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J&J dumps high-dose Opsumit trial upon failure in rare type of pulmonary hypertensionJohnson & Johnson’s plan to expand decade-old pulmonary hypertension med Opsumit has hit a snag. J&J’s Janssen hasdecided to stopa phase 3 trial for a 75-mg dose of macitentan in patients2023/9/1
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Astellas withdraws IRA lawsuit after avoiding CMS' price negotiations listExpecting to be subject to Medicare pricing negotiations, Astellas in July challenged the legality of the Inflation Reduction Act (IRA). But now that theCenters for Medicare & Medicaid Services (2023/9/1
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'Far too speculative': Amgen fights FTC's request for injunction against $28B Horizon mergerAs the Federal Trade Commission triesto block Amgen’s $28 billion acquisition of Horizon Therapeutics with an injunction, Amgen has a lot to say in court filings. The FTC’s case is “far t2023/8/28
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Ferring inks $500M deal with Royalty Pharma on new bladder cancer gene therapyRoyalty Pharma has built a niche by finding innovative products pre- and post-approval from companies that need an infusion of cash in exchange for future royalties. Fitting the bill is F2023/8/28
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After high-profile snub, Akebia plots vadadustat resubmission at FDAAfter the “extreme disappointment” of vadadustat’s anemia snub in March 2022—plus a partnership gone awry and a formal dispute with the FDA—Akebia Therapeutics has dusted itself off and readied for a2023/8/24
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After $1.7B opioid settlement, Mallinckrodt readies 2nd bankruptcy bidAfter floating the idea earlier this month, Mallinckrodt has formally declared its intention to kick off another round of bankruptcy proceedings in the coming days. The plan—which would m2023/8/24
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Novo Nordisk tapped Thermo Fisher to help make obesity drug Wegovy amid Catalent woes: ReutersNovo Nordisk is struggling to meet strongdemand forWegovy, and the company has reportedly tapped another contract manufacturer to churn out the popular weight-loss drug.2023/8/21
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PHARMA In GSK's trial of shingles vaccine in China, Shingrix keeps it 100In October of last year, GSK laid out a plan todoubleits business in China by 2025, with much of that expansion dependent upon the success of Shingrix, the company’s recombinant zoster vaccine (RZV)2023/8/21
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Apellis flags needle problems in hunt for Syfovre side effect sourceWhile nothing is certain yet, Apellis may be homing in on the source of a rare but serious side effect tied to its world-first geographic atrophy drug Syfovre. The safety update comes as the company2023/8/18
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With new lawsuit, Boehringer Ingelheim becomes latest drugmaker to take aim at IRAAs litigation challenging the Inflation Reduction Act (IRA) piles up, Boehringer Ingelheim has become the latest drugmaker to take aim at the new law. In a 62-page lawsuit, Boehringer lai2023/8/18