Regulatory Focus™ > News Articles > Regulatory Reconnaissance (9 December 2013)

Regulatory Reconnaissance (9 December 2013)

Posted 09 December 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

  • EU Health IT Sector On Alert After Parliament Adds "Prediction" To Medical Device Definition (Gray Sheet-$)
  • EU Council to meet on Tuesday on MDR and IVDR proposals (Medical Devices Legal)
  • API imports in the EU: gauging the FMD's impact (Pharmafile)
  • Going separate ways: Japan gives go-ahead to medtech-specific regulatory system (Clinica-$)
  • China 2014 Regulatory Outlook: Expect Greater Enforcement As CFDA Rolls Out New Regs (PharmAsia-$)
  • India Drug Makers See Big Three-Year Growth In Legal Expenses (PharmAsia-$)

US: Pharmaceuticals/Biotechnology

  • FDA approval for Gilead's hepatitis C drug Sovaldi (Sofosbuvir) (FDA) (Pharma Letter-$) (WSJ-$) (Press) (SCRIP-$) (AP) (The Street) (Pharma Times) (Pharmafile) (Fierce) (Pink Sheet-$) (NYTimes) (BioCentury) (Xconomy) (Reuters)
  • US FDA approves first drug treatment for Peyronie's disease (FDA) (Pharma Letter-$) (Press) (PMLive) (Pharma Times) (Reuters) (Pink Sheet-$) (Fierce) (NYTimes) (BioCentury)
  • If At First You Don't Succeed, Try Dispute Resolution (Pink Sheet-$)
  • FDA's Woodcock to Head Office of Pharmaceutical Quality; More Details Emerge (RPM First Take)
  • FDA Revives State Drug Compounding MOU With Interstate Shipping Cap (IHP-$)
  • Gene therapy scores big wins against blood cancers (AP)
  • Celgene's Revlimid looks approvable for early use in blood cancer (SCRIP-$)
  • Acura says FDA to review data from failed painkiller trial, shares jump (Reuters)
  • GSK Completes Breo Ellipta Asthma Study For Potential NDA Filing (Pink Sheet-$)
  • Do Drugmaker Plans To Release Trial Data Go Far Enough? (Forbes)
  • United Therapeutics receives subpoena for 3 drugs (Reuters)
  • Novartis/Penn's customized T cell wows ASH with stellar leukemia data (Fierce)
  • New Leukemia Drugs Bring Chemotherapy-Free Treatment Potential (Bloomberg)
  • FDA-approved medical marijuana clinical trial gets underway next month for kids with epilepsy (NJ.com)
  • Roche/AbbVie Move Beyond GDC-0199 Toxicity Issue To Show Results In Tough-To-Treat CLL (Pharmafile) (Pink Sheet-$) (Reuters)
  • J&J, Pharmacyclics leukemia drug effective long term: study (Reuters)
  • Baxter Files for Pediatric Indication of RIXUBIS [Coagulation Factor IX (Recombinant)] Treatment for Hemophilia B in the United States (Press)
  • FDA Review Cites Safety Issues for Crohn's Drug (MedPage Today)
  • Will The FDA Eliminate The Linear Barcode On Drugs? (RxTrace)
  • Otsuka Alleges Premature Notice From a Repeat Offender in SAMSCA Patent Infringement Case (FDA Law Blog)
  • When You Cannot Compel the Manufacturer to Make More of the Drug You Want to Take, You Cannot Force the Government to Compel the Manufacturer to Make More of the Drug You Want to Take (Drug and Device Law)
  • GlaxoSmithKline, Theravance lung drug works in asthma study (SCRIP-$)
  • Novartis myeloma drug clears phase III trial (PMLive) (Fierce) (SCRIP-$) (Pharma Letter-$)
  • GSK, Theravance asthma drug shows improved lung function in study (Reuters) (Press) (BioCentury)
  • Sunovion Pharmaceuticals Inc. Presents Phase 3 Pooled Analysis of Once-Daily Aptiom (eslicarbazepine acetate)as Adjunctive Treatment for Partial-Onset Seizures (Press)
  • The U.S. Food and Drug Administration Should Solidify the Legal Basis for Its Authority over Reproductive Cloning (Paper)
  • The real statin controversy: Drug Quality (AEI)
  • Gillibrand challenges FDA OK of hydrocodone drug Zohydro (News Day)
  • Novartis aims to show strength with muscle wasting drug (Reuters)
  • UofM faculty calls for review of controversial drug study (Star Tribune)

