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British drug giant GlaxoSmithKline has submitted the world’s first application for approval of a malaria vaccine, a product developed in partnership with the Bill & Melinda Gates Foundation and the PATH Malaria Vaccine Initiative. Read More
The FDA approved only the second extended-release opioid painkiller to feature abuse-deterrent properties, and hinted that future products that include such technologies could receive faster regulatory reviews. Read More
The FDA has cleared Gilead’s new treatment for three types of rare blood cancers, potentially creating another blockbuster drug for manufacturer of the hepatitis C treatment Sovaldi. Read More
A trio of European pharmaceutical trade groups is seeking greater clarity around the European Medicines Agency’s initiative to streamline the drug approval process through parallel reviews for both reimbursement and safety and efficacy. Read More
Two pharmaceutical industry groups are welcoming a recommendation by Irish regulators that could allow as many as 34 drugs to be sold through pharmacies without a prescription. Read More
The FDA this week approved the first human recombinant C1-esterase inhibitor product for adolescents and adults with acute attacks of a rare condition called hereditary angioedema (HAE). Read More
Generics maker Ranbaxy has the green light to launch an exclusive version of Novartis’ blockbuster hypertension drug Diovan, a move that comes nearly two years after the drug lost patent protection. Read More
Salix Pharmaceuticals has convinced the FDA to reverse its 2012 stance blocking the company’s sNDA for an expanded use of its opioid-induced constipation drug Relistor. Read More