increasing prevalence and incidences in the temperate zones in the region, and growing healthcare expenditure. In addition, higher demand and increased rate of adoption of biologic drugs in countries such as Australia & New Zealand, are projected to drive the psoriatic arthritis therapeutics market in Asia Pacific region.

Global Psoriatic Arthritis Therapeutics Market Segmentation:

Segmentation by drug:

Nonsteroidal anti-inflammatory drug (NSAID)Disease-modifying antirheumatic drug (DMARD)Biologic drugEnzyme inhibitor

Segmentation by diseases type:

Asymmetric Psoriatic ArthritisSymmetric Psoriatic ArthritisDistal Interphalangeal Predominant (Dip) Psoriatic ArthritisSpondylitisArthritis Mutilans

Quick Read Table of Contents of this Report @ Global Psoriatic Arthritis Therapeutics Market 2020 (Includes Business Impact of COVID-19)

Trusted Business InsightsShelly ArnoldMedia & Marketing ExecutiveEmail Me For Any ClarificationsConnect on LinkedInClick to follow Trusted Business Insights LinkedIn for Market Data and Updates.US: +1 646 568 9797UK: +44 330 808 0580

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Psoriatic Arthritis Therapeutics Market Analysis Of Global Trends, Demand And Competition 2020-2028 - 3rd Watch News

Jess Glass, Press Association

10 June, 2020 16:06

Drugs used to treat conditions including rheumatoid arthritis will be tested as potential treatments in a Covid-19 trial.

Researchers at the University of Birmingham announced on Wednesday that four drugs will be used as part of their Catalyst trial into therapeutics for patients with the virus.

The trial will use drugs that are on the market or are in late stages of clinical trials to treat hospitalised patients with Covid-19, in the hope they can prevent them from needing intensive care.

The first drug in the research is Namilumab, produced by the Oxford-based Izana Bioscience, which is in late-stage trials for use for rheumatoid arthritis and the inflammatory disease ankylosing spondylitis.

READ MORE:Coronavirus: Tougher border controls 'more effective if introduced earlier', MPs told

The drug targets substances called cytokines which are naturally released by immune cells but can cause damage during an over-reaction of the immune system known as a cytokine storm.

These substances are believed to be a key factor in the excessive and potentially dangerous lung inflammation seen in some Covid-19 patients.

The second drug is Infliximab, developed by Slough-based Celltrion Healthcare UK, and is an anti-tumour necrosis therapy.

It is currently used to treat inflammatory and autoimmune conditions including rheumatoid arthritis and irritable bowel syndrome.

The other two drugs to be used in the trial will be announced at a later date.

Researchers hope that by targeting some of the most serious symptoms of Covid-19, the severity of the disease could be reduced leading to a fall in deaths.

Researchers at the University of Birmingham are testing four different drugs which could be used to treat coronavirus

Dr Ben Fisher, co-clinical investigator of the Catalyst trial, said: "Emerging evidence is demonstrating a critical role for anti-inflammatory drugs in the cytokine storm associated with severe Covid-19 infection.

"In the Catalyst study, we hope to show with a single dose of these kinds of drugs in hospitalised patients that we are able to delay or prevent the rapid deterioration into intensive care and requirement for invasive ventilation in this critical patient group."

Up to 40 Covid-19 patients will be recruited to each part of the trial and will be randomly selected to either receive standard treatment alone or treatment with the addition of one of the four drugs.

The trial has been designed by the inflammation - advanced and cell therapy trials Team at the University of Birmingham's Cancer Research UK clinical trials unit.

In addition to the team at the university, the trial is being conducted with University Hospitals Birmingham NHS Foundation Trust, as well as teams from Oxford University and University College London.

Recruitment for patients has started in Oxford and Birmingham.

If a drug is found to be successful, the trial will be expanded for further testing on a national level.

Read the original:
Arthritis drugs used in new coronavirus treatment trial - The Irish News

WARREN, N.J., June 11, 2020 /PRNewswire/ -- GlaxoSmithKline (LSE/NYSE: GSK) announced that Voltaren Arthritis Pain Gel (diclofenac sodium topical gel, 1% (NSAID) arthritis pain reliever) recently became available over-the-counter (OTC) online and in stores nationwide, providing the over 30 million1 osteoarthritis patients across the country broader access to a leading pain relief option.

Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8731451-gsk-partners-with-paula-abdul-to-launch-voltaren-arthritis-pain-gel/

To launch the OTC offering, Voltaren is teaming up with music superstar Paula Abdul, who uses Voltaren for her arthritis pain. Staying active is important for arthritis patients everywhere, and together, Voltaren and Paula Abdul will inspire people to "rediscover the joy of movement".

"I'm excited to partner with Voltaren Arthritis Pain Gel to share my personal journey with arthritis and success using Voltaren," Paula said. "I've put my joints through a lot over the years. Dancing, jumping, flipping it's my heart and soul, but I've been pushing my joints to the limit for decades as a result. When I was diagnosed with arthritis, my doctor prescribed Voltaren which made a huge difference in relieving my pain and helping me move with ease. I am so excited it's now available OTC at stores nationwide."

Joint pain due to arthritis symptoms is a daily reality for millions of people in the United States, and with many people across the country staying at home more often, finding arthritis pain relief is more important than ever. In a recent study of 1,000 U.S. adults aged 35+ suffering from joint pain* conducted by Voltaren in partnership with Wakefield Research, 82 percent of respondents said their physical activity has decreased as a result of more time at home, and 92 percent of respondents report that their joint pain is the same or more severe during this time.

"Stay-at-home orders led to a unique set of challenges for those with arthritis," said Jissan Cherian, Director,U.S. OTC Marketing at GSK Consumer Healthcare. "Now, more than ever, we need to offer solutions that help ease the challenge of joint pain and inspire arthritis patients to rediscover the joy of movement, even as we adapt to changing routines and a new way of life."

Additional results from the survey revealed:

Voltaren Gel, a doctor-prescribed arthritis treatment in the U.S. for over 10 years with a proven safety profile, was approved by the Food and Drug Administration (FDA) as an OTC treatment in February, making it the first and only prescription strength, nonsteroidal anti-inflammatory (NSAID) topical gel for arthritis pain available OTC in the United States. As an alternative to pills, Voltaren treats joint pain by delivering medicine at the source, and is absorbed through the skin and not through the stomach like most oral medicines. Voltaren is applied directly to the site of pain, delivering powerful arthritis pain relief. It is indicated for the treatment of arthritis pain in the hand, wrist, elbow, foot, ankle or knee. To date, millions of patients around the world have relied on Voltaren as a powerful, well-tolerated and convenient therapeutic alternative for treating arthritis pain.

"As the world leader in pain relief, we have seen how Voltaren has helped people with osteoarthritis treat their pain and improve their quality of life" Cherian said. "The OTC availability of Voltaren Arthritis Pain helps to provide greater access to an effective topical treatment option for joint pain patients, so more people with osteoarthritis pain can find relief."

Voltaren Arthritis Pain Gel is now available online and at most major retailers nationwide.

About Voltaren Arthritis Pain GelThe active ingredient in Voltaren Arthritis Pain Gel, diclofenac sodium, is an effective medicine that is clinically proven to relieve joint pain due to arthritis. Voltaren penetrates throughthe skin at the application site to deliver arthritis pain relief. Voltaren offers consumers who suffer from OA a well-tolerated alternative to oral analgesics. For more information, visithttps://www.VoltarenGel.com/.

About osteoarthritis Osteoarthritis (OA) is the most common form of arthritis. OA occurs when the cartilage between joints begins to break down and wear away, resulting in joint pain and stiffness. OA occurs more frequently with age, and the pain can gradually worsen over time. The most common symptoms associated with OA include joint pain, stiffness, and decreased range of motion.

GSK's commitment to pain reliefWe are the world leader in pain relief. With a portfolio of (systemic and topical) products to relieve pain, our range brings comfort and ease to millions. World-leading brands including Advil, Panadol and Voltaren; and beloved local brands like Excedrin in the US and Fenbid in China help people manage their symptoms so they can enjoy life to the fullest.

Important safety information about Voltaren Arthritis Pain Before using the product, consumers should read the Voltaren Arthritis Pain Gel Drug Facts Label.

