Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Thousands of Drugs to get Patent Term Adjustments (28 January 2014)

Regulatory Reconnaissance: Thousands of Drugs to get Patent Term Adjustments (28 January 2014)

Posted 28 January 2014 | 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

  • Patent Term Adjustments Coming For Thousands Of Claims After Novartis Court Win (Pink Sheet-$)
  • Examining Foreign Inspection Related FDA Warning Letters (Cortelis)
  • The Year In New Drugs (CEN Mag)
  • Production snag forces worldwide hold on GSK chickenpox vaccines (Reuters)
  • Innovation, Risk, and Patient Empowerment: The FDA-Mandated Withdrawal of 23andMe's Personal Genome Service (JAMA)

In Focus: International

  • NICE widens draft guidance on Xtandi (SCRIP-$) (Pharma Letter-$) (PMLive) (BioCentury)
  • EU Clinical Trials Rules: One Step Closer But Not Yet a Done Deal (PharmExec)
  • UK: Is Value Based Assessment the New Value Based Pricing? (PharmExec)
  • India's compulsory licensing radar spies fresh meat (SCRIP-$)

US: Pharmaceuticals/Biotechnology

  • The Year In New Drugs (CEN Mag)
  • Patent Term Adjustments Coming For Thousands Of Claims After Novartis Court Win (Pink Sheet-$)
  • Production snag forces worldwide hold on GSK chickenpox vaccines (Reuters)
  • Multiple sclerosis community voices disappointment with FDA ruling on new drug (Post Crescent)
  • Pfizer weighs legal options as PA Supreme Court revives Redux design-defect suit (Fierce)
  • Caronia Decision One Year Later: Off-label Change May Be Slow, But It's Brewing (CHC)
  • CBER Hiring for Chief of its Product Review Branch (FDA)
  • Moody's: FDA Prohibition Order on Ranbaxy's Toansa Plant Is Credit Negative for Daiichi Sankyo (Moody's) (CNBC) (Fierce)

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

  • Medac Pharma, Inc. Secures FDA Acceptance of a New Drug Application (NDA) for Methotrexate-Containing Autopen (Press) (BioCentury)
  • Heron hammered over Sustol NDA resubmission delay (SCRIP-$)
  • Geron shares fall after cancer drug study update (Reuters)

US: Pharmaceuticals and Biotechnology: General

  • Judge Rejects Execution Delay Over Use of Compounded Drug (NYTimes)
  • New Arizona Rules Would Limit Abortion Drug Use (AP)

US: Medical Devices

  • Innovation, Risk, and Patient Empowerment: The FDA-Mandated Withdrawal of 23andMe's Personal Genome Service (JAMA)
  • FDA approval for CliniMACS CD34 Reagent System for prevention of graft-versus-host disease in the treatment of acute myeloid leukemia (MNT)
  • Another Decision to Allow the Use of Publicly Available FDA Documents on a FRCP 12(b)(6) Motion to Dismiss (D&D Law)
  • Kiva VCF Treatment System Receives FDA Clearance For Vertebral Compression Fractures (Press)
  • End-of-life directives rarely include device deactivation (Cardiovascular Business)

US: Dietary Supplements

  • IOM Publishes Summary of Workshop on Caffeine in Food and Dietary Supplements (FDA Law Blog)
  • Kids' vitamins often surpass daily recommendations (Reuters)
  • Balancing Label Requirements with Strong Branding (NPI)

US: Assorted And Government

  • Examining Foreign Inspection Related FDA Warning Letters (Cortelis)
  • NIH Promises To Make Scientific Studies Less Wrong (Forbes)
  • HHS-OIG: Listing of Pharmaceutical and Device Corporate Integrity Agreements 2014 (Policy and Medicine)
  • Republican senators propose Obamacare replacement plan (SCRIP-$)

Upcoming Meetings And Events

  • 28 January 2014: Allergenic Products Advisory Committee Meeting (FDA)
  • 28 January 2013: US State of the Union Address (White House)
  • 28-29 January 2013: Workshop - Strategies to Address Hemolytic Complications of Immune Globulin Infusions (FDA)
  • 29-30 January 2014: Science Advisory Board to the National Center for Toxicological Research Meeting (FDA)
  • 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • NICE widens draft guidance on Xtandi (SCRIP-$) (Pharma Letter-$) (PMLive) (BioCentury)
  • EU Clinical Trials Rules: One Step Closer But Not Yet a Done Deal (PharmExec)
  • CHMP extensions for NovoThirteen and Stelara (SCRIP-$)
  • UK: Is Value Based Assessment the New Value Based Pricing? (PharmExec)
  • Edwards Lifesciences wins E.U. approval for next-gen Sapien 3 heart valve (Mass Device) (MedGadget)
  • Outcome of the Joint EMA / EDQMworkshop on characterisation of new clotting factor concentrates (factor VIII and factor IX) with respect to potency assays used for labelling and testing of post-infusion samples (EDQM)

India

  • India's compulsory licensing radar spies fresh meat (SCRIP-$)

Japan & China

  • Covidien Receives Japanese Regulatory Approval for Reinforced Stapling Reload Technology (Press)

Other International

  • Australia issued Hazard Alert on St. Jude Imlantable Caridiac Device, Medtronic's Porcine Aortic Bioprosthesis (TGA) (TGA)

General Regulatory And Interesting Articles

  • How "Chronic Fatigue Syndrome" Obscures A Serious Illness (Buzzfeed)
  • How To Avert An Antibiotic Apocalypse (Forbes)
  • Design Flaws Plague Many Animal-Based Drug Studies, Researchers Say (Philly) (Press)
  • Want to Get the Flu? Volunteers Sneeze for Science (AP)
  • Rare Genetic Variations May Account for Severe Reaction to LABA Drugs in Some Asthmatics (Press)
  • A Simple Way to Slash Unnecessary Drug Prescriptions (Scientific American)

Regulatory Reconnaissance #244 - 28 January 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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