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The U.S. Supreme Court Jan. 22, in a closely-watched case, issued a unanimous 9-0 ruling stating that regardless of whether a patent holder is the plaintiff or defendant in a patent infringement case, the burden-of-proof for infringement remains with the patent holder. 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 FDA’s ban on the sale of prescription acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet took effect Jan. 15, and the agency will soon begin withdrawing approvals for products made by companies that defy the ban. Read More
In the latest action stemming from the high-profile pay-for-delay case FTC v. Actavis, Par Pharmaceuticals is looking to dismiss the commission’s case by arguing a federal court sanctioned the deal the FTC is now challenging, giving it immunity. Read More
Ranbaxy’s regulatory woes deepened last week as the FDA on Jan. 23 prohibited its Toansa, India, plant from making and distributing active pharmaceutical ingredients for U.S. products. Read More
Brand drugmakers are denying accusations that they are behind a covert campaign to block proposed patent law changes that would improve access to generics in South Africa. 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
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