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As AstraZeneca gears up for courtroom showdown over IRA, Novo's case faces separate HHS rebukeWhen the Biden administration welcomed the passing of the Inflation Reduction Act (IRA) in August 2022, it marked a rare defeat for the pharmaceutical industry in Washington, D.C. Naturally, drugmake2024/1/25
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Regulatory tracker: Bristol Myers filings for Breyanzi gain FDA priority reviewsWelcome to 2024's regulatory tracker for Fierce Pharma. On this page, we're recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Som2024/1/23
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Gilead's Kite wins FDA nod for new CAR-T manufacturing process to speed up Yescarta turnaroundEver since the first CAR-T launches several years ago, lengthy manufacturing timelines have been one drawback of this promising drug class. But with a new FDA blessing, Gilead Sciences is expediting2024/1/23
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Pfizer's layoff campaign ramps back up with dozens of SF-area cuts expected next monthThe start of the new year doesn’t seem to have dulled the zeal of Pfizer’s global cost-cutting campaign, which has already left hundreds of jobs in its wake. Come mid-February, Pfizer will lay off so2024/1/18
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WuXi Biologics plays defense after US bill brands certain Chinese biopharmas as security threatsNew legislation aimed at blocking a group of Chinese biopharma firms from tapping into U.S. federal funding has sent shares tumbling in recent days. Thursday, the House Select Committee on the Strate2024/1/18
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FDA clears penicillin imports from French drugmaker amid Pfizer shortageWith U.S. syphilis cases on the rise and Pfizer’s Bicillin treatment still in short supply, France’s Laboratoires Delbert is stepping in to help with temporary imports. The French drugmaker is workin2024/1/15
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JPM24: Even after Seagen buyout, Pfizer oncology chief still eyes ADC dealsSanFrancisco—Despite its recent $43 billion acquisition of Seagen, Pfizer is still on the lookout for deals centered on antibody-drug conjugates (ADCs). “Building a world-class oncology organization,2024/1/15
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Regulatory tracker: GSK's severe asthma drug Nucala wins approval in ChinaUPDATED: Thursday, Jan.11 at 10:00 a.m. China'sNational Medical Products Administrationhas approvedGSK's Nucalaas an add-on maintenance treatment for patients with severe eosinophilic asthma who ar2024/1/11
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JPM24: Bluebird CEO points to 'very innovative contract' to defend Lyfgenia's pricing premium over CRISPR rivalSan Francisco—Bluebird bio’s 40%list-price premiumfor Lyfgenia compared with Vertex and CRISPR Therapeutics’ sickle cell disease drug surprised many industry watchers last month. But bluebird CEO And2024/1/11
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JPM24: Riding label expansions and launches, AZ plots course toward 'industry-leading growth' by 2030With a late-stage pipeline spanning more than 120 clinical trialsand a firm grasp offive major disease areas, AstraZeneca appears confident heading into 2024. But the drugmaker also has its sights se2024/1/9