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Alnylam’s novel RNA therapy Onpattro wins nod for hATTR amyloidosis
pharmatimes
August 14, 2018
The US Food and Drug Administration has approved Alnylam’s RNAi therapeutic Onpattro for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis.
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With patisiran launch in its sights, Alnylam plots a major hiring spree
fiercepharma
August 08, 2018
Alnylam’s first drug approval could come any day now, and in preparation, the company is bulking up—in more ways than one.
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Alnylam Announces United Kingdom’s MHRA Grants Early Access to Patisiran
americanpharmaceuticalreview
August 06, 2018
Alnylam announced the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted patisiran, an investigational RNAi therapeutic in development for the treatment of hATTR amyloidosis, a positive scientific opinion through the Early Access
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FDA delays decision on inotersen, handing lead to Alnylam
fiercebiotech
May 07, 2018
The FDA has delayed the PDUFA date for Akcea’s hereditary TTR amyloidosis drug inotersen, handing first-mover advantage to Alnylam. Akcea suffered the setback after the FDA asked for more time to review its response to requests for information ...
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Alnylam Receives Positive Opinion for Orphan Drug Designation in the EU for ALN-TTRsc02
americanpharmaceuticalreview
April 24, 2018
Alnylam Pharmaceuticals announced the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion
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Alnylam hopes for 2018 filing for RNAi liver disease drug
pharmaphorum
April 17, 2018
The technology uses small strands of RNA to silence or interfere with the coding of rogue proteins that cause certain diseases – but ..
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Regeneron and Alnylam Team up to Tackle NASH Liver Disease
biospace
March 23, 2018
Regeneron Pharmaceuticals, Inc. and Alnylam Pharmaceuticals signed a collaborationdeal to identify RNAi therapies for nonalcoholic steatohepatitis (NASH) and other possibly related liver diseases.
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EMA Grants Alnylam Accelerated Assessment of Patisiran
americanpharmaceuticacreview
November 14, 2017
Accelerated assessment potentially provides a reduced review timeline from 210 to 150 days once the MAA is filed and validated.
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Alnylam soars on likely first RNAi treatment approval
pharmafile
September 25, 2017
Revealing data from its treatment, patisran, for Hereditary ATTR (hATTR) Amyloidosis Patients with Polyneuropathy, the results are strong enough to make the long wait for first treatment worthwhile.