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JPM24: After 'clearing the decks,' Alkermes ready to roll as pure-play neuroscience companyAge 37 might be old for a “coming-out party,” but that’s the situation for Alkermes at this year’s J.P. Morgan Healthcare Conference, chief operating officer Blair Jackson said in an interview. After2024/1/9
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JPM24: Roche says rebound in hematology sparked by potential of newly approved Lunsumio, ColumviAfter Roche went through a period of declining sales in hematology—as powerhouse Rituxan faced biosimilar competition and follow-on Gazyva failed to live up to its blockbuster expectations—the compan2024/1/4
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JPM24, Day 2: Lilly CEO says competition benefits obesity field; Novavax readies phase 3 combo trialTuesday, Jan. 9 at 8:30 p.m. ET AstraZenecalaid out its lofty goals for the end of the decade, which include not only delivering “industry-leading growth” by 2030, but placing in at least “the top-th2024/1/4
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JPM24: Pfizer CEO promises 'year of execution' after recent struggles, Seagen buyoutPfizer knows it had a bad year in 2023. Speaking to reporters at the 2024 J.P. Morgan Healthcare Conference on Monday, the company’s CEO, Albert Bourla, spoke bluntly about the hits the company took,2024/1/2
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Astellas' gastric cancer candidate rejected by FDA because of manufacturing issuesTwo successful phase 3 trials put Astellas’ monoclonal antibody zolbetuximab on track to become the first approved therapy to treat one of the hottest targets in oncology—tumors that are claudin (CLD2024/1/2
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GSK, Amneal and Kaleo pull patents from FDA database after FTC challengeFollowing the U.S. Federal Trade Commission’s recentcrackdownon “improper”patents in the FDA’s Orange Book, at least three drugmakers have made the requested changes. GSK has removed four patents rel2023/12/28
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Calliditas wins over FDA for full approval, broader label on kidney disease drug TarpeyoTwo years after securing an accelerated approval for its primary immunoglobulin A nephropathy (IgAN) therapy Tarpeyo (budesonide), Calliditas Therapeutics hasscoreda full FDA endorsement for the oral2023/12/28
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Argenx's Vyvgart Hytrulo comes up short again, this time in the rare disease pemphigusLess than one month after reporting a trial fail forVyvgart Hytrulo in a rare bleeding disorder, argenx has swung and missed in a group of chronic blistering diseases. This time, a phase 3 trial flop2023/12/26
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Biogen notches another Tecfidera patent win in Europe as officials revoke generic approvalsFollowing a significant loss at the U.S. Supreme Court last October, Biogen’s Tecfidera patent odyssey continues to spin in the company’s favor overseas. Tuesday, Biogensaidthe European Commission (E2023/12/26
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Regulatory tracker: Merck's Keytruda picks up 2 new approvals in EuropeUPDATED: Tuesday, December 19at 8:40a.m. The numberof approved indications forMerck's star cancer medicineKeytrudahas grown to 26 in Europe.Most recently, theEuropean Commissionapproved2023/12/19