Regulatory Focus™ > News Articles > Regulatory Recon: Catching Up on FDA's Approval Blitz and the Latest Pricing Chatter (27 July 2015)

Regulatory Recon: Catching Up on FDA's Approval Blitz and the Latest Pricing Chatter (27 July 2015)

Posted 27 July 2015 | By Michael Mezher 

Regulatory Recon: Catching Up on FDA's Approval Blitz and the Latest Pricing Chatter (27 July 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

In Focus: US

  • openFDA: Drilling Into The Details (openFDA)
  • Guidance: Analytical Procedures and Methods Validation for Drugs and Biologics (FDA)
  • FDA approves Praluent to treat certain patients with high cholesterol (FDA) (Reuters) (SCRIP-$) (Washington Post) (Forbes) (PharmaLetter-$) (Press)
  • New heart drugs come in more expensive than expected (Reuters) (NYTimes) (The Hill) (SCRIP-$)
  • Get Up-to-Speed on FDA's Big Week of Approvals, Filings and Designations (Pink Sheet-$) (SCRIP-$)
  • BMS and AbbVie Score FDA Approval for HCV Drugs (Pink Sheet-$) (SCRIP-$)
  • FDA Ponders Trimming PDUFA Programs (Gray Sheet-$)
  • Drug Costs:  The next episode of the American horror story (Bioworld)
  • ANDA Reviews: First-Cycle Desired, But Two-Cycles OK? (Pink Sheet-$)
  • FDA Biomarker Program Needs Overhaul, Genentech Says (Pink Sheet-$)
  • Improving Access to Medical Devices: FDA Uses Existing Clinical Data to Reduce Premarket Data Needs (FDA)
  • Patient generated healthcare data (MassDevice)          
  • FDA Mulls Expansion of Diagnostic Test Oversight (MedpageToday)
  • FDA, CDRH Receive Slight Boosts From Senate In 2016 Funding Bill (Gray Sheet -$)

In Focus: International

  • EU Follows Through on Ban of 700 generic drugs with trials by GVK Biosciences (EconomicTimes)
  • EMA to review Inductos Implants for GMP Issues (EMA)
  • Sanofi's Praluent Closes Gap On Repatha In Europe in latest CHMP opinions (SCRIP-$)
  • Safety review launched into diabetic drugs (OnMedica)
  • Foreign Industry Unites Against Annual Japan Price Cuts (Gray Sheet- $)
  • GSK's Mosquirix vaccine clears EU hurdle but is no 'complete answer' to malaria (SCRIP-$)
  • Podcast: Medical Device Distribution in the Middle East (Emergo)

US: Pharmaceuticals and Biotechnology

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

  • HTG Lands ISO 13485:2003 Recertification (GenomeWeb)
  • Data from phase 1b study of Aducanumab  for Alzheimer's treatment (MNT)
  • Positive initial phase 2a study data with ANAVEX 2-73 showing early evidence of improving cognition in patients with Alzheimer's disease (MNT)
  • Kyprolis sNDA Submitted for Expanded Relapsed Multiple Myeloma Indication (MPR)
  • Biogen Idec Finalizes Phase III Plans For Aducanumab In Alzheimer’s (Pink Sheet-$)
  • Olysio sNDA Submitted for Labeling Update (MPR)

US: Pharmaceuticals and Biotechnology: General

  • FDA Ponders Trimming PDUFA Programs (Gray Sheet-$)
  • Price vs Value: A Distinction With a Difference (DrugWonks)
  • Drug Costs:  The next episode of the American horror story (Bioworld)
  • ANDA Reviews: First-Cycle Desired, But Two-Cycles OK? (Pink Sheet-$)
  • FDA Biomarker Program Needs Overhaul, Genentech Says (Pink Sheet-$)
  • Biomarkers Are Not All Equal When It Comes to Regulatory Review (Pink Sheet-$)
  • Compounders Press for Revised MOU (FDANews) (Law360-$)
  • 900,000 Side Effect Reports That You Have Never Seen (RxViewBlog)

US: Medical Devices

  • Improving Access to Medical Devices: FDA Uses Existing Clinical Data to Reduce Premarket Data Needs (FDA)
  • Patient generated healthcare data (MassDevice)          
  • FDA Mulls Expansion of Diagnostic Test Oversight (MedpageToday)
  • Experts question the accuracy of blood glucose meters (FierceMedicalDevices)
  • Oxford Performance Materials gets FDA nod for 3-D printed spinal implant (FierceMedicalDevices)
  • Researchers ready super-tiny, micro-laparoscopy robotic surgical system for the clinic (FierceMedicalDevices) (medGadget)
  • New Study Demonstrates LINX® Safety and Efficacy Rivals Laparoscopic Nissen Fundoplication (Press)
  • UDI Impact on Medical Device Labeling: Lifting The Lid On Pandora's Box (MedDeviceOnline-Gated)

US: Assorted and Government

  • FDA, CDRH Receive Slight Boosts From Senate In 2016 Funding Bill (Gray Sheet -$)
  • Are IPRs Impacting the Pharmaceutical Industry? (PharmTech)
  • Bristol-Meyers, Pfizer Sued Over Blood Thinner Death (Law360-$)
  • Medtronic Can't Escape Patent Suit, Texas Judge Rules (Law360-$)

Upcoming Meetings and Events

Europe

  • EU Follows Through on Ban of 700 generic drugs with trials by GVK Biosciences (EconomicTimes)
  • EMA to review Inductos Implants for GMP Issues (EMA)
  • Sanofi's Praluent Closes Gap On Repatha In Europe in latest CHMP opinions (SCRIP-$)
  • Safety review launched into diabetic drugs (OnMedica)
  • Novartis melanoma drug combination wins EU green light (Reuters) (BioSpectrum)
  • Early access to medicines scheme: expired scientific opinions (MHRA)
  • Public consultation on the second draft of: Core protocol Pilot for Additional Evidence Generation (EUnetHTA)
  • Astellas antifungal gets EU nod (PharmaTimes)
  • EMA Grants Accelerated Assessment to Empliciti for Multiple Myeloma (Press)

India

  • Medicines: Veg or Non-veg? (BioSpectrum)
  • Task Force recommends simplification of approval process for clinical trials (PharmaBiz)

Japan

  • Eisai Submits NDA for Epilepsy Drug in Japan (Press)
  • Foreign Industry Unites Against Annual Japan Price Cuts (Gray Sheet- $)

Other International

  • GSK's Mosquirix vaccine clears EU hurdle but is no 'complete answer' to malaria (SCRIP-$)
  • Podcast: Medical Device Distribution in the Middle East (Emergo)
  • Taiwan, Asian nations ink deal to promote biotech sector (BioSpectrum)
  • Fully Funded Phase 4 Trials Necessary To Fill Knowledge Gaps On Malaria Vaccine Effectiveness (BBC)

General Health and Interesting Articles

Regulatory Reconnaissance #604– 27 July 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 @Michael_Mezher 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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