Category Archives: AZBio News

Amgen Makes Repatha® Available Through AMGENNOW, A Direct-to-Patient Program in the U.S.

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Eligible Patients Can Access Repatha at Nearly 60% Discount From the List Price 

THOUSAND OAKS, Calif. Oct. 6, 2025 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced the launch of AmgenNow, a new direct-to-patient program starting with Repatha® (evolocumab). This follows landmark results demonstrating Repatha significantly reduced the risk of major adverse cardiovascular events (MACE) in individuals without a prior history of heart attack or stroke in the VESALIUS-CV Phase 3 trial.Continue reading→

FDA Announces New ANDA Prioritization Pilot to Support U.S. Generic Drug Manufacturing and Testing

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[10/3/2025] Today, the U.S. Food and Drug Administration (FDA) is announcing a new pilot prioritization program for the review of abbreviated new drug applications (ANDAs) (ANDAs) that aims to spur and reward investment in U.S. drug manufacturing and research and development and strengthen the domestic pharmaceutical supply chain by providing faster reviews for generic companies who test and manufacture their products in the U.S.Continue reading→

AdvaMed Releases Technical Performance and Safety Bulletin on “Remote Device Operations: Common Challenges and Mitigation Strategies”

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WASHINGTON, D.C. – AdvaMed, the Medtech Association, recently published a technical performance and safety bulletin titled, “Remote Device Operations: Common Challenges and Mitigation Strategies” to help health care providers, device manufacturers, and IT teams navigate the complex landscape of remotely managing medical devices.Continue reading→

Pfizer Reaches Landmark Agreement with U.S. Government to Lower Drug Costs for American Patients

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  • Voluntary agreement meets the President’s four requests while also protecting the U.S. ecosystem responsible for America’s leadership in delivering medical breakthroughs
  • Agreement provides certainty from tariffs and clarity on pricing framework that furthers Pfizer’s ability to expand investment in U.S.-based innovation and return manufacturing to the U.S.
  • Pfizer to fully focus on delivering the next generation of cures, especially in cancer, obesity, vaccines, and inflammation and immunology
  • Pfizer CEO Albert Bourla joins President Donald J. Trump and members of his Administration in White House event today

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C-Path Names Colin Hill to Board of Directors

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TUCSON, Ariz., Sept. 30, 2025 — Critical Path Institute® (C-Path) today announced the election of Colin Hill, M.S., to its Board of Directors. Hill brings deep experience at the intersection of artificial intelligence, drug development, and translational acceleration. The appointment will further strengthen C-Path’s Board of Directors’ commitment to provide optimal strategic support to the organization’s growth in advancing drug development through collaboration.Continue reading→

PhRMA Announces Major Actions as Part of Industry’s Commitment to American Patients and Workers

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WASHINGTON, D.C. (September 29, 2025) – The Pharmaceutical Research and Manufacturers of America (PhRMA) today announced three major actions as part of the biopharmaceutical industry’s commitment to American patients and workers. 

PhRMA member companies are making historic investments in U.S.-based manufacturing and infrastructure, providing financial assistance to millions of insured and underinsured patients who have been failed by a broken health insurance system, and announcing a new website that will simplify access to manufacturer direct purchase and patient assistance resources. Continue reading→