Regulatory Focus™ > News Articles > Regulatory Reconnaissance (20 November 2013)

Regulatory Reconnaissance (20 November 2013)

Posted 20 November 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

In Focus: International

  • Roche's Kadcyla approved in the EU for advanced HER2-positive breast cancer (Pharma Letter-$) (Reuters) (Press)
  • EU seeks ways to make vaccines resistant to hot weather (EurActiv)
  • Ukraine plans overhaul of medical device regulatory system (Mass Device)
  • China Issues Draft Drug Contract Production Approval Requirements (PharmAsia-$)
  • Ranbaxy whistleblower Dinesh Thakur wants strong policy to unearth fraud (India Times)
  • IFPMA wants regulatory harmonisation in South America (In-Pharma)

US: Pharmaceuticals/Biotechnology

  • FDA committee recommends approval for BioMarin's Vimizim (Pharma Letter-$) (SCRIP-$) (Reuters) (BioCentury) (Fierce) (Pink Sheet-$) (Pharma Times) (Bloomberg)
  • Sequestration Remains Major Challenge to FDA's Mission (BioWorld) (BIO)
  • Track-and-Trace Law: Push Begins For 2015 Exchange Standards (Pink Sheet-$)
  • Two Drugs, Designed To Help Patients, Actually Hurt Them (The Street) (Fierce) (NYTimes)
  • Mylan recalls 480,000 bottles of blood pressure med (Fierce)
  • FDA In Its Own Words (PAM-$)
  • Medical Advances Get More Chances When Safety Issues Arise (PAM-$)
  • FDA Considers Toxicity Profiles As Meeting Unmet Need In Melanoma (PAM-$)
  • The Magnitude Matters: GSK Approvals Show How To Use PFS After Other Drugs Show Survival (PAM-$)
  • Working towards keeping stored platelets free of bacteria (FDA)
  • J&J Unit Hit With Suit Over Rheumatoid Arthritis Drug (Law 360-$)
  • USP Expands Recall to Include More OxyElite Pro Products (FDA)
  • FDA Clears Path for Generic Banzel (FDA)
  • Daiichi blood thinner safer, as effective as warfarin: study (Reuters) (Reuters) (BioCentury) (Pharma Times)
  • Gene analysis fails to help predict best warfarin dose (Reuters)
  • Amgen cholesterol drug appears safe, cut LDL 52 percent at 1 year: study (Reuters)

US: Pharmaceuticals and Biotechnology: General

  • PCORI To Dole Out $1B for Comparative Effectiveness Research (CA Healthline) (BioCentury)
  • Drug sales to hit lowest growth rate in decades (Modern Healthcare)
  • Which Biosimilars Will Payers Cover? Manufacturer Pedigree Will Be A Factor (Pink Sheet-$)
  • Retail Generic Drug Costs Go Up, Up, and Away (Drug Channels)
  • Missouri to execute inmate using drugs from secret supplier (Guardian)

US: Medical Devices

  • FDA Approves New Gene-Sequencing Devices (WSJ-$) (FDA) (NEJM) (BioCentury)
  • J&J to Pay at Least $2.5 Billion, Health Costs in Hip Settlement (WSJ-$) (Law 360-$) (NYTimes) (Reuters) (Modern Healthcare) (Pharmalot) (Fierce) (Mass Device)
  • 'Software is Not a Medical Device': House Holds Hearing on SOFTWARE Act (MDDI) (Shuren Testimony)
  • FDA and Vivione Enter into a New Three-Year Cooperative Research and Development Agreement Aimed at Expanding the Capability of the RAPID-B Diagnostic System (Press)
  • Warning letters, product launches hit Medtronic Q2 margin (Clinica-$)
  • Boston Scientific Receives FDA Clearance And CE Mark Approval For Direxion™ Torqueable Microcatheter (Press)
  • FDA Clears New Plasma Protocol Software for Fenwal Alyx System (Press)
  • AtriCure wins FDA nod for anti-stroke device trial (Mass Device)
  • Honda launches 1st large U.S. study of its walk-assisting exoskeleton (Mass Device)

US: Dietary Supplements

  • FDA: Botanical Compounds May Not be Legal Dietary Ingredients (NPI)
  • FDA Extends FSVP Comment Period (FDA)
  • DOJ Prevails in Fraud Case against Dietary Supplement Businessman (NPI)

US: Assorted And Government

  • New Warning Letters Posted (FDA)
  • US Pushing Hatch-Waxman Protections In TPP (Law 360-$)
  • Statement by U.S. Trade Representative Froman on the Conclusion of Round Two of T-TIP Negotiations (USTR)

Upcoming Meetings And Events

  • 19 November 2013: Endocrinologic and Metabolic Drugs Advisory Committee Meeting (FDA)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • 9 December 2013: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (FDA)
  • 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Roche's Kadcyla approved in the EU for advanced HER2-positive breast cancer (Pharma Letter-$) (Reuters) (Press)
  • EU seeks ways to make vaccines resistant to hot weather (EurActiv)
  • Ukraine plans overhaul of medical device regulatory system (Mass Device)
  • European Medicines Agency's Committee on Herbal Medicinal Products elects new chair and vice-chair (EMA)
  • EC Out with new Fact Sheet on Dental Amalgam (EC)
  • Estimating the potential impact of 3Rs science (NC3Rs)

Asia

  • China Issues Draft Drug Contract Production Approval Requirements (PharmAsia-$)
  • Ranbaxy whistleblower Dinesh Thakur wants strong policy to unearth fraud (India Times)
  • Indian flip-flop scars pioglitazone sales as competitors pounce (SCRIP-$)
  • Indian Drug regulator set to conduct routine inspection of Chinese suppliers (Business Standard)
  • Qiagen TB test gains Chinese regulatory approval (Fierce)

Other International

  • IFPMA wants regulatory harmonisation in South America (In-Pharma)

General Regulatory And Interesting Articles

  • How Basic Scientists Help the Pharmaceutical Industry Market Drugs (PLoS) (MNT)
  • What Does Cancer Smell Like? (NYTimes)
  • One certainty: Drug spending will hit $1 trillion in 2014 (Fierce)

Regulatory Reconnaissance #206 - 20 November 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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


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