European regulators have approved AbbVie’s all-oral, interferon-free hepatitis C drug. The company announced today that the European Commission (EC) has granted marketing authorizations for Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets) for treatment with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated liver cirrhosis, HIV-1 …
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Incyte and Agenus will partner on immuno-oncology targets in a deal worth up to $410 million. The companies announced today that they have entered into a global license, development and commercialization agreement focused on novel immuno-therapeutics using Agenus’ proprietary Retrocycle Display antibody discovery platform. According to terms of the deal, …
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Biogen Idec said that its experimental multiple sclerosis (MS) drug showed signs that it could help repair nerve damage in patients’ eyes. The company announced top-line results from the Phase II acute optic neuritis (AON) RENEW trial. According to Biogen, treatment with its anti-LINGO-1 showed evidence of biological repair of …
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Gilead Sciences Inc.’s shares were up more than two percent Monday following news that the company gained exclusive coverage from CVS Health Corp. CVS Health, the nation’s second-largest pharmacy benefit managers (PBM), said that it would make Gilead’s drugs, Harvoni and Sovaldi, the exclusive option for patients on its commercial …
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Today, Pfizer Inc. announced that it is in discussion with the US Food and Drug Administration (FDA), regarding its potential blockbuster breast cancer drug palbociclib. According to the company, it expects to get a final decision from the agency by April 13. Pfizer said that the FDA is not requiring …
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Pharmaceuticals Incorporated recently announced that US health regulators approved a supplemental new drug application (sNDA) for the use of Kalydeco (ivacaftor) in a new group of cystic fibrosis (CF) patients. The US Food and Drug Administration (FDA) approved the use of Kalydeco in people with CF ages 6 and older …
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