* Methodological NotesThe GSK Voltaren Survey was conducted by Wakefield Research (www.wakefieldresearch.com) between May 7th and May 15th, 2020, among 1,000 US adults ages 35+ suffering from joint pain, plus an additional oversample of 500 joint pain sufferers in each of three states: Georgia, Oklahoma, Louisiana, using an email invitation and an online survey.

Results of any sample are subject to sampling variation. The magnitude of the variation is measurable and is affected by the number of interviews and the level of the percentages expressing the results. For the interviews conducted in this particular study, the chances are 95 in 100 that a survey result does not vary, plus or minus, by more than 3.1 percentage points from the result that would be obtained if the interviews had been conducted with all persons in the universe represented by the sample.

About GSK GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit http://www.gsk.com.

About GSK Consumer Healthcare We are the world's largest Consumer Healthcare company following our new joint venture with Pfizer Consumer Healthcare. We develop and market a portfolio of consumer-preferred and expert-recommended brands including Sensodyne, parodontax, Poligrip, Advil, Centrum and Theraflu.

Media Inquiries:

GSK Consumer Healthcare

Caitlin Kormann

+1 617 448 0557

(Warren)

Edelman

Jessica Moschella

+1 201 953 1547

(New York City)

1https://www.cdc.gov/arthritis/basics/osteoarthritis.htm

SOURCE GSK Consumer Healthcare

http://www.gsk.com

See the article here:
GSK Consumer Healthcare teams up with Paula Abdul for the launch of Voltaren Arthritis Pain Gel - PRNewswire

New Jersey, United States,- A detailed research study on Rheumatoid Arthritis and Lupus Treatments Market recently published by Market Research Intellect. This is the latest report, which covers the time COVID-19 impact on the market. Pandemic Coronavirus (COVID-19) has affected every aspect of global life. This has brought some changes in market conditions. Rapidly changing market scenario and the initial assessment and the future of this effect is included in the report. Reports put together a brief analysis of the factors affecting the growth of the current business scenarios in various areas. Important information relating to the size of the industry analysis, sharing, application, and statistics summed up in the report to present the ensemble prediction. In addition, this report includes an accurate competitive analysis of major market players and their strategies during the projection period.

This report includes market size estimates for the value (million USD) and volume (K Units). Both top-down and bottom-up approach has been used to estimate the size of the market and validate the Market of Rheumatoid Arthritis and Lupus Treatments, to estimate the size of the various submarkets more dependent on the overall market. Key players in the market have been identified through secondary research and their market share has been determined through primary and secondary research. All the shares percentage, split, and the damage have been determined using secondary sources and primary sources verified.

Get Sample Copy with TOC of the Report to understand the structure of the complete report @ https://www.marketresearchintellect.com/download-sample/?rid=275894&utm_source=COD&utm_medium=888

Leading Rheumatoid Arthritis and Lupus Treatments manufacturers/companies operating at both regional and global levels:

Rheumatoid Arthritis and Lupus Treatments Market Competitive Landscape & Company Profiles

Competitor analysis is one of the best sections of the report that compares the progress of leading players based on crucial parameters, including market share, new developments, global reach, local competition, price, and production. From the nature of competition to future changes in the vendor landscape, the report provides in-depth analysis of the competition in the Rheumatoid Arthritis and Lupus Treatments market.

Segmental Analysis

Both developed and emerging regions are deeply studied by the authors of the report. The regional analysis section of the report offers a comprehensive analysis of the global Rheumatoid Arthritis and Lupus Treatments market on the basis of region. Each region is exhaustively researched about so that players can use the analysis to tap into unexplored markets and plan powerful strategies to gain a foothold in lucrative markets.

