Regulatory Focus™ > News Articles > Regulatory Recon: A Record Year for Orphan Drugs in the EU (12 January 2015)

Regulatory Recon: A Record Year for Orphan Drugs in the EU (12 January 2015)

Posted 12 January 2015 | By Alexander Gaffney, RAC

Regulatory Recon: A Record Year for Orphan Drugs in the EU (12 January 2015)

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

In Focus: US

In Focus: International

  • 2014 seeks spike in EU orphan drug recommendations (PharmaTimes) (Press)
  • EMA Releases New Biosimilars Guideline (EMA)
  • Europe Urges Greater Alignment On U.S. And EU Device Review (Gray Sheet-$)
  • Standardization of European HTA bodies is inevitable: EFPIA head (Pharma Letter-$)
  • India wants its officials during FDA inspections at drug units (Live Mint) (India Times)
  • Expand ‘trusted’ regulator network, Aus industry urges TGA (Clinica-$)

US: Pharmaceuticals and Biotechnology

  • AbbVie wins U.S. approval for Parkinson's treatment (Reuters) (Press)
  • FDA Review of Possible Risks of Pain Medicine Use During Pregnancy (FDA)
  • Daiichi-Sankyo pays $39m to settle allegations (Pharmafile) (Reuters)
  • Questions and Answers on Guidance for Industry: Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products (FDA)
  • EU Data Helps Sandoz’s U.S. Clinical Program For Filgrastim (Pink Sheet-$)
  • Senators Re-Introduce Bill to Allow Imported Medicines From Canada (Pharmalot) (Law 360-$)
  • Biosimilar Testing Standards To Remain Case-by-Case Decisions (Pink Sheet-$)
  • Novartis’s Biosimilar of Neupogen Clears a Big Hurdle, But Major Issues Remain for it and Other Biosimilars (FDA Law Blog)
  • FDA Allows Fresenius to Make New Drugs at Plant in US (Press)

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

  • Hospira Submits New Biologics License Application Biosimilar Retacrit (RTT)
  • Merck speeds up drug-submission plans for Hep C, lung cancer (Reuters)
  • Bristol-Myers says panel finds Opdivo lung cancer study meets endpoint (Reuters) (WSJ-$) (Fierce)
  • Portola's drug reverses effect of blood thinner Xarelto (Reuters) (BioCentury)
  • FDA asks Arrowhead to cut Hep B drug dosage in mid-stage trial (Reuters) (WSJ-$)
  • FDA Accepts Vertex NDA for Kalydeco; PDUFA Date of 17 March 2015 (Press)
  • Boehringer Touts Positive PhIII Results for Giotrif (Press)
  • Melinta reports Phase III success for antibiotic (SCRIP-$)
  • Sarepta Therapeutics Reports Long-Term Outcomes through 168 Weeks from Phase IIb Study of Eteplirsen in Duchenne Muscular Dystrophy (Press)
  • ProteoTech is Granted Orphan Drug Designation for Systebryl (PTI-110) for the Treatment of AL Amyloidosis (Press)
  • Argos tanks as its HIV immunotherapy flunks Phase II (Fierce)

US: Pharmaceuticals and Biotechnology: General

  • The Coming Battle Over DQSA Decommissioning At The Pharmacy (RxTrace)
  • CDC: Antivirals underused against nasty H3N2 flu (SCRIP-$) (AP)
  • Connecticut Transparency Law: Manufacturers Must Submit One Form at a Time Via Email (Policy and Medicine)
  • Drug Switch May Delay Executions in Ohio (NYTimes)

US: Medical Devices

US: Dietary Supplements

  • NPA: 2015 will bring challenges in Congress, media and GMP compliance (NI-USA)

US: Assorted And Government

  • Cost of FDA Flights for Inspections Come Under Fire (Washington Examiner)
  • Modernization? The Regulatory Accountability Act of 2015 Adds 74 New Steps to the Rule-Making Process (CPRblog)

Upcoming Meetings

Ebola Outbreak

  • 'Extreme measures' needed to see Ebola shot development through (Reuters)
  • Edge for 3rd-place JnJ in Ebola vaccine race? (SCRIP-$)
  • Two Leading Ebola Vaccines Appear Safe, Further Tests Starting (AP) (Washington Post) (NPR)
  • WHO Fast-tracking the development and prospective roll-out of vaccines, therapies and diagnostics in response to Ebola virus disease (WHO)

Europe

  • 2014 seeks spike in EU orphan drug recommendations (PharmaTimes) (Press)
  • Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMA)
  • Europe Urges Greater Alignment On U.S. And EU Device Review (Gray Sheet-$)
  • Standardization of European HTA bodies is inevitable: EFPIA head (Pharma Letter-$)
  • Sanofi, Regeneron submit new cholesterol drug to EMA for review (Reuters)
  • In a win for Spectranetics, Covidien's to-be-divested drug-coated balloon earns CE mark (Fierce) (Mass Device)
  • IQWiG finds no added benefit for Dendreon's Provenge or Gilead's Zydelig (SCRIP-$)
  • AstraZeneca drops CDF application (Pharmafile) (PharmaTimes)
  • Quanta SC+ Hemodialysis System for In-Office or At-Home Treatment Cleared in EU (MedGadget)

India

  • India wants its officials during FDA inspections at drug units (Live Mint) (India Times)
  • India to resume patented drug pricing efforts? (SCRIP-$)
  • Health Minister JP Nadda for innovation of cheaper new drugs (India Times)
  • High Court stops Cipla's generic drug sales (India Times)
  • Insight On India – Highlights From The Week Of Jan 4-10, 2015 (Two-Four Insight)

China

  • China Adopts Proposed Notification System for Nutritional Supplements (NPI)

Canada

  • Counterfeit OxyContin claims another life in Canada (Securing Industry)
  • Health Canada Approves Second Sight’s Argus II Retinal Prosthesis System for Treatment of Outer Retinal Degeneration (Press)

Australia

  • Expand ‘trusted’ regulator network, Aus industry urges TGA (Clinica-$)

Other International

  • WHO prequalifies Serum's meningitis vaccine for infant use (SCRIP-$) (Press)

Regulatory Reconnaissance #469 – 12 January 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.


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