Regulatory Focus™ > News Articles > Regulatory Reconnaissance: AZ's Heart Drug Epanova Wins FDA Approval (6 May 2014)

Regulatory Reconnaissance: AZ's Heart Drug Epanova Wins FDA Approval (6 May 2014)

Posted 06 May 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

  • AstraZeneca wins FDA OK for another fish-oil heart pill (Fierce) (PMLive) (Press) (Reuters) (SCRIP-$)
  • Favorable Ruling for Companies Defending Off-Label Promotion Cases (FDA Law Blog)
  • FDA's Sentinel Likely To Outpace Traditional Post-Market Studies, But Will It Replace Them? (Pink Sheet-$)
  • FDA Reports Declining 510(k) Times, And Other Improvements (Gray Sheet-$)
  • FDA's medical device user fee collections rose 50% last year (Mass Device)
  • More secret human studies uncovered in Myxo ring inquiry (Mass Device)

In Focus: International

  • What to Expect from New EU Medical Device Regulations (MDDI)
  • Explained: The Early Access to Medicines Scheme (EAMS) (PCM)
  • Price to value reboot: Will NICE's new value metrics ease cost-effectiveness hurdle for drugs? (BioCentury-$)
  • Europe approves Pierre Fabre's Hemangiol (Pharma Times)
  • New Ethical Guidelines For Japan Clinical Research Proposed (PharmAsia-$)

US: Pharmaceuticals/Biotechnology

  • AstraZeneca wins FDA OK for another fish-oil heart pill (Fierce) (PMLive) (Press) (Reuters) (SCRIP-$)
  • Favorable Ruling for Companies Defending Off-Label Promotion Cases (FDA Law Blog)
  • Latest FDA Warnings to Compounders Show Willingness to Defer to State Authorities (FDA)
  • FDA's Sentinel Likely To Outpace Traditional Post-Market Studies, But Will It Replace Them? (Pink Sheet-$)
  • FDA Seeks Input On Limiting Interstate Shipment Of Compounded Drugs (IHP-$)
  • Import Alert for Aadivinghnesh Chem's Injectable Ceftazidime (FDA)

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

  • Novartis' long-acting Signifor passes PhIII test for acromegaly (Fierce)
  • Astellas and Medivation Receive Priority Review from FDA for XTANDI (Enzalutamide) Capsules In Chemotherapy-Naive Advanced Prostate Cancer (Press) (SCRIP-$)
  • Merck Announces FDA Acceptance for Review of MK-3475 Biologics License Application for Advanced Melanoma (Press)

US: Pharmaceuticals and Biotechnology: General

  • $8 Billion And Counting: Pharma Paying Its ACA Taxes (Pink Sheet-$)
  • After $400 million in heists, big pharma fights back (The Verge)
  • US: Medical Devices
  • FDA Reports Declining 510(k) Times, And Other Improvements (Gray Sheet-$)
  • FDA's medical device user fee collections rose 50% last year (Mass Device)
  • CDRH Customer Satisfaction Initiative: Realistic or Ridiculous? (MDDI)
  • GS1 Releases UDI Guide (GS1)
  • More secret human studies uncovered in Myxo ring inquiry (Mass Device)
  • 3 Tips To Vastly Improve Your FDA Communication Strategy (MDDI)
  • AHA: FDA blood glucose guidance would have serious unintended consequences (AHA) (Law 360-$)
  • First MERS-CoV In U.S. Diagnosed With FDA Emergency-Authorized Test Kit (Gray Sheet-$)
  • BioFire Diagnostics wins FDA clearance for innovative GI panel (Fierce)
  • HealthWatch seeks FDA clearance for its 12-lead ECG tshirt (MobiHealthNews)
  • Propeller Health Receives New FDA Clearance for Next Generation Propeller Platform (Press)

US: Dietary Supplements

  • Nascent 100% confident in the quality and safety of its PQQ, despite FDA safety concerns (NI-USA)

US: Assorted And Government

  • Eshoo pitching $150B for biomedical R&D in bid for top Dem spot on House panel (BioCentury)
  • FDA Chief Counsel: Vermont GE Labeling Could Pose 'Perfect Storm' (IHP-$)
  • Why Some of the Reports FDA Generates for Congress may be Collecting Dust (Washington Post)

Europe

  • What to Expect from New EU Medical Device Regulations (MDDI)
  • Explained: The Early Access to Medicines Scheme (EAMS) (PCM)
  • Price to value reboot: Whether NICE's new value metrics will ease cost-effectiveness hurdle for drugs (BioCentury-$)
  • Europe approves Pierre Fabre's Hemangiol (Pharma Times)
  • Notified bodies: EU has distance to go to make unannounced visits a success (Clinica-$)
  • French Regulators Release Report on Breast Implants (ANSM)

India

  • State FDA act against fitness firm for publishing misleading ad under DMR Act (PharmaBiz)

Japan & China

  • New Ethical Guidelines For Japan Clinical Research Proposed (PharmAsia-$)
  • Japan Second Committee On Drugs Approves 7 New Medications (PharmAsia-$)

General Regulatory And Interesting Articles

  • The Research Race to Make Drugs More Efficient (WSJ-$)
  • Behind the Buzz to Make Injections Less Painful (WSJ-$)
  • Genome scientist Craig Venter in deal to make humanized pig organs (Reuters)

Regulatory Reconnaissance #312 - 6 May 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.

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


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe