Sun.Mar 31, 2024

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Biosimilar Competition Does Not Reduce Patient Out-of-Pocket Costs for Biologic Drugs

Drug Patent Watch

A recent study published in JAMA Health Forum sheds light on the impact of biosimilar competition on patient out-of-pocket (OOP) costs for biologic drugs in the United States.

Drugs 105
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Clinical Reasoning of a Generative AI Model Compared With Physicians

JAMA Internal Medicine

This cross-sectional study assesses the ability of a large language model to process medical data and display clinical reasoning compared with the ability of attending physicians and residents.


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New patent expiration for The Medicines drug IONSYS

Drug Patent Watch

Annual Drug Patent Expirations for IONSYS Ionsys is a drug marketed by The Medicines Co and is included in one NDA. There are eight patents protecting this drug.

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Transforming Clinical Trial Management: The Shift from Point Systems to Platform Solutions


The landscape of clinical trial management is undergoing a significant transformation, driven by the complex demands of modern medical research. At the heart of this change is a move away from traditional point systems—discrete tools designed for specific tasks within a trial—to comprehensive platform solutions that offer a unified approach to managing all aspects of a trial.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Congressional Hearing on LDTs: Split on FDA Regulation but Support for VALID

FDA Law Blog

By Ana Loloei & Jeffrey N. Gibbs — On March 21, 2024, the House Energy and Commerce held a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee Chair Brett Guthrie (R-KY), in announcing the hearing, made their views clear: “FDA has proposed a rule that relies upon dubious and misguided legal, economic, and public health arguments and

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New tentative approval for MYLAN drug efavirenz, emtricitabine and tenofovir alafenamide

Drug Patent Watch

For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact or visit www.DrugPatentWatch.

Drugs 52