Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Pfizer Seeks FDA Approval for OTC Lipitor (3 March 2014)

Regulatory Reconnaissance: Pfizer Seeks FDA Approval for OTC Lipitor (3 March 2014)

Posted 03 March 2014 | By Alexander Gaffney, RAC 

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In Focus: US

  • Lipitor: Pfizer Aims to Sell Over-the-Counter Version (WSJ-$) (Forbes)
  • Generic drugmakers ramp up campaign against FDA label proposal (Reuters)
  • FDA Approves AZ's Bydureon Pen for Once-Weekly Treatment of Adults with Type 2 Diabetes (Press) (PMLive)
  • Winning approval for new drugs may get harder, analyst warns (Market Watch)
  • GDUFA: FDA Struggles Under Higher-Than-Expected Submission Volume (Pink Sheet-$)
  • Roche racks up another PhIII setback as MetMab flops against lung cancer (Fierce) (Roche) (Reuters) (Pharma Letter-$) (SCRIP-$) (Pharma Times) (Bloomberg)
  • Industry Supports Device Development Tools, But Says: Show Me The Money (Gray Sheet-$)
  • Inspire Medical's Upper Airway Stimulator Impresses FDA Panel (Gray Sheet-$)

In Focus: International

  • EMA Releases Six New Reflection Papers and Guidelines (EMA) (EMA) (EMA) (EMA) (EMA) (EMA)
  • UK Insurance firms 'will not be sold NHS records' (Pharmafile) (OnMedica)
  • Germany extends drug price freeze to end-2017 (Pharma Times)
  • Reimbursement Deal In Germany Puts Forxiga Back On Medicine Menu (Pink Sheet-$)
  • Indian Court Dismisses Teva's Plea To Halt Natco's Generic Copaxone Exports (Pink Sheet-$)
  • S. Korea regulators may rule Samsung smartphone a medical device (Mass Device) (Fierce)

US: Pharmaceuticals/Biotechnology

  • Lipitor: Pfizer Aims to Sell Over-the-Counter Version (WSJ-$) (Forbes)
  • Generic drugmakers ramp up campaign against FDA label proposal (Reuters)
  • Generic Industry Says Proposed Drug Labeling Rule Would Undermine Hatch-Waxman Act (GPhA)
  • Opinion: Generic drug industry needs to stand up for patient safety (LA Times)
  • FDA Approves AZ's Bydureon Pen for Once-Weekly Treatment of Adults with Type 2 Diabetes (Press) (PMLive)
  • A Call To Rein In Phase III Trials (In the Pipeline)
  • Winning approval for new drugs may get harder, analyst warns (Market Watch)
  • GDUFA: FDA Struggles Under Higher-Than-Expected Submission Volume (Pink Sheet-$)
  • Déjà Flu: Vaccine Effectiveness Concerns Remain As FDA Panel Stands Pat On Strains (Pink Sheet-$)
  • Cellular And Gene Therapy Trials Should Target Children First, FDA Advisors Say (Pink Sheet-$)
  • FDA Evaluates Topical Acne Ingredients After Adverse Event Report Jump (Tan Sheet-$)
  • Simulations Plus Signs Five-Year Research Collaboration Agreement with FDA (Press)
  • FDA Expands and Clarifies Its Good Reprint Practices Guidance (FDA Law Blog)
  • Pain Guidance Lays Out Indication-Specific Trial Requirements (Pink Sheet-$)
  • The FDA's Black Lung: The agency barred a drug that could help patients with pulmonary fibrosis (WSJ)
  • Drugmakers, FDA need a SWAT team approach on shortages, group says (Fierce)
  • GPhA And Actavis Divorcing: Biosimilars Behind The Rift (Pink Sheet-$)
  • Actelion Settles Row Over Giving Drugs To Generics Makers (Law 360-$)
  • Merck Says DOJ Has Ended Its Multicountry FCPA Probe (Law 360-$)
  • FDA Speeds Innovation in Rare Disease Therapies (FDA)

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

  • Roche racks up another PhIII setback as MetMab flops against lung cancer (Fierce) (Roche) (Reuters) (Pharma Letter-$) (SCRIP-$) (Pharma Times) (Bloomberg)
  • FDA postpones Relistor meeting (BioCentury)
  • OPKO's Longer-Acting Clotting Factor VIIa-CTP Receives Orphan Drug Designation in the U.S. (Press)
  • GlaxoSmithKline Submits U.S. Regulatory Application for Promacta (eltrombopag) for Severe Aplastic Anaemia (Press) (SCRIP-$) (PMLive)
  • New Phase III data show Boehringer Ingelheim's tiotropium Respimat effective across asthma severities (Press)
  • US orphan status for GW Pharma's Epidiolex in Lennox-Gastaut syndrome (Pharma Letter-$)
  • Naurex's Rapid-Acting Novel Antidepressant GLYX-13 Get Fast Track Designation (Press)

