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A new bipartisan House bill would stop brandmakers from relying on a drug-control program to deny generics firms the batch samples they need to put together an ANDA. Read More
GlaxoSmithKline must pay a fine of roughly $490 million and change its business practices in China after a Chinese court found the company guilty in a year-old bribery case. Read More
The FDA approved Eli Lilly’s diabetes drug Trulicity as a once-weekly subcutaneous injection to improve blood sugar levels, along with diet and exercise, in adults with the type 2 form of the disease. Read More
A federal effort to spur the development of new drugs to treat antibiotic-resistant infections comes as the industry warns the antibiotics pipeline is running dangerously low and more financial incentives will be required to encourage development in this area. Read More
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
An FDA draft guidance that would require informed consent documents to include detailed descriptions of treatment alternatives to experimental drugs would confuse patients so much that recruiting subjects for clinical trials will become nearly impossible, drugmakers argue. 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