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Implemented as part of a broader initiative to make more targeted and efficient use of inspection resources, the pilot program will use artificial intelligence to enable shorter, focused screenings to complement standard FDA inspections.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.
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AbbVie and Novartis strike billion-dollar pacts while attendees at the J.P. Morgan Healthcare Conference await that one big M&A deal and Merck teases limitless buying capacity; Eli Lilly readies for potential orforglipron launch while Novo Nordisk laments compounders; the IPO window cracks open; and the FDA concludes that GLP-1s do not pose a suicide risk.
Speaking to BioSpace at the J.P. Morgan Healthcare Conference, Novartis’ chief dealmaker Ronny Gal explains why the Swiss pharma hasn’t acquired a GLP-1, and why it probably won’t.
There hasn’t been a headline-stealing deal at J.P. Morgan yet. Nevertheless, the mood is positive amid green shoots and a flurry of dealmaking to end 2025.
Merck CEO Rob Davis expressed high confidence during the company’s J.P. Morgan presentation on Monday, revealing that the company is open to deals in the range of “multi tens of billions of dollars.”
Acadia Pharma’s Catherine Owen Adams is one of the founders of a group of small- to mid-cap biotechs advocating against a ‘peanut butter blanket’ approach to drug pricing for small companies.
Johnson & Johnson’s second facility in Wilson, North Carolina, is part of a $55 billion push to make all advanced medicines used in the U.S. domestically.
The FDA previously rejected Zycubo for Menkes disease in October last year, citing issues with the drug’s manufacturing facility.
Jefferies analysts forecast a $1 billion market opportunity for each of Sarepta’s siRNA programs for facioscapulohumeral muscular dystrophy and myotonic dystrophy type 1.
Facing the loss of exclusivity on key products, Pfizer has pulled forward its lead obesity asset into Phase III and targeted a 2028 launch. CEO Albert Bourla explained the pharma’s strategy at J.P. Morgan on Monday.
Obesity took center stage on the first day of the 2026 J.P. Morgan Healthcare Conference, with industry frontrunners Eli Lilly and Novo Nordisk providing supply chain, regulatory and pricing updates.