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

  • FDA warns Mylan. Mylan, the embroiled maker of the EpiPen, received a warning letter from FDA citing quality concerns about its India-based drug manufacturing facility. (BusinessInsider)
  • The National Institute for Health and Care Excellence (NICE) declined Bristol-Myers Squibb’s immunotherapy drug, Opdivo, which treats head and neck cancer. (Reuters)
  • Rare Disease Drug Development Trends: Five Things to Know. BioPharmaDive provides an overview of five trends shaping the rare disease market. (BioPharmaDIVE)
  • ArQule announced that the FDA has approved the company’s investigational new drug application for ARQ 531. ArQule will begin Phase 1 clinical trials to evaluate ARQ 531 in patients with B-cell malignancies. (BusinessWire)
  • Cytori to begin cell therapy trial. The FDA has approved an investigational device exemption (IDE) for a pilot trial of Cytori’s cell therapy in patients with thermal burn injury. (MassDevice)


Tags: Aegis, aegis creative, cell therapy, clinical trials, drug development, FDA, immunotherapy, life science, oncology, pharma, rare disease, Reg Intel, Regulatory Intelligence

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