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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 for commercializing the medicine in the US – a boost of 8

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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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Lilly Builds Obesity Momentum With New SURMOUNT Data Besting Novo Nordisk

 
• By Alaric DeArment

The presentation and publication of the Phase IIIb study showing greater efficacy for Zepbound over Wegovy come at a time when competition has been heating up between the two obesity medications.

Trump’s MFN Executive Order More Rhetoric Than Action

 
• By Jessica Merrill

The details of Trump’s latest executive order on drug pricing are vague and the president put more blame on other countries and pharma distributors than drug companies.

Biopharma Deals ROI Has Fallen And Market Instability Could Make It Worse

 
• By Andrew McConaghie

Rising biotech valuations mean return on investment on some deals is non-existent for big pharma, though certain strategies will improve chances of success, a new analysis has found.