Regulatory Focus™ > News Articles > Regulatory Reconnaissance (11 December 2013)

Regulatory Reconnaissance (11 December 2013)

Posted 11 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

  • Female Sexual Desire Drug Rejected by U.S. Regulators (Bloomberg)
  • Budget deal would avoid shutdown, ease NIH, FDA cuts (SCRIP-$)
  • ALK and Merck Co's grass allergy tablet finally reaches FDA committee (Pharma Letter-$) (BioCentury) (Reuters)
  • FDA reviewers again question dapagliflozin's benefit-risk profile (BioCentury) (Pink Sheet-$)
  • Vedolizumab for Crohn's Wins Support (MedPage Today)
  • Tighter Standards Ahead for Generic Epilepsy Drugs? (MedPage Today)
  • FDA To Launch Voluntary Device Manufacturing Compliance Improvement Pilot This Month (Gray Sheet-$)

In Focus: International

  • J&J/Novartis fined over EU fentanyl pay-for-delay deal (SCRIP-$) (AP) (PMLive) (EC) (Fierce) (Pharmalot) (Pharma Times) (Pink Sheet-$)
  • New IMI project to revolutionise clinical trials for Alzheimer's drugs (MNT) (PMLive)
  • Collaborative approach pays off in area of neglected diseases (FT)
  • EU Council views on future medtech regulation: shifting sands clog the hourglass (Clinica-$)
  • Presentations from 1st AHWP-RAPS Joint Conference (AHWP) (AHWP)
  • China FDA Bans Korean Drug After Disagreement On Overseas Inspection (PharmAsia-$)
  • Indian Health ministry issues alert on Johnson & Johnson's defective DePuy ASR hip replacements (Pharmabiz)

US: Pharmaceuticals/Biotechnology

  • Female Sexual Desire Drug Rejected by U.S. Regulators (Bloomberg)
  • ALK and Merck Co's grass allergy tablet finally reaches FDA committee (Pharma Letter-$) (BioCentury) (Reuters)
  • FDA reviewers again question dapagliflozin's benefit-risk profile (BioCentury) (Pink Sheet-$)
  • Vedolizumab for Crohn's Wins Support (MedPage Today)
  • Tighter Standards Ahead for Generic Epilepsy Drugs? (MedPage Today)
  • Mystery Adcomm Revealed (RPM Report-$)
  • Boehringer to Pay $931,000 Fine Over Lost Pradaxa Files (Bloomberg)
  • FDA postpones fibromyalgia meeting (BioCentury)
  • FTC Tries Pulling Teva Into Cephalon Pay-For-Delay Suit (Law 360-$)
  • Dems push for animal antibiotic limits (The Hill)
  • FTC postpones biosimilar meeting (BioCentury)
  • FDA Not at Fault in Drug Shortage Case, Judge Rules (FDA Law Blog)
  • Lundbeck and Otsuka to co-develop Alzheimer's vaccine, Lu AF20513 (Pharma Letter-$) (Press)
  • FDA faces lawsuit for 'withholding' Total Colgate approval records (Cosmetics Design)

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

  • Sanofi Gaucher pill application gets priority FDA review (Reuters)
  • FDA grants priority review for Genzyme's Cerdelga (Pharma letter-$) (Press)
  • Spectrum files belinostat NDA in rare lymphoma (SCRIP-$) (BioCentury)
  • Baxter submits BLA for OBI-1 in acquired hemophilia A, supplemental filing for Rixubis (SCRIP-$) (Press) (BioCentury)

US: Pharmaceuticals and Biotechnology: General

  • Some Democrats Scold Obama Over His Position On Trade Talks (Pharmalot)
  • CVS, Cardinal Health form U.S. generic drug venture (Reuters)
  • Pentagon tasks Pfizer with radically rethinking vaccine development (Fierce)

