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FDA partially halts leukemia studies of Gilead cancer drug

BioPharma Drive: Drug Pricing

The hold is the latest setback for a drug that was the center of Gilead’s $5 billion acquisition of biotech Forty Seven in 2020.

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Use of GLP-1 Meds Have Risen 7-Fold Among Young Americans

Drugs.com

WEDNESDAY, May 22, 2024 -- The number of American teens and young adults who've been prescribed one of the new GLP-1 weight-loss drugs soared nearly seven-fold between 2020 and 2023, a new report finds. That's compared to an overall decline of.

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Biogen, Sage tremor drug fails key trial

BioPharma Drive: Drug Pricing

Known as SAGE-324, the drug was one of the key assets Biogen gained rights to through a billion-dollar research deal inked back in 2020.

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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Regulatory Authority: Pharmaceuticals and Medical Devices Agency (PMDA) The PMDA is the primary regulatory authority responsible for overseeing the drug approval process in Japan.

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PBMs and Drug Spending in 2020: Data from CVS Health (sort of), Express Scripts, Navitus, and WellDyne (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Drug Channels Outlook 2022. Since 2012, Drug Channels has examined commercial drug spending using the annual trend reports published by the largest PBMs. Specialty drug costs grew slowly—or even declined.

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Review of 505(b)(2) Drug Products Approved by USFDA from 2010 to 2020: A Focus on Intellectual Property and Regulatory Considerations

Drug Patent Watch

A review article in the Journal of Pharmaceutical Sciences analyzes the trends in drug repurposing through the 505(b)(2) pathway, as approved by the USFDA from 2010 to 2020.

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With latest fundraise, Rome Therapeutics works to drug the ‘dark genome’

BioPharma Drive: Drug Pricing

Johnson & Johnson and Bristol Myers Squibb have joined a group of new investors backing Rosana Kapeller’s startup, which launched in 2020 after incubating with GV.

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