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FDA announces new policies for cell and gene therapiesDespite most of the US Food and Drug Administration’s (FDA) responsibilities grinding to a halt as a result of the US Government shut down, FDA commissioner Scott Gottlieb and Centre for Biologics Eva2019/1/18
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US Oversight Committee launches drug price probe into major companiesThe US Committee on Oversight and Reform chairman Elijah Cummings has launched an investigation into the drug pricing practices of multiple pharmaceutical companies. The move comes less than a week a2019/1/17
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Eisai and Purdue Pharma seek US approval for lemborexant to treat insomniaEisai and its partner Purdue Pharma have submitted new drug application to the US Food and Drug Administration (FDA) seeking approval for lemborexant to treat insomnia, a sleep disorder. Lemborexant2019/1/17
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European and UK pharma industry call for action as parliament rejects Brexit dealThe European and UK pharma industry have called for preparations to ensure that patients will have access to their medications in case of a no-deal Brexit by 30 March 2019. The call follows parliamen2019/1/16
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Teva secures US regulatory approval for generic version of SabrilTeva Pharmaceuticals USA has secured approval from the US Food and Drug Administration (FDA) for its generic version of Sabril (vigabatrin) drug to treat complex partial seizures, otherwise known as f2019/1/16
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First its CEO tells pharma to watch it on pricing—and then Johnson & Johnson raises themCall it dramatic irony. Speaking to his biopharma colleagues this week in San Francisco, Johnson & Johnson CEO Alex Gorsky said the pharma industry needs to watch itself on pricing, but only days2019/1/15
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Will Trump team with Democrats to tweak the latest pricing bills? Maybe, analyst saysAlready the Democrats in Congress are showing they're serious about tackling drug prices, not only with new bills, but a new name-and-shame investigation, too. But those bills are "flawed"—and likely2019/1/15
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Novartis’ Aimovig fails to win NICE backing amid tight migraine fight with Lilly, TevaWhen a drug is locked in a tight race with two in-class competitors, earlier patient access matters. But Novartis wasn’t so lucky with its first attempt to get blockbuster hopeful Aimovig onto England2019/1/14
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JPM recap: Must-reads of the week, from FDA to IPO to M&A and moreBig deals, attempts at decent deals and impending IPOs—as usual, the J.P. Morgan Healthcare Conference was awash in deal buzz as well as the occasional rainfall. But that's far from all the talk that2019/1/14
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Pfizer partners with CytoReason on immune system models for drug discoveryIsraeli-machine learning company CytoReason has announced it has signed a collaboration agreement with Pfizer in which the latter will leverage the former’s technology to create cell-based models of t2019/1/11