Pharminent

FDA approves first heart valve designed to grow with children

The FDA approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease. The agency said it is the first heart valve designed to grow with children.

FDA approves expanded indication for Camzyos

The FDA approved an expanded indication for Camzyos, Pharmaceutical Executive reported.

HHS launches new programs to speed clinical trials

The US Department of Health and Human Services launched new programs offering funding to teams with innovative proposals for accelerating clinical trials, as it considers ending the traditional phased clinical trial system.

EMA’s PRAC publishes highlights from September 28-October 1 meeting

EMA’s Pharmacovigilance Risk Assessment Committee published highlights from its monthly meeting held September 28-October 1, 2026, covering safety signal assessments and other medicine safety responsibilities, along with the draft agenda and monthly PRAC outcome statistics.

EMA issues end-of-year submission dates for type I variations

The EMA advised marketing authorization holders seeking an outcome in 2026 on submission deadlines for type IA annual updates, individual type IA and type IAIN variations, and super-groupings.

Regeneron’s trevogrumab prevents muscle loss in phase 2 COURAGE trial

In the phase 2 COURAGE trial, Regeneron said trevogrumab prevented lean mass and muscle loss during GLP-1 receptor agonist-induced weight loss, with a predefined MRI substudy showing it prevented 70% of muscle loss associated with semaglutide treatment. A pre-specified subgroup analysis found patients meeting the low lean mass definition for sarcopenia had greater lean mass loss with semaglutide and more preservation with trevogrumab.

Regeneron’s ubamatamab shows 73% response rate in ovarian cancer

Regeneron reported initial study results for ubamatamab (MUC16xCD3) in patients with advanced low-grade serous ovarian cancer, showing a 73% objective response rate and 11-month median progression-free survival. The data were presented in a late-breaking plenary session at IGCS.

Novartis signs $7.8B Abogen deal for autoimmune T-cell engager

Novartis entered a $7.8 billion deal with Abogen covering ABO2203, which is designed to produce a T-cell engager protein in vivo through an mRNA-encoded system for autoimmune disease.

Sanofi and Regeneron expand immunology alliance with $1B upfront

Sanofi and Regeneron broadened their collaboration under a deal carrying a $1 billion upfront payment, tasking the companies with developing long-acting antibody drugs aimed at the same targets as Dupixent.

Varda raises $251M for in-orbit drug manufacturing

Varda closed a $251 million financing round to fund its work manufacturing medicines in orbit, with TriGemX, Breye, AnaCardio and ai3Bio also raising new funds.

UK commits £80M to nine dementia diagnosis technologies

The UK is providing £80 million ($105 million) in funding to nine technologies intended to diagnose dementia more quickly.

NIH awarded all grant funding in fiscal 2026, analysis finds

The NIH awarded all of its grant funding in fiscal year 2026, though delayed and opaque decisions hampered researchers, according to a STAT analysis. The agency continued reducing grants involving health disparities, race and ethnicity while making little progress toward other administration priorities.

AMA finds four PBMs controlled 75% of market in 2024

The American Medical Association found that OptumRx, Express Scripts, CVS Caremark and Prime Therapeutics together controlled 75% of the national pharmacy benefit manager market in 2024.