Regulatory Focus™ > News Articles > Regulatory Recon: A Record Year for Orphan Drugs in the US (16 February 2015)

Regulatory Recon: A Record Year for Orphan Drugs in the US (16 February 2015)

Posted 16 February 2015 | By Alexander Gaffney, RAC

Regulatory Recon: A Record Year for Orphan Drugs in the US (16 February 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • FDA’s Orphan Drug Program Shatters Records (FDA Law Blog)
  • FDA Personnel Growth Looks To Have Plateaued For Drugs Program (Pink Sheet-$)
  • US FDA working to make clinical trials less wasteful (Outsourcing Pharma)
  • FDA Starts 2015 As It Plans To Go On: A Spate Of Approvals, A Full Slate Of Possibilities (Pink Sheet-$)
  • FDA Grants Priority Review to Novartis for its Heart Failure Drug LCZ696 (PMLive) (BioCentury)
  • FDA Stands By Its Dental Amalgam Mistake (MDDI)
  • FDA announces recall of nearly 16M Teleflex humidifiers due to presence of foreign material (Fierce)
  • To Avoid Midnight Regulations in 2016, Obama Tells Agencies to Set Priorities Now (Bloomberg BNA)
  • ZMapp and the fight against Ebola (CBS)

In Focus: International

  • 8 China food and drug officials penalized after boozy lunch leaves colleague dead (Shanghaiist) (News24) (Xinhua)
  • New ENVI Report on Antibiotic Resistance (ENVI)
  • EMA's CVMP Recommends New Products (EMA)
  • Local India FDA Units Suffer from Under-Staffing (MoneyLife)
  • Finally, India to get labs to test medical devices (India Times)
  • China's 'blood famine' drives patients to the black market (Reuters)
  • Health Canada delays decision on abortion drug mifepristone (CTV)

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US: Pharmaceuticals and Biotechnology

  • FDA’s Orphan Drug Program Shatters Records (FDA Law Blog)
  • FDA Personnel Growth Looks To Have Plateaued For Drugs Program (Pink Sheet-$)
  • US FDA working to make clinical trials less wasteful (Outsourcing Pharma)
  • FDA Starts 2015 As It Plans To Go On: A Spate Of Approvals, A Full Slate Of Possibilities (Pink Sheet-$)
  • Veterinary trade group denounces press reports of alleged conflicts of interest (Fierce)
  • AstraZeneca loses US Pulmicort patent (Pharmafile) (PMLIve) (Press) (Reuters)
  • Venture Capital Growth In Orphan Drugs Aided By ‘Regulatory Certainty’ (Pink Sheet-$)
  • DEA Scheduling Reform Bill Introduced in Senate (Senate)
  • FDA Compounding Guidances Might Cull Outsourcing List (Pink Sheet-$)
  • FDA Posts Advisory Committee Materials for a Review of Drugs Not Allowed List and Bulk Substances Allowed List for Pharmacy Compounding (Tarius)
  • Amgen’s T-VEC AdCom May Shed Light On How FDA Reviews Intralesional Immunotherapies (Pink Sheet-$)
  • Big Pharma At FCA Crossroads, Philly US Atty Says (Law 360-$)
  • Sun Pharma Declines as Regulatory Issue Puts Pressure on Profit (Bloomberg)
  • Is An ASN Really The Best Way to Pass Lot-Based DSCSA Transaction Data? (RxTrace)
  • DTC Print Ads Need Consumer-Friendly Fair Balance Information (Pharmaguy)
  • US PIRG Continuing Push to Ban Overuse of Antibiotics (PIRG)
  • Maryland Bill Would Limit Antibiotic Drug Usage (MD)
  • Tennessee Introduces Biosimilar Substitution Bill (SCOUT)
  • Georgia lawmakers considering bill on 'biosimilar' drugs (Athens Online)

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

US: Pharmaceuticals and Biotechnology: General

  • 'Living' drug innovation database aims to sway policy changes (SCRIP-$)
  • NIH wraps Precision Medicine Initiative workshop (BioCentury)
  • House Bill Calls for February 28th to be Designated Rare Disease Day (House)

US: Medical Devices

  • Rep. John Shimkus, Architect Of Cures Bill Device Reform Provisions (Gray Sheet-$)
  • FDA Stands By Its Dental Amalgam Mistake (MDDI)
  • CDRH Customer Satisfaction Rating (FDA)
  • FDA approves Pelvalon's fecal incontinence device (Mass Device)
  • FDA announces recall of nearly 16M Teleflex humidifiers due to presence of foreign material (Fierce)
  • Medtronic Receives Expanded Indications of the VERTEX Reconstruction System (Press)
  • Neuronetrix gets FDA approval for brain-scan device (BizJournal)

US: Dietary Supplements

US: Assorted And Government

  • To Avoid Midnight Regulations in 2016, Obama Tells Agencies to Set Priorities Now (Bloomberg BNA)

Upcoming Meetings

Ebola Outbreak

  • ZMapp and the fight against Ebola (CBS)
  • Ebola Drug ZMapp's Ready for African Testing (NBC)

Europe

  • New ENVI Report on Antibiotic Resistance (ENVI)
  • EMA's CVMP Recommends New Products (EMA)
  • MHRA’s Beneficial EU Relationship And Profitable Synergies With NICE: An Interview With Michael Rawlins (Pink Sheet-$)
  • Medtronic Announces CE Mark and European Launch of the Euphora Semicompliant Coronary Balloon Catheter (Press)
  • Decision to withdraw Jevtana in England Called ‘flawed’ (PMLive)
  • EMA, ENVI Meeting This Week (ENVI)

India

  • Finally, India to get labs to test medical devices (India Times)
  • Insight On India – Highlights From The Week Of Feb 8-14, 2015 (Two-Four Insight)
  • Local India FDA Units Suffer from Under-Staffing (MoneyLife)
  • NPPA issues Compendium of Notified Ceiling Prices of Scheduled Drugs 2015 (PharmaBiz)

China

  • 8 food and drug officials penalized after boozy lunch leaves colleague dead (Shanghaiist) (News24) (Xinhua)
  • China's 'blood famine' drives patients to the black market (Reuters)
  • Can Some Medical Devices Skip China's Clinical Trial Mandate? (Regulatory Focus)
  • Gujarat FDCA provides training to CFDA on food & drugs monitoring to meet regulatory challenges (PharmaBiz)
  • Lifeline Scientific Wins Regulatory Approval In China (Press)

Canada

  • How not to report about vaccine safety issues, Toronto Star edition (Science-Based Medicine)
  • Canada Slams Lilly for ‘Scattershot’ Patent Filings in a Long-Running Dispute (Pharmalot)
  • Health Canada delays decision on abortion drug mifepristone (CTV)

Australia

  • Australian Regulators Say Warfarin Warning Label Requires Update (TGA) (TGA)

Other International

  • WHO issues draft guidelines on Good Pharmacopoeial Practices; invites comment by March 10 (PharmaBiz)

Clinical Trials

  • AllTrials response to EMA consultation on implementing the European Clinical Trials Regulation (AllTrials)
  • Lung Master Protocol (Lung-MAP)-A Biomarker-Driven Protocol for Accelerating Development of Therapies for Squamous Cell Lung Cancer: SWOG S1400 (PubMed)

General Regulatory And Interesting Articles

  • Continued Questions on Benzodiazepine Use in Older Patients (NYTimes)
  • Lung cancer 'breathalyser' goes into clinical trials (PharmaTimes)

Regulatory Reconnaissance #494 – 16 February 2015

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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