Regulatory Focus™ > News Articles > Regulatory Reconnaissance (12 November 2013)

Regulatory Reconnaissance (12 November 2013)

Posted 12 November 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance-our 200th!-your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • Health overhaul debate snags Senate pharmacy-oversight bill (AP)
  • GlaxoSmithKline heart drug misses goal in major study (Reuters) (Pharma Letter-$) (SCRIP-$) (Press) (Fierce) (Pharma Times)
  • Could Organovo's first commercial device, 3-D liver model for pharma, cut drug R&D costs? (MedCity News)
  • U.S. FDA review supports Vanda's sleep disorder drug (Reuters) (Bloomberg)
  • Sarepta says FDA raises doubt about drug trial, shares drop 39 percent (Reuters) (Fierce) (The Street)
  • U.S. Federal Government Recognizes IEEE 11073 Standards for Medical-Device Communication (Press)

In Focus: International

  • NICE denies early use of Janssen's Velcade (PMLive) (Pharma Times)
  • SMC backs Inlyta, Lucentis and Xtandi for NHS Scotland, but not Bosulif (Pharma Letter-$) (Pharma Times) (PMLive)
  • India's Health Ministry plans to make post-marketing surveillance mandatory for 6 years (PharmaBiz)
  • Cipla's Hamied pushes for more 'obligatory' licensing to improve access (SCRIP-$)
  • Germany's BioCer lands E.U. win for mastectomy bra (Mass Device) (MedGadget)

US: Pharmaceuticals/Biotechnology

  • Health overhaul debate snags Senate pharmacy-oversight bill (AP)
  • GlaxoSmithKline heart drug misses goal in major study (Reuters) (Pharma Letter-$) (SCRIP-$) (Press) (Fierce) (Pharma Times)
  • Could Organovo's first commercial device, 3-D liver model for pharma, cut drug R&D costs? (MedCity News)
  • U.S. FDA review supports Vanda's sleep disorder drug (Reuters) (Bloomberg)
  • Sarepta says FDA raises doubt about drug trial, shares drop 39 percent (Reuters) (Fierce) (The Street)
  • Review Confirms Differences between Brand and Generic Osteoporosis Drug, Resulting Side Effects (Drug Safety Monitor)
  • GDUFA Grace Period For Facility Fees Appears To Be Over (Pink Sheet-$)
  • Park Language May Be On The Way In FDA Warnings To OTC Firms (Tan Sheet-$)
  • FDA Eyes Freedom To Innovate As Incentive To Improve Drug Quality (IHP-$)
  • FDA Documents Paint Disturbing Picture Of Burzynski Cancer Clinic (Forbes)
  • US FDA delays approval of Paladin's Impavido (Pharma Letter-$) (SCRIP-$) (BioCentury)
  • Alzheimer's Biomarkers For Disease Progression Will Be A Hard Road, Experts Say (Pink Sheet-$)
  • Scenesse misses in Phase III trial for genetic skin disorder (BioCentury)
  • Zalicus drops pain drug after trial fails; shares tumble (Reuters) (Pharma Letter-$) (Press) (Xconomy) (BioFlash)
  • Response to Citizen Petition for Nitroglycerin Lingual Spray (FDA Lawyers Blog)
  • Ampio AWOL With Knee-Pain Drug Data Disclosures (The Street)

US: Pharmaceuticals and Biotechnology: General

  • $4.2 Billion Deal Highlights Drug Profits From Rare Diseases (NPR)
  • Pharma's Windfall: The Mining of Rare Diseases (AP)
  • How Much? A Battle Over The Cost Of The New Hepatitis C Drugs (Pharmalot)

US: Medical Devices

  • U.S. Federal Government Recognizes IEEE 11073 Standards for Medical-Device Communication (Press)
  • Report: FDA Regulation of Mobile Health 2013 (MobiHealthNews)
  • Streamlining Risk Management in Medical Devices: Establishing a Master Harms List (MDDI)
  • J&J Complains Amazon Allowing Damaged or Expired Products to be Sold on Site (WSJ-$)
  • FDA Approves Kerecis's Fish Skin Technology to Heal Wounds (MedGadget)

US: Dietary Supplements

  • Supplements may not guard against cancer, heart disease (Reuters) (NBC)
  • White House reviewing anti-terror food rules (The Hill)

US: Assorted And Government

  • Regulations.gov crashes for second time (The Hill)
  • Congress opens door to allowing HIV organ donations (The Hill)
  • Thomas.gov to be phased out for mobile-friendly Congress.gov (Federal Times)
  • Automatic Spending Cuts Would Bite More In 2014 (AP)

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

Asia

  • India's Health Ministry plans to make post-marketing surveillance mandatory for 6 years (PharmaBiz)
  • Cipla's Hamied pushes for more 'obligatory' licensing to improve access (SCRIP-$)
  • Korean Class I device exemptions continue move to post-market focus (Clinica-$)
  • India State To Form Company To Buy Generics Directly From Makers (PharmAsia-$)
  • Sanofi And Japan's National Cancer Research Center Sign Alliance For Cancer Drug Development (PharmAsia-$)
  • Russia Makes It Easier For Regional Generics To Enter Market (PharmAsia-$)

General Regulatory And Interesting Articles

  • The Past Twenty Years of Drug Development, Via the Literature (In The Pipeline)
  • Thieves Hijacking Donated Malaria Drugs in Africa (WSJ-$)
  • Invention Could Scope Out Counterfeit Drugs (Scientific American)

Regulatory Reconnaissance #200 - 12 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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