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.
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The acquisition provides the Swedish company with an approved JAK inhibitor for myelofibrosis, a rare bone marrow cancer that disrupts the body’s normal production of blood cells.
The biotechnology industry may not suffer as many losses as other industries due to generative AI, but the future of the job market is still uncertain for some.
Elfabrio’s label contains a boxed warning for hypersensitivity reactions, such as anaphylaxis, and recommends that medical support measures should be on standby when administering the treatment.
Developers of psychedelics-based therapies say the industry is poised to explode, with several reporting strong clinical trial results and the FDA granting breakthrough status for two hallucinogenic drugs.
The biotech company shuffled deals around Tuesday, dropping a four-year collaboration with Israel’s Entera Bio and picking a new partner in Massachusetts-based TScan Therapeutics.
The layoffs will go into effect on July 25, according to a Worker Adjustment and Retraining Act (WARN) notice filed in April.
The biopharma company scored two major wins on Tuesday: a court victory over HIV patent claims and an acquisition deal to expand its pipeline in cancer and inflammatory diseases.
The layoffs come as the company posts nearly $300 million in net losses and just over $80 million in revenue during the first quarter of 2023.
The pharma company will lay off 170 employees and drop all candidates but one, as it seeks to rebuild its business.
The delay and guidance downgrade follow a spate of operational issues that have affected three of Catalent’s major manufacturing sites.