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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.
Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of new approach methodologies, experts told BioSpace,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.
Kali Therapeutics’ T cell engager, for which Sanofi is initially paying $180 million, could potentially be developed for a range of B cell–driven autoimmune disorders.
The FDA detected 14 cases of vitamin B6 deficiency–linked seizures and two deaths in patients with Parkinson’s disease taking carbidopa/levodopa drugs. Both AbbVie and Novartis market levodopa-based products.
PRESS RELEASES
Partnership will enhance physician awareness of START’s portfolio of trials, streamline referrals, and support patient access to early-phase oncology research
● Findings from collaboration with global immunology company argenx show HypoSkin as translational human-based New Approach Methodology (NAM) platform ● SOT 2026 poster on early local tolerance screening demonstrates potential to reduce reliance on animal testing
CEO, Daniel Haders II, PhD, to address the inference throughput barrier in AI-driven drug discovery and lead a roundtable on deploying LLMs and AI agents to navigate the multi-parameter optimization challenge in small molecule drug design