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Latest From AbbVie Inc.

Second Judge Rejects Constitutional Challenges To Medicare Price Negotiation Program

Delaware district judge rules against AstraZeneca’s claim the IRA violates its due process rights, echoing findings made by Ohio district judge in Chamber of Commerce’s suit. Only other IRA ruling to date dismissed PhRMA’s complaint on procedural grounds without addressing the merits.

Medicare Pricing Debate

News We’re Watching: New Cybersecurity Standard; CMS Prodded On TCET; Olympus Scopes Recalled

This week, NIST published a new version of its international cybersecurity standard; SeaStar Medical’s kidney device got an HDE; and the FDA announced safety issues for DT MedTech LLC, operating room tables, and GE incubators.

Regulation Recalls

Vaccines In Brief: ACIP Recommends Valneva's Chikungunya Shot For Travelers, Lab Workers

CDC’s advisory committee also approves a VFC program update allowing for the rare, off-label use of tetanus toxoid- and diphtheria toxoid-containing vaccine in young children, and plans to move up timing of its COVID-19 vaccine recommendations for the 2024-2025 formulation.

Vaccines Advisory Committees

Drug Makers Look To Simplify Application Process With New ICH Guidance On Platform Methods

As ICH member countries prepare to implement Q2(R1)/Q14 guidelines, industry is focusing on provisions in both for platform analytical procedures, which applicants for drug approvals and biologics licenses could use to reduce method validation requirements. Pfizer undertook the first commercial application of the platform analytical approach, which is widely used in development.

Drug Approval Standards Quality
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    • Luminera
    • Mavupharma
    • Pharmacyclics, Inc.
    • Stemcentrx, Inc.
    • Syndesi Therapeutics SA
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