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Bridgebio seeks Japan approval of acoramidis for rare heart disease

Armed with strong phase III safety data in Japanese patients, Palo Alto, Calif.-based Bridgebio Pharma Inc. is planning to file for Japan approval of its investigational drug acoramidis for a rare heart disorder. ....

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FDA Rejection Is a Delay, Not a Detour for Alnylam's Aim to Treat Heart Disorder

Despite an affirmative FDA advisory committee vote, the agency declined to approve Alnylam Pharmaceuticals’ Onpattro for treating the heart complications caused by a rare, inherited protein disorder. But Alnylam has other drugs candidates for the disease, including one expected to post Phase 3 data in the first half of 2024. ....

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FDA Issues CRL for Patisiran in Treatment of ATTR Cardiomyopathy

Announced on October 9, the decision to issue a CRL is based on the FDA's belief the clinical meaningfulness of patisiran’s treatment effects for the cardiomyopathy of ATTR amyloidosis had not been established. ....

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FDA Committee Endorses Patisiran for ATTR Cardiomyopathy

The FDA CRDAC convened on Septemeber 13 to discuss the sNDA for patisiran as a treatment for ATTR-CM, with the meeting concluding in a 9:3 vote in favor of the benefit-risk profile of patisiran. ....

Pushkal Garg , Christopher Oconnor , Javed Butler , Baylor Scott , Drug Administration Cardiovascular , Vascular Institute , White Research Institute , Renal Drugs Advisory Committee , Drug Administration , Christophero Connor , Inova Heart , White Research , Fda Crdac , Attr Cm ,

Analysis of lipid nanoparticle composition

Agilent presents liquid chromatographic method development for the analysis of the lipid components of patisaran ....

Application Note , Method Development , Liquid Chromatography ,