We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Former governor of Tennessee, Alexander was first elected to the Senate in 2002. In his farewell statement on Monday, he took credit for anti-opioids legislation signed by President Trump in October and for writing the 21st Century Cures Act. Read More
Retiring Sen. Orrin Hatch (R-Utah) urged his Republican colleagues not to support the White House drug pricing plan, claiming it oversteps HHS authority. Read More
Sen. Ron Wyden (D-Ore.), the ranking member of the Senate Finance Committee, is seeking an explanation for the steadily growing cost of Pfizer’s blockbuster drug Lyrica. Read More
A federal judge on Wednesday issued a preliminary injunction against a New York state law that imposed surcharges on opioid manufacturers and distributors. Read More
The agency’s proposal would lead to a small category of biological products currently regulated as drugs — such as insulin and human growth hormone —to be regulated as biosimilars under the Biologics Price Competition and Innovation Act (BPCIA) and would “enable, for the first time, products that are biosimilar to, or interchangeable with, these products to come to market,” Gottlieb said. Read More
Sen. Orrin Hatch (R-Utah) and two colleagues have introduced a set of proposed reforms that they say will bring clarity and prevent arbitrage by making patent challengers choose one route or the other. Read More
In October 2017, Sanofi launched patent infringement litigation against Mylan’s NDA for generic versions of its Lantus vials and disposable injection pens. That litigation is still pending, with no trial date assigned. Read More
Stakeholders also argued that the new rule would have led to labels for the same drug temporarily bearing different labeling information between different generics… Read More
Sen. Cory Booker (D-N.J.) introduced legislation Tuesday designed to increase the transparency of drug coverage decisions made by state Medicaid programs, after an investigation gave rise to concerns of dishonest industry influence. Read More
Sen. Ron Wyden (D-Ore.) on Tuesday called on HHS Secretary Alex Azar to review the members of the department’s pain management task force for financial relationships with drug companies. Read More