US: Pharmaceuticals and Biotechnology: General

  • How Risperdal Whistle-Blowers Made Millions From J&J (Bloomberg)
  • 12 Things the Pharma Industry Can Do to Rebuild Real Public Trust (Xconomy)
  • An effective eye drug is available for $50. But many doctors choose a $2,000 alternative (Washington Post)
  • Novartis starts supplying meningitis B vaccine to Princeton (Reuters)
  • U.S. Supreme Court to decide whether software can be patented (Bloomberg)
  • Study Shows Prolia More Effective, Has Fewer Side Effects Compared to Zometa (DSM)
  • Feds nail importers of foreign-made Botox (Fierce)

US: Medical Devices

  • Push Underway to Bring up SOFTWARE Act in Senate (Gray Sheet-$)
  • Policy Brief: mHealth and FDA Guidance (Health Affairs)
  • FDA asserts support for consumer genetic tests despite 23andMe crackdown (Fierce) (WSJ-$)
  • 23andMe remains optimistic despite FDA issues: 'We are not going anywhere' (Venture Beat)
  • Mobile health app regulation more than just FDA, ONC (MobiHealth News)
  • Metal-On-Metal Hip Resurfacing Proves Safer Than Total Hip Replacement (Gray Sheet-$)
  • Meta-analysis Confirms That Stents Do Not Extend Life In Stable Patients (Gray Sheet-$)
  • Medtronic spinal implant proves worth at 7 years (Fierce)
  • Boston Scientific Reports Favorable Results Assessing Real-World Experience with the Precision Spectra Spinal Cord Stimulator System (Press)
  • mHealth: Mega Electronics lands FDA win for smartphone ECG monitor (Mass Device)
  • C4 Imaging Announces FDA 510(k) Clearance of its Positive-Signal MRI Marker, Sirius (Press)

US: Dietary Supplements

  • USPlabs Hit with Class Action Lawsuit over DMAA, Hepatitis Outbreak (NPI)

US: Assorted And Government

  • Lawmakers rushing to reach budget agreement to avoid another shutdown (Washington Post)
  • US Capitol Capsule: Smooth sailing for healthcare, economy? Righting the ship (SCRIP-$)
  • Paul pitches reduced regulation zones (The Hill)

Upcoming Meetings And Events

  • 9 December 2013: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (FDA)
  • 10-11 December: FTC Meeting on Biosimilars (FTC)
  • 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
  • 11 December 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 11-12 December 2013: Allergenic Products Advisory Committee Meeting (FDA)
  • 12 December 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EU Health IT Sector On Alert After Parliament Adds "Prediction" To Medical Device Definition (Gray Sheet-$)
  • EU Council to meet on Tuesday on MDR and IVDR proposals (Medical Devices Legal)
  • Use with caution: French draw up list of "critical" antibiotics (SCRIP-$) 
  • API imports in the EU: gauging the FMD's impact (Pharmafile)
  • EU pharma patent settlements continuing to rise (Pharma Times)
  • Benefits of Kogenate/Helixate NexGen outweigh risks, says EMA unit (Pharma Letter-$) (EMA)
  • Sanofi's Aubagio gains backing from UK's NICE (Pharma Letter-$)
  • OTC Firms Could Gain From Proposed EU Risk Management Plan Revision (Tan Sheet-$)
  • American Medical Systems lands CE Mark for transvaginal sling (Mass Device)
  • EU may centralise novel foods authorization (Nutra Ingredients)

Asia

  • Going separate ways: Japan gives go-ahead to medtech-specific regulatory system (Clinica-$)
  • China 2014 Regulatory Outlook: Expect Greater Enforcement As CFDA Rolls Out New Regs (PharmAsia-$)
  • India Drug Makers See Big Three-Year Growth In Legal Expenses (PharmAsia-$)
  • China Holds 2012-2013 Pharma Regulation Stats Meeting (PharmAsia-$)
  • China Approves Conbercept For Age-related Macular Degeneration (PharmAsia-$)
  • Vietnam, Cuba Sign MOI To Collaborate On Pharma Projects (PharmAsia-$)
  • Philippines FDA Orders Recall Of India-Made Antibiotic (PharmAsia-$)
  • Philippine regulators warn of deadly fake rabies vaccine (Securing Industry)

Other International

  • Pope aide questions Big Pharma on availability of life-saving drugs (Marketwatch)
  • WHO's member-state mechanism on SSFFC medical products calls for strengthening of regulatory authorities (Pharmabiz)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #217 - 9 December 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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