Ending more than seven years of litigation, the U.S. Supreme Court denied cert Jan. 19 in Idenix Pharmaceuticals LLC v. Gilead Sciences Inc. The high court’s refusal to hear the case means the Federal Circuit’s Oct. 30, 2019, split decision stands. That decision found Idenix’s 7,608,597 patent, which claimed a method of treating hepatitis C, was invalid for non-enablement and for lack of written description. The litigation began in December 2013 when Idenix filed suit in district court, claiming that the imminent FDA approval and launch of Gilead’s Sovaldi (sofosbuvir) would infringe its patent. In 2016, a jury found for Idenix, which had been acquired by Merck & Co. Inc., and awarded it a historic $2.54 billion in damages. Idenix appealed to the Federal Circuit after the district court judge overturned the jury verdict.
The U.K.’s National Institute for Health and Care Excellence (NICE) issued guidance Jan. 19 making Kite’s Tecartus (KTE-X19) available, via the Cancer Drugs Fund, as a second-line treatment for patients with relapsed or refractory mantle cell lymphoma. The guidance is the result of a managed access agreement NICE reached with Kite Pharma, of Santa Monica, Calif., a unit of Foster City, Calif.-based Gilead Sciences Inc. Trial evidence suggests people treated with the CAR T-cell therapy may live longer, but NICE said there wasn’t enough evidence to tell if the one-time treatment is a cure. Having Tecartus available through the Cancer Drugs Fund allows access to it while Kite collects further data on progression-free survival and overall survival. Ten NHS providers will be able to provide the treatment, NICE said.
In its fifth update on last year’s cyberattack, the EMA said the stolen data included internal, confidential email, dating from November, that related to its evaluation processes for COVID-19 vaccines. Some of the correspondence was manipulated before it was leaked on the internet in a way that could undermine public trust in the vaccines, according to the EMA. The criminal investigation into the data breach is continuing.
Recognizing the impact the COVID-19 pandemic is having on bioequivalence studies needed to support the approval of new generics, the U.S. FDA issued a guidance to ensure participants in those studies are protected. Such studies may have been disrupted due to travel limitations, study site closure, lab closures and other public health measures intended to control the virus. “This situation underscores the importance of balancing the protection of participant rights, welfare, and the assurance of the quality and integrity of the data while maintaining compliance with Good Clinical Practice,” the FDA said. The guidance includes recommendations on ensuring participant safety throughout the study, developing standard operating procedures, protecting scientific validity, and planning for the timely and organized resumption of bioequivalence studies.
The FDA once again revised its guidance on the use of investigational convalescent plasma in COVID-19 trials. The latest update specifies when plasma can be collected from individuals who have received an investigational or authorized COVID-19 vaccine. The previous version of the guidance, issued in November, banned the use of plasma from anyone receiving an investigational vaccine. The update also once again extends the FDA’s enforcement discretion to give blood establishments time to develop the necessary procedures to manufacture COVID-19 convalescent plasma under the conditions of the emergency use authorization granted last August. The new deadline is May 31.
The U.S. Centers for Medicare & Medicaid Services finalized a rule requiring affected payers to implement application programming interfaces (APIs) that would give health care providers updated information on prior authorization processes for their patients. The rule is applicable to patients enrolled in Medicaid and other non-Medicare programs. The APIs are intended to streamline the prior authorization process. Payers must process all such requests within 72 hours, the agency said.
Australia’s Therapeutic Goods Administration issued a frequently asked questions guidance Jan. 19 on the pharmacovigilance obligations of sponsors of drugs listed on the Australian Register of Therapeutic Goods. The document answers questions about collecting and reporting adverse drug reactions, searching Australian and worldwide medical literature, identifying and reporting significant safety issues, and updating product information. It also addresses post-registration studies and postmarketing initiatives, and Australian pharmacovigilance contacts.