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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Read our takes on the biggest stories happening in the industry.
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
The ADARx Pharmaceuticals partnership, which could be worth “several billion dollars” in the end, adds to AbbVie’s existing work in the space after the $1.4 billion acquisition of Aliada Therapeutics in October 2024.
GSK secures rights to Boston Pharmaceuticals’ efimosfermin alfa, which the pharma plans to develop for fatty liver diseases such as metabolic dysfunction-associated steatohepatitis and alcohol-related liver disease.
Belrestotug showed underwhelming efficacy outcomes in mid-stage studies of non-small cell lung cancer and head and neck squamous cell carcinoma.
Roche envisions its Indianapolis site as a “major hub” for the manufacturing of its continuous glucose monitoring systems. The news comes on the heels of an announced $700 million investment in North Carolina.
President Donald Trump unwrapped a massive drug pricing policy as CMS prepares for the next round of Medicare drug price negotiations; Vinay Prasad to take the helm at the FDA’s Center for Biologics Evaluation and Research; Bayer cuts 2,000 more employees; Eli Lilly’s Zepbound scores again; and the Galapagos story turns again.
The number of employees laid off increased year over year during the first quarter. BioSpace recaps the five largest rounds of layoffs, which included BMS and Novartis cuts.
It’s another wild twist in the story of Galapagos, a company that has been around for more than 25 years but has yet to get a therapy approved.
Meanwhile, Bayer CEO Bill Anderson said Donald Trump’s Most Favored Nations policy could present an opportunity for European countries to make sure they are also funding their “fair share” of biopharma innovation.
The commitment is part of Roche’s recently announced $50 billion investment in the U.S., but a company spokesperson said that could change if certain yet-unspecified policies are implemented that could “harm our industry’s ability to operate and innovate in America.”
The third cycle of the drug price negotiations will involve drugs under Medicare Part B. New prices are set to take effect in 2028.