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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
The British healthcare cost evaluation agency has recommended coverage of Astellas Pharma’s prostate cancer drug Xtandi and Bristol-Myers Squibb’s melanoma treatment Yervoy, noting that the therapies provide sufficient gains in overall survival of patients who were treated for the cancers. Read More
Canadian trade officials are pushing back against Eli Lilly’s $500 million damages claim against the government in an international trade dispute, claiming the brand manufacturer demonstrates a fundamental lack of understanding for Canada’s patent laws and treaty obligations. Read More
A federal court has granted Mylan’s request for a temporary restraining order to halt all sales of competitor Apotex’s generic version of Paxil CR, the latest step in Mylan’s claim to generic exclusivity on GlaxoSmithKline’s blockbuster antidepressant. Read More
Brand manufacturers who use risk evaluation and mitigation strategies (REMS) to delay generic competition by denying product samples to would-be ANDA filers are costing pharmaceutical payers billions of dollars each year, according to a new study commissioned by GPhA. Read More
The FDA released its fourth warning letter in two days against a compounding pharmacy, this time chiding a large compounder for a mixture of quality violations at its four facilities. Read More