Merck KGaA’s Cyanide Poisoning Agent Cyanokit Approved With Pivotal Animal Data
The product will launch in first quarter 2007, U.S. subsidiary VP-Regulatory Affairs Elliot Berger tells “The Pink Sheet” DAILY.
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Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.
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Highlights from day one of the BIO convention include advice for firms hoping to go public, a call for companies to push the US Congress on rare disease priority review vouchers, and updates on next-generation gene therapies.
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Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.