Eisai and Biogen completed the rolling submission of a Biologics License Application for their proposed Alzheimer’s disease drug to the U.S. Food and Drug Administration.
Like COVID, Life Science Industry Finances Gain and Lose Strength
Antivirals, BioNTech, Biopharma, Blockbusters, Business, Coronavirus Disease (COVID-19) Pandemic, COVID-19 Antibodies, Diabetes, Eli Lilly, Forecasts, GlaxoSmithKline, Initial Public Offering (IPO), Investors Business Daily, M&A, Moderna, Multiple Sclerosis, Paxlovid, Pfizer, Plasma, Quarterly results, Shingles, Stock Markets, Stocks, Teva, Therapeutics, Vir BiotechnologyAlthough 2020 was a tough year for the biopharma industry — and most other industries as well — it appeared to rebound significantly in mid-2021. However, biotech stocks are generally getting hammered during 2022, although to be fair, the entire stock market is down.
AstraZeneca, Argenx Score Phase III Wins in Autoimmune Space
AstraZeneca, Autoimmune Diseases, Biologics, Bleeding Disorders, Central Nervous System, Chronic Immune Thrombocytopenia (ITP), Clinical Trial Endpoints, Clinical Trials, Generalized Myasthenia Gravis (gMG), Mayo Clinic, Medical Centers, Neuromyelitis Optica Spectrum Disorder (NMOSD), Primary Endpoints, R&D, Rare Disorders, Supplemental Biologics License Application, TherapeuticsTwo biologic therapeutic candidates met their primary endpoints in separate Phase III trials: AstraZeneca’s Ultomiris and Argenx’s Vyvgart.
Regeneron Overcomes Loss of COVID Antibody to Post Positive First Quarter
Acquisitions, Biologics License Application (BLA), Blockbusters, Business, COVID-19 Antibodies, FDA, Monoclonal Antibodies, Quarterly results, REGEN-COV (casirivimab and imdevimab), Regeneron Pharmaceuticals, Sales, Sanofi, TherapeuticsDespite the loss of the company’s COVID-19 antibody REGEN-COV earlier in 2022, Regeneron posted a positive first quarter driven primarily by sales of Dupixent and Eylea.
Heat Biologics announced that a new development is underway in the company’s partnership with subsidiary Scorpion Biological Services.
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.
Halozyme Therapeutics announced that the company is acquiring Antares Pharma for $960 million in cash. The news caused Antares stock to rocket 47 percent in premarket trading on April 13.
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.
Sanofi plans to list the company’s drug ingredients subsidiary EUROAPI on May 6, saying the business is set to grow and improve its profitability as a separate business.
In Expected Decision, FDA Rejects Lilly’s Sintilimab in NSCLC
Alliances, Biologics License Application (BLA), Business, Checkpoint Inhibitors, Clinical Trials, Complete Response Letter, EGFR tyrosine kinase inhibitors (TKI), Eli Lilly, FDA, Hepatocellular Carcinoma, Non-Squamous Non-Small Cell Lung Cancer (NSCLC), PD-1 Inhibitors, R&D, TherapeuticsThe U.S. Food and Drug Administration rejected Eli Lilly’s Biologics License Application, issuing a Complete Response Letter for the company’s PD-1 checkpoint inhibitor sintilimab.