| Today’s Big NewsOct 30, 2023 |
| By Nick Paul Taylor Novartis’ $3.2 billion bet on Chinook Therapeutics is taking off. Top-line phase 3 data show the acquired candidate improved a sign of kidney disease, positioning the Swiss drugmaker to apply for accelerated approval from the FDA next year. |
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By Conor Hale Though Philips has argued its U.S. subsidiary should be responsible for paying damages in its massive CPAP machine recall, instructions to continue selling home ventilators came from the parent company’s top leadership, according to ProPublica and the Pittsburgh Post-Gazette. |
By Zoey Becker The company entered an advance agreement for a priority review voucher ahead of the FDA's decision on the sickle cell disease gene therapy prospect. Bluebird expects the FDA to decide on its drug by December 20. |
By Gabrielle Masson With a new CEO in charge, Blue Water is reprioritizing its pipeline, dropping six-FDA approved drugs and a wide-ranging vaccine portfolio. |
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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 Annalee Armstrong 4D Molecular Therapeutics has offered to add an immunosuppressive regimen during administration of a Fabry disease gene therapy in order to continue with human testing and lift an FDA clinical hold placed earlier this year. |
By Angus Liu Market watchers have been waiting keenly to see whether a cheap China-made cancer drug could disrupt the multibillion-dollar U.S. PD-1 cancer immunotherapy market. But the first player with a chance to follow that path has opted not to. |
By Ben Adams Canadian former professional ice hockey player Wayne Gretzky engages in a conversation with an AI-generated, younger version of himself, who aims to warn him about the dangers of RSV in a new ad. |
By Helen Floersh Prime Medicine’s prime editors have corrected a gene mutation that causes a rare liver disease in primates, a step toward taking the tech to humans. |
By Angus Liu After a quick FDA approval in a subgroup of endometrial cancer patients, GSK is trumpeting a win for its Jemperli that might help the PD-1 inhibitor expand to a broader population. |
By Nick Paul Taylor A group of pharmacy benefit managers has split off from the pack, launching a “six-figure digital media campaign” to make the case that some of the widely criticized organizations provide value to the healthcare system. |
By Conor Hale Medtronic has teamed up with the French postal service for a data partnership that aims to build an artificial intelligence-powered platform in support of a range of digital telehealth services. |
By Conor Hale The deal shakes out to a price of $3.25 per share, for what the companies described as about a 170% premium over Miromatrix’s previous trading value when averaged over 30 days. |
By Nick Paul Taylor Almirall is using World Psoriasis Day to push home its messaging about the effect of the skin disease on mental health. The company, which sells psoriasis drugs such as Ilumetri and Wynzora, used the event to highlight its data on the well-being of patients and the miniseries it made to dramatize their lives. |
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 |
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