What Else Analysts Want To Know About Phase III Data For TMC’s Inclisiran
Looking to be a game-changer with a highly effective LDL-C-lowering agent dosed twice annually, The Medicines Company says inclisiran met efficacy endpoints in a large Phase III study. But observers await fuller data, including safety details.
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Filings for the twice-yearly anti-PCSK9 injection under a partnership with Alnylam are on track, including a fourth quarter submission in the US. Detailed ORION-9 and ORION-10 data will be presented at AHA in November.
The Pink Sheet’s list of EU centralized approvals of new active substances now includes five new products, one of which is BioMarin Pharmaceutical's Palynziq for treating phenylketonuria. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).
The Medicines Co. CEO Timney On Selling Inclisiran And Why Big Pharma Is Still Interested In CV Disease
Mark Timney took over the helm at The Medicines Company in December with a singular focus: wrapping up the Phase III program for inclisiran and finding a buyer for the cholesterol-lowering drug.