When Novartis’ Zolgensma data manipulation problem first went public last August, an angry FDA said it would consider possible civil or criminal penalties. But it looks like neither of those is going to happen. Despite a Form 483 citation for
read moreThe production of Chinese active pharmaceutical ingredients (APIs) slipped by 10% to 20% during the early days of the COVID-19 outbreak in China but is quickly recovering. The bottleneck in the global supply chain for APIs is now shipping, particularly
read moreAmid operations concerns over the novel coronavirus pandemic, Mylan and Pfizer’s Upjohn unit have already postponed the close of their pending generics megamerger. Now, in order to clear antitrust hurdles in Europe, the drugmakers have agreed to meet regulators in
read moreVaccine researchers are fervently working behind the scenes to hustle a COVID-19 shot to market. Dozens of projects are in the works. FiercePharma convened a panel of experts to assess progress—and outline the challenges that remain. More: Experts weigh in
read moreSense Biodetection has also pitched in, announcing an accelerated programme to launch the world’s first instrument-free, point-of-care molecular diagnostic test for the novel virus. More: COVID-19: J&J announces vaccine candidate, Synairgen commences dosing Source: News
read moreThe approval was based on the Phase III CASPIAN trial, in which the risk of death was reduced by 27%. More: FDA approves Imfinzi for extensive-stage SCLC Source: News
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