BioMarin Vimizim Review Focuses On Meaningfulness of Walking Test; FDA Review, Questions Point To “Yes” On Approval

Vanda’s Tasimelteon For Non-24: Panel Removes Concerns Over Indication, Endpoints With Overwhelming Positive Votes

Sanofi/Genzyme Lemtrada Rests on Flawed Studies That Do Not Support FDA Approval, Safety Vote Permits Further Discussion

Putting The Brakes On Breakthrough: Cancer Immunotherapy, Dose Optimization Don’t Fit Easily In Hyper-Fast Development

Vanda’s Tasimelteon for Non-24: FDA Reviewers Recommend Approval Despite Disagreement Over Endpoints

Proposal On Generic Label Changes Takes Control From Reference Brand Sponsors

Lung Cancer “Master Protocol” Tests New Personalized Medicine Trial Model

Sanofi/Genzyme Lemtrada For MS Faces High Hurdle at FDA Advisory Meeting: Safety Issues, Adequacy of Trials Questioned

The Safety Era in Oncology? FDA Managers Reflect on Iclusig

Copay Drug Assistance In Exchanges Still Up To Plans Following HHS, CMS Policy Positions

FDA Sickle Cell Patient Meeting Set For Feb. 7; PhRMA Project May Deliver First Data

IoM Cancer Policy Forum Emphasizes Need For Clinical Trial, Coverage Policy Changes; FDA Viewed As Enabler, Not Obstacle

Personalized Medicine Report Highlights FDA Research Efforts As A Science-Based Agency

Drug Shortages: FDA Strategic Plan/FDASIA Rule Create Foundation for Stepped Up FDA Quality Effort

Iclusig Safety Issues Test New Model In Oncology: One Product Unlikely To Upend Overall Climate For Targeted Therapies

CDER Staking Out Stakeholder Engagement As Permanent Function; New Director Brings Broad Communication Experience, Stint at CMS

Advisory Committee Unanimously Supports Approval for Gilead’s Sofosbuvir; Breadth of Indication Remains to Be Seen

Zohydro Approval Follows Hydrocodone Combo Rescheduling Action; FDA Declines To Require Tamper-Resistant Features

J&J/Medivir Simeprevir Once-Daily HCV Protease Inhibitor Sails Through FDA Committee: Label Warnings Look Mild

FDA Agrees To Reschedule Short-Acting Hydrocodone Combos (Vicodin) In Latest Rx Abuse Response Step

Advisory Committee Tracker: Sanofi’s Lemtrada Is Late Addition to November Schedule; Vanda, BioMarin Also Have Key Reviews

“Breakthroughs” In Oncology: Blood Cancers Lead FDA Designations

Gilead’s Sofosbuvir for HCV Headed for Positive Panel Recommendation for Genotypes 1-4; Discussion to Focus on Genotype Subsets

Janssen/Medivir Simeprevir Once-Daily HCV Drug Gets Favorable FDA Internal Review But Agency Wants to Screen Out Significant Subset of US Patients

Shared REMS Rulemaking Is Not Ripe: FDA Maintains Informal Facilitator Role on Shared Programs; Denies Prometheus Lotronex Petition