US: Medical Devices

  • FDA To Launch Voluntary Device Manufacturing Compliance Improvement Pilot This Month (Gray Sheet-$)
  • Personal Gene Tests Face Stricter Oversight After 23andMe (Bloomberg)
  • FDA Approves Gore Viabahn Endoprosthesis for Revision of the Arteriovenous Access (Press)
  • FDA Seeks Panel Input On Regulation Of Spinal Sphere Devices, Wheelchairs (Gray Sheet-$)
  • St. Jude Medical halts Enlightn IV trial (Mass Device)
  • November 2013 510(k) Clearances (FDA)
  • C4 Imaging's 1st FDA win is for MRI marker (Mass Device)
  • Bolton begins U.S. clinical trial for Treovance abdominal stent graft (Mass Device)
  • Ethicon Receives 510(k) Clearance for New HARMONIC FOCUS+ Shears with Adaptive Tissue Technology (Press)
  • AMS Receives FDA Clearance for Surgical System to Treat Female Stress Urinary Incontinence (MedGadget)
  • Cochlear lands FDA clearance for Baha 4 bone conduction hearing (Mass Device)
  • Medtronic slips $18M verdict in surgical fire case (Mass Device)

US: Assorted And Government

  • Budget deal would avoid shutdown, ease NIH, FDA cuts (SCRIP-$)
  • PCORI Board to Vote on Proposed Funding Awards during Dec. 17 Meeting (PCORI)
  • H.R.3665 -- Medical Foods Equity Act of 2013 (Congress)

Upcoming Meetings And Events

  • 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

  • J&J/Novartis fined over EU fentanyl pay-for-delay deal (SCRIP-$) (AP) (PMLive) (EC) (Fierce) (Pharmalot) (Pharma Times) (Pink Sheet-$)
  • New IMI project to revolutionise clinical trials for Alzheimer's drugs (MNT) (PMLive)
  • Collaborative approach pays off in area of neglected diseases (FT)
  • EU Council views on future medtech regulation: shifting sands clog the hourglass (Clinica-$)
  • R&D drug firms back parallel EMA-HTA scientific advice but say it could be better (SCRIP-$)
  • EU Commission tells Council: scrutiny procedure is sticking plaster which should be removed (SCRIP-$)
  • Scottish HTA gives five drugs green light (SCRIP-$)
  • New EC Report on the Use of Animals for Research (EC)
  • Withholding trial results is research misconduct says UK doctors register (AllTrials)
  • A Medical Conference, A Tweet & A Drugmaker's Belated Response (Pharmalot) (Pharmafile) (Fierce)

Asia

  • Presentations from 1st AHWP-RAPS Joint Conference (AHWP) (AHWP)
  • China FDA Bans Korean Drug After Disagreement On Overseas Inspection (PharmAsia-$)
  • Indian Health ministry issues alert on Johnson & Johnson's defective DePuy ASR hip replacements (Pharmabiz)
  • China Publishes National Drug Quality Report For 2013 (PharmAsia-$)
  • 54 deaths reported during Indian clinical trials in three years from 2010: Minister (Pharmabiz)
  • G8 summit calls for AIDS-style fight against dementia (Reuters)
  • China Crackdown On Drug IP Infringement, Counterfeits Shifts Focus (PharmAsia-$)

Other International

  • Venezuela extends comment period for draft biosimilars guidance (SCRIP-$)
  • Ghana FDA asserts authority in blacklisted Bliss case (SCRIP-$)

General Regulatory And Interesting Articles

  • BioWorld's 7th Annual Biotech Gift Guide (BioWorld)
  • Popular Antacids Increase The Risk Of B-12 Deficiency (NPR) (Reuters) (NYTimes)
  • Drug Dispensing Contact Lenses Replacing Eye Drops in Glaucoma Treatment? (MedGadget)
  • New H7N9 bird flu resists drugs without losing ability to spread (Reuters)
  • Exercise as Potent Medicine (NYTimes)

Regulatory Reconnaissance #219 - 11 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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