BioSpace

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 #pharma #biospace hubs.li/Q0488jfV0

Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of new approach methodologies, experts told BioSpace,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. #FDA #regulatory #biospace hubs.li/Q0484gXs0

Like its pharma peers, Novartis is pouring money into Chinese operations, including expansions and upgrades at an existing manufacturing facility. #manufacturing #pharma #biospace hubs.li/Q04838v_0

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. #obesity #biospace hubs.li/Q0483flx0

Gilead’s median employee compensation in 2025 was $238,979. Daniel O’Day’s compensation package is 119 times larger. #pharma #biospace hubs.li/Q0483bSf0

Pay equity remains a critical issue in life sciences. In 2025, women’s total earnings were 88% of men’s, and the gender pay gap remained unchanged from the past two years. The 2026 BioSpace Salary Report examines ongoing gaps in total earnings, along with broader trends across compensation, benefits and career mobility. Download your FREE salary report here: hubs.li/Q047-mG30 #payequity #careers #salarytrends #hiring #biospace

If the U.S. can help Japan reform its drug pricing controls, both countries stand to benefit. #opinion #pharma #biospace hubs.li/Q04835HV0

The biotech industry needs to stop waiting for a rebound. The pandemic changed everything, though not in the ways most people think. #opinion #biotech #biospace hubs.li/Q048341S0

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. #biotech #biospace hubs.li/Q0482-qs0

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. #CDER #FDA #biospace hubs.li/Q047Y9PV0

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. #vaccines #pharma #biospace hubs.li/Q047XdjN0

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. #pharma #biospace hubs.li/Q047Wgn_0

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. #FDA #pakringsons #pharma #biospace hubs.li/Q047Wp-b0

Earendil Labs’ AI-centered platform has produced more than 40 programs, including anti-inflammatory assets that have attracted a pair of partnership agreements with Sanofi. #funding #AI #biologics #biospace hubs.li/Q047WjjQ0

Oryon Cell Therapies’ lead cell therapy is an autologous treatment designed to replace dopaminergic neurons in patients with Parkinson’s disease. Phase 1b/2a data showed that the asset can improve motor function and mobility in patients. #celltherapy #parkinsons #biospace hubs.li/Q047W9Lk0

Longevity is a long-standing buzzword in life sciences, but it now has staying power. The smart trajectory is to stop chasing aging as an abstract target and concentrate on specific mechanisms that can clearly advance specific, age-related diseases, according to two investors in a discussion with BioSpace. #insights #lifesciences #biospace hubs.li/Q047Vk420

As cell therapy advances toward clinical reality, iPSC-derived cellular products, in vivo reprogramming strategies, and manufacturing-ready reagent platforms are reshaping regenerative medicine and oncology. Recombinant antibodies and drug targets, e.g. endotoxin-free proteins, transmembrane proteins, and site-specifically labeled biomolecules are emerging as indispensable enablers of reproducibility, mechanistic insight, and clinical-scale success. #celltherapy #pharma #biospace hubs.li/Q047Vls-0

Eli Lilly and Regeneron are leading the push to treat congenital deafness with gene therapies, seeking a piece of a potential billion-dollar market and banking on local delivery and the small amount of drug required to overcome key safety concerns. #genetherapy #pharma #biospace hubs.li/Q047Vky-0

The FDA’s Commissioner’s National Priority Voucher program, unveiled in June 2025, is “shrouded in secrecy,” Democratic representative Jake Auchincloss said last month, as regulatory and biopharma leaders try to decode the criteria for investigational or approved drugs to receive a voucher. #FDA #vouchers #biopharma #biospace hubs.li/Q047Vhp00

@gossamerbio will cut about 48% of its workforce, while BiomX has disclosed it laid off a “significant” portion of its staff in December. Learn more in our layoff tracker. #layoffs #biopharma #biospace hubs.li/Q047Jq0r0