Two drugmakers targeted in a lawsuit over Tennessee’s opioid epidemic filed a third-party complaint against online “black market” drug distributors, alleging they’re responsible for the state’s opioid crisis. Source: Drug…
An advisory panel Wednesday recommended that the FDA collect more data before signing off on use of GlaxoSmithKline’s asthma drug mepolizumab for treating chronic obstructive pulmonary disease (COPD). Source: Drug…
The Senate Health Committee unanimously approved a bipartisan bill on Wednesday that would outlaw “gag clauses” that prevent pharmacists from telling patients a drug would be cheaper if they paid…
Edge Biologicals was hit with a Form 483 for violations at its Memphis, Tennessee facility, including inadequate environmental monitoring, poor complaint handling and incomplete recordkeeping observed during a March inspection.…
The European Medicines Agency released new guidelines on developing treatments for Crohn’s disease and ulcerative colitis set to take effect Jan. 1. Source: Drug Industry Daily
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…
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be used as vehicles for drug administration if they have no appreciable effect on drug performance, the FDA said in a draft guidance issued…
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…
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genetic metabolic disorders should put patients on strict diets even before clinical trials start, the FDA says in a draft guidance issued Monday. Source: Drug Industry Daily
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. Source:…