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Join us on Dec. 7 for a webinar exploring compendia surveillance and Eurofins BioPharma Product Testing’s processes in maintaining compliance. Register now.
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Today’s Big NewsNov 7, 2023 |
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January 9-10, 2024 | San Francisco, CA
January 16-18, 2024 | Virtual
Scoring for Patients: How Reducing Risk in 2023 Will Change the Fame for Drug Discovery and Development
Register today and Save $450!
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| By Eric Sagonowsky Only two months after the Federal Trade Commission said it was eying a crackdown on improper patents listed by the FDA, the agency has filed challenges against more than 100 patents in the agency's Orange Book. The companies have 30 days to respond. |
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By James Waldron Vertex Pharmaceuticals may be looking forward to a “milestone-rich period coming up,” but one candidate will no longer be joining the biotech on its journey while another will be delayed into the clinic. |
By Conor Hale The company said that in the latter half of next year, it plans to request the FDA’s permission to begin U.S. clinical studies of its Ottava system, which it described as designed to fit inside any operating room around the world. |
By James Waldron In another sign that anti-TIGIT antibodies may yet live up to some of the hype, Gilead has unveiled preliminary data showing that its Arcus Biosciences-partnered candidate domvanalimab is effective against gastric cancers in combo with Arcus’ anti-PD-1 drug. |
By Kevin Dunleavy Two long-awaited treatments for sickle cell disease (SCD) are on the docket for FDA decisions next month. One potential advantage for bluebird, giving the timing, could be a chance to view its rival's pricing before deciding itself. But on Tuesday bluebird said that Vertex’s price tag will not factor into how the Massachusetts company will price its treatment. |
By James Waldron Sometimes even an apparently successful clinical trial may not be able to save your asset—or your stock price—once you dig into the numbers. |
By Andrea Park The third quarter was a tumultuous one for Zimmer Biomet’s executive branch, but that spate of changes doesn’t appear to have knocked the company off its slow-and-steady growth plans. |
By Zoey Becker France's Parquet National Financier opened a preliminary investigation into Sanofi's financial communications during Dupixent's 2017 launch, according to press reports. Sanofi said it has not been contacted by officials and stands behind "the accuracy of our accounts." |
By Conor Hale Philips aims to link AI assistance with its Lumify hand-held probe to allow midwives who may have less experience to perform pregnancy checkups. |
By Helen Floersh The company reported that whole-genome sequence data from thousands of people pointed to 25 gene variants that predispose individuals to developing clonal hematopoiesis, and that a long-reported link between the condition and cardiovascular disease can be largely explained by smoking. |
By Andrea Park Salesforce recently pulled back the curtain on a plan to adapt its customer management and analytics software specifically for the use of life sciences companies, and several supporting roles in that production are now taking shape. |
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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| WhitepaperLearn how to develop a high-performing supply chain for cGMP chemicals used throughout your bioprocessing workflows. Sponsored by: Thermo Fisher Scientific Production Chemicals and Services |
| WhitepaperDownload our whitepaper to learn about plasmid DNA design considerations for cell and gene therapy applications. Sponsored by: Aldevron, a GMP manufacturing CDMO of DNA, RNA, and Proteins |
| WhitepaperThis paper explores AI’s potential impact on healthcare and on Medical Affairs (MA) more specifically. It also outlines what MA teams can do now to proactively leverage AI to improve service to their stakeholders. Presented by Blue Matter, strategic consultants in the life sciences |
| eBookEmulate in vivo biology with next-generation in vitro technology. Sponsored by: Emulate |
| WhitepaperAccelerate drug discovery with high-performance computing (HPC) powered by the cloud Sponsored By: AWS, NVIDIA, and Rescale |
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