Take a look at what’s going on with pharma and biotech in regulatory intelligence this week:

  • Boston Scientific has won pre-market approval for its Resonate line of defibrillators. The company claims the defibrillators feature a technology that delivers twice the usable battery capacity of competing devices. (MassDevice)
  • FDA approved the first ALS drug in more than 2 decades. The FDA has approved Mitsubishi Tanabe Pharma Corp’s edaravone for the treatment of amyotrophic lateral sclerosis (ALS) aka Lou Gehrig’s disease. (Reuters)
  • The FDA has granted Fast Track designation for Oncolytics Biotech’s immuno-oncology drug, Reolysin, for the treatment of metastatic breast cancer. (PRNewswire)
  • Teva’s drug failed in Phase 3 multiple sclerosis (MS) trial. Teva and Active Biotech’s laquinimod missed the primary endpoint in a Phase 3 study for the treatment of relapsing-remitting multiple sclerosis. (FierceBiotech)
  • Roche’s Tecentriq failed a Phase 3 trial in second-line bladder cancer, raising concerns that the FDA may revoke the conditional approval for that indication. (FiercePharma)


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