StemCell Therapy

Englands most notorious dynasty owes much to the trials of a 13-year-old girl: Margaret Beaufort, Countess of Richmond. On January 28, 1457, the young widowher first husband, Edmund Tudor, had died at age 26 several months priorbarely survived the birth of her only child, the future Henry VII. Twenty-eight years later, in large part due to Margarets tenacious, single-minded campaign for the crown, she saw her son take the throne as the first Tudor king.

Margaret never officially held the title of queen. But as Nicola Tallis argues in Uncrowned Queen: The Life of Margaret Beaufort, Mother of the Tudors, she fulfilled the role in all but name, orchestrating her familys rise to power and overseeing the machinations of government upon her sons ascension.

The latest installment in our series highlighting new book releases, which launched in late March to support authors whose works have been overshadowed amid the COVID-19 pandemic, centers on the matriarch of the Tudor dynasty, the oft-conflicting science of skin, a Pulitzer Prize-winning poets tragic past, the twilight years of Japanese isolationism and a Supreme Court decision with lasting implications for the criminal justice system.

Representing the fields of history, science, arts and culture, innovation, and travel, selections represent texts that piqued our curiosity with their new approaches to oft-discussed topics, elevation of overlooked stories and artful prose. Weve linked to Amazon for your convenience, but be sure to check with your local bookstore to see if it supports social distancing-appropriate delivery or pickup measures, too.

Margaret Beaufort had little reason to dream of the throne. The Wars of the Rosesa dynastic clash between two branches of the royal Plantagenet familyraged on for much of her early life, and more often than not, her Lancastrian relatives were on the losing side. Still, she managed to find favor under Yorkist king Edward IV and his wife, Elizabeth Woodville, embedding herself in the royal household with such success that she was named godmother to one of the couples children. All the while, Margaret worked to restore her son, Henry, then in exile as one of the last remaining Lancastrian heirs, to power.

Edward IVs untimely death in 1483, compounded by his brother Richard IIIs subsequent usurpation of the throne, complicated matters. But Margaret, working behind the scenes with the dowager queen Elizabeth and others who opposed Richards reign, ultimately proved victorious: On August 22, 1485, Henry defeated Richard at the Battle of Bosworth Field, winning the crown and, through his impending union with Elizabeth of York, daughter of Edward IV, uniting the warring royal houses after decades of civil war.

Nicola Tallis Uncrowned Queen details the complex web of operations that resulted in this unlikely victory, crediting Margaret for her sons success without lending credence to the commonly held perception of her as a religious fanatic who was obsessively ambitious on her sons behalf and who dominated his court. Instead, the historian presents a portrait of a singular woman who defied all expectations of the era, pressing against the constraints imposed by her sex and society, [and] slowly demanding more and more control over her life, until the crown on her sons head allowed her to make the unprecedented move for almost total independence: financially, physically and sexually.

A shower a day does not keep the dermatologist awayor so James Hamblin, a preventative medicine physician and staff writer at the Atlantic, argues in his latest book. Part history, part science, Clean addresses the many misconceptions surrounding skincare, outlining a compelling case for showering less and embracing (figuratively speaking) the many naturally occurring microbes found on the skin. To demonstrate his point, Hamblin swore off showering for the duration of the books writing; as Kirkus notes in its review of Clean, He did not become a public nuisance, and his skin improved.

The modern personal hygiene and beauty industry owes much to post-Industrial Revolution developments in germ theory, which identifies microbes as vectors of disease that must be destroyed or avoided. But certain bacteria and fungi are beneficial to the body, notes Hamblin in an excerpt for the Atlantic: Demodex mites, for instance, act as a natural exfoliant, while Roseomonas mucosa blocks the growth of another bacterium linked to eczema flares. And though parabens ensure the longevity of commercial products including deodorant, shampoo, toothpaste and lotion, these preservatives also eliminate helpful microbes, upsetting the balance essential to healthy skin.

Ultimately, writes Kirkus, Hamblin argues for more skin microbiome research and greater biodiversity in all aspects of our lives, underscoring the value of pets and plants and parks to enhance our livesand those that live in and on us.

When Natasha Trethewey was 19 years old, her abusive former stepfather murdered her mother. This tragedy echoes throughout the former United States poet laureates work: In Imperatives for Carrying On in the Aftermath, she describes how abusers wait, are patient, that they / dont beat you on the first date, sometimes / not even the first few years of a marriage, and reminds herself not to hang your head or clench your fists / when even your friend, after hearing the story, / says, My mother would never put up with that.

Gwendolyn Turnboughs killing was a pivotal moment in the young poets artistic development, but as Trethewey writes in her new memoir, she avoided confronting painful memories of the murder for decades. With the publication of Memorial Drivea searing examination of the authors upbringing in the Jim Crow South and the disastrous second marriage that followed her white father and African American mothers divorceshe hopes to make sense of our history, to understand the tragic course upon which my mothers life was set and the way my own life has been shaped by that legacy.

As Publishers Weekly concludes in its review, Memorial Drive is a beautifully composed, achingly sad reflection on the horrors of domestic abuse and a daughters eternal love for her mother.

Tsuneno, the central figure in historian Amy Stanleys debut book, was the loudest, the most passionate child of a 19th-century Buddhist priest named Emon. Restless and plagued by bad luck, according to Lidija Haas of Harpers magazine, she endured three failed marriages before abandoning her tiny Japanese village in favor of the bustling city of Edo, soon to be renamed Tokyo. Here, she worked a variety of odd jobs before meeting her fourth and final husband, a mercurial samurai named Hirosuke.

In addition to presenting a portrait of a city on the brink of a major cultural shiftCommodore Matthew Perry sailed into Japan and demanded the isolationist country reopen to the West in 1853, the year of Tsunenos deaththe work conveys a strong sense of its subjects personality, from her stubborn independent streak to her perseverance and self-described terrible temper. Drawing on letters, diary entries and family papers, Stanley revives both the world Tsuneno inhabited and the wise, brilliant, skillful woman herself.

To read Stranger in the Shoguns City, writes David Chaffetz for the Asian Review of Books, is to hear the sounds of the samurai trampling through the city, smell the eels grilling in tiny food stands, [and] see the color of posters for Kabuki performances.

Journalist Matthew Van Meters exploration of Duncan v. Louisiana, a 1968 Supreme Court case that affirmed defendants right to trial by jury, is decidedly timely reading, notes Kirkus in its review. Arriving amid a global reckoning on police brutality and criminal justice, Deep Delta Justice demonstrates how a seemingly minor incident brought massive, systemic change, according to the books description.

The legal battle in question began in 1966, when Gary Duncan, a 19-year-old black teenager, was arrested for placing his hand on a white peers arm while attempting to de-escalate a brewing fight. Duncan requested a trial by jury but was denied on the grounds that he was facing a misdemeanor, not felony, charge of simple battery; a judge sentenced him to 60 days in prison and a $150 fine.

Duncan appealed the verdict with the help of Richard Sobol, a white attorney at New Orleans most radical law firm. As Van Meter writes in the books prologue, the two-year legal odysseyreconstructed through first-person interviews and archival documentseventually affirmed the function of civil rights lawyers in the South and the fundamental right to a trial by jury in all cases carrying potential sentences of at least two years.

See the article here:
An Uncrowned Tudor Queen, the Science of Skin and Other New Books to Read - Smithsonian Magazine

Salmonella was previously thought to only form biofilms in the environment, such as on food processing surfaces. Biofilms are dense collections of bacteria that stick together on surfaces to protect the bacteria from harsh conditions, including antibiotics and disinfectants. Detecting biofilms in an animal during an infection was a surprise.

In research published today in PLoS Pathogens, a VIDO-InterVac team led by Dr. Aaron White (PhD) discovered that salmonella biofilms were formed in the intestines of infected mice. For the study, the team used a mouse model to replicate human food-borne illness and showed that a biofilm protein called curlithat grows on the surface of bacteriawas connected to negative health outcomes.

Curli are a special type of protein called amyloids. Similar human proteins have been associated with neurodegenerative diseases such as Alzheimers disease, Parkinsons disease, and Amyotrophic lateral sclerosis (ALS, or Lou Gehrigs disease). Scientists don't know how these diseases start, but have speculated that something must trigger the accumulation of amyloids.

We are the first to show that a food-borne pathogen can make these types of proteins in the gut, said White, a leading expert on salmonella biofilms and curli amyloids.

There has been speculation that bacteria can stimulate amyloid plaque formation in Alzheimers, Parkinsons and ALS and contribute to disease progression. The discovery of curli in the gut could represent an important link, pointing to a potentially infectious cause for these diseases.

