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UniQure plans to submit AMT-130 to the U.K.’s Medicines and Healthcare products Regulatory Agency in the third quarter of 2026 based on Phase 1/2 data showing a 75% slowing of disease—the same data the FDA has deemed unacceptable for a biologics license application.
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We must treat drug resistance as a central scientific priority rather than an unavoidable complication.
Altitude Labs, an offshoot of AI-focused techbio Recursion, is teaching scientists to build companies, one founder at a time.
With six acquisitions already this year, Eli Lilly’s business development shows no signs of stopping as executives make good on a promise to spend their GLP-1 gains.
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While ersodetug missed the Phase 3 primary endpoint of a reduction in hypoglycemia events, Rezolute argued that this goal was confounded in part by behavioral factors. The FDA acknowledged the validity of this argument.
FDA
Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of new approach methodologies, experts told BioSpace, particularly emphasizing the agency’s recommendations around defining NAMs’ regulatory purpose.
Like its pharma peers, Novartis is pouring money into Chinese operations, including expansions and upgrades at an existing manufacturing facility.
Aardvark Therapeutics’ obesity asset is based on its lead molecule, which in February was linked to reversible heart safety signals in a healthy volunteer study.
Gilead’s median employee compensation in 2025 was $238,979. Daniel O’Day’s compensation package is 119 times larger.
Following last month’s $7.8 billion purchase of CAR T biotech Arcellx, Gilead’s dealmaking train chugs along with yet another acquisition—this time securing Ouro Medicines’ pipeline of T cell engagers for inflammatory diseases.
The biotech industry needs to stop waiting for a rebound. The pandemic changed everything, though not in the ways most people think.
If the U.S. can help Japan reform its drug pricing controls, both countries stand to benefit.
Healthcare investor Kevin Tang and his allies now hold almost every leadership position at Aurinia Pharmaceuticals, the company at the heart of former CDER Director George Tidmarsh’s exit from the FDA.
The multivalent candidate, being developed by Pfizer and French partner Valneva under a 2020 pact, generated higher than 73% efficacy against the tick-borne disease in a Phase 3 trial—but failed to hit a predetermined confidence interval.