| Today’s Big NewsNov 3, 2023 |
| By Fraiser Kansteiner Pfizer is cutting roughly 200 positions at its Kalamazoo site following a review of demand for its COVID-19 vaccine and antiviral Comirnaty and Paxlovid. |
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By Andrea Park Changes are afoot within Siemens Healthineers’ diagnostics business—though it’s still unclear just how far those changes will go. |
By James Waldron More than a decade after AstraZeneca appeared to give up hope of using zibotentan to treat prostate cancer, the endothelin receptor antagonist has received a new lease on life as a combo treatment for chronic kidney disease. |
By James Waldron Lexeo Therapeutics has disclosed plans to join the coveted ranks of biotechs raking in nine figures from their Nasdaq offering, despite downsizing its ambitions over the past few days. |
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Thursday, November 9, 2023 | 11am ET / 8am PT Navigating the U.S. regulatory landscape for the use of high-purity alcohols in biologic development and manufacturing processes is crucial for maintaining product quality and patient safety. However, biomanufacturers often face significant challenges. Join us to gain key guidance from industry experts and learn important best practices. Register now.
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By Conor Hale Avail Medsystems emerged from the confusion and chaos of the COVID-19 pandemic with a plan to build a new normal: virtually connecting surgeons and operating rooms with remote experts and safely socially distant sales reps. But old habits die hard. |
By Annalee Armstrong After achieving a positive outcome in a preliminary look at a phase 1/2 trial for a solid tumor candidate, Kronos Bio is restructuring and cutting staff. |
By Kevin Dunleavy In a span of three days, Phathom Pharmaceuticals has scored two green lights from the FDA for its first-in-class heartburn drug Voquezna. The first came on Monday when the regulator signed off on Phathom’s reformulation of Voquezna to treat Helicobacter pylori infection. The second came on Wednesday when the FDA blessed Voquezna for gastroesophageal reflux disease erosive esophagitis (erosive GERD) and associated heartburn. |
By Kevin Dunleavy In its attempt to win approval in the United States for its groundbreaking T-cell therapy Ebvallo, Atara Biotherapeutics is turning to the same partner it used to gain a green light in Europe—Pierre Fabre Laboratories. In this geographic expansion of Pierre Fabre’s licensing rights, the French pharma takes over manufacturing, clinical and regulatory activities for Ebvallo in the U.S., Canada and other markets outside of the European Union. |
By Andrea Park If CooperSurgical’s latest acquisition deal sparks a sense of déjà vu, it’s for good reason. |
By Angus Liu Travere Therapeutics recently reported two pivotal trial flops for Filspari, with one threatening the drug’s accelerated approval in IgA nephropathy (IgAN) and the other raising doubts about its chances of tapping into another kidney disease. |
Fierce podcastsDon’t miss an episode |
| | While the new Alzheimer’s disease medicine Leqembi has generated lots of buzz since its debut this year, one research team is investigating whether the medicine holds promise in preventing disease progression before any Alzheimer’s symptoms are evident. In this week's episode of "The Top Line," Fierce Pharma’s Eric Sagonowsky talks with the study lead, Reisa Sperling, M.D., to learn more. |
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Thursday, November 16, 2023 | 1pm ET / 10am PT Genomics is transforming drug discovery, but finding and recruiting the right patients for targeted-therapies remains a challenge. Join us to discover how incorporating genetic counseling and genetic services can unlock larger, more diverse and better qualified patient populations for your clinical trials. Register now.
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| WhitepaperUncover the keys to efficient bioprocessing, including how outsourcing quality management can reduce risk, save time and money, and expedite biologics development. Sponsored by: Thermo Scientific™ Production Chemicals and Services |
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| WhitepaperUncover the keys to efficient bioprocessing, including how outsourcing quality management can reduce risk, save time and money, and expedite biologics development. Sponsored by: Thermo Scientific™ Production Chemicals and Services |
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