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Latest From Agenus Inc.

BrainStorm’s NurOwn Gets Many, Many Thumbs Down From US FDA Panel

In overwhelmingly concluding that efficacy has not been demonstrated for the mesenchymal stromal cell therapy, panelists went beyond just the failed Phase III trial and cited BrainStorm’s ‘statistical magic’ and failure to adequately describe the mechanism of action, as well as safety and product quality concerns.

Advisory Committees Drug Review

Imbruvica, Enbrel, Stelara Offer Best Chance Of Savings From Medicare Negotiation In First Round

The other seven drugs on the initial list for negotiation are already heavily rebated and CMS could choose not to go much lower than current net prices, SSR Health report points out.

Reimbursement Pricing Debate

Asia Deal Watch: Inventiva Finds Japan/Korea Partner For Phase III NASH Candidate In Hepalys

Plus deals involving SK pharmteco/CBM, Kezar/Everest, Cerecin/University of Alberta, PeptiDream/Genentech, Aclipse/Chong Kun Dang and Cure Genetics/Frametact.

Deal Watch Business Strategies

NurOwn Adcomm Is 20 Members Strong Despite US FDA’s ‘Struggle’ To Find Unconflicted Neurology Experts

Seven panelists are regular members of the Cellular, Tissue and Gene Therapies advisory committee, while many of the 13 temporary voting members bring neurology and neuroscience expertise. In a conflict-of-interest waiver, the agency noted a struggle to find experts in clinical neurology and neurodegenerative diseases who lack disqualifying financial interests.

Advisory Committees Regenerative Medicine
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