Pharminent

FDA approves Merck KGaA’s Pimjetmi for tenosynovial giant cell tumor

The FDA approved Merck KGaA’s Pimjetmi (pimicotinib) for the treatment of tenosynovial giant cell tumor.

FDA adds warning to GLP-1 drugs over rare eye condition

The FDA issued a new warning for GLP-1 drugs regarding a rare eye condition, with a physician outlining how serious and how common the condition is.

NICE backs NHS use of Incyte’s Zynyz in anal cancer

NICE has backed NHS use of Incyte’s immunotherapy Zynyz, which could make hundreds of patients in England and Wales with anal cancer eligible for treatment.

FDA and EMA grant pediatric waivers for Shanton’s SAP-001

The FDA and EMA have waived paediatric study requirements for Shanton’s gout candidate SAP-001, meaning such studies will not be required in marketing authorisation applications for hyperuricemia and gout.

Reports suggest FDA may scrap national priority review voucher scheme

Reports indicate that the national priority voucher scheme launched by former FDA chief Marty Makary may be discontinued.

Biogen’s pivotal lupus trial results for litifilimab expected soon

Biogen is expected to soon release results from pivotal clinical trials of litifilimab, an experimental therapy for lupus.

Oral peptide improves ulcerative colitis response in phase 2 trial

A once-daily oral peptide improved response and remission rates in patients with ulcerative colitis in a phase 2 trial, offering a potential alternative to injections or infusions.

All of Us study identifies thousands of drug-response gene variants

A study of nearly 100,000 diverse Americans in the All of Us program identified thousands of new variants in genes that influence responses to prescription drugs.

Blackstone to fund Pfizer’s monthly GLP-1 with up to $1.5B

Blackstone Life Sciences will provide up to $1.5 billion in funding to Pfizer for development of berobenatide, a once-monthly GLP-1 agonist.

Litmys and PharmaACE partner on pharma commercial forecasting

Litmys and PharmaACE formed a strategic collaboration to provide commercial forecasting and decision-making services to the pharmaceutical and biotechnology sectors.

Study says German drug price increases could raise US costs

A study reports that drug price increases in Germany could push US healthcare costs higher.

FDA has more than 1,000 open jobs amid staffing shortage

The FDA has over 1,000 open positions following a mass staff exodus last year that left the agency shorthanded, with effects on the pharmaceutical industry.