Rheumatoid Arthritis and Lupus Treatments Market, By Product

Rheumatoid Arthritis and Lupus Treatments Market, By Application

Regions Covered in these Report:

Asia Pacific (China, Japan, India, and Rest of Asia Pacific)Europe (Germany, the UK, France, and Rest of Europe)North America (the US, Mexico, and Canada)Latin America (Brazil and Rest of Latin America)Middle East & Africa (GCC Countries and Rest of Middle East & Africa)

To get Incredible Discounts on this Premium Report, Click Here @ https://www.marketresearchintellect.com/ask-for-discount/?rid=275894&utm_source=COD&utm_medium=888

Rheumatoid Arthritis and Lupus Treatments Market Research Methodology

The research methodology adopted for the analysis of the market involves the consolidation of various research considerations such as subject matter expert advice, primary and secondary research. Primary research involves the extraction of information through various aspects such as numerous telephonic interviews, industry experts, questionnaires and in some cases face-to-face interactions. Primary interviews are usually carried out on a continuous basis with industry experts in order to acquire a topical understanding of the market as well as to be able to substantiate the existing analysis of the data.

Subject matter expertise involves the validation of the key research findings that were attained from primary and secondary research. The subject matter experts that are consulted have extensive experience in the market research industry and the specific requirements of the clients are reviewed by the experts to check for completion of the market study. Secondary research used for the Rheumatoid Arthritis and Lupus Treatments market report includes sources such as press releases, company annual reports, and research papers that are related to the industry. Other sources can include government websites, industry magazines and associations for gathering more meticulous data. These multiple channels of research help to find as well as substantiate research findings.

Table of Content

1 Introduction of Rheumatoid Arthritis and Lupus Treatments Market

1.1 Overview of the Market1.2 Scope of Report1.3 Assumptions

2 Executive Summary

3 Research Methodology

3.1 Data Mining3.2 Validation3.3 Primary Interviews3.4 List of Data Sources

4 Rheumatoid Arthritis and Lupus Treatments Market Outlook

4.1 Overview4.2 Market Dynamics4.2.1 Drivers4.2.2 Restraints4.2.3 Opportunities4.3 Porters Five Force Model4.4 Value Chain Analysis

5 Rheumatoid Arthritis and Lupus Treatments Market, By Deployment Model

5.1 Overview

6 Rheumatoid Arthritis and Lupus Treatments Market, By Solution

6.1 Overview

7 Rheumatoid Arthritis and Lupus Treatments Market, By Vertical

7.1 Overview

8 Rheumatoid Arthritis and Lupus Treatments Market, By Geography

8.1 Overview8.2 North America8.2.1 U.S.8.2.2 Canada8.2.3 Mexico8.3 Europe8.3.1 Germany8.3.2 U.K.8.3.3 France8.3.4 Rest of Europe8.4 Asia Pacific8.4.1 China8.4.2 Japan8.4.3 India8.4.4 Rest of Asia Pacific8.5 Rest of the World8.5.1 Latin America8.5.2 Middle East

9 Rheumatoid Arthritis and Lupus Treatments Market Competitive Landscape

9.1 Overview9.2 Company Market Ranking9.3 Key Development Strategies

10 Company Profiles

10.1.1 Overview10.1.2 Financial Performance10.1.3 Product Outlook10.1.4 Key Developments

11 Appendix

11.1 Related Research

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Market Research Intellect provides syndicated and customized research reports to clients from various industries and organizations with the aim of delivering functional expertise. We provide reports for all industries including Energy, Technology, Manufacturing and Construction, Chemicals and Materials, Food and Beverage and more. These reports deliver an in-depth study of the market with industry analysis, market value for regions and countries and trends that are pertinent to the industry.

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Rheumatoid Arthritis and Lupus Treatments Market Analysis, Top Manufacturers, Share, Growth, Statistics, Opportunities and Forecast To 2026 - Cole of...

Researchstore.biz has published an exclusive report named Global Psoriatic Arthritis Drug Market 2020 by Company, Regions, Type and Application, Forecast to 2025 which consists of overall market scenario with prevalent and future growth prospects. The report delivers the analytical elaboration and other industry-linked information in an aim to supply specific and reliable analysis on the global Psoriatic Arthritis Drug market. The report focuses on market dynamics, growth-driving factors, restraints, and limitations this market is currently facing and is expected to face in the coming years (2020-2025). The report is further divided by company, by country, and by application/types for the competitive landscape analysis. It estimates production chain, manufacturing capacity, sales volume, and revenue.

