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Wednesday, November 20, 2024 | 11am ET / 8am PT Join us for a deep dive into electronic Clinical Outcome Assessment (eCOA) systems. We'll explore the latest trends and strategies tailored for increasingly complex clinical trial environments. Learn about the current and future state of eCOA technology, potential areas for enhancement, ways to leverage effectively, and more. Register now. 
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Today’s Big NewsNov 12, 2024 |
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De-risk clinical trials with Foresight CLARITY’s ultra-sensitive MRD detection. Foresight CLARITY is IUO-ready for prospective trials through our CLIA-registered central lab.
Learn more about Foresight CLARITY™️ 
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| By Angus Liu Despite China’s investigations that have implicated senior executives, AstraZeneca CEO Pascal Soriot argued that the company did not lose oversight and remains on track to achieve his ambitious $80 billion-by-2030 revenue goal. |
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By James Waldron Months after filing their Enhertu follow-up Dato-DXd with the FDA, Daiichi Sankyo and its antibody-drug conjugate partner AstraZeneca have taken the agency’s advice and pulled their lung cancer application to try their luck in a related indication. |
By Conor Hale The genetics testing company plans to seek out new homes for its in-house pipeline of DNA-informed immuno-oncology antibodies. |
By Gabrielle Masson GSK is paying $80 million to ink a multi-target neurodegenerative pact with Flagship-founded Vesalius Therapeutics that includes a preclinical small molecule initially targeting Parkinson’s disease. |
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Wednesday, November 20, 2024 | 11am ET / 8am PT Join us to discover how to overcome challenges, and learn about practical solutions for scalability and safety in cell therapy manufacturing. Don't miss out, register today. 
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By Andrea Park GSK unveiled its “Your Cancer Is Our Challenge” initiative with an aim of raising awareness of and breaking down the barriers to care and support that many people with gynecological cancers experience. |
By Gabrielle Masson Roche and Flare Therapeutics are igniting a partnership worth more than $1.8 billion in biobucks with hopes of discovering new small molecule cancer treatments via previously undruggable transcription factor targets. |
By Fraiser Kansteiner Intercept received a complete response letter from the FDA, dashing the company’s hopes of turning Ocaliva’s accelerated green light into a traditional approval for the rare autoimmune disease primary biliary cholangitis. |
By Nick Paul Taylor PhRMA is pushing to get pharmacy benefit manager reform over the line in Congress’ lame-duck session, using its first TV spot since the U.S. election to rail against a familiar, rebate-snaffling adversary. |
By Darren Incorvaia While awaiting an FDA decision for its small molecule revumenib in one form of acute leukemia, Syndax Pharmaceuticals is trying to build a case for its candidate in another. Though the drug met its primary endpoint in the phase 2 portion of a phase 1/2 trial, the results failed to impress investors, sending Syndax’s stock down 22%. |
By Angus Liu After a series of acquisitions and an activist investor's accusation of overspending, Pfizer is exploring an opportunity to slim down by divesting its hospital drugs unit, Reuters reports. |
By Conor Hale Johnson & Johnson MedTech has received a go-ahead from the FDA to begin human clinical trials of its Ottava surgical robot, with plans to explore its uses in laparoscopic, hybrid and open procedures. |
By Nick Paul Taylor Havas Health has appointed Anna Maria Marra CEO of Europe. Marra is joining the healthcare agency after a 22-year run at Pfizer that culminated in her leading the launch of the antibiotic Emblaveo. |
By Fraiser Kansteiner AstraZeneca on Tuesday revealed that it’s adding $2 billion more to its current outlay in the U.S., representing a total capital investment of $3.5 billion. The cash will be used to grow the company’s research and production footprint in the States by the end of 2026, generating more than 1,000 new jobs along the way. |
By Gabrielle Masson Insilico Medicine plans to push its computer-designed drug into pivotal clinical trials after a phase 2a study demonstrated improvements in a respiratory health measure for patients with idiopathic pulmonary fibrosis. |
By Andrea Park As National Diabetes Month gets underway, StrideMD is among the diabetes care providers, tech developers and drugmakers helping raise awareness of the condition. |
Fierce podcasts Don’t miss an episode |
| This week on "The Top Line," we take a closer look at this year’s biotech graveyard, which tracks biotechs that have closed or are winding down. |
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Gene therapy holds the extraordinary potential to transform global health care, boasting a pipeline that has grown tremendously through the years. Download the QPS white paper for insights into the regulatory landscape for future cell and gene therapies. 
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Whitepaper The use of prefilled syringes to administer biotherapeutics is beginning to gain traction because they offer a range of stability, efficacy, and patient safety benefits. Download this white paper to learn how Lonza has developed a novel workflow to ensure confidence regarding functionality in PFS and autoinjectors. Presented by Lonza |
Whitepaper Explore the robust cross-platform agreement between scRNA-seq and bulk RNA-seq, ensuring consistent and reproducible data on immune cell presence. Sponsored by: IQVIA Laboratories |
Whitepaper This e-book explores 7 factors that are critical to the success of emerging biopharma companies, whether they plan to out-license, partner, or launch & commercialize products. It’s an essential resource for emerging companies with products in all stages of development. Sponsored by: Blue Matter |
Whitepaper Unlock the secrets to faster, cost-effective biologics production with intensified biomanufacturing – download the whitepaper and power up your bioprocessing game! Sponsored by: Syngene International Ltd. |
Whitepaper Discover how independent adjudication can safeguard your clinical trials from misidentified adverse events and enhance the credibility of your results. Sponsored by: WCG |
Whitepaper Learn how to evaluate quality documentation to help you select the right raw materials at early decision points for your cell-based manufacturing processes. Presented by: Thermo Fisher Scientific |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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| The Lighthouse at Pier 61 in New York City |
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