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The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
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Gilead Sciences has inked three deals this year so far totaling $14.77 billion, a marked escalation of the company’s usual M&A pace. Executives detailed the rationale for buying Arcellx, Ouro Medicine and Tubulis GmbH and whether they are interested in further deals.
As Daré Biosciences approaches a pivotal year with a key product launch ahead, the company kicked off an open public offering, providing a chance for individuals to get involved for as little as $250.
The upcoming FDA decision for Replimune’s advanced melanoma drug could be a litmus test for the agency’s future regulatory decision-making, analysts say, with implications stretching well beyond one company.
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As Big Pharma companies consider foregoing European drug launches to avoid reducing drug prices in the U.S. in alignment with Trump’s Most Favored Nation policy, patients will suffer.
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With CBER director Vinay Prasad set to depart the agency at the end of the month, a coalition of patient groups and biotech executives penned a letter imploring the Trump administration to “restore regulatory clarity” for rare disease therapies. Experts on a BioSpace panel last week also acknowledged the challenges faced by a more stringent FDA.
As Big Pharma companies consider foregoing European drug launches to avoid reducing drug prices in the U.S. in alignment with Trump’s Most Favored Nation policy, patients will suffer.
COVID-19 partners Pfizer and BioNTech have been unable to recruit healthy adults aged 50 to 64 fast enough to deliver relevant post-marketing data. Moderna is apparently also facing enrollment challenges.
In this episode of Denatured, you’ll listen to Dr. Marc Hedrick, President and CEO of Plus Therapeutics and Dr. Phil Kantoff, CEO & Co-founder of Convergent Therapeutics. They discuss breakthroughs like alpha-emitting isotopes, supply chain solutions and why radiotherapeutics is biotech’s next big frontier.
As Novo Nordisk cuts 400 jobs at the troubled site, Scholar Rock has seen enough progress that it included the facility in a resubmission for FDA approval.
The FDA approved Eli Lilly’s orforglipron—to be known as Foundayo—on Wednesday, officially igniting what analysts believe will be a fierce rivalry with Novo Nordisk’s oral Wegovy.
Of the 11 companies participating in the spring cohorts of the Drive program run by MassBio and SCbio, eight have locations in Massachusetts. One cohort focuses on biotech and the other on biomarkers and diagnostics.
Biogen, Eli Lilly, Merck and Novartis spent more than $20 billion to absorb biotechs with promising or approved drugs; the rare disease space notched approvals for therapies from Denali Therapeutics, Rocket Pharmaceuticals and Biogen; and Wave’s stock lost half its value after its RNA-based obesity candidate failed to impress investors.
While peptides are currently the dominant approach to GLP-1 agonism, Ambrosia Biosciences is pursuing a small-molecule approach.
The FDA in January asked Amgen to pull Tavneos from the market, citing liver toxicity issues that affected the drug’s overall risk-benefit profile. The pharma refused.