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

Regulatory Reconnaissance (11 November 2013)

Posted 11 November 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

  • EMA to review safety of Ariad's Iclusig, but remains on the market for now (PMLive) (SCRIP-$) (Pharma Letter-$) (EMA) (BioCentury)
  • New EMA guidance on development of antibacterials to help in the fight against multidrug-resistant pathogens (EMA) (Guidance) (SCRIP-$) (Pink Sheet-$)
  • The unfinished internal market for medical devices (MedicalDevicesLegal)
  • Former Ranbaxy Owners Accused of Concealing Regulatory Deficiencies During Purcahse (India Times)
  • Device Companies Urge Indian Regulators to Ensure Sufficient Transition Time Under New Regulations (PharmaBiz)
  • India: D&C Rules to be amended to restrict waiver of trials for new drugs to national emergency, epidemics (PharmaBiz)

US: Pharmaceuticals/Biotechnology

  • FDA thumbs up for Sunovion's Aptiom as once-daily adjunctive for partial-onset seizures (Pharma Letter-$) (FDA) (SCRIP-$) (Medpage Today) (Reuters) (Press) (BioCentury) (Pharma Times)
  • FDA approves first generic versions of Aciphex delayed-release tablets to treat GERD (FDA)
  • The Next Phase In Oncology: FDA's Pazdur Has New Vision For Drug Development (Pink Sheet-$)
  • FDA: Risks certain, efficacy not for Sanofi/Genzyme MS drug Lemtrada (SCRIP-$) (Medpage Today) (Reuters) (BioCentury) (Fierce)
  • FDA awards $2.25M grant to study immunosuppresive drug in high-risk patients (Press)
  • FDA Doubles Estimated Time Needed For DMF Completeness Assessment (Pink Sheet-$)
  • Breakthrough Therapies Raise Manufacturing Issues (PharmTech)
  • Drug-Device Combo Products Under State And Federal Pedigree Laws (RxTrace)
  • Amarin Appeals FDA Ruling On Fish Oil Drug's Expansion (Law 360-$) (Pharmalot)
  • Revealed by the FDA: The results of the most recent inspection of the Burzynski Clinic (Science-Based Medicine)
  • Patient-Reported Outcomes Tools Should Be Symptom Specific, FDA Says (Pink Sheet-$)
  • FDA Advisory Committee Scheduled for BMS' Dapagliflozin (FDA) (BioCentury) (Pink Sheet-$)
  • GDUFA: Industry Says New Information Flow Lacking (Pink Sheet-$)
  • Despite $2B Deal, J&J's Risperdal Fight Rages On In Pa. (Law 360-$)
  • FDA Suspension of Ponatinib: Serious Problem, Wrong Solution (Harvard)
  • Pfizer says Rapamune failed endpoints in renal transplant study (Pharma Letter-$) (Press)
  • Alnylam Receives Fast Track Designation for Patisiran for the Treatment of TTR-Mediated Amyloidosis (ATTR) (Press)
  • ZS Pharma Announces Positive Top-Line Results of Phase 3 Trial of ZS-9 in Patients with Hyperkalemia (Press)
  • Relypsa Reports the Presentation of its Two-Part Pivotal Phase 3 Patiromer Trial in ASN Late-Breaker Poster (Press)
  • Warnings on Children's Drugs Found to Help Curb Misuse (NYTimes)
  • FDA Decision Clears Way for 14 Generic Medicines (FDA)
  • Merck's Investigational Grass Sublingual Allergy Immunotherapy Tablet Significantly Reduced Allergy Symptoms and Need for Symptom-Relief Medication in Adults and Children in Pivotal Phase III Study (Press)

US: Pharmaceuticals and Biotechnology: General

  • Health Reform May Boost Illicit Drug Sales (PharmExec)
  • Executions Stall as States Seek Different Drugs (NYTimes)

