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The FDA has so far secured 600 new hires and is looking for 1,600 more as interim leadership at the agency aims to rebuild the workforce and morale after more than a year of intense attrition.
Speaking to media on Tuesday, BIO CEO John Crowley complimented China’s rise as a biotech powerhouse but said U.S. policy needs to protect and maintain America’s lead.
While merger and acquisition activity has been robust of late, frequent changes in guidance and leadership at the regulator add risk to any transaction.
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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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On the heels of several big buys, Merck still has eyes for M&A—particularly in the oncology, immunology and cardiometabolic spaces—as the quest continues for a candidate that can top Keytruda.
Foundayo became available on April 9 and has already reached 20,000 patients as Eli Lilly builds its marketing machine for the weight loss pill.
UniQure plans to submit AMT-130 to the U.K.’s Medicines and Healthcare products Regulatory Agency in the third quarter of 2026 based on Phase 1/2 data showing a 75% slowing of disease—the same data the FDA has deemed unacceptable for a biologics license application.
After delaying a late-stage readout last year due to “irregularities” at certain study sites, pivotal data for Bristol Myers Squibb’s Cobenfy appear set to arrive later this year.
Eli Lilly’s $19.8 billion revenue for the first quarter could have been higher if not for declining prices for key medicines like Zepbound, Mounjaro and Taltz.
The patient death occurred outside the U.S. and was deemed unrelated to Newron Pharmaceuticals’ investigational schizophrenia drug.
While AstraZeneca has discontinued work on four assets—including one in asthma and another in acromegaly—the pharma has also elected to take forward a bispecific antibody that destroys the EGFR protein.
Over the last two years, Alector has suffered three setbacks for its neurodegenerative disease pipeline, often forcing the company to downsize.
Amylin drugs have become the next big thing in obesity. Eli Lilly CEO David Ricks, understandably, thinks his rivals don’t have a chance for one key reason.
In this episode of Denatured, you’ll be hearing from Yaniv Sneor, founder of the Mid Atlantic Bio Angels and Alex Pederson, an investor at Mid Atlantic Bio Angels and partner at Alloy Bio Consulting. We discuss why a life sciences-only angel group matters, how they evaluate opportunities, and the importance of strong teams, capital efficiency and a realistic path to exit.