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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
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Did Novartis hand out kickbacks or host educational dinners? A jury may decideKickbacks, $10,000 dinners and Hooters. Details that sound pulled from an episode of "Billions" are key accusations in a federal lawsuit against Swiss drugmaker Novartis that could face a jury trial2019/4/3
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AACR: Clovis' Rubraca follows Lynparza's big pancreatic cancer win with phase 2 dataATLANTA—AstraZeneca and Merck’s Lynparza earlier this year posted an unprecedented phase 3 win in the pancreatic cancer arena. Now, another drug in its class has shown some early success battling the2019/4/2
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AbbVie's massive Humira discounts are stifling Netherlands biosimilars: reportCould a drug's price ever be too low? That’s what some market-watchers are asking in the Netherlands, where AbbVie is discounting Humira as much as 89%. TheDe Groene Amsterdammerdug intothe procureme2019/4/2
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Bluebird tees up its first gene therapy approval with Zynteglo thumbs-up in EUBluebird Bio’s development of a gene therapy to treat transfusion-dependent β-thalassemia (TDT) has been far from easy, but the final path to marketis finally coming into view for the 27-year-old com2019/4/1
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Keytruda nabs key lung cancer nod in China. But are blockbuster sales really attainable?Less than a year after securing its first Chinese approval, in previously treated metastatic melanoma patients, Merck & Co.’s Keytruda has leapt ahead of Bristol-Myers Squibb’s Opdivo and nabbed2019/4/1