The company won approval in hATTR amyloidosis polyneuropathy for the RNAi drug, which offers quarterly subcutaneous dosing versus Onpattro’s I.V. administration every three weeks.
Alnylam Pharmaceuticals Inc. plans to take advantage of the existing commercial foundation of Onpattro (patisiran) to launch the newly approved hereditary transthyretin-mediated amyloidosis (hATTR)-associated polyneuropathy (PN) drug Amvuttra (vutrisiran).
The US Food and Drug Administration approved the subcutaneous RNA-interference (RNAi) agent on 13 June for hATTR-PN, based on nine-month data from the Phase III HELIOS-A clinical trial showing improvement in signs and
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
The novel RAF/MEK inhibitor and FAK inhibitor are the first treatment approved specifically for KRAS-mutated recurrent low-grade serious ovarian cancer (LGSOC).
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
The company’s FcRn inhibitor nipocalimab was approved by the US FDA for generalized myasthenia gravis (gMG), where it will join a competitive market.
Neurocrine, Madrigal and Vanda updated investors on new drug launches, while Cytokinetics talked to investors about an FDA extension for aficamten.
Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.
Workforce development will be essential to meeting president Trump’s goal to return biopharma manufacturing to the US.
