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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
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Shorla gains FDA nod for first oral liquid version of Novartis' GleevecIn 2001, a Time Magazine cover storytoutedNovartis’ targeted leukemia treatment Gleevec (imatinib) as a new kind of “ammunition in the war against cancer.” Along with a picture of the Gleevec pills,2024/12/2
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Fast-growing Adragos snaps up Swiss CDMO Baccinex, significantly expanding fill-finish firepowerGerman CDMO Adragos Pharma has been on a growth tear this year, drafting plans to boost capacity in Japan, upgrading a facility in France, taking over another from Fresenius Kabi in Norway and more.2024/11/28
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AZ's Truqap delivers phase 3 win in prostate cancer subtype after recent breast cancer missAfter a recent failed showing in a breast cancer subgroup raised doubts around AstraZeneca’s Truqap, the first-in-class AKT inhibitor is making inroads in a prostate cancer subtype. High-levelresults2024/11/28
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Bristol Myers Squibb hands pink slips to 195 workers in New Jersey as cost-cutting effort rolls onBristol Myers Squibb has executed another round of layoffs in its ongoing cost-savings push. The company has handed pink slips to 195 more employees, according to a New Jersey Worker Adjustment and R2024/11/26