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Merck antibody reduces RSV-related disease, hospitalizations in trial

BioPharma Drive: Drug Pricing

Detailed data from a Phase 2b/3 study of Merck’s treatment clesrovimab should support the company’s efforts to win approval by the 2025-2026 season.

Hospitals 105
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GSK’s ViiV to expand supply of HIV drug in Africa

BioPharma Drive: Drug Pricing

The company is committing to make at least 2 million doses of its long-acting PrEP therapy available in low- and middle-income countries next year and in 2026.

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HP&M Director, Allyson Mullen, Appointed to the Association of Medical Diagnostic Manufacturers 2024-2026 Board of Directors

FDA Law Blog: Biosimilars

Hyman, Phelps & McNamara, P.C. (HP&M), HP&M), the largest dedicated food and drug law firm in the U.S., is pleased to announce that Director Allyson Mullen has been appointed to the Board of Directors of the Association of Medical Diagnostic Manufacturers (AMDM). This prestigious appointment recognizes Ms.

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GSK partners with Chinese pharma to expand Shingrix sales

BioPharma Drive: Drug Pricing

The purchase agreement with Chongqing Zhifei Biological Products is part of GSK’s plan to double sales of the shingles vaccine by 2026.

Vaccine 112
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Bluebird, short on cash, takes on $175M in debt financing

BioPharma Drive: Drug Pricing

The funding could extend the cash-strapped gene therapy maker’s financial runway to 2026, but only if the company successfully hits certain milestones.

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ECHA flags 28 substances for evaluation over next three years

Agency IQ

BY SCOTT STEPHENS, MPA This week, ECHA finalized its annual update to the Community Rolling Action Plan (CoRAP), listing 28 substances that will be assessed under the REACH Regulation’s substance evaluation procedure during the 2024-2026 period.

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FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

FDA Law Blog: Biosimilars

Regarding CDER’s ETP, the current ETP guidance document, originally published in 2017, will be updated by the end of 2026, and will include details on communicating the type of products and stages of development for which a requestor can approach the ETP.

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