Tag: Alnylam

FDA, Regulations

FDA panel backs Alnylam drug despite doubts over benefit

September 13, 2023

Via: Biopharma Dive

Advisers to the Food and Drug Administration on Wednesday endorsed Alnylam Pharmaceuticals’ drug Onpattro for a rare heart condition, despite questions from agency scientists over the degree of benefit offered by the RNA-based therapy. The advisory committee’s 9-3 vote sets […]


Alnylam scraps trial in rare eye disorder, blaming drug price reforms

October 28, 2022

Via: Pharmaphorum

The IRA was signed by Biden in August and introduced a framework that will require Medicare, the US’s government-run insurance programme for older Americans, to negotiate with manufacturers a “reasonable” price for selected brand name drugs on the basis of […]


AstraZeneca picks up new weapon in rare disease fight with Alnylam and Pfizer, paying $30M for rights to an early-phase asset

January 7, 2022

Via: FierceBiotech

AstraZeneca is stepping up its pursuit of a rare disease market targeted by Alnylam and Pfizer. Having entered the ATTR space through its takeover of Alexion, AstraZeneca is paying $30 million for worldwide rights to Neurimmune’s NI006 in its second […]


Novartis taps Alnylam for ambitious push to fix liver function

January 6, 2022

Via: FierceBiotech

Novartis is getting back into bed with Alnylam. More than a decade after severing its ties to the RNAi pioneer, Novartis has returned to the deal table for an ambitious early-stage collaboration to restore liver function in patients with end-stage […]

Clinical Trials, FDA, Regulations, Research and Development

Alnylam makes case for lumasiran in infants ahead of FDA ruling  

October 23, 2020

Via: FierceBiotech

Alnylam has shared data from a phase 3 trial of its near-approval kidney disease drug lumasiran in children as young as three months. The RNAi therapy drove a 72% reduction in urinary oxalate from baseline, boosting Alnylam’s hopes of using […]