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Disc Medicine’s leadership tried to express optimism that its rare disease therapy bitopertin can be approved based on a Phase 3 trial set to begin shortly. However, analysts are worried that the protocol was developed with former FDA leaders.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
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The world’s largest buyer of biopharma royalties is paying $300 million up front and $200 million in milestone payments for Ferring Pharmaceuticals’ FDA-approved bladder cancer drug Adstiladrin.
In the next two weeks, the FDA will hand out regulatory verdicts to BMS, Outlook Therapeutics and BioLineRx.
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 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.
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.
As competition for life sciences talent peaks, BioSpace has undertaken research to determine what employers can do to ensure they don’t lose out on talent they actually want to hire and retain.