Priority Review

FDA approves Amgen leukemia immunotherapy

Amgen's Blincyto was approved for a rare form of leukemia after receiving Breakthrough Therapy designation and a Priority Review.

Five things for pharma marketers to know: Tuesday, December 2

Five things for pharma marketers to know: Tuesday, December 2

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Otsuka acquires Avanir; hackers target pharma; Novartis must give up nicotine patch to finalize GSK consumer deal.

Gilead buys priority voucher for $125M

The scoop means the maker of HCV drugs Harvoni and Sovaldi can give any drug an accelerated review time.

FDA clears new tool for Ebola arsenal

A US Senate bill would also make treatments for the disease eligible for priority review vouchers.

Study shows challenge of CNS drug approvals

For example: Tufts Center for the Study of Drug Development reseachers say it takes 18% longer to develop CNS drugs than it does non-CNS drugs.

Avastin pockets another Priority Review label

It's the second for this cancer drug in two weeks.

Genzyme rare-disease drug gets priority label

The FDA granted priority review for the experimental, all-oral Gaucher's disease treatment.

FDA expedites two GlaxoSmithKline treatments


GlaxoSmithKline heats up the CLL category with its second breakthrough designation therapy of the year, topped off by priority review for a melanoma combo treatment.

Business briefs: IOM, AstraZeneca, Roche

An Institutes of Medicine report says doctors are struggling to keep up with cancer tech; AstraZeneca licenses an experimental Merck cancer treatment; Roche tees up for FDA panel review of a new Perjeta indication

Business briefs: Akorn, Bayer, Lonza, plus curbing CNS drug use

Akorn expands, buying Hi-Tech Pharmacal; nursing homes miss their goal to curb antipsychotic-drug use; Bayer cancer drug gets priority review; and Lonza lays off staff

GA101 looks more like a franchise-extender for Roche


The interim results of a Phase III study augur well for use of Roche's Rituxan successor in more than one type of leukemia, one analyst said.

Business briefs: GSK, UCB, AZ, Biogen Idec, CVS, Roche, Forest

China's industry investigation widens beyond GlaxoSmithKline; PhRMA's European equivalent rallies patient groups to fight transparency; Biogen Idec says a patient's death is not linked to Tecfidera; parents swap walk-in clinics for office visit; Roche continues its CEO hunt; and Forest logs 6% sales growth.

Does a health psychology approach hold the key to Rx adherence? In MM&M's latest Leadership Exchange Uncut eBook, industry stakeholders from the payer, provider, academic and pharma realms explore the "why" behind medicine taking. Access here.

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