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The European Medicines Agency is revising the way drugmakers conduct studies for drugs to treat blood clots, for the first time separating out the clinical requirements for different types of clots. Read More
Mylan is recalling two injectables — a hypertension drug and cancer treatment — due to quality control issues. Both drugs were manufactured in India. Read More
Consumer and patient advocacy groups made their case March 26 for the FDA’s proposed rule to give labeling parity to generic makers, one day ahead of an FDA public hearing to again solicit comment on the plan. Read More
Médecins Sans Frontières is urging Indian generics makers to reject a program Gilead plans to implement in developing countries to prevent illegal diversion of its hepatitis C drugs to more lucrative markets. Read More
Boehringer Ingelheim and Teva were again 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
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
Generics maker Sandoz will pay out $12.64 million to settle accusations it misrepresented average sales price information in reports to Medicare. 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