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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
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GSK tees up AstraZeneca rivalry with positive Jemperli-Zejula readout in endometrial cancerOn a missionto grow in oncology, GSK has more positive data to report in endometrial cancer. This time, the company is touting results for itsPD-1 inhibitor Jemperli and PARP inhibitor Zejula, which2023/12/19
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Charles River snags clearance to produce Vertex and CRISPR's Casgevy from Tennessee plantFollowing a string of approvals in the United States and beyond, Vertex Pharmaceuticals continues to build out its manufacturing network for the world’s first CRISPR-based genetherapy, Casgevy. Monda2023/12/14
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Merck, Astellas and Pfizer bring down the house with Keytruda-Padcev FDA nod in bladder cancerThe combination therapy was hailed with astanding ovationin October at the European Society for Medical Oncology (ESMO) conference in Madrid. Less than two months later, the FDA has added its acclaim2023/12/14
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Bristol Myers Squibb's Opdualag comes up short in late-stage colorectal cancer trialBristol Myers Squibb’s PD-1/LAG3 combo Opdualag has more than proved its worth in melanoma since its first-in-class approval in 2022. Now, the drug's first venture outsidethe melanoma arena has come2023/12/12