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Makers of branded opioid pain relievers that want to claim their drugs are resistant to abuse must, in most cases, subject their products to three forms of tests to show the FDA how effectively they prevent misuse. Read More
Generics makers may soon have a new way to challenge first-filer marketing exclusivity held by their rivals under certain circumstances after a federal appeals court reinstated a lawsuit from Apotex. Read More
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