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.
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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.
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Part B of the study, cleared to proceed in Canada, remains on hold in the U.S. due to findings from non-clinical chronic toxicology studies.
The Swiss pharma is expanding its neuroscience pipeline with an upfront $500 million payment to DTx Pharma and additional payments of up to $500 million upon completion of certain milestones.
Following disappointing topline data, BridgeBio’s acoramidis has scored a late-stage win in transthyretin amyloid cardiomyopathy, leading to significant survival and quality of life benefits.
The Federal Trade Commission is asking for more information regarding Pfizer’s planned $43 billion acquisition of Seagen, according to the latter’s Securities and Exchange Commission filing on Friday.
Full data for Eli Lilly’s Phase III TRAILBLAZER-ALZ 2 study, presented Monday at the 2023 Alzheimer’s Association International Conference, confirm positive results announced in May.
This week: Cancer license deals from J&J and BeiGene, a potential $7B acquisition by Roche and confirmed $1.9B Lilly buy, EU fine for Illumina, and more legal challenges to the Inflation Reduction Act
Eli Lilly said Friday it plans to pay up to $1.925 billion to acquire Versanis and its lead asset, bimagrumab, a monoclonal antibody that aims to reduce fat mass without affecting muscle mass.
Bringing new drugs to the market costs billions of dollars. It could not be done without investments by both the NIH and biopharma companies.
The Swiss pharma is in talks to acquire Roivant Sciences’ RVT-3101, an anti-TL1A antibody that recently showed promising results in a Phase IIb ulcerative colitis trial, reports The Wall Street Journal.
A new report by the U.S. Government Accountability Office finds that despite the promise of regenerative medicine technologies they are held back by regulatory and manufacturing challenges.