Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Shire's Potential Blockbuster Xiidra for Dry Eye Disease; Sage Postpa

Regulatory Recon: FDA Approves Shire's Potential Blockbuster Xiidra for Dry Eye Disease Sage Postpartum Depression Drug Succeeds in Phase II Trial (12 July 2016)

Posted 12 July 2016 | By Michael Mezher 

Regulatory Recon: FDA Approves Shire's Potential Blockbuster Xiidra for Dry Eye Disease Sage Postpartum Depression Drug Succeeds in Phase II Trial (12 July 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • FDA Commissioner Calls for Better National System to Track Device Safety (Focus) (Modern Healthcare) (JAMA)
  • FDA Approves Shire's Xiidra for Dry Eye Disease (FDA) (Reuters) (Bloomberg)
  • Obama renews call for public health insurance option (Reuters) (NYTimes) (JAMA, Editorial 1, 2)
  • Sage Therapeutics Drug Eliminates Postpartum Depression in Mid-Stage Trial (The Street) (Reuters) (Press) (In the Pipeline)
  • Federal Circuit: Use of a CMO Prior to Filing Drug Patents Does Not Invalidate the Patents (Focus)
  • Amgen Opens Trial In Fight Over Neulasta Generic (Law360-$)
  • Congress Shouldn't Pass The 21st Century Cures Act In A Summer Rush (Health Affairs Blog)
  • A Fair Plan For Fairer Drug Prices (Health Affairs Blog)
  • Reality Check On The 'Noninferior' Abbott Bioresorbable Stent (CardioBrief)
  • For Lab Industry, FDA Draft Guidance on NGS Testing Inseparable From Larger LDT Debate (GenomeWeb)
  • Infection experts warn of more U.S. superbug cases in coming months (Reuters)
  • FDA approves Insightec's Exablate Neuro focused ultrasound device (MassDevice) (FDA) (Press)
  • Feuerstein: CytRx Sarcoma Drug Flops Late-Stage Clinical Trial (The Street) (BioCentury)

In Focus: International

  • NICE draft guidance backs UCB's Cimzia for severe RA (PharmaLetter-$)
  • SMC accepts five new medicines for use in NHS Scotland (EPR)
  • AstraZeneca mulling a $10-billion bid for Medivation – report (Pharmafile)
  • Mozambique certified polio free: health ministry (Reutes)
  • Health Canada approves AstraZeneca's Tagrisso (PharmaLetter-$)
  • Action needed as decline in HIV cases stalls, AIDS agency says (Reuters)
  • EMA: Implementation of the ISO IDMP standards (EMA)
  • Insight - False hope? China's military hospitals offer illegal experimental cures (Reuters)

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US: Pharmaceuticals & Biotechnology

  • Data backs broader use of Pfizer's Sutent in kidney cancer (PharmaTimes)
  • More or Less – A Look at FDA Press Releases at Half Year (Eye on FDA)
  • Juno submits 'Complete Response' to FDA following 3 deaths in ph II trial (OutsourcingPharma)
  • International "Big Data" Study Offers Fresh Insights into T2D (NIH)
  • KaloBios CEO on its post-Shkreli 'restart' (OutsourcingPharma)
  • Giving Patients Some Choice May Boost Drugs' Effectiveness (WSJ-$)
  • Common medications can make heart failure worse (Reuters)
  • Amicus Therapeutics Appoints Former FDA Division Deputy Director Andrew Mulberg as Vice President, Regulatory Strategy (Press)
  • Risk Management In Clinical Research (Imarc)
  • Merck Cuts Back – Again (In the Pipeline)
  • Cancer hospital advertising triples since 2005 (Reuters)
  • Repatha Approved for Single Monthly Injection (CardioBrief)
  • Sucampo 0-2 as it ditches cobiprostone studies after second failure (Fierce)
  • Fundamental Action Mechanisms of Phage Therapy are Revealed (ICT)
  • Merger of Evelo and Epiva Biosciences will create leading immuno-microbiome platform company (PharmaLetter-$)
  • ​Mass. filmmaker plans feature film about early days of Vertex Pharmaceuticals (Boston Biz Journal)
  • With Bugs As Drugs, Evelo CEO Plans Immune, Cancer Trials in 2017 (Xconomy)
  • Braeburn Pharmaceuticals to Conduct First Series of Probuphine (buprenorphine) Implant Trainings in Tampa on July 15, 16 and 17 for Qualified Healthcare Providers (Press)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Coherus BioSciences says Neulasta biosimilar shows positive topline results; shares jump (Pharmafile) (BioCentury)
  • Mazindol Granted Orphan Drug Designation in the US & Europe for Treatment of Narcolepsy (Press)
  • InVivo Therapeutics Announces Update on the INSPIRE Study and FDA Approval of Expansion of the Study to 20 Evaluable Patients (Press)

US: Medical Devices

  • Medtech venture funding collapses (EP Vantage)
  • Final FDA Guidance Issued on Medical Device Electromagnetic Compatibility (Emergo)
  • Theranos' Outlook May Be Grim, But Its Technology Still Has Merit (The Street)
  • Ethicon's HARMONIC HD 1000i Shears Cleared by FDA (Medgadget)
  • Getinge wins expanded FDA clearance for Sterizone VP4 (MassDevice)
  • FDA Clears Expanded Indications for Medtronic NuVent(TM) EM Sinus Dilation System with Image Guidance (Press)
  • Alafair Biosciences Receives FDA 510(k) Clearance for VersaWrap Tendon Protector (Press)
  • HEPATIQ Receives Additional FDA Clearance (Press)

US: Assorted & Government

  • Pharma deals under a microscope at FTC (PharmaLetter-$)
  • It's Just Too Much (Drug and Device Law)
  • Information Innovators Inc. Awarded $100 Million Web Content Management System Support Services (WCMSSS) Contract with the FDA (Press)

Upcoming Meetings & Events


  • Impact of Brexit on EU Medical Devices Regulation and Structures (Covington)
  • Perplexit (BioCentury)
  • How the Brexit Shock Can Inspire More Effective Solutions to Medicine's Adherence Problem (MDDI)
  • Swiss biotech company tests anti-ageing promise of pomegranates (Reuters)
  • Volunteers wanted to help determine the future of pharmacovigilance (MHRA)
  • Innovation case study: Queen's University Belfast (MHRA)
  • Biocad sees arthritis drug BCD-121 as potential game-changer (PharmaLetter-$)
  • Tissue Regenix CE Mark expected 6 months early (MassDevice)
  • NHS groups ready to roll out PAM (PharmaTImes)
  • SMC gives green light for BMS' Opdivo (PMLive)


  • China launches beginning of the end of drug markups at state-run hospitals (Fierce) (Press)
  • Almost 40 Indonesian medical facilities procured fake vaccines (Securing Industry)



  • Romania reports first case of Zika virus (Reuters)
  • NIH's Fauci On Combating Zika: 'You Have To Have The Resources To Act Quickly' (KHN)
  • Austrian biotech plans Zika vaccine clinical trials in 12 months (Reuters)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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