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Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the reshoring of pharmaceutical manufacturing.
Former European Trade Commissioner Phil Hogan and former US Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
Heightened diligence standards and longer decision timelines for early-stage startups slowed venture activity last year, J.P. Morgan found in a report published ahead of the bank’s annual healthcare conference in San Francisco.
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With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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The partners have yet to disclose what their priority indications are, though EVOQ’s NanoDisc technology aims to enable the development of potentially curative treatments for autoimmune conditions such as celiac disease and type 1 diabetes.
An unnamed source clarified that Sandra Retzky has not been fired from the FDA, but it remains unclear where she was reassigned.
Veradermics is the second hair regrowth specialist to fundraise this week, after Pelage Pharmaceuticals announced Wednesday it had brought in $120 million for its own therapy.
BioSpace’s Q3 2025 U.S. Life Sciences Job Market Report reveals a turbulent quarter for biopharma hiring, with record declines in job postings, rising layoffs, and cautious employer sentiment shaping the industry’s employment landscape.
Due largely to CSL, Merck and Novo Nordisk’s reorganizations that could total about 19,350 people, Q3 cuts rose significantly year over year and quarter over quarter, based on BioSpace tallies.
Novo Nordisk strikes another deal, this time with Omeros, amid a broader pipeline restructuring that recently claimed its cell therapy work.
After beating Novo Nordisk’s semaglutide last month, Lilly’s much anticipated oral candidate orforglipron has taken down AstraZeneca’s Farxiga in a head-to-head trial.
Despite announcing a broad pivot to siRNA earlier this year, Sarepta is following through with an investigational gene therapy: its limb-girdle muscular dystrophy candidate. But the treatment’s path forward, analysts say, is highly uncertain.
The company is pursuing a Phase III trial for its topical stem cell-rejuvenating molecule that aims to reactivate hair growth.
2025 has been a busy year for Boehringer Ingelheim, which has so far inked at least five hefty partnerships—including its latest one with South Korea’s AimedBio for an antibody-drug conjugate therapy for cancer.