The report provides a detailed analysis of global market size, regional and country-level market size, segmentation market growth, market share, competitive landscape, sales analysis, the impact of domestic and global market players. It contains advanced information associated with the global Psoriatic Arthritis Drug market status, trends analysis, segment, and forecasts from 2020-2025. It explains market scenarios, comparative pricing between major players, cost, and profit of the specified market regions.

NOTE: This report takes into account the current and future impacts of COVID-19 on this industry and offers you an in-dept analysis of Psoriatic Arthritis Drug market.

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Key Players Analysis:

The report analyzes the top manufacturers, exporters, and retailers (if applicable) around the world concerning their company profile, product portfolio, capacity, price, cost, and revenue. For competitor segment, the report covers the following global Psoriatic Arthritis Drug market key players and some other small players: Abbvie, Pfizer, Janssen, Amgen, Celgene, Eli-lilly

In market segmentation by types, the report covers: TNF Inhibitors, PDE4 Inhibitors, Interleukin Blockers, Other,

In market segmentation by applications, the report covers the following uses: Mild Psoriatic Arthritis, Moderate Psoriatic Arthritis, Severe Psoriatic Arthritis,

Regionally, this report focuses on several key regions: North America (United States, Canada and Mexico), Europe (Germany, France, UK, Russia and Italy), Asia-Pacific (China, Japan, Korea, India, Southeast Asia and Australia), South America (Brazil, Argentina, Colombia), Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

Moreover, the report exhaustively investigates business opportunities, market scope, threats, and barriers. The report aims to help companies in strategizing their decisions in a better way and finally attains their business goals. The research answers important business questions like how the global Psoriatic Arthritis Drug market will perform in the existing market scenario. It also presents the potential industry supply, market demand, market value, market competition, key market players, and the industry estimate from 2020-2025.

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Read more:
Global Psoriatic Arthritis Drug Market with (Covid-19) Impact Analysis: Growth, Latest Trend Analysis and Forecast 2025 - Cole of Duty

New Jersey, United States,- A detailed research study on Rheumatoid Arthritis Drugs Manufacturers Profiles, Market recently published by Market Research Intellect. This is the latest report, which covers the time COVID-19 impact on the market. Pandemic Coronavirus (COVID-19) has affected every aspect of global life. This has brought some changes in market conditions. Rapidly changing market scenario and the initial assessment and the future of this effect is included in the report. Reports put together a brief analysis of the factors affecting the growth of the current business scenarios in various areas. Important information relating to the size of the industry analysis, sharing, application, and statistics summed up in the report to present the ensemble prediction. In addition, this report includes an accurate competitive analysis of major market players and their strategies during the projection period.

This report includes market size estimates for the value (million USD) and volume (K Units). Both top-down and bottom-up approach has been used to estimate the size of the market and validate the Market of Rheumatoid Arthritis Drugs Manufacturers Profiles,, to estimate the size of the various submarkets more dependent on the overall market. Key players in the market have been identified through secondary research and their market share has been determined through primary and secondary research. All the shares percentage, split, and the damage have been determined using secondary sources and primary sources verified.

Get Sample Copy with TOC of the Report to understand the structure of the complete report @ https://www.marketresearchintellect.com/download-sample/?rid=231874&utm_source=COD&utm_medium=888

Leading Rheumatoid Arthritis Drugs Manufacturers Profiles, manufacturers/companies operating at both regional and global levels:

Rheumatoid Arthritis Drugs Manufacturers Profiles, Market Competitive Landscape & Company Profiles

Competitor analysis is one of the best sections of the report that compares the progress of leading players based on crucial parameters, including market share, new developments, global reach, local competition, price, and production. From the nature of competition to future changes in the vendor landscape, the report provides in-depth analysis of the competition in the Rheumatoid Arthritis Drugs Manufacturers Profiles, market.

Segmental Analysis

Both developed and emerging regions are deeply studied by the authors of the report. The regional analysis section of the report offers a comprehensive analysis of the global Rheumatoid Arthritis Drugs Manufacturers Profiles, market on the basis of region. Each region is exhaustively researched about so that players can use the analysis to tap into unexplored markets and plan powerful strategies to gain a foothold in lucrative markets.

