Two weeks after the U.S. FDA rejected Acer Therapeutics’ New Drug Application for Edsivo (celiprolol), the company initiated a restructuring plan that includes the elimination of 29 employees.
Morris Plains, N.J.-based Immunomedics announced that the company’s president, chief executive officer and board member, Michael Pehl, was stepping down for personal reasons.
Mylan NV said U.S. health regulators were unable to approve the company’s generic version of GlaxoSmithKline’s blockbuster inhaled lung drug Advair for the second time, as they found “minor deficiencies” in the treatment.
Boston-based Intarcia Therapeutics undertook a restructuring that includes the termination of up to 60 employees and the closing of two programs.
Almost one year after filing a New Drug Application for an ADHD drug and less than one year after announcing it secured $200 million in financing, Ironshore Pharmaceuticals closed its doors.
Shares of TherapeuticsMD Inc. shot up more than 51 percent in morning trading after the U.S. Food and Drug Administration reversed course on its rejection of that company’s vaginal pain medication.