US: Pharmaceuticals and Biotechnology: General

  • Costly hepatitis drug Sovaldi rattles industry (Washington Post)
  • Don't Be Forced to Switch Away from Generic Formulations (JAMA Internal)
  • 'Magic' Overdose Drug Works, But Demand And Price On The Rise (NPR)
  • Endo's $193m Settlement For Misconduct May Become Big Tax Write-Off (US PIRG)
  • Is orphan drug reimbursement getting tougher? (SCRIP-$)

US: Medical Devices

  • Industry Supports Device Development Tools, But Says: Show Me The Money (Gray Sheet-$)
  • Inspire Medical's Upper Airway Stimulator Impresses FDA Panel (Gray Sheet-$)
  • Could Adaptive Design Have Saved Medtronic's Renal Denervation Clinical Trial? (MDDI)
  • Glaucoma Specialists Outline Clinical Trial Design For Minimally Invasive Surgery Devices (Gray Sheet-$)
  • InControl Medical Gains Expanded FDA Clearance for New InToneMV Device Providing Men and Women a Non-Surgical Treatment Option for Urinary and Fecal Incontinence (Press)

US: Dietary Supplements

  • Advocacy Groups Say POM Claims Prey On Consumer Desperation (Tan Sheet-$)
  • Israel Removed from USTR's Special 301 List (DrugWonks)

US: Assorted And Government

  • FDA Budget Request Expected Next Week (Strengthen FDA)
  • Unannounced Senate Hearing to Focus on FDA Oversight (Strengthen FDA)
  • Upcoming FDA Meeting on Communicating Risk (FDA)
  • SCRIP's US Capitol Capsule (SCRIP-$)
  • More African Americans need to participate in clinical trials (Washington Post)
  • Rep. Pitts Tours FDA Headquarters (Press)

Upcoming Meetings And Events

  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Draft reflection paper on the wording of indication for medicinal products for treatment of type 2 diabetes (EMA)
  • Draft guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function (EMA)
  • Draft concept paper on revision of the points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (CHMP/EWP/2655/99) and conversion to a CHMP guideline (EMA)
  • Draft guideline on the evaluation of medicinal products for the treatment of chronic constipation (EMA)
  • Guideline on the use of porcine trypsin used in the manufacture of human biological medicinal products (EMA)
  • Guideline on process validation for finished products - information and data to be provided in regulatory submissions (EMA)
  • Insurance firms 'will not be sold NHS records' (Pharmafile) (OnMedica)
  • Germany extends drug price freeze to end-2017 (Pharma Times)
  • Reimbursement Deal In Germany Puts Forxiga Back On Medicine Menu (Pink Sheet-$)
  • UK Governments outline plans for tackling rare diseases (RPS)
  • Covidien Announces CE Mark Approval for Puritan Bennett 980 Ventilator (Press)
  • Opinion: It's imperative that opening up clinical trial data doesn't compromise patient safety (PMLive)
  • Lundbeck Limited, A Menarini Pharma, Bayer plc, HRA Pharma UK and GlaxoSmithKline breach the ABPI Code of Practice (PMCPA)
  • EDQM Joins Twitter (EDQM)

India

  • Indian Court Dismisses Teva's Plea To Halt Natco's Generic Copaxone Exports (Pink Sheet-$)
  • Experts omit 'Therapy' from stem cell guidelines as efficacy of stem cell therapy yet to be proven (PharmaBiz)
  • Government cautious on cancer drug patent regimes (India Times)

Japan & China

  • Takeda Submits NDA for TAK-438 in Japan (Press)

Other International

  • S. Korea regulators may rule Samsung smartphone a medical device (Mass Device) (Fierce)

General Regulatory And Interesting Articles

  • Just One Dose Of Many Common Medicines Can Kill A Child (NPR)
  • Pro-Vaccine Messages Actually Backfire, Study Finds (NBC)
  • On the Quality of Vendor/Supplier Audits (Polaris)
  • Should Pharma Be Criticized For Investing Too Much In Fighting Cancer? (Forbes)
  • The Awesome Power Of Risk (Life Science VC)
  • Women's Health Harmed as Medical Studies Ignore Gender (Bloomberg)
  • Rare Mutation Kills Off Gene Responsible for Diabetes (NYTimes)
  • Slap on a Flu Patch? New Vaccine Would Skip the Needle (NBC) (MedGadget)
  • Tick test for persistent Lyme disease tried in humans (Reuters)
  • Too many patients do not report drug side-effects (OnMedica)

Regulatory Reconnaissance #267 - 3 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.

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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