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Merck/Endocyte Mulling Vintafolide’s Future After Failure In Ovarian Cancer

 
• By Lisa LaMotta

Endocyte is potentially propelled back to a Phase I company after its nearest commercial prospect flops and its collaboration with Merck is expected to disintegrate now that the drug missed PFS in ovarian cancer.

Endocyte Inc. and partner Merck & Co. Inc. have another shot with vintafolide with a lung cancer trial due to report on overall survival in the fall – but the compound took a major hit when a data safety monitoring board stopped a Phase III ovarian cancer trial due to lack of efficacy.

The drug, a conjugate of folic acid that targets folate receptors on the surface of cancer cells and is linked...

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More from United States

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.

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.

More from North America

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.

August Brings Fresh Faces And Tough Calls To US FDA User Fee Calendar

 
• By Bridget Silverman

The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.

Court Allows MSN Marketing Of Entresto Generic, But More Legal Issues Pending

 
• By Dean Rudge

Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.