Regulatory Reconnaissance (28 June 2013)

Posted 28 June 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

In Focus: International

  • European Medicines Agency recommends Approval of Fourth Advanced Therapy in Europe (EMA)
  • Genzyme Receives Positive CHMP Opinion for Lemtrada (alemtuzumab) in Europe (Genzyme)
  • Regulatory Update - GSK receives positive CHMP opinions for Tafinlar (dabrafenib) and Tyverb (lapatinib) (GSK)
  • EC Proposes "Fairer" Mixed Fee Systemt Cover EMA's Pharmacovigilance Costs (SCRIP)
  • Raptor's Rare Disease Drug Recommended in Europe (Reuters)
  • EMA Acts to Impose Some Sort of Order on Secondary Data Analysis (SCRIP)
  • Indian Drug Companies May Have to Disclose Actions Taken by International Drug Regulators (India Times)
  • CFDA Aims to Fully Implement New GSP Standards by 2016 (PharmAsia) (CFDA)
  • CFDA Delegates Some of its Medical Device Inspection Duties (CFDA)

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  • US FDA OK's Baxter's recombinant factor IX Rixubis (FDA) (Baxter) (SCRIP) (MedPage Today) (Reuters) (BioCentury) (MNT) (Pharma Times) (PMLive)
  • CDER's Sequestration Strategy Aided By 400 Missing FTEs (Pink Sheet)
  • GlaxoSmithKline's drisapersen to receive FDA Breakthrough Therapy designation for potential treatment of patients with Duchenne Muscular Dystrophy (GSK) (Fierce) (SCRIP) (Pharma Times) (PMLive)
  • FDA expands Novartis Exelon Patch use for severe Alzheimer's (SCRIP) (Novartis)
  • Alexion's Soliris (eculizumab) Receives Orphan Drug Designation for the Treatment of Neuromyelitis Optica (Alexion)
  • Why the Supreme Court is wrong on generic drugs (Fortune)
  • Genentech eyes 'breakthrough' cancer immunotherapies in pact with U.K. biotech (Fierce)
  • FDA shuts down over 1,600 online pharmacies (FDA) (CBS) (MNT) (PMLive)
  • FDA Approves ANDA's for Accord Healthcare's Topetecan Hydrochloride (#202351) and Sagent Pharmaceuticals' Levetiracetam (#091627) (FDA)
  • FDA Gives Tentative Approval to AUrobindo's NDA for Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate (#022343) (FDA)
  • Drug Shortages Remain in 2013 (Policy and Medicine)
  • FDA Seeks to Evaluate Drug-Induced Effects on Cardiac Ion Channels (FDA)
  • Novel Heart Failure Drug From Novartis Gains 'Breakthrough Therapy' Designation From FDA (Forbes)
  • Forest to file hypertension combo NDA on Phase III success (SCRIP)
  • Peregrine plunges on bad bavituximab data (SCRIP) (MarketWatch)
  • Resverlogix stock craters on failure of cardio drug trial (Fierce) (Bloomberg)
  • Study Finds No Vaccine Link to Guillain-Barré (NYTimes)
  • Merck Off The Hook In Fosamax Fracture Suit, Judge Rules (Law 360)
  • Drug Shortage Situation for Vitamin K1 Ends (FDA)
Pharmaceuticals: General
  • Maine Residents Can Now Import Drugs From Foreign Pharmacies (Pharmalot) (NPR)
  • G'Bye Y'All! Novo Nordisk Suspends Paula Deen As A Spokesperson (Pharmalot) (NYTimes)
  • Painkillers, Profits and Politics (CRP)
  • Creating A For Unused Medicine (Fast Coexist)
  • Quality Agreement Dictates Price in Manufacturing Relationships (Outsourcing Pharma)
  • Global 2000: World's Biggest Drug Companies 2013 (Forbes)
  • SAS And GSK Pull Big Pharma Into Big Data Collaboration (Forbes)
  • RxRights Launches Petition Opposing New Pharmacy Domain (RxRights)
  • Fish-Oil Pills Lure Drugmakers Even as Benefits Unproven (Bloomberg)
Medical Devices
  • Reactions to Myriad, two weeks later (Harvard BOH) (BioFlash)
  • U.S. Businessman Leaves Beijing Factory After Labor Standoff (Bloomberg)
  • Medtronic 'Artificial Pancreas' Success Tainted by Infusion Pump Recall (Eye for Pharma)
  • FDA Safety Notification: Mammography Problems at San Sebastian X-Ray in San Sebastian, Puerto Rico (FDA)
  • Respironics California, Inc. Recall of V60 Ventilator Designated Class I by FDA (FDA)
  • FDA-cleared iPhone app measures balance as a part of concussion screening on the sidelines (MedGadget)
  • Hacking: Penetration tests reveal that even blunt tools can crack medical devices (Mass Device)
Assorted And Government
  • Bartlett's Benefits Will Extend Beyond Generic-Drug Makers (Law 360)
  • Senate votes to confirm Obama's regulatory czar (The Hill)
  • FDA Appropriations Bill Introduced in the Senate (Congress)
  • EU, US May Get Same Results In Pay-For-Delay Enforcement (Law 360)
  • Summary Of FDA Advertising and Promotion Enforcement Activities In May 2013 (Covington)
  • Abortion-Drug Case on High Court's Docket for Now (NYTimes) (WSJ)
  • FDA's MedWatch Safety Alerts: May 2013 (FDA)
  • Bioethics and Medical Experts Join Chorus of Criticism of Inadequate Consent Procedures in NIH Baby Study (Public Citizen)
  • H.R.2477 -- Planning Actively for Cancer Treatment (PACT) Act of 2013 (Congress)
  • Federal Trade Commissioner Warns Americans Need More Control Over Their Personal Health Data (ThinkProgress)
Upcoming Meetings And Events
  • 24 June 2013: Science Board Meeting (FDA)
  • 25 June 2013: Meeting Of The National Biodefense Science Board (Dhhs)
  • 25-26 June 2013: Standardizing And Evaluating Risk Evaluation And Mitigation Strategies (FDA)
  • 26 June 2013: General And Plastic Surgery Devices Panel Of The Medical Devices Meeting (FDA) (Materials)
  • 27 July 2013: Gastroenterology And Urology Devices Panel Of The Medical Devices Advisory Committee Meeting (FDA) (Materials)
  • 27 June 2013: Mobile Medical App Entrepreneurs: Changing The Face Of Health Care (House)
  • 27 June 2013: A Tangle Of Trade Barriers: How India's Industrial Policy Is Hurting U.S. Companies (House)
  • 29 June 2013: Clinical Development Programs For Opioid Conversion (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)


