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An FDA task force Tuesday recommended the agency expand the amount of information about inspections and enforcement that it releases, allowing the public to view a more detailed record of a company’s compliance history. Read More
The UK’s Health Research Authority is helping drugmakers do a better job justifying their trial designs and protocol assumptions early on to avoid trial failures due to insufficient information. Read More
Emergent BioSolutions has received an orphan drug designation for an expanded indication for BioThrax, its anthrax vaccine already in wide use by the U.S. military. Read More
Indian Cabinet Secretary Ajit Seth and other top Indian officials today are laying a framework to begin discussions about intellectual property rights with U.S. drugmakers, a number of whom have lost patent protection in India in recent months. Read More
The European Medicines Agency said late last week that additional drugs have been diverted in a still unfolding case of product tampering that began with stolen vials of the cancer drug Herceptin (trastuzumab). Read More
The FDA has approved GlaxoSmithKline and Genmab’s Arzerra and Leukeran as a first-line combination treatment for the most common form of blood and bone marrow cancer. Read More
Impax said Friday it has refiled an NDA for its Parkinson’s disease drug Rytary after implementing quality systems improvements at the plant where the drug was slated to be made. Read More
The EMA is tightening stability testing requirements for drugmakers submitting applications for significant post-approval manufacturing changes that involve active substances. Read More