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India's Zydus hit with warning letter as FDA flags glass contamination concerns and moreLast week, Zydus Lifesciences confirmed the receipt of an FDA warning letter at its Waghodia plant in Gujarat, India, marking the latest in a string of production reprimands for the Indian drugmaker.2024/9/3
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Sanofi, Regeneron to seek approval for Dupixent in bullous pemphigoid after positive phase 3 studySanofi and Regeneron’s superstar anti-inflammatory biologic Dupixent is on a roll. On the same day the companiesunveiled positive datafrom a study in chronic spontaneous urticaria (CSU) and anew an2024/8/29
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After FDA rejection, Sanofi and Regeneron show data that could pave way for Dupixent to treat hives conditionEleven months after sustaining arejectionfrom the FDA for Dupixent to treat chronic spontaneous urticaria (CSU), Sanofi and Regeneron have presented data from a phase 3 trial that could help push the2024/8/29
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Gilead's Trodelvy triplet underwhelms, but exec says data bolster company's phase 3 lung cancer designGilead Sciences has been looking for a win for Trodelvy after two surprise trial failures earlier this year. But it looks like that win won’t come from a triplet regimen that combines the antibody-dr2024/8/27
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As Sandoz contract winds down, GSK will close antibiotics plant in UKWith the expiration of a contract to produce antibiotic medicines for Sandoz, GSK will shutter a 75-year-old manufacturing facility in its home country. The U.K. pharma will close its plant in Ulvers2024/8/27
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Lilly looks inward as it completes hunt for new CFO with appointment of 23-year vet Lucas MontarceThree months on, Eli Lilly has closed the books on its search for a new chief financial officer. And as with its previous CFO, Anat Ashkenazi, the company didn’t have to look far. Lilly on Mondayreve2024/8/22
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AstraZeneca's Alexion loses $130M to Syntimmune shareholders in post-merger payment suitWhen AstraZeneca’s Alexionpicked uprare disease specialist Syntimmune in 2018 for $400 million, the latter’s FcRn inhibitor dubbed SYNT001 was the crown jewel of the deal. After Alexion scrapped its2024/8/22
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Akeso, Summit's PD-1 bispecific crushes Merck's Keytruda in study, signaling potential new standard in lung cancerThe Keytruda-beating data from Akeso and Summit’s ivonescimab that oncology industry watchers had been awaiting are here. The China-only data are impressive, signaling the PD-1/VEGF bispecific antibo2024/8/20
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J&J bolsters Rybrevant-Lazcluze's case against AZ's Tagrisso with survival analysisJohnson & Johnson’s newly FDA-approved lung cancer combination of Rybrevant and Lazcluze is inching ever closer to a statistically significant survival showing, which could help it better challen2024/8/20
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GSK posts COPD win for Nucala as Sanofi-Regeneron rival Dupixent nears delayed FDA decisionGSK is heading into the weekend with a win for its respiratory blockbuster Nucala—but for now, the details are slim. On Friday, GSK said that its IL-5 antibody Nucala plus inhaled maintenance therapy2024/8/15