While the FDA’s approach to evaluating safety and efficacy in the development and review of COVID-19 vaccines for the U.S. market will be at the center of its Oct. 22 advisory committee meeting, the panel also will be asked to discuss the practicalities, and ethics, of continuing to conduct trials once a candidate has been granted an emergency use authorization. Read More
With a Nov. 6 FDA adcom meeting on Biogen Inc.'s Alzheimer's candidate, aducanumab, creeping ever closer, the candidate's prospects stole the show in its third-quarter earnings report, even outshining attention to the cloud of generics raining on the company's years-long Tecfidera (dimethyl fumarate) parade. FDA acceptance for aducanumab's BLA lines the candidate up for a priority review and regulatory action by March 7, the company said. Furthermore, global progress remains underway, with an EU marketing application now made and one in Japan on deck. Read More
Nuvation Bio Inc. and Panacea Acquisition Corp., a special purpose acquisition company (SPAC) sponsored by Ecor1 Capital, said they will merge, with the combined company to be renamed Nuvation. Read More
Crispr Therapeutics AG's first stab at developing an allogeneic CAR T-cell therapy, CTX-110, looks promising, but the efficacy data were overshadowed by a death in the study. Read More
Chinese pharma giant Huadong Medicine Co. Ltd. has licensed rights to mirvetuximab soravtansine, an antibody-drug conjugate (ADC) for ovarian cancer, from Immunogen Inc., marking its first step into a realm embraced by a growing number of Chinese biopharma player: innovative medicines. Read More
PERTH, Australia – Sydney-based Actinogen Medical Ltd. will advance its lead compound, Xanamem, into two proof-of-concept phase II studies in Alzheimer’s disease and fragile X syndrome. Read More
To end criminal and civil claims stemming from its marketing of Oxycontin (oxycodone hydrochloride) and other opioid products, Purdue Pharma LP agreed Oct. 21 to pay more than $8 billion and to cease operating as a for-profit private company – provided the court presiding over its bankruptcy agrees. Read More
New hires and promotions in the biopharma industry, including: Avrobio, Azurrx, Bicycle, Medicinova, Neoleukin, Pharmaessentia, Rheos, Taiwan Liposome, Tempest. Read More
Biopharmas raising money in public or private financings, including: Aptinyx, C4X, FSD, Idorsia, Kiromic, Praxis, Regenerx, Replimune, Tarsus. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB Science, Affinivax, Biogen, Briacell, Cidara, Crispr, Gilead, Mycovia, Myovant, Onxeo, Pfizer, Trevi, Vir. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adial, Ascentage, Cyclo, Diurnal, Effrx, Hillstream, Pharming, Protagonist, PTC, Roche, TG, Xeris, Zosano. Read More
