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.
In the latest move by Novartis to protect its top selling multiple sclerosis drug Gilenya (fingolimod) from generic competition, the Swiss drugmaker filed lawsuits against dozens of drugmakers seeking to market Gilenya copies. Read More
Liquids or soft foods should only be used as vehicles for drug administration if they have no appreciable effect on drug performance, the FDA said in a draft guidance issued Tuesday. Read More
A federal appeals court on Friday ruled a Native American tribe cannot assert sovereign immunity against inter partesreviews by the U.S. Patent and Trademark Office, in the latest ruling in a battle over Allergan’s dry-eye drug. Read More
Sponsors studying genetic metabolic disorders should put patients on strict diets even before clinical trials start, the FDA says in a draft guidance issued Monday. Read More
The FDA announced on Monday that it will take enforcement action against compounders using the unapproved bulk substance cesium chloride, partially granting a December 2017 petition by Public Citizen. Read More
The pharmacy benefit manager group believes the rule will target anti-kickback and Medicare Part D statutes and the protection of pharmaceutical company rebates. Read More