| Today’s Big NewsNov 1, 2023 |
| By Max Bayer,Gabrielle Masson More than 20 biotechs entered the biotech graveyard this year, spurred by a difficult financing environment. There were more than three times as many companies that closed or wound down in 2023 compared to 2022. |
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By Fraiser Kansteiner The FDA approved Cosentyx for the treatment of moderate to severe hidradenitis suppurativa in adults, Novartis said Tuesday. The green light makes Cosentyx the first new biologic to treat the lesser-known skin affliction in nearly a decade. |
By Annalee Armstrong If you’ve been living under a rock for the past several years, you probably still know what a GLP-1 inhibitor is—at least by brand name. But the 33,000 attendees at the European Society for Medical Oncology would like to remind you that there’s plenty of breakthroughs in cancer worthy of the same kind of fanfare. |
By Conor Hale Pioneering Intelligence will work to kickstart new AI companies, standing alongside Flagship’s other initiatives such as Pioneering Medicines. |
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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 Joseph Keenan Japan’s Daiichi Sankyo plans to conduct an absorption-style merger of two wholly owned manufacturing companies in a bid to leverage its dominance in the antibody-drug conjugate space. |
By Max Bayer FDA advisers appear satisfied with CRISPR Therapeutics and Vertex Pharmaceuticals’ assessment of potential off-target effects from their CRISPR-based gene therapy exa-cel, quelling the top concern from the FDA as an approval deadline nears. |
By Zoey Becker The approval was based off of Merck's phase 3 KEYNOTE-966 trial and marks Keytruda's sixth in gastrointestinal cancers. Meanwhile, AZ's Imfinzi scored its first approval in the space last year. |
By Conor Hale The Biden administration is launching a federal outfit to evaluate the safety of AI, and to address its impact in healthcare, R&D and the broader societal concerns that have recently come to the fore. |
By James Waldron GSK has dropped its in-house STING agonist only a day after a similar drug the British Big Pharma reserved the rights was finally lifted from clinical hold limbo. |
By Kevin Dunleavy Sales of Argenx’s Vyvgart increased by 151% to $329 million in the third quarter as the momentum for the treatment continues with its recent approval to be administered subcutaneously. The company also announced that it will use a priority review voucher to speed an FDA decision on an application for Vyvgart to treat a second immunoglobin G-mediated autoimmune disease. |
Fierce podcasts Don’t miss an episode |
| In this episode of “The Top Line,” we delve into the FDA's controversial approval of Aduhelm, a drug for Alzheimer's disease, despite an independent advisory committee's resounding rejection. The decision has sparked questions about potential bias within the regulatory body. |
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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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Whitepaper Uncover 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 |
| Edison Ballroom, New York City |
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