US: Medical Devices

  • Report Raises Concerns on Robotic Surgery Device (WSJ-$) (Mass Device)
  • Boston Scientific's Watchman Left Atrial Appendage Gets an Advisory Committee Meetings (FDA)
  • EHR Association backs no FDA regulation for electronic health record systems (GovHealthIT) (iHealth Beat) (MedCity News)
  • Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology (IOM)
  • SOFTWARE Act Would Limit FDA's Power, Ensure Regulatory Restraint (Forbes)
  • Final Coverage-With-Evidence-Development Guidance Delayed By CMS Staff Cuts (Gray Sheet-$)
  • Class 1 Recall for Pentax' Gas/Water Valve; CO2 Gas Flow May Not Turn Off (FDA)
  • SonoSite Announces 510(k) Clearance for the World's First Ultrasound Kiosk, the X-Porte (Press)
  • Topera lands CE Mark, 510(k) clearance for heart catheter (Mass Device)

US: Dietary Supplements

  • Navigating Dietary Supplement Regulations (NPR)
  • How To Squeeze Snake Oil From Deer Antlers And Make Millions (Forbes)

US: Assorted And Government

  • Can FDA Get Back to "the Regular Order" of Business? (Strengthen FDA)
  • Agency moves toward social media for regs (The Hill)
  • Businesses hire up to deal with more regs (The Hill)
  • Sixth Annual Sentinel Initiative (FDA)
  • SCRIP Capitol Capsule (SCRIP-$)

Upcoming Meetings And Events

  • 13 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
  • 13 November 2013: Vaccines and Related Biological Products Advisory Committee Meeting (FDA)
  • 14 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
  • 19 November 2013: Endocrinologic and Metabolic Drugs Advisory Committee Meeting (FDA)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • 9 December 2013: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (FDA)
  • 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EMA to review safety of Ariad's Iclusig, but remains on the market for now (PMLive) (SCRIP-$) (Pharma Letter-$) (EMA) (BioCentury)
  • New EMA guidance on development of antibacterials to help in the fight against multidrug-resistant pathogens (EMA) (Guidance) (SCRIP-$) (Pink Sheet-$)
  • The unfinished internal market for medical devices (MedicalDevicesLegal)
  • ABPI Code changes to improve payment transparency (Pharma Times)
  • HTA in EU: multiparty early dialogue pilot takes shape, launch due in 2014 (Clinica-$)
  • Corcept submits mifepristone MAA (BioCentury)
  • Yervoy gets first-line use label in the EU (SCRIP-$) (BioCentury)
  • NanoViricides Announces that DengueCide Has Received Orphan Drug Designation From the European Medicines Agency (EMA) (Press)
  • Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 5-7 November 2013 (EMA)
  • UK medicines agency issues OxyElite Pro 'no-no' (Nutra Ingredients)

Asia

  • Former Ranbaxy Owners Accused of Concealing Regulatory Deficiencies During Purcahse (India Times)
  • Device Companies Urge Indian Regulators to Ensure Sufficient Transition Time Under New Regulations (PharmaBiz)
  • India: D&C Rules to be amended to restrict waiver of trials for new drugs to national emergency, epidemics (PharmaBiz)
  • Clinical trials to get more challenging in India (India Times)
  • Indian Health Ministry amending D&C Rules to insert definition on phytopharmaceutical drugs (PharmaBiz)

General Regulatory And Interesting Articles

  • As Early-Stage Clinical Trial Costs Rise; Late-Stage Costs Level Off (Press)
  • This Amazing Robot Exoskeleton Helps The Paralyzed Walk Again (Forbes)
  • Dialysis machine components may be contaminating blood with BPA (MNT)
  • Gene puts African-Americans at higher risk for kidney failure (Press)
  • Battle against resistant bacteria takes huge leap forward (Press)
  • Mother's immunosuppressive medications not likely to put fetus at risk (Press)
  • In animal study, 'cold turkey' withdrawal from drugs triggers mental decline (Press)
  • Racial difference in blood clotting warrants a closer look at heart attack medications (Press)

Regulatory Reconnaissance #199 - 11 November 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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