Rheumatoid Arthritis Drugs Manufacturers Profiles, Market, By Product

Rheumatoid Arthritis Drugs Manufacturers Profiles, Market, By Application

Regions Covered in these Report:

Asia Pacific (China, Japan, India, and Rest of Asia Pacific)Europe (Germany, the UK, France, and Rest of Europe)North America (the US, Mexico, and Canada)Latin America (Brazil and Rest of Latin America)Middle East & Africa (GCC Countries and Rest of Middle East & Africa)

To get Incredible Discounts on this Premium Report, Click Here @ https://www.marketresearchintellect.com/ask-for-discount/?rid=231874&utm_source=COD&utm_medium=888

Rheumatoid Arthritis Drugs Manufacturers Profiles, Market Research Methodology

The research methodology adopted for the analysis of the market involves the consolidation of various research considerations such as subject matter expert advice, primary and secondary research. Primary research involves the extraction of information through various aspects such as numerous telephonic interviews, industry experts, questionnaires and in some cases face-to-face interactions. Primary interviews are usually carried out on a continuous basis with industry experts in order to acquire a topical understanding of the market as well as to be able to substantiate the existing analysis of the data.

Subject matter expertise involves the validation of the key research findings that were attained from primary and secondary research. The subject matter experts that are consulted have extensive experience in the market research industry and the specific requirements of the clients are reviewed by the experts to check for completion of the market study. Secondary research used for the Rheumatoid Arthritis Drugs Manufacturers Profiles, market report includes sources such as press releases, company annual reports, and research papers that are related to the industry. Other sources can include government websites, industry magazines and associations for gathering more meticulous data. These multiple channels of research help to find as well as substantiate research findings.

Table of Content

1 Introduction of Rheumatoid Arthritis Drugs Manufacturers Profiles, Market

1.1 Overview of the Market1.2 Scope of Report1.3 Assumptions

2 Executive Summary

3 Research Methodology

3.1 Data Mining3.2 Validation3.3 Primary Interviews3.4 List of Data Sources

4 Rheumatoid Arthritis Drugs Manufacturers Profiles, Market Outlook

4.1 Overview4.2 Market Dynamics4.2.1 Drivers4.2.2 Restraints4.2.3 Opportunities4.3 Porters Five Force Model4.4 Value Chain Analysis

5 Rheumatoid Arthritis Drugs Manufacturers Profiles, Market, By Deployment Model

5.1 Overview

6 Rheumatoid Arthritis Drugs Manufacturers Profiles, Market, By Solution

6.1 Overview

7 Rheumatoid Arthritis Drugs Manufacturers Profiles, Market, By Vertical

7.1 Overview

8 Rheumatoid Arthritis Drugs Manufacturers Profiles, Market, By Geography

8.1 Overview8.2 North America8.2.1 U.S.8.2.2 Canada8.2.3 Mexico8.3 Europe8.3.1 Germany8.3.2 U.K.8.3.3 France8.3.4 Rest of Europe8.4 Asia Pacific8.4.1 China8.4.2 Japan8.4.3 India8.4.4 Rest of Asia Pacific8.5 Rest of the World8.5.1 Latin America8.5.2 Middle East

9 Rheumatoid Arthritis Drugs Manufacturers Profiles, Market Competitive Landscape

9.1 Overview9.2 Company Market Ranking9.3 Key Development Strategies

10 Company Profiles

10.1.1 Overview10.1.2 Financial Performance10.1.3 Product Outlook10.1.4 Key Developments

11 Appendix

11.1 Related Research

Customized Research Report Using Corporate Email Id @ https://www.marketresearchintellect.com/need-customization/?rid=231874&utm_source=COD&utm_medium=888

About Us:

Market Research Intellect provides syndicated and customized research reports to clients from various industries and organizations with the aim of delivering functional expertise. We provide reports for all industries including Energy, Technology, Manufacturing and Construction, Chemicals and Materials, Food and Beverage and more. These reports deliver an in-depth study of the market with industry analysis, market value for regions and countries and trends that are pertinent to the industry.

Contact Us:

Mr. Steven Fernandes

Market Research Intellect

New Jersey ( USA )

Tel: +1-650-781-4080

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Read the original post:
Rheumatoid Arthritis Drugs Manufacturers Profiles, Market Analysis, Top Manufacturers, Share, Growth, Statistics, Opportunities and Forecast To 2026 -...

