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

  • FDA approved Genentech’s Lucentis (ranibizumab) for all forms of diabetic retinopathy. (Reuters)
  • Roche announced that the FDA granted accelerated approval for Tecentriq for the treatment of bladder cancer in patients who are not eligible for cisplatin chemotherapy. Tecentriq, an anti-PD-L1 immunotherapy was previously approved for the treatment of bladder cancer in patients who have progressed during or after any platinum-containing chemotherapy or within 12 months of receiving chemotherapy before or after surgery. (FirstWordPharma)
  • OncoMed Pharmaceuticals said that its drug, Tarextumab, which was being evaluated in combination with chemotherapy for the treatment of patients with small-cell lung cancer (SCLC), failed to meet the primary endpoint of a Phase 2 study. (FirstWordPharma)
  • Bristol-Meyers Squibb (BMS) and Nordic Bioscience announced that they will partner on the development of biomarker technology. Under the agreement, the companies will collaborate on the development of translational biomarkers and diagnostics for the monitoring of nonalcoholic steatohepatitis (NASH) and other fibrotic diseases. (GEN)
  • FDA advisory committee to review Puma’s Neratinib for the extended adjuvant treatment of HER2-positive breast cancer. Puma Biotechnology announced that the FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) discussion for Neratinib on May 24, 2017. (BusinessWire)



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Tags: Aegis, aegis creative, biomarkers, biotech, breast cancer, clinical trials, drug development, FDA, immunotherapy, life science, oncology

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