FDA commissioner resigns amid HHS leadership changes
FDA Commissioner Marty Makary has resigned, leaving the agency under acting leadership. Kyle Diamantas, the FDA’s deputy commissioner for foods and chief counselor to HHS Secretary Robert F. Kennedy Jr., has been named acting commissioner. The change comes as several senior HHS roles remain unfilled or are being held on an interim basis, including leadership positions at the CDC and the Office of the Surgeon General. NIH Director Jay Bhattacharya is currently overseeing the CDC, while the White House has nominated Dr. Erica Schwartz to serve as CDC director and Dr. Nicole Saphier to serve as surgeon general, both pending Senate confirmation. Source
BMS and Hengrui strike broad early-stage medicines deal
Bristol Myers Squibb and Hengrui Pharma have entered a global strategic collaboration covering 13 early-stage programs across oncology, hematology, and immunology. The agreements include four oncology and hematology assets from Hengrui, four immunology assets from BMS, and five additional programs to be jointly discovered and developed using Hengrui’s discovery engine and platform technologies. BMS will pay Hengrui up to $950 million, including a $600 million upfront payment and two potential anniversary payments of $175 million each. The total potential value could reach around $15.2 billion, including option exercises and development, regulatory, and commercial milestones, with Hengrui also eligible for tiered royalties on products commercialized outside its territory. Source
Boehringer licenses Immunitas antibody program for inflammatory disease
Boehringer Ingelheim has entered a global licensing agreement with Immunitas Therapeutics for a preclinical antibody program targeting chronic inflammatory and autoimmune diseases. The program is designed to selectively target pathogenic cells at sites of inflammation, with the aim of delivering deeper and more durable disease control than therapies that block individual inflammatory signals. Source
GSK partners with SBP Group to support bepirovirsen launch in China
GSK has entered an exclusive strategic collaboration with Sino Biopharmaceutical, through its subsidiary Chia Tai Tianqing Pharmaceutical Group, to support the potential launch of bepirovirsen in mainland China. Bepirovirsen is an investigational antisense oligonucleotide for chronic hepatitis B that is under priority regulatory review in China.
The therapy is designed to act through three mechanisms: inhibiting viral DNA replication, reducing hepatitis B surface antigen levels, and stimulating immune responses to improve the chances of a durable functional cure. The regulatory submission is supported by positive Phase 3 B-Well 1 and B-Well 2 data, which showed statistically significant and clinically meaningful functional cure rates. Source
Delos and AP Biosciences launch antibody-focused biotech creation partnership
Delos Capital and AP Biosciences have launched a strategic collaboration to create and incubate new biotechnology companies focused on next-generation antibody therapies. The partnership will initially focus on autoimmune diseases, using bi- and tri-specific antibody approaches that combine novel and more established targets and mechanisms. Source
Halozyme and GSK partner on subcutaneous oncology formulations
Halozyme has entered a global collaboration and license agreement with GSK to develop subcutaneous formulations of multiple oncology targets using Halozyme’s ENHANZE drug delivery technology. The deal includes antibody-drug conjugates, marking Halozyme’s first ENHANZE agreement involving ADC targets, as well as an option for additional future targets. Source
The Patient
FDA expands VYVGART label to all adult gMG serotypes
argenx has received FDA approval to expand the label for VYVGART, a biologic FcRn-blocking antibody fragment, and VYVGART Hytrulo, its subcutaneous co-formulation with hyaluronidase, to all adult patients with generalized myasthenia gravis regardless of serotype. The approval covers anti-AChR antibody-positive, anti-MuSK antibody-positive, anti-LRP4 antibody-positive, and triple-seronegative patients, giving VYVGART the broadest approved MG label to date. Source
FDA approves Ocrevus for pediatric RRMS
Genentech has received FDA approval for Ocrevus intravenous infusion to treat relapsing-remitting multiple sclerosis in pediatric patients aged 10 years and older who weigh at least 55 pounds. The approval expands use of the anti-CD20 therapy into a younger population with limited high-efficacy treatment options. Source
For this week’s cell and gene therapy news – including Novo Nordisk’s Parkinson’s cell therapy finding a new home, an AML-inspired CAR-T approach from MSK, base and prime editing advances in inherited epilepsy, large-insertion genome writing, and scalable manufacturing moves across AAV, MSC, and T cell therapies – click here.