When lockdown came into force, I was anxious. Im at high risk of getting a severe form of Covid-19, since I have rheumatoid arthritis (RA) and swallow an army of immunosuppressant drugs every day. I live in London with my boy Mr Darcy, my handsome Lucas Terrier but my parents felt it was safer for me to be with them, in Hampshire. We get on well. Ever since I was diagnosed with RA aged 18 (I am now 46) we have been through so much adversity together that we have become a team.

It was March 25, another day, much the same as the day before, I thought, until it happened. I was walking Darcy on Stockbridge Down when I heard my left hip make a crunching sound. Over the past twenty-eight years, I have had multiple joint replacement operations, and two of these have been hip replacements and revision surgery on this particular left-hand side. With every step I made, I winced at this crunching sound like a tyre going over gravel. Unbeknownst to me I had broken my pelvis and fractured my hip. Essentially my replacement joint had shattered.

With Mr Darcy alongside, oblivious to my fear, I staggered a quarter of a mile back to my car. In shock, I drove home. With hindsight, I dont know how I managed to get home.

The following day, an x-ray was taken, confirming a catastrophic hip replacement failure. I was advised not to walk at all (not that I could), to use a wheelchair and if I had to move around the house, to get around on a gutter frame. No stairs. It was frightening going from a generally active person I love my swimming and dog walks to someone trapped in a body, unable to move for fear of doing further damage. To add to the trauma, no operation could be done because of Covid-19.

Ordinarily, I would have had surgery immediately. Yet we were nowhere near the peak of the virus. It was a question of waiting, the surgeon told me. Reluctantly, I could see his point; I understood an operation wasnt possible. I understood the risk of getting the virus too and feared passing it on to my parents. We were stuck.

Almost three months on and I can honestly say the last twelve weeks have been the most gruelling weeks I have ever endured. Mentally I have been down some dark paths: paths of wanting to give up simply take my own life and be done with further pain and surgery. Why bother living like this? I have been down paths of reliving the trauma of previous surgery dreading the operation to come, yet knowing that unless I have it I wont be able to walk my Darcy again, something I so desperately miss.

Originally posted here:
'Ive dislocated my hip and the pain is so bad Ive thought about taking my own life' - Telegraph.co.uk

New Jersey, United States,- A detailed research study on Rheumatoid Arthritis Drugs Market recently published by Market Research Intellect. This is the latest report, which covers the time COVID-19 impact on the market. Pandemic Coronavirus (COVID-19) has affected every aspect of global life. This has brought some changes in market conditions. Rapidly changing market scenario and the initial assessment and the future of this effect is included in the report. Reports put together a brief analysis of the factors affecting the growth of the current business scenarios in various areas. Important information relating to the size of the industry analysis, sharing, application, and statistics summed up in the report to present the ensemble prediction. In addition, this report includes an accurate competitive analysis of major market players and their strategies during the projection period.

This report includes market size estimates for the value (million USD) and volume (K Units). Both top-down and bottom-up approach has been used to estimate the size of the market and validate the Market of Rheumatoid Arthritis Drugs, to estimate the size of the various submarkets more dependent on the overall market. Key players in the market have been identified through secondary research and their market share has been determined through primary and secondary research. All the shares percentage, split, and the damage have been determined using secondary sources and primary sources verified.

Get Sample Copy with TOC of the Report to understand the structure of the complete report @ https://www.marketresearchintellect.com/download-sample/?rid=212614&utm_source=COD&utm_medium=888

Leading Rheumatoid Arthritis Drugs manufacturers/companies operating at both regional and global levels:

Rheumatoid Arthritis Drugs Market Competitive Landscape & Company Profiles

Competitor analysis is one of the best sections of the report that compares the progress of leading players based on crucial parameters, including market share, new developments, global reach, local competition, price, and production. From the nature of competition to future changes in the vendor landscape, the report provides in-depth analysis of the competition in the Rheumatoid Arthritis Drugs market.

