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.
The UK’s health-cost watchdog has recommended coverage of GlaxoSmithKline’s melanoma drug Tafinlar, but is requiring GSK to provide a discount on the product. Read More
The UK’s health-cost watchdog has recommended coverage of Janssen hepatitis C drug Olysio, but also has asked for more data proving its effectiveness in certain patient populations. Read More
The UK’s health-cost watchdog said it’s not ready to change the way it appraises medicines and other technologies, but acknowledged that further consideration is needed on how new treatments are developed, evaluated and supported for adoption in the National Health Service (NHS). Read More
Generics makers with first-to-file ANDA status say they are frustrated by the FDA’s slow approval times, claiming their 180-day market exclusivity period is jeopardized by agency inaction. Read More
AstraZeneca and Nektar Therapeutics say they hope to market their newly approved opioid-induced constipation drug Movantik in early 2015, but the launch date remains uncertain as the Drug Enforcement Administration considers a request to deschedule the product. Read More
Manufacturers operating in Europe should report any product-quality defect to the drug application holders and individual EU regulatory bodies if the incident requires a recall or creates supply restrictions, according to a revised chapter of a European Commission guideline on good manufacturing practices. Read More
The FDA’s database of inactive drug ingredients needs a complete overhaul to better facilitate ANDA filings, say generics makers, that laid out a variety of other shortfalls they see in the agency’s generic drug approval process. Read More