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Monday, October 17, 2022 | 11am ET / 8am PT Given the wide array of post transcriptional and post translational regulatory processes that govern cellular dynamics, additional omics types are needed to capture a more comprehensive understanding of the molecular landscape of a tumor. Register now to learn more. 
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Today's Big NewsOct 14, 2022 |
| By Nick Paul Taylor The omaveloxolone saga has delivered yet another twist. Having previously put an advisory committee meeting on hold, the FDA has now scrapped plans to convene experts to discuss Reata Pharmaceuticals’ candidate altogether, leaving analysts to argue over whether the change is a good or bad omen. |
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By James Waldron A month after a full rebrand from Adagio to Invivyd, the biotech is already facing a double-hit of C-suite departures and is at the same time also culling commercial roles as a continued effort to distance itself from the struggles of its COVID-19 antibody. |
By Nick Paul Taylor The FDA has sunk Travere Therapeutics’ hopes of winning approval for its kidney disease candidate this year by requesting changes to the proposed risk evaluation mitigation strategy that are expected to delay the PDUFA date by three months. |
By Gabrielle Masson Enliven Therapeutics and Imara are combining forces to push Enliven’s precision oncology pipeline forward in a new merger deal accompanied by a Roche-backed $165 million fundraise. |
By Helen Floersh In a development that sounds fit for a horror film, scientists have transplanted human brain cells into rats. These human-rat brain hybrids could be used to study diseases like autism and schizophrenia, potentially marking a major turning point in scientists’ ability to develop effective treatments. |
By Kevin Dunleavy In terms of approvals and launches, the biosimilars industry experienced a slowdown during the pandemic. But in the lab, there has been no such stagnation in the development of the copycats. This willingness of companies to pursue the development of biosimilars in increasing numbers bodes well for the industry's future, Amgen said in its "2022 Biosimilar Trends Report." |
By Andrea Park With less than a week to go until the FDA’s long-awaited rule enabling hearing aids to be sold over the counter takes effect, consumer tech makers are lifting the curtain on their first entries in the brand-new medical device category. |
By Frank Diamond Perhaps the silver lining around the cloud of a WTW survey of health insurers in the world predicting higher cost increases next year is that North America will see the lowest increase. |
By Max Bayer,Gabrielle Masson Days after reportedly going on leave, BIO CEO Michelle McMurry-Heath resigned as CEO of BIO, one of the leading lobbyists for the biotech and pharma industries. |
By Teresa Carey This week on "The Top Line," we talk about our latest analysis on the world’s most productive biopharmas. We also discuss Biogen's tumultuous year and who it is considering for a new CEO. |
By Angus Liu BeiGene's Brukinsa posted another head-to-head win against AbbVie and Johnson & Johnson's blockbuster Imbruvica. China's Hua Medicines has won a first-in-class approval for a Bayer-partnered diabetes med. Novavax has ended a COVID vaccine contract manufacturing deal with Fujifilm. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we talk about our latest analysis on the world’s most productive biopharmas. We also discuss Biogen's tumultuous year and who it is considering for a new CEO. |
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Scaling biotechs are at a unique intersection of capital, opportunity and flexibility. And real estate is key to driving business forward. Get answers to six key questions to ensure you have the space and solutions to grow where and when you need to. Learn more. 
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