Roche

NEWS
The last two weeks have marked the second-quarterly financial report by numerous biopharma companies. Here’s a quick look at some of the major ones.
As Britain’s “Brexit” from the European Union moves closer and closer, the European Medicines Agency (EMA), the equivalent to the U.S. Food and Drug Administration (FDA), temporary halted some of its activities in preparation.
IGM Biosciences, a privately-held biotech company located in Mountain View, California, announced that Daniel S. Chen will be the company’s new chief medical officer. Chen arrives from Genentech/Roche, where he was most recently vice president, Global Head of Cancer Immunotherapy.
Roche announced that its Phase III IMpassion130 clinical trial met its co-primary endpoint of progression-free survival (PFS) in triple-negative breast cancer (TNBC).
This week had a few disappointing clinical trials, as do most weeks, but it also had a number of significant successes. Here’s a look at some of the clinical trials that met their primary endpoints this week.
Cambridge, Massachusetts-based Biogen exercised its option to acquire additional shares of Samsung Bioepis, a joint venture with Samsung BioLogics that was founded in 2012.
Platelet Biogenesis (PBG) was awarded a two-year, $3.5 million grant from the U.S. Department of Defense (DoD). The funds are to support the company’s proprietary bioreactor to produce therapeutic amounts of platelets.
A recent survey shows that 90 percent of biopharma companies are making significant investments in real-world evidence capabilities to support multiple annual objectives that include driving drug development and meeting regulatory requirements.
The FDA accepted Genentech’s New Drug Application (NDA) for baloxavir marboxil, a single-dose, oral flu treatment for people 12 years and older. It also granted it Priority Review.
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