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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
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
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
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
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
The Pennsylvania Supreme Court has affirmed that drugmakers can be held liable for negligent drug design, opening up a new avenue for patients seeking financial relief for injury claims in the state. Read More
The Supreme Court on Wednesday, 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