Merck Expects Expedited Filing Of HDL-Cholesterol Drugs Using Existing Data
• By The Pink Sheet
Merck believes it will be able to submit its developmental atherosclerosis therapies targeting HDL cholesterol without conducting major outcomes trials, Merck Research Lab President Peter Kim said during the firm's annual business review in Whitehouse Station, N.J. Dec. 15
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”
ZIN, the Dutch health technology assessment body, estimates that the number of patients eligible for treatment with a PARP inhibitor will be halved following a reassessment of drugs in the class.