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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
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
Generic drugmakers and the biotech industry have drafted a set of rules to govern when and how biosimilars can be substituted for brand-name biologics. 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
Sterile injectables maker Hospira was hit with a new Form 483 containing nearly two dozen observations after FDA investigators followed up an October 2012 inspection that uncovered inadequate sanitization procedures at its Irungattukottai, India, facility. Read More
The FDA’s ban on the sale of prescription acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet went into effect Jan. 14, and the agency will soon begin withdrawing approvals for products made by companies defying the ban. Read More