The FDA slapped Akorn, a sterile drug manufacturer, with a Form 483 over unexplained discrepancies and batch failures following an inspection of its Decatur, Ill., plant conducted from March 28…
BeiGene’s anti-PD-1 monoclonal antibody tislelizumab has racked up more positive phase 3 numbers, proving itself just as good as sorafenib in extending the lives of patients with unresectable hepatocellular carcinoma.…
Abecma (idecabtagene vicleucel), a first-in-class CAR-T cell treatment codeveloped by Bristol Myers Squibb and 2seventybio, significantly improved progression-free survival relative to standard therapy in patients with relapsed multiple myeloma, the…
A federal court in Kansas has ruled that a class action antitrust lawsuit against Mylan over marketing and distribution of its EpiPen can go forward. Source: Drug Industry Daily
The FDA is reviewing a Biologics License Application (BLA) for an innovative, first-in-class treatment for potentially fatal Clostridium difficile infections — an enema-delivered human stool transplant. Source: Drug Industry Daily
Nebulized ensifentrine, an investigational inhaled anti-inflammatory, reduced exacerbations of chronic obstructive pulmonary disease (COPD) by 42 percent over 24 weeks — a significant benefit that could propel Verona Pharma to…
GlaxoSmithKline (GSK) and clinical-stage biopharma company Mersana Therapeutics have forged a global collaboration, giving GSK the exclusive option to codevelop and commercialize Mersana’s antibody-drug conjugate (ADC) XMT-2056 targeting HER2. Source:…
Karuna Therapeutics’ investigational schizophrenia drug KarXT (xanomeline-trospium) reduced symptoms of the disorder in a late-stage study, with clinically meaningful changes seen within two weeks of beginning treatment. Source: Drug Industry…
Regeneron Pharmaceuticals has sued Viatris over the company’s proposed biosimilar of Regeneron’s blockbuster vision loss drug, saying it violates multiple patents. Source: Drug Industry Daily
Data from an ongoing phase 3 study show the investigational PD-L1 antibody sugemalimab buys an extra four months of progression-free time for patients with unresectable stage III non-small cell lung…