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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
High-ranking FDA officials visiting India have laid out a new approach to facility inspections for Indian manufacturers that would reward firms if their quality management system exceeds minimum compliance requirements. Read More
The U.S. Supreme Court has declined to hear one of three petitions submitted over a Pennsylvania appellate decision refusing to recognize generic drugs as largely immune from product liability lawsuits. Read More