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Amgen, in an expected move, is appealing a federal judge’s decision that cleared the way for Sandoz to launch Zarxio, its biosimilar of Amgen’s chemotherapy product Neupogen. Read More
Boehringer Ingelheim and Teva are again being accused of blocking generic competition to the brandmaker’s antistroke drug Aggrenox just days after their bid to toss a similar lawsuit was denied. Read More
The FDA continues to look into improving generic bioequivalence testing, sponsoring research into BE evaluation of drugs for which doctors are most likely to resist substituting a generic, such as anticoagulants. Read More
The FDA has halted imports of drugs from two Ipca manufacturing facilities in India due to good manufacturing practice violations, marking the second and third FDA-imposed import alerts against the drugmaker this year. Read More
Regeneron has won yet another indication for its Eylea injection, this time for patients with diabetic macular edema who develop retinopathy. Read More
The National Institute for Health and Care Excellence yesterday recommended that the National Health Service cover drugs for acute coronary syndrome and type 2 diabetes, but turned down one for multiple myeloma. Read More
A federal judge has given the go-ahead to a class action lawsuit alleging Boehringer Ingelheim and Teva conspired to put off generic competition to the antistroke drug Aggrenox. Read More