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Pharmaceutical companies can expect to wait about 165 days for Health Canada to make a final decision on appeals of an approval or rejection of a drug, according to guidance released earlier this month that sets specific timelines for every step of the dispute resolution process. 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
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 Centers for Medicare & Medicaid Services has announced that it plans to begin paying for biosimilars through its Part B, Part D and state coverage policies by this summer. 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