As expected, the FDA's Vaccines and Related Biological Products Advisory Committee voted near-unanimously on Dec. 17, with one abstention, that available evidence shows the benefits of Moderna Inc.'s COVID-19 vaccine, mRNA-1273, outweigh its risks for people 18 and older. The vote bolsters the likelihood that the regulator will grant the vaccine an emergency use authorization (EUA), which could come as soon as Friday. Not the same as an approval, the authorization would allow for the vaccine's use for the prevention of COVID-19 in the U.S. even as further trials and regulatory evaluation remains underway ahead of a company BLA submission. Read More
The licensing deal with Glaxosmithkline plc (GSK) gives Surface Oncology Inc. “enough cash to take us through the next three years” and plenty of flexibility to continue its internal work, CEO Jeff Goater told BioWorld. GSK, of London, is gaining exclusive worldwide development and commercial rights to Cambridge, Mass.-based Surface’s preclinical program with SRF-813. Read More
By acquiring privately held Cadent Therapeutics Inc., Novartis AG gains full rights to Cadent’s allosteric modulator program, part of which the two companies began collaborating on in 2015, and all the company’s outstanding stock. Cambridge, Mass.-based Cadent will receive as much as $770 million, $210 million of it up front, plus $560 million in milestones. Read More
Macrogenics Inc., which started the year with a pipeline prioritization, ends 2020 with its first FDA approval. The agency cleared its HER2-targeting Fc-engineered monoclonal antibody margetuximab in combination with chemotherapy for use in patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. Read More
HONG KONG – Hummingbird Bioscience Pte. Ltd. is collaborating with artificial intelligence (AI) company Tempus Labs Inc. to advance HMBD-001, a differentiated anti-HER3 neutralizing antibody developed using Hummingbird's Rational Antibody Discovery platform, into clinical trials in HER3-driven cancers, including those that harbor neuregulin 1 (NRG1) fusions. Read More
New hires and promotions in the biopharma industry, including: Advanced Proteome, Beyondspring, CASI, Eom, Evaxion, Immune Regulation, Keros, Medigene, Rinri, Spero, Tessa, Touchlight. Read More
