Protocols

Merck KGaA, Pfizer win another quick FDA review for avelumab; WHO tries to spur more incentives for antibiotics R&D

→ Merck KGaA and its Big Pharma partner Pfizer have won another priority review of their checkpoint inhibitor avelumab. Following up on a speedy review win last November for in metastatic Merkel cell carcinoma, the companies say regulators will be just as fast covering their application for metastatic urothelial carcinoma (mUC) with disease progression on or after platinum-based therapy. The partners are competing with AstraZeneca for fourth place in the lineup to get a checkpoint out on the market. Merck, Bristol-Myers Squibb and Roche all got there first, but everyone’s scrambling to stake out as much territory as possible for a new market likely worth tens of billions of dollars.

Dr Marie-Paule Kiely, WHO

→ The World Health Organization has come up with a list of the 12 most lethal families of bacteria which pose a direct threat to people around the globe. They concentrated heavily on drug-resistant gram-negative bacteria. WHO wants governments to come up with added incentives for researchers. “This list is a new tool to ensure R&D responds to urgent public health needs,” says Dr. Marie-Paule Kieny, WHO’s Assistant Director-General for Health Systems and Innovation. “Antibiotic resistance is growing, and we are fast running out of treatment options. If we leave it to market forces alone, the new antibiotics we most urgently need are not going to be developed in time.”

The Boston Business Journal reports that Momenta is expanding in Kendall Square at 301 Binney Street, taking over space vacated by Biogen.


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