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Sponsors of clinical trials for new migraine therapies should focus on enrolling more women of childbearing age early in the drug development process, as more women than men have the condition, according to a new FDA draft guidance. Read More
Dr. Reddy’s Laboratories has settled a class-action lawsuit over its alleged role in delaying generic entry of AstraZeneca’s heartburn drug Nexium in return for assisting plaintiffs in their case against AZ and the remaining generics manufacturer defendants. Read More
A coalition of drugmakers wants to boost performance at clinical trial sites by establishing common standards for good clinical practices and skill requirements for investigators. Read More
India’s national drugs authority is again surveying pharmacists and testing drug samples in an effort to better grasp the extent of the country’s counterfeit and substandard drugs problem. Read More
Pharmaceutical intellectual property rights remain a significant sticking point in a proposed draft of the massive Trans-Pacific Partnership (TPP) trade pact leaked last week. Read More
Two lawmakers wrote to HHS Secretary Sylvia Burwell seeking an analysis of national drug pricing and efforts by the Obama administration to bring rising generic prices under control. The letter is likely a precursor to congressional hearings. Read More
Pfizer is the latest company to win approval of opioid abuse-deterrent labeling, after the FDA cautiously okayed new statements about Embeda late Friday. Read More
The European Medicines Agency is urging companies developing drugs and vaccines for Ebola to seek orphan designation to hasten the evaluation of applications for products that could help victims of the current outbreak in West Africa. Read More