PTC Therapeutics said it cannot resolve differences it has with the FDA in interpreting clinical trial data for Translarna, a drug it developed for Duchenne muscular dystrophy. The rare disease drug developer’s decision to withdraw Translarna’s FDA submission comes nearly a year after a negative European regulatory decision for the drug. The post PTC Therapeutics…
VBC models deliver significant benefits for CKD management by coordinating medical, behavioral, and social support through multidisciplinary teams. This approach enables providers to personalize care, address barriers to access, and use data-driven strategies to identify and prioritize high-risk patients. The post Closing the CKD Care Gap with Value-Based Care Models appeared first on MedCity News.
Giving healthcare teams powerful AI tools without training undermines their ability to use potentially system-changing tools safely and effectively. The post AI Can’t Improve Healthcare if Clinicians and Staff Aren’t Trained to Use, Orchestrate It appeared first on MedCity News.
Mayo Clinic has about 100 petabytes of structured and unstructured EHR data, and about 28 petabytes have been de-identified, but in the Mayo Clinic way. Now that data capability is being combined with institutional expertise to provide a compelling case for pharma companies looking to leverage data, AI and provider expertise in drug development The…
Infigratinib achieved statistically significant improvement in growth rate and body composition in a Phase 3 clinical trial that tested the BridgeBio Pharma drug in achondroplasia, the most common form of dwarfism. Regulatory submissions are planned for later this year. The post BridgeBio Stands Tall as Phase 3 Data Put Dwarfism Drug on Track for FDA…
Telepsychiatry provider Talkiatry has raised a $210 million Series D round led by Perceptive Advisors, bringing its total funding to more than $400 million. CEO Robert Krayn said the company is focused on scaling its clinician-employed model and improving outcomes as competition intensifies across behavioral health and virtual care. The post Talkiatry Rakes In $210M…
The AI revolution doesn’t mean erasing the value of humans. It means giving nurses more time to do what they signed up to do — deliver care directly to patients. The post Empathetic AI Nurses Can Vastly Improve Nurses’ Work and Patient Care appeared first on MedCity News.
[Sponsored] Here are the best disaster recovery solutions for health care organizations. The post A Guide to the Best Disaster Recovery Solutions for Health Care Organizations appeared first on MedCity News.
When applied with a rigorous, subject-matter-expert guided process, AI-currated RWD is an essential resource giving life science organizations new power to monitor the diverse variety of ways drugs are actually utilized post-approval. The post Blinded by Science: The Importance of RWD and Post-market Surveillance appeared first on MedCity News.
[Sponsored] Small practices play a critical role in healthcare delivery, but they cannot continue to absorb ever-increasing administrative demands without consequences. The post The Hidden Administrative Tasks Draining Small Practices appeared first on MedCity News.