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6 Observations on Right Value FDA-483
FDA has released the Form FDA-483 issued following an 8/24-9/8 inspection at Right Value Drug Stores, an Irving, TX outsourcing facility. The six inspection observations were: * failure to follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * failure of laboratory controls
HHS Initiative Aimed at Cutting Drug Development to Under 4 Years
HHS’ Advanced Research Projects Agency for Health has launched a funding initiative aimed at dramatically shortening clinical development of drugs and biologics through adaptive platform trials, artificial intelligence, and real-time data analysis. The “Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS)” program is seeking technologies and trial approaches
Roche Wins Priority Review for Multiple Sclerosis Drug
FDA has accepted for priority review a Roche NDA for fenebrutinib, an investigational non-covalent Bruton’s tyrosine kinase (BTK) inhibitor for treating relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The submission is based on data from the Phase 3 FENhance 1 and 2 RMS studies and
Pierre Fabre Resubmits Tabelecleucel BLA
Pierre Fabre Pharmaceuticals (PFP) says its tabelecleucel BLA has been resubmitted with a proposed indication as monotherapy for treating adult and pediatric patients 2 years of age and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. PFP resubmitted