Read what’s going on with pharma and biotech in regulatory intelligence this week:

  • Novartis receives first-line indication for breast cancer drug. The FDA has approved kisqali, in combination with letrozole, for a type of breast cancer that occurs in menopausal women. In a late-stage trial, kisqali showed improved progression-free survival over letrozole alone. (Reuters)
  • “Office of Patient Affairs” may be coming soon. The FDA is considering establishing an “Office of Patient Affairs” in an effort to improve patient engagement. (RAPS)
  • Scynexis trials for its antifungal IV formulation are on hold. After several patients developed blood clots during a Phase I study, the FDA has prohibited Scynexis from starting any new trials involving Scy-078, the company’s glucan synthase inhibitor being developed to treat systemic fungal diseases. (in-Pharma Technologist)
  • Roche and Mylan settle biosimilar dispute over Herceptin. On the heels of the announcement of positive phase 3 data for the combination of Herceptin and Perjeta in the treatment of early-stage breast cancer, Roche has inked a global licensing deal with Mylan. The deal provides Mylan with global launch dates for its biosimilar of Herceptin in exchange for Mylan to withdraw legal challenges to two related patents. (Endpoints)
  • Boehringer Ingelheim receives orphan drug designation for myelodysplastic syndromes (MDS) treatment. FDA has granted orphan drug status to the investigational anti-CD33 monoclonal antibody, BI 8366858. MDS are a group of bone marrow disorders and in some cases can progress to acute myeloid leukemia (AML). (PRNewswire)


Tags: Aegis, aegis creative, biosimilar, breast cancer, clinical trials, drug development, FDA, life science, oncology, pharma

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