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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be used as vehicles for drug administration if they have no appreciable effect on drug performance, the FDA said in a draft guidance issued Tuesday.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genetic metabolic disorders should put patients on strict diets even before clinical trials start, the FDA says in a draft guidance issued Monday.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
The Pharmaceutical Care Management Association is concerned about a proposed rule that could remove safe harbor protections for pharmaceutical company rebates and significantly change how drug prices are formulated. Read More
The FDA released new ICH guidelines designed to help researchers navigate the sometimes conflicting regional requirements and differences in global clinical trials. Read More
The FDA on Friday published 26 new product-specific draft guidances for generic drug trials and 17 revisions, saying it hopes to broaden access and help cheaper drugs get to market more quickly — including opioids formulated to deter abuse. Read More