Collaborator Dr. agla Tkel (PhD) and her team from Temple University determined that the presence of curli led to autoimmunity and arthritistwo conditions that are known complications of salmonella infections in humans.

In mice, these reactions were triggered within six weeks of infection, demonstrating that curli can be a major driver of autoimmune responses, said Tkel.

The next step in the research is to confirm that this also occurs in humans, and test if other food-borne pathogens related to salmonella can cause similar autoimmune reactions.

This important discovery suggests that food-borne pathogens could initiate or worsen autoimmunity and have the potential to contribute to amyloid disorders such as Alzheimers and Parkinsons disease, said VIDO-InterVac Director Dr. Volker Gerdts (DVM).

ReferenceIn vivo synthesis of bacterial amyloid curli contributes to joint inflammation during S. Typhimurium infection. Amanda L. Miller et al. PLOS Pathogens,July 9, 2020, https://doi.org/10.1371/journal.ppat.1008591.

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Food Poisoning Bacteria Causes Autoimmunity and May Be Linked to Alzheimers and Parkinsons - Technology Networks

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Merck’s and Eisai’s applications seeking accelerated approval of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). The applications were based on data from the Phase 1b KEYNOTE-524/Study 116 trial, which showed clinically meaningful efficacy in the single-arm setting. These data were recently presented at the 2020 American Society of Clinical Oncology Annual Meeting and supported a Breakthrough Therapy designation granted by the FDA in July 2019. Ahead of the Prescription Drug User Fee Act (PDUFA) action dates of Merck’s and Eisai’s applications, another combination therapy was approved based on a randomized, controlled trial that demonstrated overall survival. Consequently, the CRL stated that Merck’s and Eisai’s applications do not provide evidence that KEYTRUDA in combination with LENVIMA represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease. Since the applications for KEYNOTE-524/Study 116 no longer meet the criteria for accelerated approval, both companies plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination. As such, LEAP-002, the Phase 3 trial evaluating the KEYTRUDA plus LENVIMA combination as a first-line treatment for advanced HCC, is currently underway and fully enrolled. The CRL does not impact the current approved indications for KEYTRUDA or for LENVIMA.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200708005239/en/

Merck and Eisai are continuing to evaluate the KEYTRUDA plus LENVIMA combination across 13 different tumor types in 18 clinical trials, including the LEAP (LEnvatinib And Pembrolizumab) clinical program.

About KEYTRUDA® (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s 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 industry’s 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 or Mismatch Repair Deficient 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.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

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).

Endometrial Carcinoma

KEYTRUDA, in combination with LENVIMA, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. 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 trial.

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

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

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

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

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

Immune-Mediated Colitis

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

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

Immune-Mediated Hepatitis

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

Hepatotoxicity in Combination With Axitinib

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

Immune-Mediated Endocrinopathies

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

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

Immune-Mediated Nephritis and Renal Dysfunction

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

Immune-Mediated Skin Reactions

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

Other Immune-Mediated Adverse Reactions

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

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

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

Infusion-Related Reactions

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

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

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

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

Increased Mortality in Patients With Multiple Myeloma

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

Embryofetal Toxicity

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

Adverse Reactions

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

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

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

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

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

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

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

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

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

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

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

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

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

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those 2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those 2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).

In KEYNOTE-057, KEYTRUDA was discontinued due to adverse reactions in 11% of 148 patients with high-risk NMIBC. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.4%). Serious adverse reactions occurred in 28% of patients; those 2% were pneumonia (3%), cardiac ischemia (2%), colitis (2%), pulmonary embolism (2%), sepsis (2%), and urinary tract infection (2%). The most common adverse reactions (20%) were fatigue (29%), diarrhea (24%), and rash (24%).

View post:
Merck and Eisai Receive Complete Response Letter for KEYTRUDA (pembrolizumab) plus LENVIMA (lenvatinib) Combination as First-Line Treatment for...

On June 14, I sat in a pew at a local parish for the first time in months. After weeks of virtual celebrations, I found it fitting that we would gather in-person on the feast of the Body and Blood of Christ. It felt good to be together as a communal body. Though our faces were partially covered, the familiar space and feeling of ritual allowed the anxiety of gathering to succumb, for a moment, to the peace of place and presence.

I cherished the peace, yet, as I listened to the presider's homily and then to the prayers of the faithful, I winced not at what was being said, but what wasn't.

We prayed for an end of violence, for peace, and for those working to end injustice, never once using the words race or racism, let alone "Black Lives Matter."

In the wake of the brutal murder of George Floyd and weeks of protests that swelled across the country and on our city streets, there was an implicit silence. This parish, which I'd come to know as progressive, failed to name the racism and white privilege/supremacy that has been thrust into the public consciousness.

I winced because I thought this was a place where I would be able to grapple with the Gospel and the issues of our day. I thought this was a place where I would find challenge in the face of systemic social sin and I didn't.

I also winced because I knew that most Sundays before that I wouldn't have batted an eye at the absence of the issue and these words from the preacher's mouth or our communal prayer. Speaking of justice and peace would have soothed my soul and I would have been able to carry on as usual without even noticing the omission. Yet, now, rightfully, everything seems far from normal.

"There is no way to tell the truth about race in this country without white people becoming uncomfortable." Bryan Massingale poignantly writes, "Because the plain truth is that if it were up to people of color, racism would have been resolved, over and done, a long time ago. The only reason for racism's persistence is that white people continue to benefit from it."

That last line from Massingale's must-read op-ed on white privilege and what we can do about it continues to stick with me. This is not a problem separate from me or the church or my religious congregation. It is something whose effects I witness on a daily basis be it in the classroom with students from Central and South America, watching students at our local inner city public school line up for laptops months after instruction went online, or meeting with neighbors, a majority of whom are Black and Latino, in need of food assistance and other basic needs.

We serve the needs we are aware of and learn the stories of those we walk with, all while striving to root out the causes of such racism. In the end, however, if we are honest with ourselves, we also must face the fact that we a congregation of women religious that is predominantly white benefit from unjust systems and perpetuate, despite our best efforts, implicit biases and cultural norms based on our whiteness.

The demand to admit and counteract our personal, ecclesial, societal, and congregational blindness to racism is clear. As Sr. Mumbi Kigutha clearly conveyed in these pages a few weeks ago, we must "move from a place of tokenism to a place of egalitarianism," making efforts across the board to "critically interrogate" as well as recognize, celebrate and proclaim that Black Lives Matter.

So often we pray to have our eyes opened, to see as God sees. Perhaps the first step in gaining that vision is admitting our blindness. Awakening to the fact that we might not be seeing everything is an unsettling admission. It pushes us to expand our vision, to let new light illuminate the larger reality of the world we may never have seen or wanted to see.

These past few weeks, I've heard stories of individuals in staff meetings asking for forgiveness of transgressions in sweeping statements like "if I've ever done anything to offend anyone, please accept my apology." I don't doubt the sincerity of these statements but I wonder if they are meant more to make the offender feel better than to name specific transgressions, to do the work of identifying and naming microaggressions in everyday life, or to admit to (and begin to see) the ways in which those of us in the majority have benefited and continue to benefit from a society that assumes that white lives matter more, good intentions can carry the day, and that white lives are innocent, good and somehow more worthy of protection than others.

In the same way, I think about the multitude of black squares that "blacked out" Instagram in early June in an effort to amplify black voices. This act which genuinely intended to raise awareness instead ended up largely playing out as performative allyship, giving those from non-marginalized groups who posted it a sense of having done the right thing without really helping the marginalized groups it was intended to benefit.

If we remain blind to our actions and intentions, carrying on what is "normal" and thus perpetuating the racism ingrained in our society, we serve only ourselves and impede the work of movements that are trying to create change. Our intentions, which I believe are good, can unintentionally cause harm to our sisters and brothers. Without a critical eye, we can never see what we are blind to and without naming our blind spots and those in the people we interact with, we can never hope to have the open eyes we've prayed for.

Once we can admit our blindness, we can see our blind spots more clearly.

For the past few years, I've gone to a local rec center in the city of Camden early each morning to work out. Within the first few months, I became friendly with the people who would arrive at the same time. Because it was so early, we needed to be buzzed from one part of the building to the next. The security guard on duty was notoriously tired by the time we arrived at the end of his all-night shift. One morning, two men, both of whom were black, and I arrived at the same time but the security guard was nowhere to be found.

Having seen him push the button on the desk numerous times, I wondered aloud if we might go behind the desk and do the same. My two companions looked right at me and quickly responded they were fine waiting as I craned my neck to better see the button; just then the security guard emerged from the back office wiping the sleep from his eyes. The men chuckled nervously and the guard buzzed us in. Recounting the story to a friend later that day, I heard my own confusion at the men's reaction. Then, like a light bulb going off, I realized how blind (and privileged) I had been.

