News
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
FEATURED STORIES
Dual and even triple or quadruple track processes have come roaring back in 2026 thanks to a glut of M&A that has refilled investors’ wallets. Big Pharma is being put on notice that time is critical if they want to acquire.
Policymaking at FDA has been anything but business as usual under the Trump administration, but former regulators cite the agency’s new investigational new drug pilot program as a sign of normalcy.
The FDA’s recently altered outlook on the evidence required for approval of rare disease drugs could have immediate benefits for companies including Skyhawk Therapeutics, Capricor Therapeutics and Biohaven.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
THE LATEST
From the price of forthcoming weight loss pill orforglipron, to Most Favored Nation drug pricing and the market battle with Novo Nordisk, pricing was the number one issue for Eli Lilly on its second quarter earnings call.
Higher competition for fewer roles remains the status quo for biopharma professionals, based on BioSpace data. Additionally, the U.S. Bureau of Labor Statistics has reported that recent job growth is lower than previously believed.
Strand Therapeutics’ lead asset is STX-001, an intra-tumor self-replicating mRNA therapy that carries a payload expressing the immunomodulatory protein IL-12.
Eli Lilly’s orforglipron cut body weight to a lesser extent than rival Novo Nordisk’s semaglutide, falling into analysts’ bear scenario for the oral med. Executives brushed off the concerns and said the drug will still have a wide advantage on the market.
Sarepta did not hold an investor call for its second-quarter earnings report or provide an updated full-year revenue outlook.
In this episode presented by Cresset, BioSpace’s head of insights Lori Ellis discusses the emerging geopolitical battle for AI supremacy and global AI governance with Mutlu Dogruel, VP of AI and Mark Mackey, CSO of Cresset.
The small molecule drug, acquired by Jazz Pharmaceuticals in its $935 million Chimerix pick-up this spring, is intended for relapsed adult and pediatric patients with H3 K27M mutations.
The German giant has already trimmed more than 10,000 employees since initiating a massive restructuring initiative in July 2023. Bayer said even more cuts are coming as it weathers up-and-down sales across its portfolio.
Terns, once a rising star in obesity and the MASH space, will refocus on cancer and partner out a handful of obesity assets.
Maziar Mike Doustdar, who was named as Novo Nordisk’s new CEO last week, spoke on a second quarter earnings call of reallocating resources to the company’s “main core” of metabolic disease.