Regulatory Focus™ > News Articles > Regulatory Reconnaissance: FDA Probing PCSK9 Inhibitors Over Neucognitive Concerns (10 March 2014)

Regulatory Reconnaissance: FDA Probing PCSK9 Inhibitors Over Neucognitive Concerns (10 March 2014)

Posted 10 March 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.

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In Focus: US

In Focus: International

  • EU industry link-up to boost product tracking system (SCRIP-$)
  • Collaboration Holds the Key to Clarity on EN ISO 14971:2012 (MDDI)
  • Indian Regulators Call Allegations of Fake Indian Drugs "Baseless" (BioSpectrum) (S4S) (PharmaBiz)
  • Takeda files for diabetes drug trelagliptin succinate approval in Japan (Pharma Letter-$) (SCRIP-$) (BioCentury) (Press)

US: Pharmaceuticals/Biotechnology

  • FDA Probing PCSK9 Inhibitors Over Concerns About Neurocognitive Effects (Reuters) (PMLive) (SCRIP-$) (Pharma Letter-$) (Forbes) (BioCentury) (Fierce) (Bloomberg)
  • Ranbaxy hit with second generic Lipitor recall (Pharmafile) (WSJ-$) (Reuters) (Pharma Times) (Bloomberg)
  • US FDA, EMA offer similar explanations for ADC regulations (BioPharma Reporter)
  • 500 Drugs Updated with Directions for Child Use Since 2002 (Scientific American)
  • Seven year market exclusivity? Industry hits out at Obama's pro-biosimilar Budget (BioPharma Reporter)
  • The Drug Supply Chain Security Act Explained (RxTrace)
  • Drug Shortages: Purchasers Requiring Paybacks; FDA's Review Policy Questioned (Pink Sheet-$)
  • Celebrex Generics: Will Any Qualify For 180-Day Market Exclusivity? (Pink Sheet-$)
  • On FDA's Decision to Phase out Antibacterial Hand Soap (TIE)
  • FDA's Office of Prescription Drug Promotion (OPDP) Enforcement: A Summary of 2013 Warning and Untitled Letters (Porzio) (PDF)
  • FDA Says Zefazone (Cefmetazole Sodium) Was Not Withdrawn for Reasons of Safety or Efficacy (FDA)
  • Local foundation petitions White House for approval of DMD drugs (BizJournal)
  • California Board of Pharmacy Issues Notice Stating That It Has Inactivated California's E-Pedigree Provisions (Porzio)

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

  • Ph III study for Jakavi meets endpoint in patients with polycythemia vera (Pharma Letter-$) (BioCentury) (Fierce) (Press) (Pharma Times)
  • FDA Designates Regado's REG1 in PCI as a Fast Track Development Program (Press)
  • Panel recommends Northwest Bio brain-cancer trial continue (Reuters) (Fierce)
  • NewLink's cancer vaccine brings hopeful investors back down to earth (Fierce)

US: Pharmaceuticals and Biotechnology: General

  • Gilead's Sovaldi sales through the roof already, analyst predicts at least $8B this year (Fierce)
  • UK drug group rattled by Texan snake round-up dispute (FT-$)
  • J&J Selling K-Y Lubricant Brand to Reckitt Benckiser (PharmPro)

US: Medical Devices

  • FDA, Global Partners Prepare To Ramp Up Single-Audit Program (Gray Sheet-$)
  • Anne Wojcicki Discusses Future of 23andMe, Consumer Genetics at SXSW (MDDI)(Guardian)
  • Medical Devices; General and Plastic Surgery Devices; Classification of the Absorbable Lung Biopsy Plug (FDA)
  • Mixed response to Alzheimer's blood test (Pharma Times) (Pharmafile)
  • AngioDynamics lands FDA win, takes over 510(k) process for rejected Medcomp (Mass Device)
  • Medtronic denies involvement with on-demand orgasm implant (Mass Device)
  • MedShape Morphix SP Suture Anchor Promotes Bone Tissue Growth, Gets FDA Nod (MedGadget)
  • Cardiovascular Systems Receives FDA Clearance for Diamondback Devices Designed to Expand the Treatment of Peripheral Artery Disease (PAD) (Press)
  • Class 1 Recall for Philips Respironics' Trilogy Ventilator (FDA)
  • February 2014 510(k) Clearances (FDA)

US: Dietary Supplements

  • FDA Supplement GMP Warnings Cite Specification Failings (Tan Sheet-$)

US: Assorted And Government

  • FDA Winding Down White Oak Construction; Outside Rents Going Up (Pink Sheet-$)
  • Commissioner Hamburg. On a unicycle. Enough said. (Twitter)
  • What's new in the FDA's 2015 budget? (FDA)
  • FDA's Budget Justification (FDA)
  • SCRIP US Capitol Capsule: Myriad Decision to Lead to More Patent Rejections (SCRIP-$)
  • Obama's regulatory czar to testify before Senate panel (The Hill)
  • HIT startup uses EHR data to get docs to recommend clinicial trials to patients (MedCity News)

Europe

  • EU industry link-up to boost product tracking system (SCRIP-$)
  • Collaboration Holds the Key to Clarity on EN ISO 14971:2012 (MDDI)
  • RoHS 2 Directive (2011/65/EU) Changes to Annex IV (Med Dvcs & Control/Monitoring Instruments) Exemptions Listing (Eisner Safety)
  • MolMed seeking conditional EU approval of TK (BioCentury)
  • ABPI worried about Xgeva use (Pharmafile)

India

Japan & China

General Regulatory And Interesting Articles

  • A New Biocompatibility Test: Zebrafish Embryo Toxicity Testing (MDDI)
  • New class of antibiotics discovered (India Times)

Regulatory Reconnaissance #272 - 10 March 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.


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