Although people who recover from COVID-19 usually gain some immune defenses against reinfection, they get additional protection from vaccines, especially against severe disease, according to two studies published on March 31 in The Lancet Infectious Diseases. Additionally, two gold-standard trials published in The New England Journal of Medicine on March 30 help settle questions about two controversial therapies touted by many early in the pandemic with decidedly mixed results – failure for the antiparasite drug ivermectin and success for antibody-rich blood plasma from COVID-19 survivors.
Y-mAbs Therapeutics Inc. announced that the company completed the resubmission of its Biologics License Application (BLA) for 131I-omburtamab to the U.S. FDA.
Merck’s Acceleron Integration To Take Out 143 Jobs in Cambridge, MA
Anemia, Blockbusters, Blood Vessels, Business, Cambridge, Clinical Trials, Committee for Medicinal Products for Human Use (CHMP), Erythroid maturation agents, First-In-Class, Job Cuts, Keytruda, Massachusetts, Pulmonary Arterial Hypertension, R&D, Royalties, Therapeutics, Transforming Growth Factor-beta (TGFb)Merck announced that the company will lay off 170 people from Cambridge, Massachusetts-based Acceleron Pharma, which was acquired during November 2021 for about $11.5 billion.
The U.S. Centers for Disease Control and Prevention (CDC) on March 29 updated its recommendation to allow certain immunocompromised individuals and people over the age of 50 to receive an additional booster dose of COVID-19 vaccines.
Bayer to Highlight New Cardiovascular and Renal Data at ACC.22, Including Late-Breaking Presentations for KERENDIA as Well as Oral Factor XIa Inhibitor Program
American College of Cardiology, Bayer, Business, Cardiovascular, Clinical Data, Clinical Trials, Factor XIa (FXIa) Inhibitors, First-In-Class, Kidney Disease, Kidneys, Medical Societies, Mineralocorticoid Receptor Antagonists (MRAs), Pharma Companies, R&D, TherapeuticsBayer will present a range of new clinical data at the American College of Cardiology’s 71st Annual Scientific Session (ACC.22), being held April 2-4, 2022, in Washington, D.C. Data from KERENDIA® (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA)1 and asundexian, an investigational oral Factor XIa inhibitor2 will be presented at the meeting. These data highlight Bayer’s ongoing commitment to patients with cardiovascular (CV) and kidney diseases.
Pfizer announced positive top-line results from the company’s year-long Phase III trial of etrasimod for the treatment of ulcerative colitis (UC). Pfizer plans to pursue regulatory filings for the drug during 2022.
HIV drugs may lower COVID risk; COVID and flu co-infection raises risk of severe illness, death
Clinical Trials, Coronavirus Disease (COVID-19) Pandemic, HIV, Hospitalized COVID-19 Patients, Influenza, Nasal Sprays, Protease inhibitors, R&D, SARS-CoV-2 virus, Small Molecules, The Lancet, TherapeuticsCertain drugs used to treat HIV may have a role in preventing SARS-CoV-2 infections, according to preliminary data that may help explain why people living with the condition have not appeared to be at higher risk for serious COVID-19 despite being generally more vulnerable to infections. Additionally, having COVID-19 and influenza at the same time puts hospitalized adults at much greater risk of critical illness and death compared to having COVID-19 without the flu, researchers reported in The Lancet.
Novo Nordisk receives FDA approval of higher-dose Ozempic 2 mg providing increased glycemic control for adults with type 2 diabetes
Approvals, Blockbusters, Blood Sugar Levels, Cardiovascular Events, Deaths, FDA/Regulatory, Glucagon-Like Peptide-1 (GLP-1) Analogs, Heart Attacks, Heart Diseases, New Doses, Stroke, Therapeutics, Type 1 DiabetesThe U.S. Food and Drug Administration approved a 2 mg dose of Novo Nordisk’s Ozempic (semaglutide) injection, a once-weekly glucagon-like peptide-1 (GLP-1) analog indicated along with diet and exercise to improve blood sugar in adults with type 2 diabetes and to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes and known heart disease.
Retrospective Study on Real-World Treatment Patterns and Outcomes of Acthar Gel in Patients with Refractory Rheumatoid Arthritis Published in Drugs in Context
Autoimmune Diseases, Drugs in Context, NSAIDs, Peer-Reviewed Analysis, Refractory rheumatoid arthritis (RA), Standard of care drugs, TherapeuticsGlobal biopharmaceutical company Mallinckrodt plc announced the publication of findings from a retrospective medical records study assessing the real-world utilization and outcomes of Acthar Gel (repository corticotropin injection) in patients with refractory rheumatoid arthritis (RA) that did not adequately respond to standard-of-care therapies.
Checkpoint inhibitor pioneer James P. Allison, who won the 2018 Nobel Prize in Medicine, will helm a new research and innovation hub at The University of Texas MD Anderson Cancer Center that is focused on developing new immunotherapy breakthroughs in oncology.