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.
FROM OUR EDITORS
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 company’s sales guidance for 2023 has been raised to $98.8 billion to $99.8 billion, driven by cancer drugs and medical devices. J&J’s stock rose about 5% in early trading Thursday.
The program—a joint initiative between CDER and CBER—aims to accelerate the development of therapies for rare diseases.
The company is handing back a multivalent Shigella vaccine candidate to LimmaTech Biologics, which spun out in 2015 after GSK’s acquisition of GlycoVaxyn for $190 million.
Illumina is laying off 79 workers in San Diego, and according to an internal email, more layoffs will be announced soon.
At almost 80,000 square feet, the addition will allow the Japan-based to create jobs for in-office and hybrid workers in the region.
The proposed regulatory framework provides a tougher stance on mergers, impacting industries such as biopharma where the FTC’s recent lawsuit seeks to block Amgen’s Horizon Therapeutics buy.
The Federal Trade Commission and the company had been in settlement discussions, but those talks have ended as the agency’s antitrust lawsuit seeks to block the Horizon Therapeutics sale.
Republican lawmakers have called on the Food and Drug Administration to explain its foreign inspection programs for drug manufacturers in China and India as shortages continue in the U.S.
With Eisai and Biogen’s Leqembi now fully approved, researchers are exploring combinations—including with therapies targeting tau and microglial function—that could increase its effectiveness.
BioSpace rounded up companies with products for Alzheimer’s, ALS, Parkinson’s and Huntington’s in the final stages of clinical testing.