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Generic drugmakers have joined forces with the biotech industry to craft biosimilar substitution legislation in Washington State. They plan to use the bill as a template for similar drives across the country. Read More
A group of 28 Republican lawmakers is adding to the avalanche of opposition to the FDA’s proposed generic drug safety labeling rule, saying it will sow confusion and increase drug costs. Read More
Valeant Pharmaceuticals is objecting to the FDA’s planned eye-tracking study to assess how viewers see risk information in ads because it would exclude individuals wearing bifocals and hard contact lenses. Read More
Sponsors of vaccine trials intended to support a marketing submission in China have seven days to report study-related fatalities and another eight days to file follow up reports, according to a new China Food and Drug Administration guideline. Read More
UK regulators plan to reimburse drugmaker Astellas for its prostate cancer drug Xtandi (enzalutamide), but not in patients who have already been treated with Janssen’s Zytiga (abiraterone). Read More
The FDA has hit two compounding pharmacies with warning letters for quality violations and failure to have prescriptions for products they were compounding. Read More
Pharma companies applying for approval to sell drugs in Canada must submit quality summary documents, certifications of their products’ comparability with monographs of the European Pharmacopoeia and detailed drug master files that comply with the International Conference on Harmonisation’s registration for human use quality standards Read More
Pfizer’s lung cancer drug dacomitinib has failed in two Phase III clinical trials and analysts aren’t holding out much hope for results from a third Phase III study expected next year. Read More
Boehringer Ingelheim and Teva Friday were hit with their fourth class action lawsuit over an alleged $120 million pay-for-delay deal to keep generics of the anti-stroke drug Aggrenox off the market. Read More
A New Jersey federal judge Friday dismissed a pay-for-delay case involving a “no-authorized generic agreement” between GlaxoSmithKline and Teva, saying the Supreme Court’s landmark 2013 ruling in Federal Trade Commission v. Actavis applies antitrust scrutiny only to pay-for-delay deals that involve money. Read More