Review Of Reviews: Drug Review Profiles 2014

Pharmaceutical Approvals Monthly’s Drug Review Profile stories from 2014.

Drug	Review Profile Stories
GE Healthcare’s Vizamyl (flutemetamol F 18)	(Also see "FDA Review Of GE’s Vizamyl Shows Caution In The Face Of Alzheimer’s Disease Unknowns" - Pink Sheet, 19 Feb, 2014.)
Gilead’s Sovaldi (sofosbuvir)	(Also see "How Sovaldi Won A Broad Label: Emerging Data Swayed Reluctant FDA" - Pink Sheet, 19 Mar, 2014.) (Also see "Better Late Than Never: “Breakthrough” Status Aided Sovaldi’s On-Time Approval" - Pink Sheet, 19 Mar, 2014.) (Also see "Sovaldi NDA Review Marred By Manufacturing Compliance Issues" - Pink Sheet, 22 Apr, 2014.) (Also see "Gilead’s Foreign API Supplier Faced FDA Import Alert" - Pink Sheet, 22 Apr, 2014.)
Johnson & Johnson’s Olysio (simeprevir)	(Also see "What’s In A Name? Janssen’s Loss Of Sovriad Was Gilead’s Gain With Sovaldi" - Pink Sheet, 22 May, 2014.) (Also see "Olysio Pre-treatment Screening Cleared Way For FDA Nod In Partial And Null Responders" - Pink Sheet, 22 May, 2014.)
Novartis’ Zykadia (ceritinib)	(Also see "Dose Finding At Breakthrough Speed: FDA Found A Role For Anecdotal Reports On Zykadia" - Pink Sheet, 18 Jun, 2014.) (Also see "Zykadia Expedited Timeline Challenged By Late-Breaking GMP Concern" - Pink Sheet, 18 Jun, 2014.) (Also see "FDA Proposed Master Protocol For Zykadia Trial; Novartis Had Other Plans" - Pink Sheet, 18 Jun, 2014.)
Merck’s Zontivity (vorapaxar)	(Also see "FDA Changed Course On Zontivity Because Of Skepticism Of Subgroups At High Levels" - Pink Sheet, 30 Jul, 2014.) (Also see "Zontivity’s Small Effect On Absolute Risk Reflects Advances In Therapy" - Pink Sheet, 30 Jul, 2014.)
Purdue’s Targiniq ER (extended-release oxycodone/naloxone)	(Also see "Targiniq Review Shows How High FDA’s CV Safety Bar Is For Opioid Antagonists" - Pink Sheet, 25 Sep, 2014.) (Also see "Points To Consider For CV Safety Assessment Of Opioid Antagonists" - Pink Sheet, 25 Sep, 2014.) (Also see "No OxyContin Comparison? Then No Priority Review For Targiniq ER" - Pink Sheet, 25 Sep, 2014.) (Also see "Abuse-Deterrent Opioid Claims Need Studies, Studies And More Studies" - Pink Sheet, 25 Sep, 2014.)
Takeda’s Entyvio (vedolizumab)	(Also see "Legacy Cost: Takeda’s Entyvio Development Shaped By Tysabri Fallout" - Pink Sheet, 24 Oct, 2014.) (Also see "Unintended Consequences Of REMS Weighed On Entyvio Review Team" - Pink Sheet, 24 Oct, 2014.) (Also see "Biogen Idec Suggests PML Risk Manageable For Tecfidera, After Reporting First Case" - Pink Sheet, 24 Oct, 2014.)
BioMarin’s Vimizim (elosulfase alfa)	(Also see "FDA Takes Long, Skeptical View Of Vimizim’s Six-Minute Walk Endpoint" - Pink Sheet, 19 Nov, 2014.) (Also see "FDA Quietly Consults Patients To Understand Six-Minute Walk Significance" - Pink Sheet, 19 Nov, 2014.) (Also see "In Manufacturing, Absence Of Evidence Is Not Evidence Of Absence, FDA Tells BioMarin" - Pink Sheet, 19 Nov, 2014.) (Also see "FDA Awaits Data On Clinical Significance Of Vimizim Neutralizing Antibodies" - Pink Sheet, 19 Nov, 2014.) (Also see "Low Survival To Adulthood Key To Vimizim Pediatric Priority Voucher" - Pink Sheet, 19 Nov, 2014.)