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Fierce Pharma Asia—Astellas' plant closure, lab debut; China's probe into AstraZeneca staffersAstellas is closing a gene therapy manufacturing facility in South San Francisco. But, across the country, the company opened a new R&D center in Massachusetts. Chinese authorities detained sever2024/8/15
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Despite trial scare, Travere's Filspari gains full FDA nod in kidney disease showdown with NovartisA year after missing on a trial endpoint, Travere Therapeutics can breathe a sigh a relief. The FDA has converted Filspari’s conditional nod in the kidney disease IgA nephropathy (IgAN) into a full a2024/8/13
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BIOSECURE Act heads for possible vote in House of Representatives next weekAfter running up against a roadblock earlier this summer, the controversial BIOSECURE Act could gain new momentum next week. The U.S. House of Representatives isslated to considerthe legislation duri2024/8/13
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Bayer's Kerendia passes key test, cutting risk of cardio death and heart failureBayer’s Kerendia was approved in 2021 to treat patients with chronic kidney disease (CKD) associated with Type 2 diabetes. For the nonsteroidal mineralocorticoid receptor antagonist (nsMRA) to accomp2024/8/8
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FDA signs off on Adaptimmune's Tecelra as the first engineered cell therapy for a solid tumorAdaptimmune has won accelerated FDAapprovalfor Tecelra (afami-cel), a treatment for metastatic or unresectable synovial sarcoma. Tecelra’s approval comes with several firsts. It’s the first engineere2024/8/8
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Another IRA lawsuit bites the dust with ruling on Novo Nordisk case; company pledges to appealLike clockwork, another lawsuit challenging the constitutionality of the Inflation Reduction Act's (IRA's) price-setting measures has been shot down in the courts. One after another, arguments from d2024/8/6
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GSK blows Jemperli marching brass against Keytruda with expanded FDA nod in endometrial cancerMerely a month into an FDA approval for a broad first-line endometrial cancer population, Merck’s Keytruda has some company. On Thursday, the FDA expanded the endometrial cancer use for GSK’s Jemperl2024/8/6
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Alpha Cognition's delayed-release Alzheimer's drug Zunveyl passes muster with FDAAmid an influx of new drugs targeting one of the believed root causes of Alzheimer’s disease, a new symptomatic med has hit the scene, courtesy of Vancouver’s Alpha Cognition. On Monday, the FDAgave2024/7/30
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After tense standoff, AstraZeneca and Daiichi's Enhertu turned away by NICE on pricing groundsAfter a prior skirmish over tax policy in England, AstraZeneca is now butting heads with officials in the country over innovative drug access. In a decisionreleasedMonday, England’s National Ins2024/7/30
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J&J's Texas two-step bankruptcy maneuver shut down again by appeals courtJohnson & Johnson’s latest attempt to get a handle on its talc litigation using the controversial Texas two-step bankruptcy strategy has once again fallen flat after a federal appeals court ruled2024/7/25