Drug development programs face unique challenges in demonstrating the safety and effectiveness of drugs for treating rare diseases. The FDA’s Accelerating Rare disease Cures (ARC) Program started the Learning and Education to...more
On July 10, the Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S.150), which seeks to increase competition and lower drug prices by imposing limits on patent litigation related to biological...more
On June 6, 2023, Merck & Co. filed a lawsuit against the U.S. government in federal court over the Inflation Reduction Act (IRA)’s Medicare drug price negotiation program, which allows Medicare to directly negotiate prices...more
6/13/2023
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Drug Pricing ,
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Inflation Reduction Act (IRA) ,
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Pharmaceutical Industry
Lundbeck Pharmaceutical Company, headquartered in Denmark, recently announced the acquisition of Prexton Therapeutics B.V. for $1.1 billion (U.S.). Lundbeck is a publicly traded company focusing on psychiatric and...more
Seven years after Mylotarg® (gemtuzumab ozogamicin) was voluntarily withdrawn from the market, the U.S. Food and Drug Administration has re-approved Mylotarg® product....more