Regulatory Recon: FDA Panel Supports New Use for Brintellix, New Studies Confirm Main Results of Califf Led Xarelto Trial (4 February 2016)

Posted 04 February 2016 | By Michael Mezher 

Regulatory Recon: FDA Panel Supports New Use for Brintellix, New Studies Confirm Main Results of Califf Led Xarelto Trial (4 February 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

In Focus: International

  • 'Make in India': Indian Customs Duties Raised in Bid to Promote Local Med-Device Manufacturing (Thomson Reuters)
  • Cancer Treatment in India Ranks High, Access a Challenge (Economic Times)
  • UK keeps funding for clinical research sites flat through to 2022 (FierceBiotech) (UK DoH)
  • Interview: PDCO's Dirk Mentzer On How To Succeed With Pediatric Research (SCRIP-$)

US: Pharmaceuticals and Biotechnology

  • Woodcock: Drug Safety Surveillance System Ready for Full Operation (Focus)
  • Can 'Moon Shot' Lift FDA Out Of Its Silos? (SCRIP-$) (Focus)
  • FDA's Orange Book Preface Gets a Facelift: What's New? (FDA Law Blog)
  • FDA Puts Heat Biologics Bladder Cancer Trial on Partial Hold (Xconomy)
  • Aspirin May Protect Against Staph Blood Infections (NYTimes)
  • How Payments Technology Can Help Clinical Research Sites (Geeks Talk Clinical)
  • Vendors must collaborate to develop cell therapy production automation, experts (BioPharma-Reporter)

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

  • FDA Approves Merck's Single-Dose EMEND (fosaprepitant dimeglumine) for Injection, in Combination with Other Antiemetic Agents, for the Prevention of Delayed Nausea and Vomiting in Adults Receiving Moderately Emetogenic Chemotherapy (Press)
  • FDA Grants TapImmune Fast Track Designation For Lead Vaccine In Ovarian Cancer (RTTNews)

US: Medical Devices

  • Draft Guidance: List of Highest Priority Devices for Human Factors Review; Draft Guidance (Focus) (FDA)
  • Device Firms Get Extra Time To Remove Drug Codes From Product Labels (Clinica-$)
  • David Boies's Dual Roles at Theranos Set Up Conflict (NYTimes)
  • Lab in a suitcase for real-time Ebola surveillance (MNT)
  • Brain scans to catch depression before it starts (Reuters)
  • To Respond to a Disease Outbreak, Bring in the Portable Genome Sequencers (IEEE Spectrum)
  • VA to launch trial of ReWalk's exoskeleton system (MassDevice)
  • Active Implants launches another NUsurface meniscal implant trial site (MassDevice)
  • Shkreli May Not Talk Drug Pricing Before Congress But His Memos Say Plenty (Forbes)
  • Class 1 Device Recall Draeger Emergency Transport Ventilator (FDA I, II)

US: Assorted and Government

  • Valeant's Interim CEO to Seek Change to Rules for Prescription Assistance (WSJ-$)
  • Pharma M&A: Agile shouldn't mean ad hoc (McKinsey)
  • Why Senator Markey's Message Hurts Children (Harvard Bill of Health)
  • More states enter drug transparency fray (BioCentury)
  • Agilent Sues Start-Up Twist Bioscience Over Alleged Trade Secrets Theft (WSJ-$)
  • Sens. Push Pay-For-Delay Ban To Slow Drug Spending (Law360-$)
  • Biogen Escapes 1 Of 4 FCA Suits Over Alleged Kickbacks (Law360-$)
  • House GOP fails to knock down Obama veto of anti-Obamacare bill (MassDevice)
  • Texas Woman Sentenced to Prison in Prescription Drug Smuggling Ring (DoJ)
  • HHS: Privacy laws don't bar fraud victims from seeing thieves' medical data (FierceHealthIT)

Upcoming Meetings and Events                                                                                                                                              


  • AstraZeneca says European Commission green-lights marketing for its Tagrisso to treat lung cancer (PharmaLetter-$)
  • Cell and gene therapy firms talk manufacturing in Belgium (BioPharma-Reporter)
  • Ignyta Announces Initiation of Phase 1/1b Clinical Trial of Taladegib in Combination with Paclitaxel by Cancer Research UK (Press)
  • The Latest on Fighting Tuberculosis in Russia (LillyPad)
  • Arch Biopartners Submits Orphan Drug Application For AB569 To European Medicines Agency (Press)


  • Elixir Medical Corp Receives Indian Patent For Drug-Device Combination (24 Insight)


  • Canada's Price Negotiators On Where Firms Go Wrong (SCRIP-$)
  • Canadian researchers expose security risk in wearable fitness trackers (MassDevice)

Zika Virus

  • Birth Defects in Brazil May Be Over-Reported Amid Zika Fears (NYTimes)
  • Brazil urges Latin America to coordinate fight against Zika (Reuters)
  • Florida governor declares health emergency in four counties over Zika (Reuters)
  • Surge of Zika Virus Has Brazilians Re-examining Strict Abortion Laws (NYTimes)
  • Zika Outbreak Means It Is Now Time To Cancel Rio Olympics (Forbes)
  • Venezuela medical shortages put Zika-linked Guillain-Barre cases at risk (Reuters)
  • Brazil confirms Zika infection from a blood transfusion (Reuters)
  • Zika Virus Fears Could Cost These Countries $63.9 Billion In Lost Tourism (Forbes)
  • Pfizer, J&J, Merck evaluating technologies for Zika vaccine (Reuters) (SCRIP-$)
  • CDC adds 2 destinations to interim travel guidance related to Zika virus (CDC)
  • Top airlines offer to re-assign crew from Zika-hit routes (Reuters)
  • Zika virus a trending topic on social media platforms (Reuters)
  • Zika alarm rises after U.S. sex link, more Brazil birth defects (Reuters)
  • 'Zika isn't important': The infuriating case of a scientist's search for funding. (Washington Post)

Other International

General Health and Other Interesting Articles

  • Sleep Problems Tied to Type 2 Diabetes (NYTimes)
  • In New Anti-Aging Strategy, Clearing Out Old Cells Increases Life Span of Mice by 25 Percent (MIT Technology Review)
  • No Alcohol for Sexually Active Women Without Birth Control, C.D.C. Recommends (NYTimes)
  • Reproductive technology linked to birth defects, childhood leukemia (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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