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There was a significant drop-off in NME approvals by FDA in 2016, but there were not enough new drug applications with user fee goals to reach the lofty 2015 total.

The U.S. biotechnology arena is undergoing a record-breaking M&A cycle for the industry. After generating M&A activity valued at $235 billion during 2014, the U.S. biotech sector produced more than $100 billion in deals during first-quarter 2015.

Swiss drugmaker Roche (RHHBY) is doubling down on its immunotherapy oncology pipeline, on Monday announcing it will pay Indian company Curadev Pharma up to $555 million to develop and market its IDO1 and TDO inhibitors IDO1 (indoleamine-2, 3-dioxygenase-1) and TDO (tryptophan-2, 3-dioxygenase) are enzymes that mediate cancer-induced immune suppression, which tumor cells and a certain […]

FDA Grants Genentech’s Obinutuzumab (GA101) Priority Review for Previously Untreated Chronic Lymphocytic Leukemia (CLL) Announcement Follows FDA Breakthrough Therapy Designation for GA101 in CLL FDA Decision on the GA101 Biologics License Application (BLA) Is Expected by the End of 2013. South San Francisco, Calif. — July 2, 2013 — Genentech, a member of the Roche […]