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In warning letters, FDA tells 8 companies to stop selling illicit eye drugsEight companies are finding themselves inhot water for allegedly churning out illicit eye drugs, the FDA said Tuesday. The drugs are unapproved and illegally marketed, the FDA said, which is especial2023/9/11
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Patent cliffs, divestitures and maturing biotechs all point to more pharma M&A: analystsBiopharma M&A is on an uptick compared to the post-pandemic doldrums of the last two years. Analysts anticipate that the trend will continue in 2023 and into 2024 as companies attempt to beef up2023/9/8
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Amgen, J&J most vulnerable to IRA price negotiations in 2026: Moody'sNow that the Centers for Medicare & Medicaid Services (CMS) hasrevealedits list of the first 10 drugs subject to Medicare price negotiations under the Inflation Reduction Act (IRA), it’s time to2023/9/5
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BlueWhale Bio surfaces with $18M on mission to overhaul cell therapy productionUniversity of Pennsylvania spinout BlueWhale Bio has surfaced on a mission to smash bottlenecks in cell and gene therapy manufacturing. The new companyuncloakedThursday with news it has raised $182023/9/5
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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