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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
As part of its continuing effort to improve the ANDA approval process, the FDA is again focusing attention on the quality of ANDA submissions, this time asking industry for help. 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
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
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
The European Medicines Agency (EMA) on Friday said it will investigate reports that emergency contraceptives such as Teva’s Plan B One-Step lose effectiveness in some women who weigh more than 165 lbs. Read More
A new Tufts University report praises the FDA’s breakthrough therapy program for its potential to advance new drugs and biologics targeting unmet needs. Read More