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A win for antisense: Isis/Genzyme score US OK for Kynamro

 
• By Donna Young

A month after a competitor's drug was approved, Genzyme and Isis Pharmaceuticals gained the US FDA's nod to market Kynamro (mipomersen sodium) to treat patients with homozygous familial hypercholesterolemia (HoFH), a rare genetic lipid disorder that causes extremely high elevations of low-density lipoprotein cholesterol (LDL-C), causing early onset of arthrosclerosis, with patients often experiencing heart attacks in their early teens, often dying before age 30.

A month after a competitor's drug was approved, Genzyme and Isis Pharmaceuticals gained the US FDA's nod to market Kynamro (mipomersen sodium) to treat patients with homozygous familial hypercholesterolemia (HoFH), a rare genetic lipid disorder that causes extremely high elevations of low-density lipoprotein cholesterol (LDL-C), causing early onset of arthrosclerosis, with patients often experiencing heart attacks in their early teens, often dying before age 30.

Investors gave shares of Carlsbad, California-based Isis, which initially developed the drug – later collaborating with Genzyme, which is responsible...

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Final Chance To Have Your Say: Take Scrip's Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Scrip, or if you love it how it is, now is the time to have your voice heard.

Galapagos Expands Point-Of-Care CAR-T Study To The US

 
• By Andrew McConaghie

CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.

Analysts Split On Eisai’s Chances Of Changing EU Regulator’s Mind On Leqembi

 
• By Andrew McConaghie

A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand

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Spain’s SpliceBio Secures Sanofi and Roche Support In $135m Financing

 
• By Kevin Grogan

Series B cash will be used to advance its Stargardt disease gene therapy.

In Brief: PolyPid’s D-PLEX100 Aces Phase III Trial, US Partner, Submission Eyed

 
• By Sushmita Panda

PolyPid's D-PLEX100 meets Phase III endpoints this time around, significantly reducing surgical point infections in abdominal colorectal surgery, and is set for a US approval submission early next year.

Insmed’s PAH Data Indicate Potential To Surpass Established Therapies

 
• By Joseph Haas

Insmed’s inhaled treprostinil exceeded goals for reducing pulmonary vascular resistance and improving six-minute walk test distance in Phase IIb data.