I have work to do. (We all do.) More work than I can even realize at this point. I don't say this to be commended or comforted; I am simply acknowledging the uncomfortable grace I'm encountering.

This does not cover all the areas of our/my blindness. Nor does it offer an answer (or answers) to the issue of racism. In writing it, I had to admit to my blind spots and shortcomings and the inadequacies of my language. I had to face the inadequacy of the energy I have put forth in becoming anti-racist and better educating myself about the struggles of my Black and brown sisters and brothers.

In all honesty, this is an unfinished piece because we as a society and as groups and individuals are in an unfinished process. Acknowledging this fact is not to dismiss it but to underscore the work yet to be done. I pray that we all might have the presence of mind and heart to go deeper, to lift up voices we have failed to hear or seek out to listen to before, and to humbly see our blindness and illuminate it as we continue to engage in the work of change.

[A Sister of St. Joseph of Philadelphia, Colleen Gibson is the author of the blog Wandering in Wonder and has been published work in various periodicals including America, Commonweal and Give Us This Day. She currently serves as coordinator of services at the Sisters of St. Joseph Neighborhood Center in Camden, New Jersey.]

The rest is here:
Admitting blindness: seeing my blind spots and trying to do better - Global Sisters Report

HARRISBURG, Pa. (WHTM) The Department of Health is urging Pennsylvanians to take steps to prevent eye injuries that can occur more frequently during the summer months.

During the summer, many children and adults are staying active by playing outside and taking part in organized or recreational sports, Secretary of Health Dr. Rachel Levine said. While we need people to take additional precautions as part of COVID-19 when participating these types of activities, it is also very important that individuals take the proper steps to protect their eyes from serious injuries. Eye injuries can be severe and impact an individuals future and entire way of life.

According to theAmerican Academy of Ophthalmology, more than 40 percent of eye injuries each year are related to sports or recreational activities. Eye injuries are the leading cause of blindness in children in the United States, and most injuries that are reported in school-aged children are sports-related.

Ninety percent of eye injuries can be prevented through wearing protective eyewear, including safety glasses and goggles, safety shields, and eye guards. Ordinary prescription glasses, contacts, and sunglasses do not protect against eye injuries.

The Department of Health says as part of COVID-19, it is important to take steps to protect yourself from the spread of the virus while participating in organized sports. Coaches, athletes, and spectators must wear face coverings, unless they are outdoors and can consistently maintain social distancing of at least 6 feet. Athletes are not required to wear face coverings while actively engaged in workouts and competition that prevent the wearing of face coverings, but must wear face coverings when on the sidelines, in the dugout, etc. and any time 6 feet of social distancing is not possible.

The sun can also damage eyes, which is why it is important to wear sunglasses and sport-appropriate UV-protective goggles.

Even eye injuries that seem minor at first should be checked out, as serious eye issues can cause vision loss or blindness.

Top Stories:

See the rest here:
Department of Health: Steps to protect eyes this summer - ABC27

Vision Care Market: Snapshot

World over, vision care has made some significant advances on the adoption of new population health approaches, especially in developed countries, underpinning the evolution of the vision care market. The goal is to achieve the care paradigm that promotes timely, effective, safe, and equitable treatment. More importantly, vision care must conform to standards of patient-centered care. This entire ecosystem needs to be engendered by standard clinical practice guidelines. Developed markets have been shifting toward the adoption of consistent evidence-based guidelines a key aspect in the expansion of the vision care market. An effective health approach hinges squarely on these evidence-based guidelines. The need has nudged the healthcare industry for increasing the awareness about comprehensive eye examinations in various parts of the world.

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Adoption of integrated model of care is a key part of comprehensive eye examinations. These examinations have occupied a key role in the vision care market for detect incipient eye diseases. That aside, such vision care also helps in diagnosing chronic conditions. A case in point is the use of comprehensive eye examinations in detecting multiple sclerosis and diabetes in adult population. Vision screening is different from an eye examination, nonetheless very crucial. In several countries, these screenings have helped identify potential vision problems and facilitate their early treatments. The significance is most evident in community settings. Thus, vision screening is emerging out as a vital diagnostic tool in children in various populations, opening new avenues in the vision care market. In recent years, the proponents of vision care underscore the importance of global partnerships and multisectoral collaboration.

Global Vision Care Market: Overview

An upcoming report on the global vision care market by TMR Research could be a valuable source of information for major stakeholders in the market. The report would offer a brilliant study of the market with its focus on market dynamics, segmentation, and geographical outreach. It could prove to be a useful guideline for players wanting to cement their position in the global vision care market.

Vision care or maintaining eye health are the major concerns globally. Vision-related diseases elevate the risk of blindness or significant vision loss. Good vision eases out daily important activities such as writing, reading, and watching. These also helps in communication, health, work, developmental learning and impacts in overall quality of life. Various factors such as chronic diseases, pollution, and unhealthy diets can affect in functioning of the eyes. Thus, plenty of products and treatments are developed to control vision related problems.

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Global Vision Care Market: Trends and Opportunities

Increasing usage of laptops, tablets, PCs, and phones in day-to-day lives, growing older population, and rising number of vision-related problems are believed to be driving the global vision care market. Apart from blindness, there are various vision related problems such as astigmatism, myopia, macular edema, retinal tears, and diabetic retinopathy. Growing demand from the population aged 65+ years, increasing healthcare industry, and rapid technological advancement in eye care products are expected to boost the global vision care market.

Although, declining eye care treatment rate, product design, and brand name are also projected to hinder the growth in the global vision care market. However, growing brand awareness and paradigm shift in the consumer behavior are projected to propel the global vision care market.

Global Vision Care Market: Market Potential

Growing advent of innovative product launches is expected to fuel the global vision care market. There are several products available for vision care such as contact lens, glass lens, contact lens solution, and IOLs. The incorporation of technology in developing vision care products increase efficiency, improves quality and precision of the final product, and reduces overall cost. Increasing demand for restoring normal vision with eyeglasses or contact lenses, cost-effectiveness in using vision care products instead of LASIK eye surgery, and rising advanced medical treatment are believed to be driving the global vision care market.

Global Vision Care Market: Regional Outlook

Region wise, there is a possibility of North America to lead the global vision care market as the region has witnessed rapid development in healthcare industry. Growing population suffering from eye related disorders, rapid technological advancement, and increasing healthcare industry with advanced infrastructure could also be fueling the global vision care market. The prominent countries in this region are US and Canada. Easy availability of glass lens and innovative product launches with the help of modern technology are projected to propel the global vision care market in these countries.

Global Vision Care Market: Competitive Dynamics

Some of the prominent players operating in the global vision care market are Johnson & Johnson, Valeant Pharmaceuticals, Novartis, ZEISS and The Cooper Companies. The upcoming TMR report would provide crucial information on their product offerings, market standing, and strategies for progress.

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TMR Research is a premier provider of customized market research and consulting services to busi-ness entities keen on succeeding in todays supercharged economic climate. Armed with an experi-enced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

Link:
Vision Care Market Statistics, Trends, Analysis Size and Growth Factors by 2028 - Cole of Duty

ISLAMABAD:

Prime Minister Imran Khan on Friday ordered distribution of wheat from government warehouses in Punjab to the local markets to mitigate the effects of an impending flour crisis.

The bureaucracy had advised the premier to distribute wheat stocks from government warehouses in October.

However, the premier said, You should immediately bring wheat to the market and provide it at a cheaper price by setting up markets and sale points.

The premier added that if need be, wheat would be imported in October if needed.

Earlier, on Jun 9 it was reported that Pakistan is facing a shortfall of 1.4 million tons of wheat because of a decrease in yield, a development that is set to aggravate the existing flour crisis in the coming months.

The Federal Committee on Agriculture (FCA) was informed about the impending crisis during a meeting held on Wednesday, June 9, to review the Khareef season.

The wheat production target last year was set at 27 million tonnes. This year, there is a shortfall of 1.4 million tonnes and 79.95pc of the procurement target has been achieved.

Speaking during the meeting, Federal National Food Security and Research Minister Syed Fakhar Imam stressed the need to increase wheat production.

We need a breakthrough in high-yield wheat variety through genetic engineering, he added.

Our country has the best irrigation system which is not being used properly. Wheat is grown on 36pc of the countrys cultivated area.

Food Security Commissioner Dr Waseem informed the participants of the meeting that after many years, the country had exceeded the chickpea production target of 540,000 tonnes.

This year, there will be saving of Rs87 million as there will be less chickpea import, he added.

