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Latest From Mesoblast Limited

US FDA’s ODAC: The Advisory Committee That Can Only Say ‘No’

It has been more than two years since a sponsor went before the Oncologic Drugs Advisory Committee and won a favorable vote on approval of a new drug application. Can FDA really expect an advisory committee to keep saying ‘no’ all the time?

Advisory Committees Drug Approval Standards

Stock Watch: Positive Trial Announcements Need A Pinch Of Salt

The announcement of a positive clinical trial and an intention to proceed to a regulatory submission are causes for a company’s investors to rejoice. Sometimes that can be premature.

Stock Watch Approvals

Tech Transfer Roundup: MD Anderson, Moffitt Lead Busy Academic Cancer Partnering Space

MD Anderson teams with Eisbach on precision oncology and with Yingli on a five-year translational research effort. Moffitt inks tie-ups with Dyve and Turnstone.

Tech Transfer Round-Up Deals

JCR Pharma: Crossing Oceans And The Blood-Brain Barrier

After 45 years as a domestic Japanese biopharmaceutical company, JCR Pharmaceuticals is expanding into global markets. The company is betting that its manufacturing strength – which helped land a COVID-19 vaccine manufacturing deal with AstraZeneca – and blood-brain barrier crossing J-Brain Cargo technology will lead to success in Western markets.   

Japan Business Strategies
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