Priority Review

Five things for pharma marketers to know: Wednesday, March 25

Five things for pharma marketers to know: Wednesday, March 25

By

Keytruda trial stopped due to positive results; new bill proposes continuing FDA rare pediatric voucher program; AstraZeneca signs five-year research pact with Harvard Stem Cell Institute

Five things for pharma marketers to know: Tuesday, March 10

Five things for pharma marketers to know: Tuesday, March 10

By

HCV drugs and other specialty medications drove a 13% increase in last year's prescription spending, the CBO overestimated just how much healthcare reform would cost, and an FDA panel voted 17-0 in favor of Kythera's drug that can reduce double chins.

Five things for pharma marketers to know: Thursday, February 19

Five things for pharma marketers to know: Thursday, February 19

By By

Lilly delays Phase-III cholesterol drug results; PatientsLikeMe and Walgreens team up for "drug reaction reviews"; Roche skin-cancer drug receives 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

By By

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

By

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

By

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.

The 2015 healthcare agency questionnaire, for firms hoping to be featured in the Top 100 Agencies issue, is live. Click here to be considered.

Email Newsletters