Potato production for the current year is 4.43 million tonnes against 4.4 million tonnes recorded last year. Balochistan also recorded a bumper crop of tomato this year.

Imam said there was a need to increase the production of oil seeds (sunflower, canola, rosehip and mustard).

The Indus River System Authority representative informed the participants of the meeting that there would 9pc more water available for Khareef season this year.

Originally posted here:
PM Imran orders distribution of wheat from government warehouses - The Express Tribune

Opinions of Thursday, 9 July 2020

Columnist: Joy Adzovie

File photo: Some GM crops

Genetically Modified Crops (GM crops) have generated a lot of controversies over the years. They have sparked debates among farmers and consumers alike with people always particularly paying attention to labelled GM and non-GM commodities on the market.

Some describe it as genetic modification. Some call it genetic engineering. Some call them genetically modified organisms (GMOs). Others describe them as biotechnology products, although biotechnology is a broader term. But all of them refer to the same thing.

A lot of ethical concerns have arisen about GM technology over the years. A very common claim made by some anti-GM activists is that you cannot play God which implies that scientists are defying the natural order of creation. Others are concerned about possible health risks associated with the consumption of GM foods although they have been proven scientifically to be safe, 20 years after their introduction.

In fact, in countries like USA, Brazil and South Africa, more than 80% of all soya beans, maize and cotton are GM crops. But there has been no single evidence of any of these crops negatively impacting the health of consumers in those countries. Before GM food is released for consumption, it is subjected to rigorous scrutiny which has zero tolerance for errors.

So, what exactly are GM crops?

In a bid to optimize yield, farmers have been breeding suitable varieties of crops through conventional selection for several centuries. This has made most wild ancestors of crops such as teosinte of maize go into extinction leaving the elite cultivars which look bigger and develop more desirable traits over the generations.

This method of breeding is known as selective breeding or artificial selection which is globally accepted but currently inefficient to feed a fast-growing population anticipated to reach 9.6 billion in the next couple of decades.

The exponential rise in population is inversely related to available land area hence the need for a more strategic approach to efficiently utilize the limited land resource to feed the growing global population. Also, pests and diseases, climate change, amidst other abiotic factors severely constrain crop production.

Biotechnology (which includes genetic modification) is an applied science that harnesses the natural biological capabilities of microbial, plants and animal cells for the benefit of mankind. It has changed the quality of life through improved medicine, diagnostics, agriculture and waste management, as well as offered opportunities for innovation and discoveries.

Genetic engineering is used to efficiently and precisely modify targeted plants using advanced biotechnological techniques. Advances in molecular biology have helped eliminate certain gaps in breeding such as reducing time to successfully introduce (introgress) a gene of interest into a commercial crop variety through a process called speed breeding and eradicating linkage drags associated with conventional breeding. The principle is a simple one.

To genetically improve or enhance a crop such as sweet potato which is susceptible to nematode attack, another crop such as tomato that is resistant to nematode attack is identified and the gene of interest is isolated. The gene isolated from the tomato is then introduced into the sweet potato. The host plant becomes a transgenic or genetically modified plant which expresses the desired trait (resistance to nematode) in subsequent generations.

Genetic engineering has had several uses such as in biofortification of crops to increase the concentration and availability of nutrients in crops hence solving hidden hunger problem faced by several African countries. The technology has also been used in the enhancement of plant architecture to optimize land usage and increase yield per area of land cultivated; and improved crops with heightened tolerance or resistance to both biotic and abiotic stresses including diseases and weather.

Benefits of GM crops

Some analysis shows that between 1996 and 2015, GM technology increased global production of corn by 357.7 million tons, soybean by 180.3 million tons, cotton fiber by 25.2 million, and canola by 10.6 million tons. GM crops also significantly reduced the use of agricultural land due to this higher productivity.

In 2015 alone, they prevented almost 20 million hectares from being used for agricultural purposes, thus reducing the environmental impact of cultivating forests or wildlands. This is a great environmental benefit derived from higher agricultural yield.

Unfortunately, in Africa, only a few countries including South Africa and South Sudan have allowed for the growing of GM crops and are enjoying from these benefits. Ghana has not allowed for the local production of GM crops although parliament passed a law in 2011 to allow for their introduction.

Genetic engineering is a viable way to eradicate hunger and ensure food security in the coming decades hence is pivotal to achieving Sustainable Development Goal (SDG) 2 on eliminating hunger. Yield losses due to changing or fluctuating climate, pests, and diseases, drought, acidic or saline soils and, heat stress can all be remedied by growing genetically modified crops. GM technology is a blessing to mankind and promises a hunger-free future especially in such unsettling times with the COVID-19 pandemic. Lets embrace it.

Joy Adzovie

Teaching and Research Assistant - University of Ghana

BSc. Agriculture- University of Ghana

GhanaWeb is not responsible for the reportage or opinions of contributors published on the website. Read our disclaimer.

Send your news stories to and via WhatsApp on +233 55 2699 625.

Original post:
Genetically Modified Crops: The solution to global food insecurity - GhanaWeb

ISLAMABAD:

Prime Minister Imran Khan on Friday ordered distribution of wheat from government warehouses in Punjab to the local markets to mitigate the effects of an impending flour crisis.

The bureaucracy had advised the premier to distribute wheat stocks from government warehouses in October.

However, the premier said, You should immediately bring wheat to the market and provide it at a cheaper price by setting up markets and sale points.

The premier added that if need be, wheat would be imported in October if needed.

Earlier, on Jun 9 it was reported that Pakistan is facing a shortfall of 1.4 million tons of wheat because of a decrease in yield, a development that is set to aggravate the existing flour crisis in the coming months.

The Federal Committee on Agriculture (FCA) was informed about the impending crisis during a meeting held on Wednesday, June 9, to review the Khareef season.

The wheat production target last year was set at 27 million tonnes. This year, there is a shortfall of 1.4 million tonnes and 79.95pc of the procurement target has been achieved.

Speaking during the meeting, Federal National Food Security and Research Minister Syed Fakhar Imam stressed the need to increase wheat production.

We need a breakthrough in high-yield wheat variety through genetic engineering, he added.

Our country has the best irrigation system which is not being used properly. Wheat is grown on 36pc of the countrys cultivated area.

Food Security Commissioner Dr Waseem informed the participants of the meeting that after many years, the country had exceeded the chickpea production target of 540,000 tonnes.

This year, there will be saving of Rs87 million as there will be less chickpea import, he added.

Potato production for the current year is 4.43 million tonnes against 4.4 million tonnes recorded last year. Balochistan also recorded a bumper crop of tomato this year.

Imam said there was a need to increase the production of oil seeds (sunflower, canola, rosehip and mustard).

The Indus River System Authority representative informed the participants of the meeting that there would 9pc more water available for Khareef season this year.

Read this article:
PM orders to bring wheat from government warehouse to general ma - The Express Tribune

The National Environment Management Authority (NEMA) plans to draft regulations that will guide the environmental release of genetically modified organisms.

Kasese district chairman leading a team that visited Mubuku GM cassava trial garden. PHOTOS: Prossy Nandudu

The National Environment Management Authority (NEMA) plans to draft regulations that will guide the environmental release of genetically modified organisms.

Under the revised Act of 2019, NEMA was given the mandate to regulate GMOs in the environment although the regulations were not made, until the Genetic Engineering Regulatory Act (GERA) that is before parliament is passed into law to give details on the regulatory process.

This was revealed by the executive director NEMA, Dr.Tom Okurut during a meeting organised by the Science Foundation for Livelihoods and Development (SCIFODE) at a monthly media bio cafe, on NEMA Act 2019 emerging regulations and guidelines on Wednesday.

"In the absence of a specific law for GMO regulation, we should move to draft regulations and guidelines, we didn't want to go first, now that it has stayed, we cannot delay, we must start because GMOs are already with us," said Okurut.

To ensure that the process takes shape, Okurut said they're in talks stakeholders such as the Ministry of Science Technology and Innovations (MOSTI), Uganda National Council for Science and Technology (UNCST), researchers among others to secure funding for the process.

According to Okurut, the NEMA Act 1995 had omissions especially on aspects such as oil and gas industry waste, electronic waste, and management of GMOs.

He, however, adds that these have since been catered for in the amended act of 2019, apart from the aspect of GMOs that we are supposed to make laws that will regulate it. But for NEMA to make the regulations, they had to wait for the GERA bill to be passed into law, an issue which is not yielding results.

"There are still pseudo scientists peddling lies about the technology without taking time to understand the basic science used by researchers in developing these products and we need the law to regulate the use, entry, consumption of all products from GMOs," Okurut said.

