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The UK’s health cost-benefit watchdog refused to recommend Roche’s Kadcyla as a treatment for HER2-positive breast cancer, saying the $151,000 per patient cost is out of reach for the National Health Service. Read More
Massachusetts doctors who want to prescribe the painkiller Zohydro will need to complete a risk-assessment and pain management treatment agreement with their patients, under sweeping restrictions announced Tuesday by Gov. Deval Patrick (D). Read More
The FDA hopes to soon wrap up the 45-plus year process of clearing from the market older drug products that were never proven effective before being sold. Read More
The European Medicines Agency is tightening stability testing requirements for drugmakers submitting applications for significant post-approval manufacturing changes that involve active substances. Read More
Hospira’s quality struggles continue as the injectable giant voluntarily recalled seven lots of generic anesthetic propofol due a defect that led to metal particles in certain vials. Read More
Pfizer Monday reached an agreement to settle a class action lawsuit alleging that the drugmaker attempted to improperly delay the launch of generics of its epilepsy drug Neurontin. Read More
Indian authorities quietly suspended Ranbaxy’s Toansa facility from exporting active pharmaceutical ingredients to Europe late last month, signaling the country’s new, tougher approach to manufacturing quality violations. Read More
The European Commission is mandating that drugmakers implement a detailed protocol for transferring testing methodology from one lab to another to ensure product quality. Read More
Israeli drugmaker Teva announced April 17 that it has reached a settlement with Pfizer to hold back marketing generic Celebrex (celecoxib) in the U.S. until December. Read More