Regulatory Focus™ > News Articles > Regulatory Reconnaissance (23 May 2013)

Regulatory Reconnaissance (23 May 2013)

Posted 23 May 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

In Focus: International

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  • FDA panel backs limited rollout of Merck's sleep drug suvorexant (Fierce) (The Pink Sheet) (PMLive) (SCRIP Intelligence) (The Pharma Letter) (Pharma Times) (Law 360) (BioCentury) (WSJ) (Reuters) (AP) (Merck) (Med Page Today) (FDA News)
  • Steven Nissen: FDA Trying to Absolve Itself of Avandia Responsibility in Upcoming Meeting (Forbes)
  • Celgene Announces U.S. FDA Grants Priority Review for ABRAXANE® sNDA in Advanced Pancreatic Cancer (Boardvote)
  • Salix to file budesonide foam NDA on Phase III success (SCRIP Intelligence)
  • FDA to Review the REMS of Prometheus Labs' Lotronex (FDA) (BioCentury)
  • Will Ranbaxy Labs Be Excluded From Medicare And Medicaid? (Forbes)
  • Pfizer Guards Viagra Sales, Moves Against Tainted Supplements (The Pink Sheet)
  • FDA ANDA Approval for Hikma Pharma's Sumatriptan Succinate (#078298) (FDA)
  • GSK, BARDA antibiotic pact: 1st biothreat 'portfolio' response (SCRIP Intelligence)
  • FDA approves Sandoz hypertension drug (DSN)
  • Perosphere Receives FDA IND Clearance to Initiate Clinical Investigations of the Safety and Efficacy of PER977 to Reverse the Activity of Anticoagulation Therapies including Factor Xa- and IIa-Inhibitors (Business Wire)
Medical Devices
  • FDA's Ortho Panel supports down-classification of pedicle screw spinal systems (Mass Device)
  • DePuy Pinnacle lawsuits: Judge orders J&J's DePuy Orthopaedics to produce compliance reports (Mass Device)
  • Medicare Nixes Coverage For New Cancer Tests (Forbes)
  • General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting (FDA)
  • Varian Medical Systems Receives FDA 510(k) Clearance of its Nexus DRF Digital X-Ray Imaging System (PR Newswire)
  • FDA clears Nephosity iPad app for diagnostic imaging (Mobi Health News)
  • One Year Data from St. Jude Medical Study Demonstrates Safe, Rapid and Sustained Blood Pressure Reduction with EnligHTN Renal Denervation Technology (Business Wire)
Assorted and Government
Upcoming Meetings and Events
  • 21 May 2013: First-Ever Patient Network Town Hall (FDA)
  • 21-22 May 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee (FDA)
  • 22 May 2013: Markup of Senate Compounding, Track and Trace Legislation (HELP)
  • 22 May 2013: Congressional Hearing: "Food and Drug Safety, Public Health, and the Environment in China" (CECC)
  • 22 May 2013: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (FDA)
  • 22 May 2013: CVM's New Animal Drugs for Use in Feeds Workshop (FDA)
  • 23 May 2013: Energy and Commerce Committee Hearting, "Examining Drug Compounding" (E&C) (Janet Woodcock to Testify)
  • 23 May 2013: Reagan-Udall Foundation Annual Open Public Meeting (RU)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)


  • Final Assault: Daiichi Sankyo Threatens Legal Action Against Former Ranbaxy Shareholders For Concealing Information (PharmAsia News) (Medical Daily) (India Times)
  • Ranbaxy makes manufacturing strides, many dictated by consent decree (Fierce) (India Times) (Ranbaxy) (SCRIP Intelligence) (The Pharma Letter) (Pharma Times)
  • Canada to Permit Gay Males to Donate Blood, With Strong Exceptions (Health Canada)
  • Pfizer Takes Issue with European Commission's Plans to Regulate ATMPs (In-Pharma Technologist)
  • EU28: Science, Medicines, Health A regulatory system fit for the future (EMA)
  • Swedish registry questions superiority of bivalirudin over heparin in patients undergoing PCI for NSTE-ACS (The Pharma Letter)
  • CFDA issues The Second Drug Quality Announcement of 2013 (CFDA)
  • Astellas Receives Marketing Authorization for Vesomni from the Netherlands Medicines Evaluation Board (Astellas)
  • Italian Parliament Orders Clinical Trial of Controversial Stem Cell Treatment (Science Insider)
  • Bayer Files Application For First Chronic Thromboembolic Pulmonary Hypertension Drug In Japan (PharmAsia News)
  • 'Conflict minerals' the latest trap for medtech (Clinica)
  • ATMP Regulation gets bad rap (Clinica)

General Regulatory and Interesting Articles

  • Immunotherapy: The biggest drug class in history? (Reuters)
  • Pfizer takes its shot at a vaccine for evasive superbug (Reuters)
  • Grapefruit-Derived Nanovectors Provide A Secret Weapon In Medical Drug Delivery (MNT) (BioSpectrum)

Regulatory Reconnaissance #73 - 23 May 2013

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.

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