Sun.Jan 22, 2023

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Can the FDA keep the momentum going for rare disease drug approvals?

Pharmaceutical Technology

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases.

Hormones 254
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FDORA Enacted; HP&M Issues Detailed Summary and Analysis

The FDA Law Blog

On December 29, 2022, the President signed into law the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act, 2023 , Pub. 117-328 (2022). FDORA primarily amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.

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FDA accepts Lilly-Boehringer Ingelheim’ sNDA for Jardiance

Pharmaceutical Technology

Eli Lilly and Company and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets for chronic kidney disease (CKD) in adult patients.

Drugs 219
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A Paradoxical ST-Segment Elevation Distribution Rendering a Challenging Prediction

JAMA Internal Medicine

This case report describes a patient in their 50s with sudden-onset chest pain

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2022 Research: The Rapid Rise of Ocean Freight Visibility

Download this a benchmark study from FourKites and The Journal of Commerce exploring how international shippers’ usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19.

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Which pharmaceutical companies have the greatest global patent coverage?

Drug Patent Watch

This chart shows the pharmaceutical companies with patents in the most countries. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is… The post Which pharmaceutical companies have the greatest global patent coverage?

Drugs 52
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Effect of Disposable Elevator Cap Duodenoscopes on Microbial Contamination and Technical Performance of ERCP

JAMA Internal Medicine

This randomized clinical trial determines contamination rates after high-level disinfection and technical performance of duodenoscopes with disposable elevator caps compared with those with standard designs