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A 'pivotal moment': Ionis enters next phase of commercial evolution with Tryngolza's FDA approvalWith an FDAapprovalfor Tryngolza (olezarsen) to treat the rare genetic disorder familial chylomicronemia syndrome (FCS), Ionis Pharmaceuticals enters a new era. While Ionis has gained several FDA nod2024/12/19
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FDA reaffirms decision to erase Eli Lilly's tirzepatide from shortage list, halting future flow of knockoffsThe FDA hasdoubled downon its decision to remove Eli Lilly’s tirzepatide from its list of products that are in shortage. The agency’s move means that compounding pharmacies will have to halt producti2024/12/19
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After two rejections, FDA approves Mesoblast's first-of-its-kind cell therapyAn FDA advisory panel vote of 9-1 torecommendthe approval of Mesoblast Limited’s graft versus host disease (GVHD) cell therapy was a cruel tease for the Australian company. More than four years later2024/12/17
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Novartis to shutter 2 MorphoSys sites, lay off 330 staffers in post-buyout consolidationIn a move that follows an increasingly common trend in biopharma M&A, Novartis is shedding sites and staffers from the German cancer biotech it acquired earlier this year. Novartis confirmed Thur2024/12/17
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Playing catch-up with Pfizer and Roche, China-made ALK drug clears FDA in lung cancerFollowing in the footsteps of several Big Pharma companies, another ALK inhibitor has made its entry into the U.S. The new entrant is ensartinib from Xcovery Holdings, a subsidiary of China’s Betta P2024/12/12
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Trio of Indian drugmakers issue recalls tied to impurity, labeling issuesIndian drugmakers Aurobindo, Glenmark and Zydus have issued separate sweeping drug recalls over issues pertaining to impurities and labeling. The product pulls were reported in a recent edition of th2024/12/12
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Regeneron's Eylea HD passes key test in retinal vein occlusion, teeing up 2025 FDA filing as Eylea threats mountWith Eylea biosimilar competition creeping in and Roche’s Vabsymo jockeying for market share in key indications, Regeneron is racing to carve out a new market for the high-dose version of its blockbu2024/12/10
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After studies flag possible link between Novo's Ozempic and rare eye disorder, EU plans to investigate: ReutersIt’s not a new question, but it is one that is gaining increased traction: Is there a link between Novo Nordisk’s diabetes superstar Ozempic and blindness? After the recent release of two independent2024/12/10
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Sandoz shells out $275M in latest effort to move past 'legacy' price-fixing litigationSandoz has agreed to pay another group of plaintiffs in the long-running price-fixing litigation it inherited from former parent company Novartis, marking a further step by the company to leave the "2024/12/5
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Pfizer expects $1B hit from IRA's Part D redesign and no major M&A in 2025After pulling off a surprise third-quarter beat and full-year guidance raise amid shareholder activism earlier this year, Pfizer now expects its 2025 revenues to come in the same range as in 2024. Pf2024/12/5