  • European Medicines Agency recommends approval of fourth advanced therapy in Europe (EMA)
  • Genzyme Receives Positive CHMP Opinion for Lemtrada (alemtuzumab) in Europe (Genzyme)
  • Regulatory Update - GSK receives positive CHMP opinions for Tafinlar (dabrafenib) and Tyverb (lapatinib) (GSK)
  • EC proposes "fairer" mixed fee system to cover EMA's pharmacovigilance costs (SCRIP)
  • Raptor's rare disease drug recommended in Europe (Reuters)
  • Vivus desperately seeks partner following EU avanafil approval (SCRIP)
  • EMA acts to impose some sort of order on secondary data analysis (SCRIP)
  • Strange Bedfellows No More: EMA Moves Closer to Payers (PharmExec)
  • MHRA Pioneer Business Engagement Assessments (MHRA)
  • French warnings lead to sharp fall in sales of newer combined OCs (SCRIP)
  • Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2013 to 31 May 2013 (EU)


  • Indian drug companies may have to disclose actions taken by international drug regulators (India Times)
  • CFDA Aims To Fully Implement New GSP Standards By 2016 (PharmAsia) (CFDA)
  • CFDA Delegates Some of its Medical Device Inspection Duties (CFDA)
  • Sanofi wins diabetes drug approval in Japan (Reuters) (Pharma Letter)
  • Approval in Japan for Bisono Tape, Transdermal Patch of β1Blocker for The First Time in The World (Astellas)
  • Two New Formulations of Otsuka's E Keppra Developed Dry Syrup Obtains Approval (Otsuka)
  • India's Vaccine shortage opens up window for corruption (Times of India)
  • Korea's Fair Trade Commission Fines Ildong Pharmaceutical For Rebates (PharmAsia)

Other International

  • International sweep gets $41 million in counterfeit drugs (Fierce)
  • Canada Considers Paying Plasma Donors (Health Canada) (2)
  • Support for good regulatory practices in APEC will foster growth: experts (APEC)

General Regulatory And Interesting Articles

  • How dead cattle led to the discovery of warfarin (PMLive)

Regulatory Reconnaissance #98 - 28 June 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

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