Okurut was backed by the director of regulation and biosafety at the Ministry of Science Technology and Innovations, Dr.James Kasigwa who seconded NEMA to use the amended act and regulate GMOs.

"Since we don't have a dedicated law, we can make use of NEMA act to have a stop-gap, issues of GMOs are real. Kenya now plants genetically modified cotton, they are about to release cassava and our borders are porous, what is in Kenya, will find its way into Uganda. Let us leverage any provisions in NEMA to have anything workable to put in place a regulatory framework," added Kasigwa.

Dr. Kasigwa noted that MOSTI is willing to cooperate with NEMA to ensure that a regulatory framework is in place

Currently, the agriculture sector is faced with the challenge of pests and diseases and climate change which are threatening many crops like bananas devastated by the bacterial wilt, Maize production suffers from drought-related insect pests among others.

"Fortunately many of these have been addressed through biotechnology and are in research fields waiting for regulation to be availed to the farming community to improve our productivity and competitiveness," added Isaac Ongu, the executive director of Scifode.

Follow this link:
Nema To Draft Biosafety Regulations And Guidelines - New Vision

The Genome Editing market report by Reports and Data provides an extensive overview of the vital elements of the Genome Editing market and factors such as drivers, restraints, latest trends, regulatory scenario, competitive landscape, technological advancements, and others. This is the latest report covering the current COVID-19 scenario. The coronavirus pandemic has greatly affected every industry worldwide. It has brought along various changes in market conditions. The rapidly changing market scenario and the initial and future assessment of the impact are covered in the research report. The report discusses all the major aspects of the market with expert opinions on the current status, along with historical data.

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In market segmentation by manufacturers, the report covers the following companies-

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The report also emphasizes the initiatives undertaken by the companies operating in the market including product innovation, product launches, and technological development to help their organization offer more effective products in the market. It also studies notable business events, including corporate deals, mergers and acquisitions, joint ventures, partnerships, product launches, and brand promotions.

Key Factors Explained In The Report:

Genome Editing product types, applications, geographies, and end-user industries are the key market segments that are comprised in this study. The report speculates the prospective growth of the different market segments by studying the current market standing, performance, demand, production, sales, and growth prospects existing in the market.

The segmentation included in the report is beneficial for readers to capitalize on the selection of appropriate segments for the Genome Editing sector and can help companies in deciphering the optimum business move to reach their desired business goals.

In market segmentation by types of Genome Editing , the report covers-

In market segmentation by applications of the Genome Editing , the report covers the following uses-

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Geographically, this report studies the top producers and consumers in these key regions:

North America

Europe

China

Japan

Southeast Asia

India

Objectives of the study:

Our panel of expert analysts specializing in the value chain has conducted an exhaustive, industry-wide study to offer readers accurate insights into the future of the Genome Editing market and give key market players authentic information derived via both primary and secondary sources of data collection. Additionally, the report also comprises of inputs from our consultants, which can help companies make the most of the available market opportunities. It also offers a detailed breakdown of the sales of Genome Editing and the factors that could potentially influence the growth of the industry. The information provided in this report will be able to help readers capitalize on the available growth prospects.

The Genome Editing market research covers a detailed analysis of the following data:

BROWSE THE COMPLETE REPORT AND TABLE OF [emailprotected] https://www.reportsanddata.com/report-detail/genome-editing-market

Key Questions Answered:

Inconclusion, the Genome Editing Market report is a reliable source for accessing the Market data that will exponentially accelerate your business. The report provides the principal locale, economic scenarios with the item value, benefit, supply, limit, generation, request, Market development rate, and figure and so on. Besides, the report presents a new task SWOT analysis, speculation attainability investigation, and venture return investigation.

David is an Experience Business writer who regularly contribute to the blog, He specializes in manufacturing news

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Genome Editing Market Emerging Trends, Business Opportunities, Segmentation, Production Values, Supply-Demand, Brand Shares and Forecast 2020-2027 |...

FT819 CAR T-cell Product Candidate Derived from Clonal Master iPSC Line with Novel CD19-specific 1XX CAR Integrated into TRAC Locus

Phase 1 Clinical Study will Evaluate FT819 for Patients with Advanced B-cell Leukemias and Lymphomas

SAN DIEGO, July 09, 2020 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Companys Investigational New Drug (IND) application for FT819, an off-the-shelf allogeneic chimeric antigen receptor (CAR) T-cell therapy targeting CD19+ malignancies. FT819 is the first-ever CAR T-cell therapy derived from a clonal master induced pluripotent stem cell (iPSC) line, and is engineered with several first-of-kind features designed to improve the safety and efficacy of CAR T-cell therapy. The Company plans to initiateclinical investigation of FT819for the treatment of patients with relapsed / refractory B-cell malignancies, including chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL), and non-Hodgkin lymphoma (NHL).

The clearance of our IND application for FT819 is a ground-breaking milestone in the field of cell-based cancer immunotherapy. Our unique ability to produce CAR T cells from a clonal master engineered iPSC line creates a pathway for more patients to gain timely access to therapies with curative potential, said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. Four years ago, we first set out under our partnership with Memorial Sloan Kettering led by Dr. Michel Sadelain to improve on the revolutionary success of patient-derived CAR T-cell therapy and bring an off-the-shelf paradigm to patients, and we are very excited to advance FT819 into clinical development.

FT819 was designed to specifically address several limitations associated with the current generation of patient- and donor-derived CAR T-cell therapies. Under a collaboration with Memorial Sloan Kettering Cancer Center (MSK) led by Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering, and Head, Gene Expression and Gene Transfer Laboratory at MSK, the Company incorporated several first-of-kind features into FT819 including:

The multi-center Phase 1 clinical trial of FT819 is designed to determine the maximum tolerated dose of FT819 and assess its safety and clinical activity in up to 297 adult patients across three types of B-cell malignancies (CLL, ALL, and NHL). Each indication will enroll independently and evaluate three dose-escalating treatment regimens: Regimen A as a single dose of FT819; Regimen B as a single dose of FT819 with IL-2 cytokine support; and Regimen C as three fractionated doses of FT819. For each indication and regimen, dose-expansion cohorts of up to 15 patients may be enrolled to further evaluate the clinical activity of FT819.

At the American Association for Cancer Research (AACR) Virtual 2020 Meeting, the Company presented preclinical data demonstrating FT819 is comprised of CD8 T cells with uniform 1XX CAR expression and complete elimination of endogenous TCR expression. Additionally, data from functional assessments showed FT819 has antigen-specific cytolytic activity in vitro against CD19-expressing leukemia and lymphoma cell lines that is comparable to that of healthy donor-derived CAR T cells, and persists and maintains tumor clearance in the bone marrow in an in vivo disseminated xenograft model of lymphoblastic leukemia.

Fate Therapeutics has an exclusive license for all human therapeutic use to U.S. Patent No. 10,370,452 pursuant to its license agreement with MSK1, which patent covers compositions and uses of effector T cells expressing a CAR, where such T cells are derived from a pluripotent stem cell including an iPSC. In addition to the patent rights licensed from MSK, the Company owns an extensive intellectual property portfolio that broadly covers compositions and methods for the genome editing of iPSCs using CRISPR and other nucleases, including the use of CRISPR to insert a CAR in the TRAC locus for endogenous transcriptional control.

1 Fate Therapeutics haslicensedintellectual propertyfrom MSK on which Dr. Sadelain is aninventor.As a result of the licensing arrangement, MSK has financial interests related to Fate Therapeutics.

About Fate Therapeutics iPSC Product PlatformThe Companys proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Companys first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Companys platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics iPSC product platform is supported by an intellectual property portfolio of over 300 issued patents and 150 pending patent applications.

About Fate Therapeutics, Inc.Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Companys immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Companys immuno-regulatory product candidates include ProTmune, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit http://www.fatetherapeutics.com.

Forward-Looking StatementsThis release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the advancement of and plans related to the Company's product candidates and clinical studies, the Companys progress, plans and timelines for the clinical investigation of its product candidates, the therapeutic potential of the Companys product candidates including FT819, and the Companys clinical development strategy for FT819. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk of difficulties or delay in the initiation of any planned clinical studies, or in the enrollment or evaluation of subjects in any ongoing or future clinical studies, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials or to support regulatory approval, difficulties in manufacturing or supplying the Companys product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that results observed in preclinical studies of FT819 may not be replicated in ongoing or future clinical trials or studies, and the risk that FT819 may not produce therapeutic benefits or may cause other unanticipated adverse effects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Companys actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Companys periodic filings with the Securities and Exchange Commission, including but not limited to the Companys most recently filed periodic report, and from time to time in the Companys press releases and other investor communications.Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

Contact:Christina TartagliaStern Investor Relations, Inc.212.362.1200christina@sternir.com

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Fate Therapeutics Announces FDA Clearance of IND Application for First-ever iPSC-derived CAR T-Cell Therapy - GlobeNewswire

Nanomedicine Market Overview 2020 2025

This has brought along several changes in This report also covers the impact of COVID-19 on the global market.

