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Latest From Bayer AG

US Drug Shortages Aid Aurobindo’s Q4 Growth, Decentralized Trials On For Xolair Biosimilar

Drug shortages, stable prices and a demand recovery in the US helped drive Aurobindo’s growth in Q4. Meanwhile, the company is developing a biosimilar to Roche/Novartis’s multi-billion product Xolair, as predicted by Scrip earlier. Use of decentralized mode for its Phase III trials is a notable aspect

Commercial Sales & Earnings

Keeping Track: Entasis’ Antibiotic Xacduro, Two Opioid Misuse Therapies Clear US FDA; Pfizer’s Paxlovid Makes It Official

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Approvals

Pfizer’s Marstacimab Wins In Phase III, But Caution On Market Position, Clotting Remain

The drug showed efficacy in hemophilia A and B with no sign of clots, an issue that historically has dogged anticoagulation agents, but it remains unclear whether that advantage will hold.

Clinical Trials Blood & Coagulation Disorders

Big Pharma Companies Have Higher US FDA Approval Percentage Than Everybody Else

Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a Pink Sheet analysis of FDA approval decisions since 2021.

US FDA Performance Tracker Drug Review
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  • Other Names / Subsidiaries
    • Actus Therapeutics, Inc.
    • AskBio
    • Asklepios BioPharmaceutical, Inc.
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    • NanoCor Therapeutics
    • BrainVectis
    • Algeta ASA
    • Bayer CropScience AG
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    • Berlex Laboratories
    • BlueRock Therapeutics
    • Conceptus Inc.
    • Dihon Pharmaceutical Group Co., Ltd.
    • Intendis GmbH
    • Jenapharm
    • Medrad Inc.
    • Possis Medical
    • Schering AG
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