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

  • Cancer immunotherapy comes at a hefty price. Some cancer drugs that improve overall survival cost more than $250,000 per year. Learn more about the exploding market of cancer immunotherapy. (Reuters)
  • Expanded testing for Zika vaccine. More than 2,000 volunteers are enrolled in a round of clinical trials for a potential vaccine for the Zika virus. The vaccine, which was developed by scientists at the National Institute of Allergy and Infectious Diseases, could be available by the end of this year. (Washington Post)
  • Biogen wins Tecfidera patent dispute. The US Patent Trial and Appeal Board ruled against Forward Pharma A/S, finding Biogen’s patents on Tecfidera to be valid. Tecfidera, which treats multiple sclerosis (MS), had sales of about $4B in 2016. The ruling frees Biogen from future royalty payments to the Danish company. (Reuters)
  • Pfizer has received approval of a supplemental New Drug Application (sNDA) for Ibrance, converting the accelerated approval of the product to regular approval. Ibrance treats hormone receptor-positive, HER2-negative metastatic breast cancer and can now be administered with an aromatase inhibitor, in addition to the original indication, in combination with letrozole. (Pfizer)
  • Wearable medical device may extend the lives of patients with brain cancer. Data presented this week suggests that a wearable medical device that delivers electrical fields through the scalp may extend the survival of patients with brain tumors. The study, conducted in the U.S. and abroad, indicates that electrical fields may block the division of cancer cells in patients who are also receiving chemotherapy. (Washington Post)



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Tags: Aegis, aegis creative, biotech, clinical trials, drug development, FDA, immunotherapy, life science, medical device, Multiple Sclerosis, oncology, pharma, Reg Intel, Regulatory Intelligence, vaccines, zika

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