The risingtechnology in Nanomedicine Marketis also depicted in thisresearchreport. Factors that are boosting the growth of the market, and giving a positive push to thrive in the global market is explained in detail.

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Key Competitors of the Global Nanomedicine Market are: , GE Healthcare, Johnson & Johnson, Mallinckrodt plc, Merck & Co. Inc., Nanosphere Inc., Pfizer Inc., Sigma-Tau Pharmaceuticals Inc., Smith & Nephew PLC, Stryker Corp, Teva Pharmaceutical Industries Ltd., UCB (Union chimique belge) S.A,

Historical data available in the report elaborates on the development of the Nanomedicine on national, regional and international levels. Nanomedicine Market Research Report presents a detailed analysis based on the thorough research of the overall market, particularly on questions that border on the market size, growth scenario, potential opportunities, operation landscape, trend analysis, and competitive analysis.

Major Product Types covered are:Regenerative MedicineIn-vitro & In-vivo DiagnosticsVaccinesDrug Delivery

Major Applications of Nanomedicine covered are:Clinical CardiologyUrologyGeneticsOrthopedicsOphthalmology

This study report on global Nanomedicine market throws light on the crucial trends and dynamics impacting the development of the market, including the restraints, drivers, and opportunities.

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The fundamental purpose of Nanomedicine Market report is to provide a correct and strategic analysis of the Nanomedicine industry. The report scrutinizes each segment and sub-segments presents before you a 360-degree view of the said market.

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The report further highlights the development trends in the global Nanomedicine market. Factors that are driving the market growth and fueling its segments are also analyzed in the report. The report also highlights on its applications, types, deployments, components, developments of this market.

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Market share assessments for the regional and country level segments. Market share analysis of the top industry players. Strategic recommendations for the new entrants. Market forecasts for a minimum of 9 years of all the mentioned segments, sub segments and the regional markets. Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations). Strategic recommendations in key business segments based on the market estimations. Competitive landscaping mapping the key common trends. Company profiling with detailed strategies, financials, and recent developments. Supply chain trends mapping the latest technological advancements.

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New Comprehensive Report on Nanomedicine Market to Witness an Outstanding Growth during 2020 2025 with Top Players Like - Jewish Life News

The federal government may continue to pay for controversial human embryonic stem cell research, a federal appeals court ruled Friday.

The three-judge panel says the government has correctly interpreted a law that bans the use of federal funds to destroy human embryos for research. The ruling is unlikely to put the issue to rest and one of the judges pleaded for Congress to make clear what the government should and should not be able to do.

The hard-to-understand case pits science against mostly religious arguments against using embryos in medical research. It's even more confusing because there are so many differenlt types of cells called stem cells.

Dr. James Sherley of Boston Biomedical Research Institute and Theresa Deisher of AVM Biotechnology in Seattle, who both do research using adult stem cells and oppose the use of human embryonic stem cells, sued in 2009. They said federal guidelines violate the law and would harm their work by increasing competition for limited federal funding.

Its been back and forth in the federal courts since then, and Sherley has vowed to take the case all the way to the Supreme Court.

The embryonic stem cells at issue are the bodys master cells. Found in days-old embryos, they are the source of all the cells and tissues in the body blood, brain, bone and muscle. Researchers are studying them to investigate how disease develops and are using some as transplants to treat diseases from Parkinsons to cancer. They are being tested in people to repair spinal cord injuries and as a possible cure for some forms of blindness.

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Opponents of the research say its unacceptable to destroy a human embryo to get the cells. The 1996 Dickey-Wicker amendment, added by Congress to budget language every year, forbids the use offederal funds in research that destroys embryos.

When he was president, George W. Bush decided that the ban extended to human embryonic stem-cell research and greatly limited the federal program.

As one of his first acts after he entered office, President Barack Obama issued an executive order reversing this and encouraging the National Institutes of Health to pay for embryonic stem-cell research, so long as federal money wasnt used to directly make the stem cells. To get the cells, someone in a private lab using private money has to take apart the embryos usually left over from fertility clinics and destined for the trash can. Federal funds may be used to work with the cells that private labs make available.

On Friday, Judge Janice Rogers Brown, Judge David Bryan Sentelle, and Karen LeCraft Henderson of the U.S. Court of Appeals in Washington upheld an earlier court ruling throwing out the case. The law, they said permits federal funding of research projects that utilize already-derived embryonic stem cellswhich are not themselves embryosbecause no human embryo or embryos are destroyed in such projects.

As we have held before, the NIH interpretation of the statutes actual language is reasonable, they added.

"NIH will continue to move forward, conducting and funding research in this very promising area of science. The ruling affirms our commitment to the patients afflicted by diseases that may one day be treatable using the results of this research," NIH director Dr. Francis Collins said in a statement.

But Judge Brown wasnt entirely happy and asked Congress to please clear up the unclear wording of the Dickey-Wicker amendment and saying there are aspects of this case that should trouble the heart.

Given the weighty interests at stake in this encounter between science and ethics, relying on an increasingly Delphic, decade-old single paragraph rider on an appropriations bill hardly seems adequate, she wrote in Fridays opinion.

Supporters of the research said they were thrilled. This ensures that Americas best scientists can continue to move this work forward despite ideologically driven attempts to derail it, said Amy Rick, president of the Coalition for the Advancement of Medical Research.

There are other types of stem cells, including so-called adult stem cells, found in everyone's bodies. But scientists say they don't have the same powerful properties as embryonic stem cells. Labs are also working to re-program ordinary cells to behave like embryonic cells. A deeply divided Congress has decided not to weigh in on the issue until elections give one party or the other more power.

Maggie Fox, Senior Writer and Maggie Fox, Senior Writer

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Court rules controversial stem cell research is legal

Young or old, hospitalized or asymptomatic, anyone who had COVID-19 is at risk, doctors say

***EDITORS NOTE: This article is Part 2 of 2. Please read Part 1, "Two weeks then gone? Not even close, say doctors about the lingering effects of COVID-19" by clicking here.

Following is a breakdown of some of the lingering effects of COVID-19 infections, according doctors and public health officials treating and examining cases.

Lungs

Since coronavirus is, at its most simplified, a respiratory virus, the lungs are typically where doctors say they see the most damage.

"I think lung fibrosis is the most worrying," said Dr. Michael Hamblin, associate professor and chemist specializing in Dermatology at Harvard Medical School. "The virus damages the lungs and you get this fibrosis which dramatically decreases your breathing capacity."

Lingering lung problems can affect people of all ages, said Dr. Aileen Marty, infectious disease specialist at Florida International University. She cites international research that shows some young people who report being asymptomatic actually have scar tissue in their lungs of which they are unaware.

"When studies have been done on people who feel great, about 67% of those people have changes on chest x-rays," she said. "CT scans will then refine those images, but changes on the CT scans are worse than the changes on the film."

Young people, in particular, may not realize they have diminished lung capacity until they are older, Marty said. And because the "majority" of COVID-19 hospitalizations in Florida right now are patients in their 30s and below, she said, a significant number of younger patients might be surprised to find themselves with breathing problems down the road.

"A young person may have 150% lung capacity, so if they lose 10-15%, they don't notice it; they feel great," she said. "The problem is, we dont know how much of that tissue gets scarred up. The virus is causing the damage, it's just their youth is not letting them perceive the damage."

Neurological disease

"Patients with COVID-19 are experiencing an array of effects on the brain, ranging in severity from confusion to loss of smell and taste to life-threatening strokes," said Dr. Robert Stevens, associate director of the Johns Hopkins Precision Medicine Center of Excellence for Neurocritical Care at Johns Hopkins Medicine in a June 4 report. "Younger patients in their 30s and 40s are suffering possibly life-changing neurological issues due to strokes."

Researchers at University of Bonn in Germany in a separate June 4 publication found some of these effects might be long lasting.

"Evidence strongly suggests that patients surviving COVID-19 are at high risk for subsequent development of neurological disease and in particular Alzheimers disease," they wrote.

Even those with no prior neurological problems could find themselves with issues, as detrimental effects from the virus put COVID-19 survivors "at risk for developing long-term neurological consequences either by aggravating a pre-existing neurological disorder or by initiating a new disorder," researchers said.

