FDA OKs Merck’s Keytruda for treatment-resistant bladder cancer
The FDA approves Merck’s (NYSE:MRK) Keytruda (pembrolizumab) as monotherapy for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy (bladder removal).
Catabasis Pharma teams up with UK DMD charity in edasalonexent study
Catabasis Pharmaceuticals (CATB -1.6%) will partner with Duchenne UK, a London-based research charity that funds the development of treatments for Duchenne muscular dystrophy (DMD), on a Phase 2 clinical trial evaluating edasalonexent (CAT-1004) in non-ambulatory DMD patients.
Target enrollment in the one-year study is 16 participants at least 10 years old, regardless of mutation type, who have not received steroid therapy for at least six months.
Duchenne UK has committed over $600K to support patient and clinical trial site costs.
Edasalonexent is a small molecule inhibitor of NF-kB, a protein that plays a key role in regulating muscle health.
FDA accepts Nabriva’s refiled Contepo application; shares up 8% after hours
The FDA accepts for review Nabriva Therapeutics’ (NASDAQ:NBRV) resubmitted marketing application for Contepo (fosfomycin) for the treatment of complicated urinary tract infections. The agency’s action date is June 19.
The company received a CRL last year citing deficiencies at one of its contract manufacturers.
Shares up 8% after hours.
Mylan recalls lots of nizatidine due to NDMA contamination
Mylan N.V. (MYL -1.2%) initiates a voluntary nationwide recall of three lots of Nizatidine Capsules, USP, including the 150 mg and 300 mg strengths, due to trace amounts of N-nitrosodimethylamine (NDMA) in product manufactured by Tamilnadu, India-based Solara Active Pharma Sciences Limited.
The company has informed the FDA about the issue.
Veracyte collaborates with Acerta Pharma
Veracyte (NASDAQ:VCYT) announces a multi-year partnership with Acerta Pharma, the hematology R&D arm of AstraZeneca (NYSE:AZN), to provide genomic information that will support the development of oncology therapeutics.
