Food and Drug Administration (FDA)
NEWS
The biopharma industry is starting to leverage mobile apps and other digital technologies to improve access to clinical trials. Novartis launched FocalView, an app for ophthalmic patients involved in eye-related clinical trials.
Last week, the FDA’s advisory committee review of Eli Lilly and Incyte’s baricitinib for rheumatoid arthritis expressed safety concerns. Not surprisingly, the Arthritis Advisory Committee’s recommendation yesterday was mixed, split right along safety concerns.
Sanofi announced that Elias Zerhouni, head of Global Research and Development, is retiring on June 30. The company has appointed John Reed to replace him as of July 1.
Safety Concerns Force Loss of Breakthrough Therapy Designation for Synthetic Biologic’s C. Diff Drug
Shares of Synthetic Biologics are down more than 14 percent this morning after the company announced that SYN-004 (ribaxamase), the company’s treatment for the Clostridium difficile infection (CDI), lost the Breakthrough Therapy Designation awarded by U.S. Food and Drug Administration last year.
The FDA granted Pfizer’s Trumenba, a vaccine for meningococcal B disease in children ages one to nine years, Breakthrough Therapy Designation and declined to approve its biosimilar of Roche’s Herceptin for breast cancer.
Sage Therapeutics has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for brexanolone (SAGE-547) to treat postpartum depression (PPD).
Bluebird bio announced interim data from two different two-year clinical trials of LentiGlobin gene therapy for transfusion-dependent beta-thalassemia (TDT).
The U.S. Food and Drug Administration (FDA)’s Peripheral and Central Nervous System Drugs Advisory Committee unanimously recommended the approval of London, UK-based GW Pharmaceuticals’ Epidiolex for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome.
Ahead of next Monday’s U.S. Food and Drug Administration (FDA) committee review of Eli Lilly and Incyte’s baricitinib for rheumatoid arthritis, concerns over blood clots, may scuttle the drug’s chances.
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