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Decentralized: Navigating the future of inclusive clinical trials
Decentralized clinical trials have emerged as a promising approach to overcome traditional barriers, enhance representation, and improve the quality of research by bringing biomedical studies directly into communities. However, recent policy changes under the Trump administration, including the removal of FDA guidance on clinical trial diversity, have raised concerns about the future of inclusive research.…
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How retail pharmacies are bringing clinical trials to the community
Walgreens is now conducting a COVID-19 vaccine study at 20 locations across eight states, aiming to recruit 3,600 participants as part of a partnership with the U.S. government that will allow retail pharmacies to conduct clinical trials. Traditionally, these studies happen at academic centers, which can feel distant or inaccessible for many. The recent shift…
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WHO offers roadmap for making clinical trials more inclusive
As health journalists, we’re always on the lookout for developments that could reshape how medical research is conducted and reported. Changes in government policies, pharmaceutical regulations, or research methods and funding can dramatically affect how research is conducted. This in turn affects research outcomes and, ultimately, healthcare delivery. For years, journalists like myself have reported…
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Sanofi’s FDA Nod in Hemophilia Gives Patients More Convenience, Brings Roche New Competition
Sanofi’s FDA Nod in Hemophilia Gives Patients More Convenience, Brings Roche New Competition FDA approval of Sanofi hemophilia A drug Altuviiio provides patients with a therapeutic option that lasts longer than most other products available, including one already marketed by the French pharma giant. Altuviiio also gives Sanofi a way to better compete against blockbuster…
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STAT+: Charles River suspends shipments of monkeys used in research amid federal probe
STAT+: Charles River suspends shipments of monkeys used in research amid federal probe Charles River Laboratories, one of the largest clinical research organizations in the U.S., is suspending shipments of non-human primates that are widely used in pharmaceutical research after receiving a subpoena from federal authorities probing a Cambodian smuggling ring. The move comes after…
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Apellis Drug Becomes First Approved Therapy for Vision-Loss Disorder Geographic Atrophy
Apellis Drug Becomes First Approved Therapy for Vision-Loss Disorder Geographic Atrophy The FDA approved Apellis Pharmaceuticals’ Syfovre as a treatment for geographic atrophy, a retinal disorder that is a leading cause of blindness. The drug, administered as an injection into the eye, will launch in March at the price of $2,190 per vial. Information Courtesy…
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STAT+: Government watchdog calls for stronger oversight of for-profit research review boards
STAT+: Government watchdog calls for stronger oversight of for-profit research review boards The federal government needs to boost its oversight of the institutional review boards that approve scientific studies and protect clinical trial participants, especially since more for-profit companies are taking running these reviews, a report from a government watchdog warns. Also known as ethics…
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