Neurological disease can be evidenced by cognitive decline, in which brain cells lose function or die, resulting in reduced intellectual or motor skills.

This condition affected one-third of hospitalized patients at the time of discharge, the researchers said. They also noted a growing number of "Kawasaki-like multisystem inflammatory syndromes now being recognized in children and teenagers" something they called "clinically striking."

Symptoms of Kawasaki disease include fever, rash, inflammation of the mouth, lips and throat and swelling of the hands and feet.

Blood clots, inflammation, heart

COVID-19-induced blood clots can result in strokes, heart attacks, pulmonary embolisms and kidney failure, as well as prevent oxygen flow to the hands and feet, Hamblin said.

"A lot of people ended up with necrosis of the extremities, so they have fingers and toes amputated because they turn black from COVID," he said. "Your blood inappropriately clots and you get no blood supply to the extremities and they die."

COVID-19-induced hyper-inflammation, which can result in respiratory failure or other severe problems, is also something he said doctors are working to understand.

One cause may be a "cytokine storm," which is when the body releases too many infection-fighting substances into the bloodstream.

"[The body] is trying to limit the infection and overcome the virus; however, it leads to an excessive inflammatory response rather than harming the virus," researchers said in a June 2 paper published in the U.S. National Library of Medicine.

University of Bonn researchers warn that inflammation can result in long-lasting, detrimental effects on the brain.

"The fact that systemic inflammation has been shown to promote cognitive decline and neurodegenerative disease makes it likely that COVID-19 survivors will experience neurodegeneration in the following years," they wrote.

While inflammation is observable, the underlying causes are less so, Hamblin said. And that is something doctors must determine if they hope to treat it effectively.

"The question is, is it the virus affecting the cells of the blood vessels or is it more like a serious infection where the immune cells go into overdrive and create systemic inflammation?" he said. "Local inflammation is not too bad, but systemic inflammation is very bad."

Kidneys

Kidneys act as a filter to eliminate toxins, waste and excess water from the body. Blood clots caused by COVID-19 can impair the kidneys ability function, leading to a host of problems throughout the the body.

"If the kidney function isn't normal, that's going to be a very significant issue over time," said Dr. C. John Sperati, kidney specialist and associate professor of medicine at Johns Hopkins Medicine.

Chronic kidney disease can lead to heart disease, as well as the need for dialysis. High potassium, acid, and protein levels; swelling of the arms and legs; and fluid in the lungs are indicators one might have kidney trouble, he said.

Those with pre-existing conditions are most likely to suffer kidney damage from COVID-19, but people with no previous kidney problems are also at risk, he said.

"In some cases 90% of ventilated patients in the ICU have gone on to develop kidney issues," he said. "If you were in the ICU, there is a 50-70 percent chance of kidney damage. Many of those will get better, but we dont have enough data to see how much recovery they will have."

Sperati said people tend to seek care for lung or heart problems before kidney trouble because the symptoms of the former tend to be more apparent. Unless kidney damage is severe, he said, many people might not know they have a problem until a blood test is performed.

"Its going to be one of those sort of silent killers thats under the surface," he warned. "If it resolves, good, but if it doesnt, that becomes a major health issue that needs to be addressed over time."

Psychological issues

Suffering through a COVID-19 infection, particularly for those who have been hospitalized or intubated, can be emotionally and mentally devastating, said Dr. Jessi Gold, assistant professor of psychiatry at Washington University in St. Louis, Missouri.

"When you leave the ICU, you can end up having dreams and not know if the things happened to you or not," she said. "You might have these really dark visions."

Like physical symptoms, psychological symptoms can persist even after the virus is gone.

"Just because you were in the ICU and lived, doesnt mean you are better," Gold said. "It can take months and months, if not years, and you can end up very different than your previous self."

Anxiety and depression, including Post Traumatic Stress Disorder, or PTSD, can accompany flashbacks, nightmares or a crushing sense of being unable to breathe, she said.

Even the most common stressors reported by ICU patients are exacerbated during COVID-19, she said. Feelings of isolation and worry are heightened because family and friends are typically not allowed to visit and nurses must avoid unnecessary contact with sick patients.

Those who convalesce at home can also be traumatized, she said, because fear of contracting the virus may cause those who would otherwise help out to steer clear, leaving the patient miserable and alone.

One area in need of additional research involves the idea that some psychological implications related to COVID-19 may be caused by factors beyond a persons individual experience while ill, Gold said.

"I wouldn't be surprised if there are things that we will find out over time where well see that the disease itself causes biological problems that affect the brain and your mood and how you are feeling," Gold said. "That it is not the circumstance the experience, stress, anxiety or trauma of it but that it is actually coming from the disease itself."

Click here to read Part 1, "Two weeks then gone? Not even close, say doctors about the lingering effects of COVID-19."

@WendyRhodesFL

wrhodes@pbpost.com

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Lingering effects of COVID-19 on the lungs, heart, brain, kidneys and immune system - Palm Beach Post

A lot of scientific brain power and research dollars are being going to tests and treatments for the novel coronavirus. And much recent attention has been focused on antibody testing. Theres a lot of excitement, because the presence of antibodies in your blood can reveal if youve been infected previously with the virus and produced an immune response to fight it off. But beyond that basic finding, theres not much scientific evidence to translate what this means to your own health, as well as others.

Before I bust the biggest myths about the testing, its important to know exactly what antibodies are. Theyre proteins produced by the body that recognize and bind to a virus. Once this happens, a process is triggered, which inactivates the virus and eliminates it from the body. This is the bodys natural immune response to a viral infection.

And while the field of immunology and antibody response has been studied for decades and is well-defined for many viruses (like polio), when it comes to COVID-19, the whole process is not well understood because its a never-seen-before virus.

So before you consider going for a COVID-19 antibody test, its time to do a little myth-busting to first understand what your results actually can tell you. Remember to always talk with your doctor for personal guidance.

MYTH #1: All antibody tests provide reliable information

Fact: Only a fraction of the tests advertised meet FDA specifications. At first, the FDA didnt require manufacturers to get authorization from the agency, making test quality very inconsistent. But this changed on May 4, when the FDA announced that all companies had to submit validation data and apply for emergency utilization authority (EUA) to sell a test. Fewer than 20 of the dozens of tests available have achieved that so far. Always look for a test that documents accuracy of at least 99 percent, and ideally 99.5 percent. The FDA lists this information on their website.

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MYTH #2: All antibody tests measure the same thing

Fact: Different tests measure different types of antibodies, with some more specific than others. A positive test only indicates that you were infected at some point in the past.

The typical first responder antibody of the immune system is called IgM (immunoglobulin M). Another type, IgA, found in the lining of the respiratory and digestive tracts contributes to the early response. The body next produces IgG (immunoglobulin G), an antibody better able to recognize and target a specific virus. The IgM component typically disappear after a few months, while the IgG lasts longer, and is likely the most useful measure for longer term immunity.

Only the small number of antibody tests receiving EUA authorization from the FDA are reliable, as they are at least 99 percent accurate and specific for particular antibodies directed against COVID-19. Some tests are measuring other kinds of viral antibodies.

Otherwise, you are open to a greater likelihood of a result that is a false positive (you really DONT have antibodies) or a false negative (you really DO have them). Either false result doesnt help make informed health decisions.

MYTH #3: If you have antibodies, you are protected from getting the virus again

Fact: There is no evidence that a positive antibody test protects you from another infection.With the presence of antibodies, there is some protection, but theres still no information on how long that protection lasts and what level of antibodies you need to get that protection. A reliable antibody test only indicates if your body has produced antibodies to a previous infection. It also does NOT tell you if you have an active infection.

MYTH #4: You can go to your doctors office for a test

Fact: An antibody test cannot be done at a doctors office. You need to go to a large laboratory chain like Quest Diagnostics or LabCorps. And you can request the test via your primary care doctor, or schedule it directly. Its important to check with your insurance carrier for coverage.

And remember that this is a blood test, with a scheduled blood draw at the lab. While there is a home test available, using a pin-prick blood test, the accuracy is uncertain and not recommended at this time.

Madelyn Fernstrom, PhD is NBC News health editor. Follow her on Twitter @drfernstrom.

See the article here:
Busted! The 4 biggest myths about COVID-19 antibody testing - NBC News

Lack of sleep can increase risk of high blood pressure

Lack of sleep or sleep deprivation can play havoc with your health. For starters, it can negatively affect your immunity and may interrupt with your weight loss goals. Not sleeping well for nights in a row can affect your mental abilities as well. Getting less than seven hours of sleep on a regular basis can lead to health consequences that affect your entire body. Digestive system, respiratory system, immune system and central nervous system can all be affected by lack of sleep or sleep deprivation.

