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With the launch of the FDA’s Office of Pharmaceutical Quality, all ANDA filers are now eligible for OPQ’s real-time communications program — the quick-turnaround method the agency will use to resolve minor questions about chemistry, manufacturing and controls during ANDA reviews. Read More
The White House in its fiscal 2016 budget proposal Monday asked Congress to appropriate $486 million for CDER, a bump in funding of less than one percent, and $215 million for CBER, an increase of two percent. Read More
A federal judge has tossed out a liability lawsuit filed against brandmakers Wyeth and Alaven Pharmaceuticals, saying they were not responsible for the death of a patient who took generic Reglan not made by the companies. Read More
A federal court has ruled that any payment from a brand drugmaker to settle a patent infringement case that results in delay of a competitive generic product is enough to support a pay-for-delay claim, potentially lowering the bar for such lawsuits. Read More
Australian authorities have suspended a biosimilars naming initiative, pending review, in the wake of a recent World Health Organization proposal on how biosimilars should be named. Read More
The FDA has given a Teva subsidiary the first greenlight for a generic Nexium in a snub to Ranbaxy, which is suing the agency after having its ANDA first-filer status on the therapy revoked over GMP violations at its India plants. Read More
Astellas Pharma will pay $98 million to settle a class action lawsuit that accuses the brandmaker of filing a frivolous citizen petition and subsequent lawsuit solely to delay generic competition to its transplant drug Prograf. Read More
Gilead has expanded its licensing agreements with eight India-based generic drugmakers to market cheaper copies of its pricey blockbuster hepatitis C therapy Sovaldi in 91 developing countries. Read More
The White House released a joint statement by President Barack Obama and Indian Prime Minister Narenda Modi pledging to negotiate a harmonized approach to intellectual property protections and establish standard definitions for what is patentable. Read More
As negotiators continue to shape the Trans-Pacific Partnership trade deal, the length of patent protection for biologics remains a sticking point, with the U.S. continuing to push for 12 years of protection before a biologic drug can be copied. Read More
The European Medicines Agency is recommending halting sales of 700 drugs that were approved based on testing data provided by CRO GVK Biosciences, following an inspection that found the Hyderabad, India, firm manipulated echocardiogram data. Read More