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The FDA’s drug review process can often be “unpredictable,” and review teams typically “differ greatly” in what they ask of drug sponsors, Sen. Bill Cassidy said.
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FDA vouchers are normally a coveted prize for biopharma companies, but a surprise rejection for Disc Medicine’s rare disease drug has biopharma reconsidering.
PitchBook’s 2025 biopharma VC analysis clocked $33.8 billion in capital dispatched in 2025, mainly to companies with later-stage programs ready to roll into the clinic.
Long an R&D company that partnered off assets, RNAi biotech Ionis Pharmaceuticals shifted in 2025 to bring two medicines to market alone. Analysts are already impressed—and there’s more to come in 2026.
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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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A BioSpace LinkedIn poll found that job ghosting and ghost jobs are the biggest pet peeves for applicants now. Recruitment Manager Greg Clouse offers advice on dealing with them.
Helmed by Roche alums, Newleos Therapeutics is taking over four drugs dropped from the Swiss pharma’s pipeline in early 2024.
Year-over-year BioSpace data show there were fewer job postings live on the website in the fourth quarter of 2024, and the decrease was higher than the third quarter’s drop.
Biogen and Eisai have spent much of Leqembi’s launch convincing physicians and patients that it’s safe to treat Alzheimer’s disease. With patients now hitting the 18-month mark of treatment, the conversation is finally shifting to efficacy.
The pharma giant inked its third T cell engager deal of 2025 Wednesday—this time with Xilio Therapeutics for tumor-activated immunotherapies.
The Boston-area company’s previous raises were also aimed at getting its investigational antibody treatment for inclusion body myositis through clinical trials. Now, Abcuro is eyeing a regulatory submission and potential launch.
The funding agreement comes as Biogen revealed a modest Q4 sales beat, which analysts expect will be “overshadowed” by the company’s forecasted dip in 2025 revenues.
The approval comes days after Germany’s Merck KGaA confirmed it was in advanced talks to acquire SpringWorks.
Just a few months after Vir Biotechnology lost an emergency authorization for its COVID-19 antibody, Marianne de Backer stepped in as CEO to answer a critical question: What’s next?
The partnership dates back to 2015, when Incyte paid $60 million upfront for access to four checkpoint programs, including TIM-3, LAG-3, OX40 and GITR.