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The scientific community universally recognizes peer-reviewed literature as the foundation of credible and reproducible research. However, its exponential growth presents a significant challenge for R&D teams in biotech and pharma companies. Learn how to leverage AI to ensure that today’s advancements in drug discovery, clinical trials and regulatory processes are based on data that is up-to-date, validated and meaningful. Download now. 
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Today’s Big NewsJul 18, 2025 |
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Thursday, July 22, 2025 | 10am ET / 7am PT Join us to take an exciting look at the forefront of REMS transformation. Learn how leading technology, integrated strategies and operational excellence are redefining what’s possible. Gain the insights you need to reduce complexity, enhance compliance and deliver more value across the REMS lifecycle. Register now. 
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| By Fraiser Kansteiner,Gabrielle Masson Although Sarepta initially appeared to have avoided the worst possible outcome for Elevidys—market withdrawal—thanks to the gene therapy’s new black box warning, the FDA is signaling stronger misgivings about the approved drug amid a third patient death from an investigational treatment. |
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By Darren Incorvaia Sail Biomedicines is shrinking its crew for the second time this year. The Flagship Pioneering-backed biotech is laying off about 36 employees as the company sharpens its focus on immunology, a company spokesperson confirmed to Fierce Biotech. |
By Angus Liu The other shoe has dropped for Roche’s bid to move Columvi into earlier treatment of diffuse large B-cell lymphoma in the U.S. In a complete response letter, the FDA suggested that Roche's phase 3 Starglo data do not provide enough evidence to support the proposed indication in a U.S. population, according to the company. |
By Angus Liu With the Reblozyl flop, all four of the pivotal trials that have read out this year for BMS’ currently marketed drugs have turned up negative. |
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Wednesday, July 23, 2025 | 2pm ET / 11am PT The development of radiopharmaceuticals is transforming oncology. Designing successful clinical trials in this space, requires a precise balance of insight, efficiency, and strategy. Join our expert panel to explore the imaging strategies, trial design principles, and regulatory alignment considerations you need to know about. Register now. 
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By James Waldron The opening salvo of second-quarter earnings calls this week came against President Donald Trump’s renewed threat of a tariff on pharmaceuticals. |
By Nick Paul Taylor Neurologists think more in terms of drug class and indication than in brand names, according to a ZoomRx survey with implications for how marketers communicate with physicians. |
By Conor Hale The former Fierce Medtech Fierce 15 winner entered a placeholder goal of up to $100 million, though no pricing terms were disclosed. |
By Zoey Becker The company attributed its decision to cancel its plans for an mRNA manufacturing plant in the country to "changes in the business environment both globally and in Japan." |
By Darren Incorvaia,Zoey Becker Reeling from the deaths of two patients who took Duchenne muscular dystrophy gene therapy Elevidys, Sarepta is launching a massive overhaul of its organization. The company’s chief customer officer Dallan Murray is headed out the door, to be replaced by Patrick Moss, formerly senior vice president of U.S. market access and sales and now chief commercial officer. |
By Angus Liu Biotech deals involving assets developed in China are surging, a Jefferies report shows. Takeda is preparing its narcolepsy candidate oveporexton for an FDA filing after two positive phase 3 readouts. Merck & Co.'s PD-1xVEGF partner is being acquired. And more. |
Fierce podcasts Don’t miss an episode |
| In this episode of "The Top Line," we explore how pharma marketing is evolving—and what early-career professionals need to know to grow and stand out in a rapidly changing, highly regulated industry. |
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QPS delivers global RWE solutions to support regulatory and drug development goals. With access to diverse data sources and deep regulatory expertise, QPS transforms real-world data into actionable insights. +(2)+(2)+(1)+(1)+(1).png)
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Whitepaper This white paper outlines how we apply industry-backed practices and proprietary technologies to proactively safeguard sterility and performance. Sponsored by: Lonza |
Whitepaper Presented by Blue Matter, strategic consultants in the life sciences Sponsored by Blue Matter Consulting |
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| The Lighthouse at Pier 61 in New York City |
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