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FDA approves Amgen’s postmenopausal osteoporosis drug EvenityAmgen has received the US Food and Drug Administration (FDA) approval for Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk for fracture. Evenity is a humanised mo2019/4/11
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Researchers develop new vaccine to teach immune system to attack cancerResearchers at Mount Sinai in the US have developed a new immunotherapy that can be injected directly into a tumour cell and teach a patient’s own immune system to kill cancer throughout the body. Ca2019/4/11
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England's NICE rebuffs Pfizer and Astellas' Xtandi in nonmetastatic prostate cancerPfizer and Astellas’ Xtandi is looking for a leg up on prostate cancer rival Erleada from J&J. But it won't be getting it in England. In a final appraisalreleasedMonday, the National Institute fo2019/4/10
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GSK's Dovato chalks up first 2-drug regimen nod for new HIV patients, but will doctors use it?In a landmark win for GlaxoSmithKline’s ViiV Healthcare and its ambition to reduce the number of medications HIV patients are taking—and beat rival Gilead Sciences along the way—the FDA has approved2019/4/10
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FDA declares 40 generics free of carcinogens as 'sartan' recalls continueAs recalls on blood pressure drugs continue to plague drugmakers, the FDA declareda slate of 40 generic pills safe to use. On Thursday, the agency releaseda listof 40 generic angiotensin II receptor2019/4/9
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FDA expands Ibrance’s label to include male breast cancer patientsPfizer has announced that the US Food and Drug Administration (FDA) has accepted its request to expand the indications for Ibrance (palbociclib) to include the treatment of men with breast cancer. Th2019/4/8
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Novartis and Amgen dispute over migraine drug reaches courtNovartis has filed a lawsuit against Amgen for allegedly trying to inappropriately back out of their collaboration agreements covering the development and commercialisation of migraine drug Aimovig.2019/4/8
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Sandoz resubmits BLA for biosimilar pegfilgrastim to FDANovartis unit Sandoz has resubmitted a biologics licence application (BLA) of its proposed biosimilar pegfilgrastim to the US Food and Drug Administration (FDA) seeking approval to address febrile ne2019/4/4
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Sangamo announces promising early results for haemophilia A gene therapyCalifornia-based Sangamo Therapeutics, alongside its partner Pfizer, has announced interim results from Phase I/II Alta study evaluating an investigational SB-525 gene therapy for severe haemophilia2019/4/4
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Pharma spends big as Massachusetts lawmakers review drug-pricing billsState legislators in Massachusetts are preparing to review a slew of bills aimed at state-level drug pricing, and the pharmaceutical industry is opening its checkbook to fight back. The state’s Joint2019/4/3