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Tuesday, December 3, 2024 | 11am ET / 8am PT Join us for a deep dive into the development and manufacturing of monoclonal antibodies. We’ll explore an industry case study, providing access to key findings, top strategies and solutions for enhancing productivity and efficiency in mAb production. Don’t miss out on important insights, register now. 
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Today’s Big NewsNov 5, 2024 |
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QPS has extensive expertise in the conduct of oncology clinical studies,
having successfully managed over 50 oncology studies globally.
Download the QPS Case Study to learn how QPS performed two global Phase III studies in prostate cancer patients. .+(1).png)
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| By Angus Liu AstraZeneca’s stock price dropped by 8.4% during Tuesday’s trading in London after a report fueled fears of a potentially escalating insurance fraud investigation in China. |
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By Gabrielle Masson Arcellx has shared several data cuts on anito-cel, a CAR-T being developed with Gilead’s Kite Pharma to treat relapsed or refractory multiple myeloma. After seeing the data, analysts underscored the therapy’s best-in-class potential compared to Johnson & Johnson and Legend Biotech's FDA-approved treatment Carvykti. |
By Zoey Becker With its first Casgevy revenues in the books, Vertex lifted its full-year sales outlook as it turns its attention to two product launches in 2025, including an expected new entrant in the pain market. |
By Darren Incorvaia Sanofi has released phase 3 data from the LUNA 3 trial of rilzabrutinib that should spark some buyer’s delight. The drug, which the French pharma giant acquired through a buyout of Principia Biopharma in 2020, raised and sustained platelet levels in 23% of immune thrombocytopenia patients who received it, compared to none in the placebo arm. |
By Conor Hale In patients with chronic limb-threatening ischemia, the drug-eluting scaffold cut the number of repeat procedures by about half in two years. |
By Ben Adams With the FDA approval of the first specific drug for Metabolic Associated Steatohepatitis (MASH) in March this year, Madrigal’s Rezdiffra is a pioneer in a market set for rapid change. |
By Nick Paul Taylor Beam Therapeutics has presented the first clinical data on its base editing technology. All four sickle cell disease patients in the efficacy cohort had fetal hemoglobin levels above Beam’s target—and the result achieved by Vertex’s rival therapy—but one patient died, likely as a result of the conditioning regimen. |
By Kevin Dunleavy With its first FDA approval coming in August and a second expected next month, these are exhilarating days for 19-year-old Syndax Pharmaceuticals as it transforms into a commercial enterprise. To help foot the bill to launch its approved graft-versus-host disease drug Niktimvo and the expected launch of its leukemia treatment revumenib, Syndax has struck a $350 million deal with Royalty Pharma. |
By James Waldron Sana Biotechnology has become the latest cell therapy biotech to shift resources from cancer to autoimmune diseases, as part of a strategic refocus that sounds likely to include a side order of layoffs. |
By Angus Liu Intra-Cellular Therapies’ atypical antipsychotic medication Caplyta has been on a roll, delivering fast commercial growth and coming up triumphant in yet another late-stage trial. |
By Conor Hale Inquis' Aventus thrombectomy system received FDA clearances earlier this year for clearing out peripheral blood vessels and venous thromboembolism. |
By Nick Paul Taylor Arrowhead Pharmaceuticals has begun laying the groundwork for its entry into a rare disease market, kicking off an awareness campaign focused on the unmet need its drug candidate is positioned to serve. |
Fierce podcasts Don’t miss an episode |
| This week on "The Top Line," we explore how each presidential candidate’s approach to drug pricing could shape future policy. |
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Wednesday, November 13 , 2024 | 10am ET / 7am PT Join industry experts to gain insights pertinent to efficient and effective drug development. Understand and execute a risk-based critical thinking approach related to injectable drug packaging and delivery. Register now. 
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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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