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Amgen is taking Novartis’s biosimilar division to court over alleged patent infringement for seeking FDA approval to produce a generic version of its blockbuster drug Enbrel. Read More
Drugmakers producing hormones should consult with the FDA before seeking to opt out of an environmental assessment because of the impact of those drugs on the water supply. Read More
The Senate HELP Committee’s second of three markups is scheduled for March 9 to examine several pieces of legislation as part of the Senate’s piecemeal version of the House’s 21st Century Cures Act. Read More
The FDA has updated its list of scheduled guidances for the calendar year 2016, with a major focus on pharmaceutical quality, data integrity and generics. There are 102 planned guidances this year, compared with 92 last year. Read More
The FDA said its Center for Drug Evaluation and Research and the Office of Prescription Drug Promotion issued 47 warning letters last year, compared with 52 in 2014. Read More