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Tuesday, June 17, 2025 | 11am ET / 8am PT We invite you to join industry experts to explore advanced process analytical technologies (PAT), and how they are transforming bioprocessing. Register now.
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Today’s Big NewsJun 9, 2025 |
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Monday, June 16, 2025 | 12pm ET / 9am PT Join a candid and informative discussion between precision medicine experts. They will share lessons learned and concrete opportunities to transform clinical trial design, execution and outcomes. Register now.
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| By Gabrielle Masson After nearly 25 years with Sanofi, Sanjay Gurunathan, M.D., has left for GSK, where he will lead vaccine and infectious disease R&D for the British pharma. |
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By Angus Liu After questioning the benefits of checkpoint inhibitors in stomach cancer cases without PD-L1 expression, the FDA has moved to restrict the use of Merck's and Bristol Myers Squibb's immunotherapies in those patients. |
By Conor Hale Caris recently began rolling out its MI Cancer Seek companion diagnostic test for genomic tumor profiling. |
By Zoey Becker Astellas chief commercial officer Claus Zieler recently donned a second hat as medical affairs officer, marking the last step of uniting the two business areas. |
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Wednesday, June 18, 2025 | 12pm ET / 9am PT In this webinar, we will present two new methods for blood preservation that can be easily implemented at any clinical site just after the patient’s blood collection. Register to learn more.
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By Kevin Dunleavy One day before the potential FDA approval of a rival respiratory syncytial virus monoclonal antibody from Merck, Sanofi has revealed an aggressive supply effort for its RSV blockbuster Beyfortus, including a plan to begin shipping its AstraZeneca-partnered shot early in the third quarter. |
By Darren Incorvaia Axsome Therapeutics has hit a costly snag in its mission to bring esreboxetine to market for fibromyalgia. The FDA has refused to review the CNS specialist’s new drug application for the asset, with the agency determining that one of the two trials in the filing was not up to snuff. |
By Zoey Becker The drug is the first triple-combo pill for the initial treatment of hypertension in the U.S. |
By James Waldron Merck & Co.’s ambition to get the first oral PCSK9 inhibitor to market came one step closer this morning as the pharma unveiled a pair of phase 3 wins for enlicitide decanoate in patients with high cholesterol. |
By Nick Paul Taylor Abcuro has begun to add commercial muscle ahead of the anticipated launch of an inflammatory disease drug, appointing ex-Priovant Therapeutics executive Courtney Cupples to its C-suite to lead preparations. |
By Conor Hale The company’s Spur implant carries a series of small spikes that penetrate calcifications from within the peripheral blood vessel, to help reduce the effects of recoil once the stent is removed from the artery. |
By Andrea Park Despite some recent setbacks to its sickle cell disease pipeline, Pfizer is plowing ahead in improving education around the disease. |
By Angus Liu Dietmar Berger became Gilead Sciences’ new chief medical officer this year after the company’s oncology department suffered some prominent setbacks. But the drug development veteran still believes that the virology giant made the right move to branch out into oncology and immunology. |
By Joseph Keenan After delivering strong sales growth last year and with more expansion in mind, CDMO giant Wuxi Biologics is breaking ground on a new microbial production plant in Chengdu, China. |
Fierce podcastsDon’t miss an episode |
| | This week on "The Top Line," the Fierce team reports from ASCO, highlighting key takeaways on clinical data, standout campaigns and buzz from the exhibit floor. |
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Supported by 30 years of experience conducting complex Phase I & II clinical trials, QPS Miami supports special populations and diverse indications like NASH, diabetes, obesity and oncology. Learn More.
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| WhitepaperWe analyzed ~300 launches to identify the factors most correlated with commercial success & built a framework for peak go-to-market performance. Presented by Blue Matter, strategic consultants in the life sciences |
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