Regulatory Reconnaissance: Big Cardiology Results Upend Regulatory Landscape (31 March 2014)

Posted 31 March 2014 | By Alexander Gaffney, RAC 

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In Focus: US

In Focus: International

  • Bayer gets EU nod to widen use of lung drug Adempas (Reuters) (Press)
  • It's official: safety feature deadline in EU will be 2018 (Securing Pharma)
  • GSK pulls bid to extend use of kidney drug to ovarian cancer (Reuters) (Press)
  • China Plans Bureau Merging Drug Regulation With Enforcement Power (PharmAsia-$)
  • China FDA admits approval limits, but solutions sketchy (SCRIP-$)
  • INN debate: IFPMA pushes for biosimilar label changes (BioPharma Reporter)

US: Pharmaceuticals/Biotechnology

  • FDA Biogen's Aprolix, coagulation Factor IX concentrate, for patients with Hemophilia B (FDA) (MedPage Today) (Reuters) (Press) (BioCentury) (AP) (Fierce)
  • FDA approves Janssen's Topamax for migraine prevention in adolescents (FDA) (Pharma Times)
  • Expanded Access INDs: FDA's Near-Perfect Approval Rate Underscores Problems, Advocates Say (Pink Sheet-$)
  • U.S. FDA moves to offset shortage of common saline solution (Reuters)
  • The Sound Of Silence: FDA Ponders How To Label When No Subgroup Difference Found (Pink Sheet-$)
  • Takahashi: Look Out for These Data Integrity Issues (Gold Sheet-$)
  • Cahilly: Focus on India Masks the Real Data Integrity Problems (Gold Sheet-$)
  • FDA Approves OTC Nexium 24HR (Press) (DSN)
  • Fibromyalgia Patient Meeting Shines Light On Lesser Known Symptoms (Pink Sheet-$)
  • Colon Cancer Community Weighs "Master Protocol" Approach (Pink Sheet-$)
  • How do you solve a problem like Afrezza: An FDA dilemma (SCRIP-$) (BioCentury) (Fierce) (Pink Sheet-$)
  • FDA Wants Your Perspective on Clinical Trial Demographic Data (FDA)
  • FDA Compounder Inspections: States Taking Early Leave (Pink Sheet-$)
  • Compounding: FDA Refining Post-Inspection Hand-off To States (Pink Sheet-$)
  • J&J Suggests Targeting OTC Monograph With Public-Private Initiative (Tan Sheet-$)
  • Cubist antibiotic tedizolid fares well in FDA review (SCRIP-$)
  • FDA allows Curis to resume testing cancer drug (Reuters) (Xconomy)
  • Lariam: The Drug That Can Make You Kill (AlterNet)
  • DSCSA: Transaction Statement (RxTrace)
  • FDA further extends expiration dates of DuoDote auto-injector lots (FDA)

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

US: Pharmaceuticals and Biotechnology: General

  • Physician Payments Sunshine Act: Phase I Aggregate Report Due Today, Instructions for filing (Policy and Medicine)
  • U.S. wants at least $1 billion from drugmakers who delay generics (Reuters)
  • What's The Definition of "Selling"? GSK, Mylan And Apotex Relitigate Paxil Generic Settlements (Pink Sheet-$)
  • NIH Considers Granting License to Experimental Rabies/Ebola/Marburg Virus Vaccine (NIH)
  • Calif. Bill For Statewide Drug Disposal Program Advances (Law 360-$)
  • Gilead says has discounted hepatitis C drug for some health plans (Reuters)
  • Specialty Drug Prices and Utilization After Loss of U.S. Patent Exclusivity, 2001-2007 (NBER)

US: Medical Devices

  • FDA Draft Guidances Drag Out (MDDI)
  • Why a Massive Spike in Recalls is a Good Thing-Sort Of (MDDI)
  • Class 1 Recall for Drager Power Supply Unit (FDA)
  • Medtronic Makes Surprise Turn on Blood-Pressure Device (WSJ-$) (CardioBrief) (Fierce)
  • Study Finds Medtronic Valve Superior to Surgery (WSJ-$) (Bloomberg) (Mass Device)
  • Renal denervation fails to lower blood pressure in critical test (Reuters) (NEJM) (CardioBrief) (Mass Device) (Gray Sheet-$) (NEJM)
  • Abbott Announces FDA Approval of Its Supera Stent to Treat People with Peripheral Artery Disease (Press) (Mass Device)
  • Edwards heart valve system tops Medtronic version in small study (Reuters) (CardioBrief) (Bloomberg)
  • New Long-term Data Demonstrate Patients with Mild Heart Failure Sustained Lower Mortality Rates After Receiving Boston Scientific CRT Defibrillators (Press)
  • Arthrosurface touts FDA win for ToeMotion Total Toe tech (Mass Device)

US: Assorted And Government

  • SCRIP's US Capitol Capsule (SCRIP-$)
  • Rep. Mike Rogers, House E&C Member on Health Subcommittee, to Retire (WaPo)


  • Bayer gets EU nod to widen use of lung drug Adempas (Reuters) (Press)
  • It's official: safety feature deadline in EU will be 2018 (Securing Pharma)
  • Guideline on the clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia  (EMA)
  • GSK pulls bid to extend use of kidney drug to ovarian cancer (Reuters) (Press)
  • UK public urged to comment on Medical Innovation Bill (Pharma Times)
  • EC approves Latuda for schizophrenia (BioCentury)
  • Sorin Group's Perceval  Sutureless Aortic Valve Receives CE Mark Approval for Extended Age Indication (Press)
  • Biotronik wins CE mark for new pacers that instantly broadcast patient problems to doctors (Fierce)
  • Rationing of chemotherapy in Europe a possibility if shortages problem not resolved, hospital pharmacist congress hears (PJO)
  • CytRx Receives Orphan Medicinal Product Designation from the European Commission for Aldoxorubicin in Soft Tissue Sarcoma (Press)


  • Thakur: Data Integrity Requires Stronger Local Enforcement (Gold Sheet-$)
  • Technical Committee denies permission to 19 clinical trial proposals recommended by NDACs (PharmaBiz)
  • DCGI gives more time on relabelling requirements of imported drugs (PharmaBiz)
  • Commerce Ministry may postpone implementation of barcoding on primary level packaging post review (PharmaBiz)

Japan & China

  • China Plans Bureau Merging Drug Regulation With Enforcement Power (PharmAsia-$)
  • China FDA admits approval limits, but solutions sketchy (SCRIP-$)
  • Takeda Pharma says Japan approves two flu vaccine drugs (Reuters)
  • Tokyo Proposes Area Industrial Zones To Trim Generic, Other Regulations (PharmAsia-$)

Other International

General Regulatory And Interesting Articles

  • Suspended Animation? Docs Try Stopping Clock to Save Lives (NBC)
  • Investors see something good brewing in a biotech's hops-derived type 2 diabetes drug (MedCity News)
  • Toward a Pill That Helps Us Learn as Fast as Kids (The Atlantic)

Regulatory Reconnaissance #287 - 31 March 2014

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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