Insufficient sleep has been linked to a number of health problems. Here are some of them.

1. Weight gain: Not sleeping well for even one night can put your body in sleep debt. What's worse is that it may increase cravings and appetite. Sleep deprivation disturbs the balance of chemicals which signal the brain that you are full. As a result, you are likely to overeat even if you are full. This may lead to weight gain, obesity and other health risks linked to being overweight.

2. Low libido: Not sleeping well can lower your sex drive. The decrease in libido in men maybe because of a drop in testosterone levels.

Also read:Disrupted Sleep And Your Relationship With Food: Know The Surprising Link

3. Diabetes risk: Body's release of insulin can be affected by lack of sleep. Insulin is the hormone which is required to regulate blood sugar levels. People who don't sleep sufficiently are likely to have higher blood sugar levels and are at higher risk of developing type 2 diabetes.

4. Weak immunity: Sleeping too less can affect immune system's ability to fight virus that cause cold, flu and other infections. It makes you more susceptible to getting sick on being exposed to germs.

5. Mood swings: Being sleep deprived for too long can make you short-tempered, moody and emotional. Being chronically sleep deprived can lead to anxiety and increase risk of depression.

6. Poor concentration and focus: Your thinking, problem-solving skills, concentration and creativity can be negatively affected if you are sleep deprived and haven't rested well.

Lack of sleep can affect your thinking, concentration and focusPhoto Credit: iStock

Also read:Losing Out On Sleep Amidst Lockdown? Milk, Eggs And Bajra Can Help

7. Poor balance: Balance and coordination can be negatively affected if you have not been sleeping well off late. It increases your risk of falls and accidents.

8. High blood pressure: Sleep deprivation needs to be taken seriously by hypertension patients. Sleeping for less than five hours at night increases your risk of getting high blood pressure.

9. Heart disease risk: High blood pressure is one of the top causes of heart disease. Sleep deprivation can also increase inflammation in the body, which can also increase risk of heart disease.

10. Poor memory: When you are asleep, the brain forms connections that can help you process and remember information. Not sleeping well can affect both short and long-term memory.

Also read:Do You Have Sleep Apnoea? Know The Symptoms; It May Cause Memory Loss, Depression

Working on your sleep and making time for it no matter how busy your life is, can help in preventing sleep deprivation.

Also read:Increased Stress, Disturbed Sleep And Other Risks Associated With Drinking Too Much Alcohol

Disclaimer: This content including advice provides generic information only. It is in no way a substitute for qualified medical opinion. Always consult a specialist or your own doctor for more information. NDTV does not claim responsibility for this information.

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Weak Immunity And 9 Other Risks Associated With Sleep Deprivation - NDTV

Dr. Rebecca Auer says the study could help experts understand why some COVID-19 patients are relatively asymptomatic while others end up in intensive care or die

OTTAWA A national clinical trial this summer will focus on protecting cancer patients against severe COVID-19 infectionby attempting to boost their compromised immune system.

Researchers from The Ottawa Hospital say they want to explore the potential of IMM-101, a preparation featuring a dead pathogen containing properties that can stimulate the "first-response arm" of the immune system.

Study lead Dr. Rebecca Auer, surgical oncologist and director of cancer research at the Ottawa Hospital, says it could help experts understand why some COVID-19 patients are relatively asymptomatic while others end up in intensive care or die.

"The difference it seems between these two different presentations has to do with how strong your innate, or your sort of non-specific, first-line defence immune system response is to the virus," Auer said Wednesday.

"And so we're hoping that by boosting and stimulating this innate immune response, particularly in those vulnerable patients that have a reduced immune response to begin with, we'd be able to prevent symptomatic infections and prevent serious infections."

Cancer patients are at much higher risk of severe complications from COVID-19 because chemotherapy, cancer surgeryand radiation treatments suppress innate immunity even further.

Auer points to an "urgent need" to protect them while the world waits for an effective COVID-19 vaccine, which could take another year or more to develop, test, and implement.

A successful trial could also protectcancer patientsagainst other respiratory infections as well as the coming flu season, says Auer, noting the threat of illness is a fairly big problem for those undergoing treatment.

"A study demonstrated that about 13 to 15 per centof cancer patients will have to delay or stop their treatment because of influenza during the average flu season," she says.

"And also cancer patients don't respond as well to the influenza vaccine every year because their immune system isn't as strong. So we think that the IMM-101 may in itself be able to help prevent symptomatic influenza infections."

Auer says IMM-101 has also been tested elsewhere for its anti-cancer properties and that, too, will be examined in this trial, although it's not the primary objective.

The researchers say the bacteria, Mycobacterium obuense, is safe to use in cancer patients because it has been killed by heat.

The Canadian study will recruit 1,500 patients currently receiving cancer treatment,and participants will be randomly assigned to receive either regular care, or regular care plus IMM-101.

Auer says the treatment would be administered as an injection in the arm, to be followed by two more booster shots.

Researchers will follow patients for a year, watching for any respiratory infections and monitoring whether the treatment works and how long it lasts.

The trials will take place in eight centres located in Ontario, British Columbia and Quebec.

Researchers saypeople interested in participating should speak with their cancer specialist.

Researchers from the Ottawa Hospital came up with the idea and worked with the Canadian Cancer Trials Group at Queen's University to design the trial.

Dr. Chris O'Callaghan of the Queen's University group notes cancer patients are also at greater risk of COVID-19 infection because they require regular medical care, making it difficult to adhere fully to public health guidelines.

"These patients are unable to practice social isolation due to the need to regularly attend hospital to receive critically important cancer treatment, says O'Callaghan, who will oversee the trial.

Auer says asuccessful trial of IMM-101 could also suggest usefulness in treating any patient with a reduced innate immune system, such as older patients with chronic illness.

She notes that the tuberculosis vaccine known as BCG which uses a similar formulation to IMM-101 but uses live bacteria instead of dead bacteria is being tested around the world to see if it can boost the immunity of health-care workers exposed to COVID-19.

Funding and in-kind support, valued at $2.8 million, comes from the Canadian Cancer Society, BioCanRx, the Ontario Institute for Cancer Research, The Ottawa Hospital Foundation, The Ottawa Hospital Academic Medical Organization, ATGen Canada/NKMax, and Immodulon Therapeutics, the manufacturer of IMM-101.

By Cassandra Szklarski in Toronto

This report by The Canadian Press was first published July 8, 2020.

The Canadian Press

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Erythritol Market Data Breakdown with Revenue and Gross Profit Analysis 2020-2026

The GlobalErythritolMarket report provides a detailed analysis of the market all key factors affecting global and regional markets, including drivers, imprisonment, threats, challenges, opportunities and industry-specific trends. This business research document puts forward an in-depth evaluation of each crucial aspect of the worldwide market that relates to the Erythritol Market size, market share, market growth factor, key vendors, revenue, top regions, industry trends, product demand, sales volume, capacity, cost structure, and expansion in the Erythritol Market. The report begins from overview of Industry Chain structure, and describes industry environment, then analyses market size and forecast of Erythritol by product, region and application, in addition, this report introduces market competition situation among the vendors and company profile, besides, market price analysis and value chain features are covered in this report.

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Global Erythritol Industry Developments and Assessment 2020-2026 | Zibo ZhongShi GeRui Biotech, Zhucheng Dongxiao Biotechnology - Owned

Facial Injectable Marketreport covers the COVID 19 impact analysis on key drivers influencing market Growth, Opportunities, the Challenges and the Risks faced by key players and the Facial Injectable market as a whole. The complete profile of the worldwide top manufacturers like (Bloomega BioTechnology, Allergan, Merz Pharma, Bausch Health, Galderma, Integra Lifesciences, Tei Biosciences, Fibrogen) is mentioned such as Capacity, Production, Price, Revenue, Cost, Gross, Gross Margin, Sales Volume, Sales Revenue, Consumption, Growth Rate, Import, Export, Supply, Future Strategies, and The Technological Developments that they are making are also included within this Facial Injectable market report. The historical data from 2012 to 2020 and forecast data from 2020 to 2026.

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Scope of Facial Injectable Market:Facial Injectable, also commonly known as Dermal Fillers, are the products used for aesthetic purposes such as anti-aging and enhancing the appearance of facial skin and help in a trending application known as bio-engineering or facial rejuvenation.

Geographically, North America dominated the facial injectable market driven by a high number of aged and adult population, higher awareness, higher spending on such treatment, presence of world class infrastructure and service providers and stringent guidelines in the region.

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Facial Injectable Market Trends and Forecast Analysis by Business Manufactures and Product Type-Bloomega BioTechnology, Allergan, Merz Pharma, Bausch...