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The FDA has upheld the accelerated approval of Jazz Pharmaceuticals’ Zepzelca (lurbinectedin), even though the drug failed to reach its primary endpoint in the confirmatory Phase III ATLANTIS trial.
Alnylam Pharmaceuticals released its report for Q3, in which the company stated it will no longer initiate a Phase III trial for vutrisiran in Stargardt disease.
Two Phase III trials of Genentech (Roche)'s Vabysmo hit the primary endpoint in macular edema caused by branch and central retinal vein occlusion, showing non-inferiority to Regeneron’s Eylea.
Minneapolis-based DiaMedica Therapeutics plans to conduct additional studies in order to resolve a clinical hold on its DM199 program for the treatment of acute ischemic stroke (AIS).
Candel revealed a collaboration with the University of Pennsylvania to assess the combination of Candel’s viral immunotherapy and UPenn’s CAR-T cell treatments in solid tumor models.
With diagnostics for Alzheimer’s already approved and therapeutics in late-stage clinical trials, the next hurdle is to translate these advances into clinical practice. The Davos Alzheimer’s Collaborative is working on it.
VitroLabs Inc, the California based biotech company leading the commercialization of cell cultivated animal leather, announces the appointment of two new members to its Board of Directors
The FDA’s Oncologic Drugs Advisory Committee voted unanimously against approving l-omburtamab for children with a rare form of neuroblastoma, citing complex review issues.
Merck, Bristol Myers Squibb, Biogen and others presented their latest data from MS programs at the 38th ECTRIMS conference.
An FDA adcomm that met Wednesday to vote on GlaxoSmithKline’s daprodustat for adult patients with anemia due to chronic kidney disease (CKD) produced mixed results.
AstraZeneca released data Wednesday morning from two studies in breast cancer: the Phase III CAPItello-291 trial studying capivasertib and the Phase II SERENA-2 trial studying camizestrant.
One month after a contentious FDA advisory meeting, Oncopeptides announced positive data from the Phase III LIGHTHOUSE trial of Pepaxto in RRMM patients.
The FDA has greenlit the use of Johnson & Johnson’s Tecvayli in heavily pretreated adult patients with relapsed or refractory multiple myeloma.
BioSpace checked in with some of the members of our NextGen Bio Class of 2022 to see what they’ve done to earn their place on the list - and what’s on the horizon.
Ipsen hit another stumbling block in its bid for an FOP approval as the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee postponed its meeting on the NDA for palovarotene capsules.
GSK terminated its cell therapy pact with Lyell Immunopharma. It’s opting to advance its own programs without use of Lyell’s T-cell modulating technologies that were at the center of the partnership.
Normunity is launching its creation of novel precision anti-cancer immunotherapies, backed by $65 million of Series A financing, the company announced Tuesday.
AstraZeneca reported Tuesday that its Phase III MESSINA trial hit one primary endpoint but missed the other. The study was evaluating Fasenra in eosinophilic esophagitis.
Novartis’ positive-third quarter growth report was slightly marred by several clinical setbacks that resulted in the termination of studies in liver transplant and non-small cell lung cancer.
If you want to maximize your career earnings, it pays to consider which cities are the most affordable. Here are the top five most affordable cities for biopharma in the U.S.