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Top Stories Monday, June 27, 2016 Bristol-Myers Squibb claims to have sewed up more than 80% of the U.S. and other major markets' share of PD-1 spending with its Opdivo. Now, it’s moving ahead with its latest Breakthrough Therapy Designation, the sixth that the FDA has given for the immuno-oncology agent. Monday, June 27, 2016 VM BioPharma has begun late-stage testing for its diabetic peripheral neuropathy gene therapy VM202 as it looks to take on Pfizer’s Lyrica. Monday, June 27, 2016 The Medicines Company expects to submit an NDA early next year to the FDA for its Carbavance (meropenem-vaborbactam). That’s on the heels of top-line pivotal data to treat patients with complicated urinary tract infections (cUTI) that demonstrated superiority as compared to another antibiotic, piperacillin-tazobactam. Monday, June 27, 2016 French med dev and biotech Advanced Accelerator Applications has seen the FDA allow its experimental cancer candidate Lutathera a speedy review--which could see the drug approved by the end of the year. Monday, June 27, 2016 The University of Victoria and BC Cancer Agency can be added to Big Pharma names Glaxo and Celgene after the Vancouver-based Zymeworks signs a new research deal that focuses on cell engineering in cancer. Monday, June 27, 2016 June has been a bad month for British allergy biotechs. First, Circassia came up short in a Phase III cat allergy trial. Now, Allergy Therapeutics has reported it failed to determine the recommended dose in Phase II, forcing it to run another study and delaying the date at which it can start a pivotal study of its grass pollen allergy product. More from EuroBiotech Report
| | | Takeda Pharmaceutical has returned Japan rights for Amgen’s oncology candidates fulranumab and trebananib as it continues the fast-paced reshuffle of its development portfolio to focus on gastroenterology, oncology and CNS. Story from FiercePharmaAsia Agilis Biotherapeutics has become the first gene therapy company to be picked by the NIH Therapeutics to be a part of the Rare and Neglected Diseases Program. Release Puma Biotechnology has submitted its marketing authorization application to the EMA for its early breast cancer candidate neratinib. Statement The French government will pay out €1.08 billion ($1.19 billion) to the Global Fund to Fight AIDS, tuberculosis and malaria for the 3-year period beginning in 2017. Release | |
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