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.
House and Senate conferees reached agreement late Tuesday on a final version of an expansive legislative package to address the opioid crisis. Read More
Alkeus Pharmaceuticals will receive $1.75 million over four years for a phase II study of an experimental drug treatment for Stargardt disease. Read More
A survey found that over half of marketing authorization holders with “an important step in their regulatory processes in the UK” were on track to ensure that their authorizations remain valid post-Brexit. Read More
Endo argued that the FDA’s handling of bulk compounding laws violated the Drug Quality and Security Act when it treated the legislation as non-binding guidance instead of as a legal mandate. Read More
The FDA issued final guidance Tuesday for outsourcing facilities on compounding and repackaging radiopharmaceuticals, along with draft guidance on insanitary conditions at compounding facilities. Read More
The EMA lowered its estimate for the number of centrally authorized drugs that may face post-Brexit supply disruptions from 108 to 39 — including 25 human medicines. Read More
Against a backdrop of declining sales for its branded hepatitis drugs, Gilead announced plans to launch its own “authorized generics” of two of its hep C treatments. Read More
The enforcement action “should send a clear message to the burgeoning iV therapy industry and sellers of all healthcare products,” said FTC Chairman Joe Simons. Read More
Genentech and Boehringer Ingelheim want the FDA to amend or clarify parts of its draft guidance on the use of liquids or soft foods as drug administration vehicles. Read More
In the latest development in the ongoing saga over Allergan’s transfer of Restasis patents to a Native American tribe, the partners sued Amneal for infringing upon two patents for the dry-eye drug. Read More