Regulatory
The FDA has taken important steps through Operation TrialBlazer and stronger scrutiny of foreign clinical data, but more must be done to make the United States more competitive in attracting clinical trials as China’s capabilities rise.
A surge of consolidation, rising appetite for specialized manufacturing and a shift toward decentralized trials is reshaping Switzerland’s life sciences landscape. From peptide producers to organoid CROs, service providers are scaling and diversifying as global sponsors turn to Swiss hubs for talent, innovation and regulatory strength.
In this episode of Denatured, you’ll hear from Max Bronstein, CEO of Aviva Strategies and Teresa Barnes, Chief Executive Warrior of PF Warriors. We dig into why U.S. patients are losing access to rare disease trials happening abroad and how the FAIR Act’s accelerated, harmonized reviews could help the U.S. keep pace while getting lifesaving studies to patients faster.
Ebvallo, which Pierre Fabre Pharmaceuticals and Atara Biotherapeutics are proposing to treat a posttransplant complication, joins a wave of rejected or discouraged therapies on which the FDA has reversed previous guidance after the exit of former Commissioner Marty Makary.
Summit Therapeutics scores a $2 billion equity investment from AstraZeneca to support ivonescimab’s late-stage development; uniQure crashes after four-year data from its Huntington’s disease gene therapy failed to impress; Kyverna Therapeutics brings new light to a struggling CAR T space in autoimmune disease.
The results are nevertheless “unprecedented,” UniQure executives said on an investor call Tuesday, emphasizing that the updated natural history database used as the control group for the Phase 1/2 study of AMT-130 underestimates disease progression.
In the Phase 3 TEMPO program, AbbVie’s Juvmo elicited significant improvements in motor symptoms and prolonged periods with good symptom control.
Merck and Daiichi Sankyo’s withdrawal of an accelerated approval request for the antibody-drug conjugate ifinatamab deruxtecan is a “net positive” for rivals like GSK and Roche, according to RBC Capital Markets.
Stem cell therapies vary widely yet many physicians still treat them as interchangeable. A more credible model requires diagnostics, product characterization and conventional medical context to determine who and when should receive regenerative treatment.
In Thursday’s Senate committee meeting, FDA commissioner nominee Heidi Overton was repeatedly questioned about her ability to retain the FDA’s independence under President Donald Trump, as well as about her views on vaccines and abortion drugs.
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