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Isis Builds On Platform Strategy With Fourth Biogen Tie-Up

 
• By Lisa LaMotta

The antisense company has made it clear that it will not pursue commercialization of its own drugs, but intends to partner out all of its assets, while still retaining the most advantageous economics. Its fourth agreement with Biogen Idec, a strategic collaboration, is the most extensive and lucrative to date with the partner.

Ionis Pharmaceuticals Inc. has linked up with Biogen Inc. for a fourth collaboration in less than two years – one that is broader in scope and heftier financially than previous transactions – prompting analysts and investors to hope that the smaller company’s antisense technology has been proving itself in clinical trials, despite Biogen’s reluctance to commit to a full licensing of the most advanced program on which the companies are partnered.

The two companies announced the collaboration, which Isis is referring to as ‘Biogen 4’, on Sept. 9. The broad six-year strategic research collaboration will use Isis’ antisense technology to discover...

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US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 
• By Sarah Karlin-Smith

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

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• By Sue Sutter

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• By Sarah Karlin-Smith

The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.

More from North America

Drug, Biologic Policy Staff Return To US FDA, As RIF Process Hangs In Legal Limbo

 
• By Sarah Karlin-Smith

The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

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