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Keeping Track: US FDA Clears Santen’s Omlonti, Fennec’s Pedmark; Lilly’s Retevmo Adds Tumor-Agnostic Claim

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

US FDA Performance Tracker Approvals

Regulators Keep Rare Diseases Open For Business

The cost of rare diseases to patients and society at large is 10 times higher than for many of the biggest mass market diseases combined. With 95% of rare diseases lacking a treatment or cure, there is an economic imperative for policymakers to keep encouraging pharmaceutical companies to develop more orphan drug treatments. In Vivo looks at the US and EU regulatory impetus to keep rare diseases open for innovation. 

Rare Diseases FDA

Pfizer’s Buying Spree Continues With GBT, Gaining A Sickle Cell Disease Franchise

Pfizer has reached a deal to buy Global Blood Therapeutics for $5.4bn, gaining the sickle cell therapy Oxbryta and building on efforts to reach underserved patient groups.

Blood & Coagulation Disorders Deals

APAC Regulatory Roundup: Infectious Disease A Common Theme As COVID Lingers

A roundup of key regulatory and policy developments in the Asia-Pacific in the first half of the year reveals broad developments across the region's diverse markets, although there seemed to be a common thread - a renewed focus on infectious diseases amid the lingering impact of the pandemic and the emergence of new threats.

Asia Pacific Infectious Diseases
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  • Other Names / Subsidiaries
    • Adolor Corporation (ADLR)
    • Calixa Therapeutics, Inc.
    • Optimer Pharmaceuticals, Inc.
    • Trius Therapeutics, Inc.
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