Regulatory Focus™ > News Articles > Regulatory Recon: AbbVie Petitions FDA on Biosimilar Labeling (4 June 2015)

Regulatory Recon: AbbVie Petitions FDA on Biosimilar Labeling (4 June 2015)

Posted 04 June 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: AbbVie Petitions FDA on Biosimilar Labeling (4 June 2015)

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

In Focus: US

In Focus: International

  • How Influential Are Patient/Professional Group Submissions on Reimbursement Decisions for Orphan Drugs? (Context Matters)
  • Towards a general approach for the EU medical devices and IVD regulation proposals? (MDL)
  • Commission Rejects "Stop Vivisection" European Citizens' Initiative (EC)
  • European Commission Plans Major Revisions to Drug GMPs (FDAnews-$)
  • Docs shocked at revival of UK Medical Innovation Bill (SCRIP-$)
  • Predictors of a Positive Cancer Drug Fund Decision (Context Matters)
  • The Case For Streamlining India’s Clinical Trial Approval Process (24 Insight)
  • Indian industry acknowledges some compliance shortcomings, survey finds (Fierce)
  • Remsima first biosimilar to be approved via Brazil's comparability pathway (BioPharma Reporter)

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US: Pharmaceuticals and Biotechnology

  • AbbVie seeks unique labels for biosimilars (BioCentury) (Policy and Medicine) (FDA Law Blog)
  • Federal Circuit dances with biosimilar law's complexity in Zarxio fight (SCRIP-$) (Bidness) (Law 360-$) (Reuters)
  • FDA Program Cuts Loom If ‘Cures’ Bill Isn’t Fully Funded, Ostroff Warns (Pink Sheet-$)
  • Copaxone And Complex Generics: Difficult-To-Copy Does Not Mean Impossible (RPM Report-$)
  • Bill Promoting Daily Contraceptive OTC Switch Prompts Criticism As Affordable Care Act Attack (Pink Sheet-$)
  • FDA Grants 12 Year Exclusivity to Flublok Influenza Vaccine (Press)
  • The 21st Century Cures Act — Will It Take Us Back in Time? (NEJM)
  • FDA Advisory Committee to Review the Impact of Oxycontin ER’s Abuse-Deterrent Formulation on Abuse (Tarius)
  • FDA Still Working on Duchenne Guidance (PPMD)

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

  • Adapt Pharma Limited Commences Rolling NDA Submission To The FDA For Intranasal Naloxone (Press)
  • FDA Grants Breakthrough Therapy Designation for Genzyme’s Olipudase Alfa (Press) (PMLive)
  • Results from Investigational IMPROVE-IT Study of VYTORIN® (ezetimibe and simvastatin) Published in the New England Journal of Medicine (Merck)

US: Pharmaceuticals and Biotechnology: General

  • How Much Should a Miracle Drug Cost? (Bloomberg)
  • House Liberals Hope Drug-Cost Concerns Will Help Kill Trade Bill (National Journal)
  • How States Are Working to Control Prescription Drug Costs (National Journal)

US: Medical Devices

  • Justice Dept. expands probe of scope makers linked to superbug outbreak (Reuters)
  • St. Jude Medical gets FDA OK to resume trial of Portico TAVR (Fierce) (Press)
  • March 2015 PMA Approvals (FDA)
  • Roche receives FDA clearance for the cobas HSV 1 and 2 Test for the detection of herpes simplex virus (Press)
  • FDA Clears NovaBay Pharmaceuticals’ New High-Tech Device, intelli-Case, for Safely Disinfecting Contact Lenses with Hydrogen Peroxide (Press)
  • FDA clears first 'smart' spirometer, enabling continuous tracking of lung function via tablet (Fierce)
  • Accuro Handheld Ultrasound Needle Guidance System Cleared by FDA (Press)
  • FDA approves enhancement to only minimally invasive device for epilepsy (Fierce)
  • FDA Expands Label Indication for PleuraFlow to Reduce Retained Blood (Press)
  • Baxter Initiates Voluntary Recall of Select Product Codes of Peripheral Vascular Patch (FDA)

US: Dietary Supplements

  • Will FTC Kill Homeopathic Products – or Will FDA? (FDA Law Blog)
  • Mandatory AERs in Supplement Industry Fall for First Time in Five Years (NPI)

US: Assorted And Government

  • House panel approves toxic chemical safety bill (The Hill) (E&C)
  • Fundraising and the Delayed Kidney Transplantation: A Loophole in the Ban against Commercialization? (Harvard)
  • Senate Judiciary Committee considering IPR reforms (BioCentury)
  • The curious case of Finland and the US trade watch list (SCRIP-$)

Upcoming Meetings and Events

Ebola Outbreak

  • Zoloft as Ebola cure? Antidepressant is one of a number of promising drugs being looked at by scientists (WaPo) (LA Times)

Europe

  • How Influential Are Patient/Professional Group Submissions on Reimbursement Decisions for European Medicines Agency Orphan Drugs? (Context Matters)
  • Towards a general approach for the EU medical devices and IVD regulation proposals? (MDL)
  • Commission Rejects "Stop Vivisection" European Citizens' Initiative (EC)
  • European Commission Plans Major Revisions to Drug GMPs (FDAnews-$)
  • Docs shocked at revival of UK Medical Innovation Bill (SCRIP-$)
  • Predictors of a Positive Cancer Drug Fund Decision (Context Matters)
  • Price cut secures UK reimbursement for Boehringer's Vargatef  (SCRIP-$)
  • The age of phage? World first cGMP certification for phage therapy plant (In-Pharma)
  • EU approves constipation drugs (PharmaTimes) (EPR)
  • EC approves Helsinn’s Akynzeo for prevention of chemotherapy-induced nausea and vomiting (EPR)
  • St. Jude Medical Receives CE Mark Approval of Industry's First Neuromodulation Trial System to Employ Apple and Bluetooth Wireless Technology (Press)

India

  • The Case For Streamlining India’s Clinical Trial Approval Process (24 Insight)
  • Indian industry acknowledges some compliance shortcomings, survey finds (Fierce)
  • Pharma industry grappling with pricing, regulatory issues: Survey (India Times)

Canada

  • Health Canada Adopts ICH Q4B Annex 12 (R1) (HC)

Australia

  • Australia Adopts EU Drug Guidelines (FDAnews-$)
  • TGA: No Need for Routine Blood Monitoring With Xarelto—Yet (TGA)

Other International

  • Remsima first biosimilar to be approved via Brazil's comparability pathway (BioPharma Reporter)

General Regulatory And Interesting Articles

  • Huggable Smart Teddy Bear Starting Clinical Trial at Boston Children’s Hospital (MedGadget)
  • One on One with BioCentury: Karl Deisseroth (BioCentury)
  • International Group Says Mammograms Of 'Limited' Value For Women In 40s (NPR)

Regulatory Reconnaissance #569 – 4 April 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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