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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.

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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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US FDA Expands Label For BMS’s Camzyos Days After Phase III Stumble

 
• By Alaric DeArment

The agency loosened requirements for echocardiograms and removed contraindications for a number of commonly used drugs.

Seven Up For Sanofi and Regeneron With Dupixent CSU Approval

 
• By Kevin Grogan

The IL-4/IL-13 inhibitor has been approved in the US as the first targeted therapy in over a decade for chronic itching.

Japan’s Ciconia Seeks Academic Candidates To Hatch In Global Market

 
• By Lisa Takagi

Japanese incubator Ciconia has just started verifying its first drug candidate with a vision of building domestic startups with globally competitive assets.