Segmental Analysis

Both developed and emerging regions are deeply studied by the authors of the report. The regional analysis section of the report offers a comprehensive analysis of the global Rheumatoid Arthritis Drugs market on the basis of region. Each region is exhaustively researched about so that players can use the analysis to tap into unexplored markets and plan powerful strategies to gain a foothold in lucrative markets.

Rheumatoid Arthritis Drugs Market, By Product

Rheumatoid Arthritis Drugs Market, By Application

Regions Covered in these Report:

Asia Pacific (China, Japan, India, and Rest of Asia Pacific)Europe (Germany, the UK, France, and Rest of Europe)North America (the US, Mexico, and Canada)Latin America (Brazil and Rest of Latin America)Middle East & Africa (GCC Countries and Rest of Middle East & Africa)

To get Incredible Discounts on this Premium Report, Click Here @ https://www.marketresearchintellect.com/ask-for-discount/?rid=212614&utm_source=COD&utm_medium=888

Rheumatoid Arthritis Drugs Market Research Methodology

The research methodology adopted for the analysis of the market involves the consolidation of various research considerations such as subject matter expert advice, primary and secondary research. Primary research involves the extraction of information through various aspects such as numerous telephonic interviews, industry experts, questionnaires and in some cases face-to-face interactions. Primary interviews are usually carried out on a continuous basis with industry experts in order to acquire a topical understanding of the market as well as to be able to substantiate the existing analysis of the data.

Subject matter expertise involves the validation of the key research findings that were attained from primary and secondary research. The subject matter experts that are consulted have extensive experience in the market research industry and the specific requirements of the clients are reviewed by the experts to check for completion of the market study. Secondary research used for the Rheumatoid Arthritis Drugs market report includes sources such as press releases, company annual reports, and research papers that are related to the industry. Other sources can include government websites, industry magazines and associations for gathering more meticulous data. These multiple channels of research help to find as well as substantiate research findings.

Table of Content

1 Introduction of Rheumatoid Arthritis Drugs Market

1.1 Overview of the Market1.2 Scope of Report1.3 Assumptions

2 Executive Summary

3 Research Methodology

3.1 Data Mining3.2 Validation3.3 Primary Interviews3.4 List of Data Sources

4 Rheumatoid Arthritis Drugs Market Outlook

4.1 Overview4.2 Market Dynamics4.2.1 Drivers4.2.2 Restraints4.2.3 Opportunities4.3 Porters Five Force Model4.4 Value Chain Analysis

5 Rheumatoid Arthritis Drugs Market, By Deployment Model

5.1 Overview

6 Rheumatoid Arthritis Drugs Market, By Solution

6.1 Overview

7 Rheumatoid Arthritis Drugs Market, By Vertical

7.1 Overview

8 Rheumatoid Arthritis Drugs Market, By Geography

8.1 Overview8.2 North America8.2.1 U.S.8.2.2 Canada8.2.3 Mexico8.3 Europe8.3.1 Germany8.3.2 U.K.8.3.3 France8.3.4 Rest of Europe8.4 Asia Pacific8.4.1 China8.4.2 Japan8.4.3 India8.4.4 Rest of Asia Pacific8.5 Rest of the World8.5.1 Latin America8.5.2 Middle East

9 Rheumatoid Arthritis Drugs Market Competitive Landscape

9.1 Overview9.2 Company Market Ranking9.3 Key Development Strategies

10 Company Profiles

10.1.1 Overview10.1.2 Financial Performance10.1.3 Product Outlook10.1.4 Key Developments

11 Appendix

11.1 Related Research

Customized Research Report Using Corporate Email Id @ https://www.marketresearchintellect.com/need-customization/?rid=212614&utm_source=COD&utm_medium=888

About Us:

Market Research Intellect provides syndicated and customized research reports to clients from various industries and organizations with the aim of delivering functional expertise. We provide reports for all industries including Energy, Technology, Manufacturing and Construction, Chemicals and Materials, Food and Beverage and more. These reports deliver an in-depth study of the market with industry analysis, market value for regions and countries and trends that are pertinent to the industry.

Contact Us:

Mr. Steven Fernandes

Market Research Intellect

New Jersey ( USA )

Tel: +1-650-781-4080

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