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Gilead Prevails in Antiviral Patent Suit From University of Minnesota Regents

March 9, 2023

A federal appeals court has ruled in favor of Gilead Sciences, rejecting the Regents of the University of Minnesota’s claim the drugmaker violated the university’s patent protections for sofosbuvir, a Hepatitis C antiviral branded as Sovaldi, among others.

Many Accelerated Approval Drug Labels Lack Required Marketing Information

March 9, 2023

FDA guidance requires that drug labels note accelerated approval status and specify the endpoints that supported the approval.

NICE Recommends Novo Nordisk’s Wegovy for Weight Management

March 9, 2023

NICE limited its recommendation of the drug to a maximum of two years of use.

FDA Accepts Ionis NDA for Eplontersen in Rare Hereditary Disease

March 9, 2023

The FDA’s target action date on the NDA is Dec. 22.

FDA Grants Leqembi Priority Review for Full Approval

March 8, 2023

Leqembi slowed cognitive decline in treated patients by 27 percent. Read More

FDA Action Date on BioMarin’s Roctavian Delayed Due to ‘Substantial’ Data

March 8, 2023

BioMarin has several clinical studies underway to evaluate the gene therapy for severe hemophilia A. Read More

FDA Expands Approval of Eli Lilly’s Verzenio for High-Risk Early Breast Cancer

March 8, 2023

Verzenio first received FDA approval in 2017. Read More

B. Braun Gets Form 483 for Batch Discrepancies, Quality Lapses

March 8, 2023

The FDA rapped German pharmaceutical company B. Braun Medical for failing to thoroughly review unexplained batch discrepancies, a quality control unit that lacks the authority over drug products, failure to follow production and process control procedures, and other lapses observed during an inspection of the company’s Daytona, Fla., plant. Read More

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Gilead Prevails in Antiviral Patent Suit From University of Minnesota Regents

Many Accelerated Approval Drug Labels Lack Required Marketing Information

NICE Recommends Novo Nordisk’s Wegovy for Weight Management

FDA Accepts Ionis NDA for Eplontersen in Rare Hereditary Disease

FDA Grants Leqembi Priority Review for Full Approval

FDA Action Date on BioMarin’s Roctavian Delayed Due to ‘Substantial’ Data

FDA Expands Approval of Eli Lilly’s Verzenio for High-Risk Early Breast Cancer

B. Braun Gets Form 483 for Batch Discrepancies, Quality Lapses

Many Accelerated Approval Drug Labels Lack Required Marketing Information

Genentech Seeks Patent Royalties From Biogen for Blockbuster MS Drug

FDA and FTC Team Up to Counter Misleading Info About Biosimilars

FDA Denies Petition to Grant Simufilam Breakthrough Designation

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The Revised ICH E8: A Guide to New Clinical Trial Requirements

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