Clinical research
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.
Kailera Therapeutics and Hengrui Pharma’s weekly injection showed benefits beyond weight loss in a mid-stage trial, leading to more regular menstrual cycles in patients with polyendocrine metabolic ovarian syndrome.
Merck has revealed detailed data for tulisokibart from a mid-stage trial in hidradenitis suppurativa that analysts say could help carve out a place in a crowded market that already includes AbbVie’s Humira and UCB’s Bimzelx.
Bristol Myers Squibb will soon release Phase 3 data for admilparant that could make or break Contineum Therapeutics’ rival product. But reports of a death due to liver injury in the pharma’s program have caused some unease about the drug class.
Amid rising industry concerns about U.S. competitiveness with China, the Trump administration is rolling out four ARPA-H initiatives to modernize clinical trial design, site activation, consent and patient data collection.
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.
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.
It’s not enough for organizations to want scientists to think like entrepreneurs. They have to incentivize and reward for that behavior.
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.
PRESS RELEASES