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In the next two weeks, the FDA will hand out regulatory verdicts to BMS, Outlook Therapeutics and BioLineRx.
The Danish drugmaker is leveraging Thermo Fisher Scientific as Wegovy demand surges and amid production problems with manufacturer Catalent, Reuters reported on Wednesday.
Data suggests divarasib could be more potent than already approved KRAS inhibitors from Amgen and Mirati, but the study’s authors caution against cross-trial comparisons.
The company appears to be terminating the development of two Phase I antibody-drug conjugates in cancer, ABBV-011 and the Pfizer-partnered ABBV-647.
After slimming down its infectious diseases and vaccines business, Johnson & Johnson now appears to be ending research and development at a Dutch-based unit, except for a few programs.
The consumer healthcare brand is joining the growing biosimilars market in the U.S. with its new subsidiary Cordavis, which will market a Humira biosimilar as its first product.
To successfully compete against one another and Big Pharma for top talent, biotech companies need to do a better job of selling themselves.
After identifying structural variations in the 19-gauge filter needle included in some eye injection kits, Apellis has advised doctors to only use 18-gauge kits already in circulation and that will be distributed.
Spurred by an “inadvertent” disclosure, Roche’s Genentech on Wednesday released interim and immature overall survival findings for its anti-TIGIT antibody tiragolumab in non-small cell lung cancer.
Under the $1.4 billion Project NextGen initiative, Regeneron was awarded a $326 million grant for its preventive monoclonal antibody, while Johnson & Johnson got $10 million to bankroll startups.
The RET kinase inhibitor showed “statistically significant and clinically meaningful improvements” in progression-free survival compared to Exelixis’ Cabometyx and Sanofi’s Caprelsa.
The biotech’s experimental vaccine has shown a neutralizing response to XBB sublineages of COVID-19, which currently dominate new cases in the U.S. and Europe.