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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.
FEATURED STORIES
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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Read our takes on the biggest stories happening in the industry.
Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies.
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Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Speaking at a conference this morning, Pfizer CEO Albert Bourla suggested that Metsera’s therapies could begin hitting the market in 2028.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
Korro Bio is moving back to square one as a preclinical biotech after the failure of KRRO-110 in alpha-1 antitrypsin deficiency. The company’s stock is down 80% on all the news.
The decision to pause dapiglutide will help Zealand focus investment into assets that have “the greatest potential for clinical differentiation” in obesity.
In January, AbbVie and Calico’s fosigotifator failed to show significant signs of efficacy in the HEALEY ALS platform trial for amyotrophic lateral sclerosis.
Alixorexton’s Phase II performance sets it up for late-stage success, according to analysts at Truist Securities. Alkermes expects to launch a global late-stage program early next year for narcolepsy type 2.
The plausible mechanism pathway “could accelerate gene therapy/editing development,” analysts at William Blair said Thursday, while adding that additional clarity is needed.
The back-heavy deal includes a $5 million upfront payment for two novel T cell engagers, though the companies have yet to disclose priority indications.
In this episode presented by Slone Partners, Leslie Loveless, Co-CEO and Managing Partner discusses how hiring and the building of executive teams has responded to the current biotech environment.