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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
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Chasing Pfizer and Lilly, Sun Pharma wins FDA nod for alopecia areata med LeqselviAfter Eli Lilly’s Olumiant won the distinction of becoming the first med approved by the FDA to treat the follicle-attacking autoimmune disease alopecia areata, Pfizer followed up with a green light2024/7/25
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Eisai, Biogen's Alzheimer's med Leqembi turned down in Europe—but analyst says it's merely a 'delay'Despite winning approvals in a range of countries like the U.S., China, Japan and Israel, Eisai and Biogen’s anti-amyloid Alzheimer’s disease med Leqembi has come up short in the eyes of European reg2024/7/23
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FDA advisers, frustrated by AZ's Imfinzi design, call for revamp of perioperative lung cancer trialsThe FDA’s Oncologic Drugs Advisory Committee (ODAC) has unanimously called for a revamp of perioperative clinical trial designs in resectable non-small cell lung cancer (NSCLC) to include assessment2024/7/23
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AbbVie boosts profit outlook as Humira successors branch into gastroenterology marketWith a new chief at the helm and higher profit projections in sight, AbbVieisentering a “new chapter," CEO Robert Michael told analysts Thursday. During the second quarter, AbbViereporteda 29.8% plun2024/7/18