Archive for July 2018
Edge Biologicals Called Out for Inadequate Procedures, Recordkeeping
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. Source: Drug Industry Daily
Read MoreEMA Adopts Revised Drug Development Guidelines for Two Inflammatory Diseases
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
Read MoreNovartis Sues Over Generics for Gilenya After Favorable PTO Ruling
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. Source: Drug Industry Daily
Read MoreFDA Draft Guidance Outlines Use of Liquids or Soft Foods as Drug Vehicles
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be used as vehicles for drug administration if they have no appreciable effect on drug performance, the FDA said in a draft guidance issued Tuesday. Source: Drug Industry Daily
Read MoreCourt Finds St. Regis Tribe Cannot Block Allergan Patent Challenges
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. Source: Drug Industry Daily
Read MoreTrials for Inherited Metabolic Disorders Should Put Patients on Strict Diets, FDA Says
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genetic metabolic disorders should put patients on strict diets even before clinical trials start, the FDA says in a draft guidance issued Monday.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
Read MoreFDA Moves Against Cesium Chloride As Bulk Substance in Compounded Drugs
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: Drug Industry Daily
Read MoreConnecticut Drugmaker Flagged for Repeat Violations
The FDA cited Milbar Laboratories, an OTC drug manufacturer based in East Haven, Connecticut, for repeat inspection observations including failure to sterilize a purified water system. Source: Drug Industry Daily
Read MorePBMs Voice Concern Over Proposal to Remove Protections for Drug Rebates
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. Source: Drug Industry Daily
Read MoreFDA Adopts ICH E17 Guidance on Multiregional Clinical Trials
The FDA released new ICH guidelines designed to help researchers navigate the sometimes conflicting regional requirements and differences in global clinical trials. Source: Drug Industry Daily
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