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Sanofi/Genzyme And Isis Submit Kynamro For Lowering Cholesterol

 
• By Wendy Diller

It’s been a long haul, but Sanofi’s Genzyme business unit and Isis have submitted their NDA for a drug that helps lower cholesterol levels in high-risk patients with a rare genetic cardiovascular disease that doesn’t respond well to statins.

Long-term liver toxicities do not appear to be a significant problem for Kynamro, a second-generation anti-sense drug that manages severe high cholesterol in patients with a rare inherited genetic disease, the companies sponsoring the drug, Sanofi/Genzyme Corp. and partner Ionis Pharmaceuticals Inc. say.

Results of a two-year, ongoing, open extension study incorporating patients from a Phase III program for the drug found that...

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More from United States

HHS mRNA Vaccine Funding Cut Impact Limited (And One Contract Isn’t Even mRNA)

 
• By Alaric DeArment

HHS' culling of mRNA vaccine projects under BARDA will heavily impact pandemic preparedness. Tiba Biotech was even “caught off guard” by its inclusion, because its project was neither a vaccine nor mRNA-based.

Manufacturers Can Keep Their Shoes On: FDA PreCheck To Streamline US Facility Applications

 
• By Derrick Gingery

The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?

US FDA Requires Opioid Class Labeling Changes Despite Adcomm Advice

 
• By Kate Rawson

Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.

US FDA Skips User Fee Increase For More Staff Amid Exodus, Hiring Difficulties

 
• By Derrick Gingery

A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.

More from North America

New US FDA Chief Counsel More Familiar With Trump World Than Food and Drug Law

 
• By Sarah Karlin-Smith

Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.

Pharma Cooperating With Trump On Direct Sale To Consumers, Pfizer CEO Says

 
• By Jessica Merrill

Pfizer is in active discussions with Trump on MFN pricing and collaborating with peers on direct sales as an approach to lower drug prices, CEO Albert Bourla said.

Cuban: Drugmakers Are More Afraid of PBMs Than Trump

 
• By Leslie Small

The billionaire investor said during a recent conference that brand drug manufacturers want to work with his Cost Plus Drug Co., but are afraid the PBMs will retaliate.