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Alnylam Ramps Up Commercial Planning For Givosiran Based On Phase III Data

 
• By Jessica Merrill

The company expects to complete a rolling NDA submission for its second RNAi therapeutic in mid-2019, and sees an opportunity to target severe and more moderate patients with acute hepatic porphyria.

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Alnylam Pharmaceuticals Inc. expects to launch its second commercial drug and the second RNAi therapeutic in the US in early 2020, after announcing positive Phase III data on givosiran in patients with the ultra-rare disease acute hepatic porphyria (AHP).

The company already has launched a disease awareness initiative and is providing genetic testing support for patients through its Alnylam Act program. A revised timeline for givosiran's filing with the US FDA has been a bit of a step back, however, as Alnylam had been hoping to file early based on interim data released last year, but was hung up by early safety signals, which have not been eliminated

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Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

Marea Eyes Cardioprotective Benefit With ANGPTL4 Inhibition

 
• By Joseph Haas

Phase IIa data for ANGPTL4-targeted antibody shows reduced triglycerides and remnant cholesterol, which Marea asserts indicates potential to protect against cardiovascular outcomes.

First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 
• By Andrew McConaghie

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.

In Brief: Strong OS Results For Immutep’s Eftilagimod/Keytruda Combo In Head And Neck Cancer

 
• By Sushmita Panda

Australian firm's combo of eftilagimod and Keytruda shows 17.6-month median overall survival in first-line HNSCC patients with low PD-L1, raising hopes for potential accelerated approval.

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In Brief: Positive New Data For Aptose’s Triplet Therapy In 1L AML

 
• By Sushmita Panda

Aptose’s tuspetinib triplet shows early mutation-agnostic promise in new data from Phase I/II program for frontline acute myeloid leukemia.

Chinese Firms Build Obesity Clinical Pipeline But Face Wider Hurdles

 
• By Xu Hu

Despite the ability to initiate clinical trials quickly and having strong manufacturing capacity, Chinese companies are facing multiple challenges in the obesity space.

Aldeyra Plans To File Reproxalap Again With New Dry Eye Symptom Data

 
• By Joseph Haas

The biotech hopes a third time will be the charm after two FDA complete responses, with plans to position its eye drop as offering quicker onset of action.