Pfizer Inc. on April 29 said a large trial found that the company’s COVID-19 oral antiviral treatment Paxlovid was not effective at preventing coronavirus infection in people living with someone infected with the virus.
FDA approves Bristol Myers’ oral heart disease drug
Approvals, Boxed Warning, Bristol Myers Squibb, Cardiac Arrest, Cardiac myosin inhibitors, FDA, Genetic Inflammatory Conditions, Heart Disease, Heart Muscles, Hypertrophic cardiomyopathy (HCM), Left Ventricular Ejection Fraction (LVEF), Oral Therapy, Therapeutics, Wholesale Acquisition CostThe U.S. Food and Drug Administration (FDA) approved Bristol Myers Squibb’s oral heart disease drug, making Camzyos (mavacamten) the first cardiac myosin inhibitor to be permitted for use in the country.
AstraZeneca’s Alexion Scores Third FDA Approval For Ultomiris
Alexion, Approvals, AstraZeneca, Blockbusters, C5 Complement Inhibitors, Clinical Trial Endpoints, Clinical Trials, FDA, Generalized Myasthenia Gravis (gMG), Neuromuscular Disorders, New England Journal of Medicine, New Indications, Primary Endpoints, R&D, Secondary Endpoints, Supplemental New Drug Application (sNDA), TherapeuticsAstraZeneca’s Alexion received a supplemental New Drug Application approval for Ultomiris (ravulizumab-cwvz) from the U.S. Food and Drug Administration to treat adults with generalized myasthenia gravis (gMG).
Nektar Cuts 70% of Workforce on Heels of BMS-Partnered Collapse
Autoimmune Disease, Bladder Cancer, Blockbusters, Bristol Myers Squibb, Business, Cancer, CAR-T Therapy, Checkpoint Inhibitors, Clinical Trials, Collaborations, Job Cuts, Melanoma, Product Pipeline, R&D, Renal Cell Carcinoma (RCC), ReorganizationNektar Therapeutics outlined a strategic reorganization plan that includes cutting 70 percent of the company’s workforce, only weeks after Bristol Myers Squibb abandoned its clinical collaboration program with Nektar on bladder cancer and renal cell carcinoma.
The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee is holding a meeting on April 21, 2022, to discuss safety findings across the entire class of PI3K inhibitors for hematological cancers.
Arcturus Therapeutics announced positive Phase III trial results for the company’s mRNA vaccine candidate ARCT-154, which is intended to prevent COVID-19 caused by the SARS-CoV-2 virus.
Omicron infection induces limited immune response in unvaccinated; COVID hospital deaths rise on weekends
Coronavirus Infections, COVID-19 Antibodies, Covid-19 Data, COVID-19 Deaths, COVID-19 Studies, Covid-19 Variants, Immune Response, Messenger RNA (mRNA) Vaccines, Omicron (B.1.1.529) (South Africa), Omicron BA.2, R&D, World Health OrganizationUnvaccinated people infected with the Omicron variant are unlikely to develop immune responses that will protect them against other variants of the coronavirus, a new study suggests. Additionally, the average number of global deaths from COVID-19 were 6 percent higher on weekends compared to weekdays throughout the pandemic, according to statistics reported to the World Health Organization between March 2020 and March 2022.
Two strategic biopharmaceutical collaborations were announced, each merging one company’s innovative biologic technology with a second company that can drive potential therapeutics over the finish line to commercialization.
GlaxoSmithKline is acquiring California biopharmaceutical firm Sierra Oncology for $1.9 billion in a deal expected to help both companies take a major step in developing a treatment for rare types of cancer.
AACR: Monday’s Stars Include Affimed, Hoth and Blueprint
American Association for Cancer Research (AACR), Antibodies, Checkpoint Inhibitors, Clinical Trials, DNA, Efficacy Data, Epidermal Growth Factor Receptor-Mutated (EGFRm) Non-Small Cell Lung Cancer (NSCLC), Hodgkin Lymphoma, Microsatellite instability-high (MSI-H) cancer, Non-Hodgkin Lymphoma, PD-1/PD-L1 inhibitors, R&D, Solid Tumors, TherapeuticsThe American Association for Cancer Research (AACR) Annual Meeting is running from April 7-13 in New Orleans, with hundreds of presentations on cutting-edge cancer research. The presentations run the gamut from preclinical studies to late-stage clinical trials. BioSpace looks at some of the preclinical and early-stage studies presented.