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PTC Therapeutics Announces Waylivra Approval in Brazil as First Treatment for Familial Chylomicronemia Syndrome firstwordpharma
August 24, 2021
PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária), has approved Waylivra™ (volanesorsen) as the first treatment for familial chylomicronemia syndrome (FCS)
Phase III trial to study familial chylomicronemia syndrome drug initiated europeanpharmaceuticalreview
December 03, 2020
Ionis Pharmaceuticals’ Phase III trial to evaluate AKCEA-APOCIII-LRx in patients with familial chylomicronemia syndrome has begun.
NICE u-turn sees Akcea's Waylivra win NHS funding pharmatimes
September 21, 2020
Akcea Therapeutics UK's Waylivra (volanesorsen), the first and only therapy for Familial Chylomicronaemia Syndrome (FCS), will be funded on the NHS after all, following a u-turn by the National Institute for Health and Care Excellence (NICE).
NICE issues draft guidance, finding negative opinion for volanesorsen europeanpharmaceuticalreview
January 06, 2020
Waylivra (volanesorsen) has not been recommended for treatment of familial chylomicronaemia syndrome, according to draft guidance from NICE.
Albemarle Expands RSM Capabilities contractpharma
September 12, 2019
Albemarle Fine Chemistry Services (FCS), a U.S. domestic supplier of regulatory starting materials (RSMs), intermediates, and high-value active pharmaceutical ingredients (APIs) to the pharmaceutical industry...
Waylivra granted conditional marketing authorisation in Europe pharmatimes
May 09, 2019
Waylivra granted conditional marketing authorisation in Europe.