Regulatory Focus™ > News Articles > Regulatory Recon: FDA Gets a Third Biosimilar Filing, This Time from Apotex (18 February 2015)

Regulatory Recon: FDA Gets a Third Biosimilar Filing, This Time from Apotex (18 February 2015)

Posted 18 February 2015 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Gets a Third Biosimilar Filing, This Time from Apotex (18 February 2015)

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

In Focus: US

  • Apotex Announces FDA Has Accepted For Filing its Biosimilar Application for Filgrastim (Press) (SCRIP-$)
  • Can Accelerated Drug Approval in Oncology Go Any Faster? (Thomson Reuters)
  • Compassionate access still unaddressed a year after Josh Hardy media campaign (BioCentury-$)
  • A Decision Tree for Compassionate Use (BioCentury-$)
  • How Iodine is Working With FDA to Rate Your Medications (Bloomberg)
  • Can the AIA’s New IPR and PGR Post-Grant Proceedings Trigger a Forfeiture of 180-Day Exclusivity Under the Failure-to-Market Provisions? (FDA Law Blog)
  • Gilead’s Pill Can Stop HIV. So Why Does Almost Nobody Take It? (Bloomberg)
  • Cutting the Gordian Helix — Regulating Genomic Testing in the Era of Precision Medicine (NEJM)
  • Pelvic Mesh lawsuits: J&J drops claim that women were asked to lie for payouts (Mass Device)

In Focus: International

  • Safety signals: EMA recommendations now available in all EU languages (EMA)
  • Pharma firms violate marketing regulations every week, claims study (PMLive) (MNT) (PLos)
  • Off-label law undermines regulatory integrity: EFPIA chief (PharmaTimes)
  • How companies, EMA hope to improve dose-finding in Phase II (BioCentury-$)
  • China FDA issues draft revisions to GCPs (BioCentury)

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US: Pharmaceuticals and Biotechnology

  • Can Accelerated Drug Approval in Oncology Go Any Faster? (Thomson Reuters)
  • Compassionate access still unaddressed a year after Josh Hardy media campaign (BioCentury-$)
  • A Decision Tree for Compassionate Use (BioCentury-$)
  • How Iodine is Working With FDA to Rate Your Medications (Bloomberg)
  • Can the AIA’s New IPR and PGR Post-Grant Proceedings Trigger a Forfeiture of 180-Day Exclusivity Under the Failure-to-Market Provisions? (FDA Law Blog)
  • Background Analysis: US FDA Advisory Committee to Review Celltrion’s Proposed Biosimilar to Remicade– MAR 17, 2015 (Tarius)
  • To Correct or Not To Correct Social Media Misinformation (Corporate Counsel)
  • Consumer Advocates Prefer DeLauro Antibiotics Bill Requiring 'Superior' Drugs To Draft 'Cures' Measure (IHP-$)
  • FDA Expands Indication for REVLIMID (Lenalidomide) in Combination with Dexamethasone to Include Patients Newly Diagnosed with Multiple Myeloma (Press)
  • Compounding Pharmacy: New FDA Documents Concerning (Press)
  • Liver injury with novel oral anticoagulants: assessing post-marketing reports in the US Food and Drug Administration Adverse Event Reporting System (PubMed)
  • Assessment of a candidate marker constituent predictive of a dietary substance-drug interaction: case study with grapefruit juice and CYP3A4 drug substrates (PubMed)
  • Orphan drugs for rare diseases soar (Boston Herald)
  • More Drugs Born in Japan Approved for U.S. Market (WSJ)
  • FDA Updates REMS for Xeljanz (FDA)
  • Oklahoma House committee to take up "Right To Try" measure (AP)
  • Piedmont Animal Health lands FDA approval for animal health medication (BizJournal)

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

  • Apotex Announces FDA Has Accepted For Filing its Biosimilar Application for Filgrastim (Press) (SCRIP-$)
  • Seattle Genetics Submits Supplemental BLA to FDA for Phase 3 AETHERA Trial of ADCETRIS (Brentuximab Vedotin) in Post-Transplant Hodgkin Lymphoma Patients at High Risk of Relapse (Press)
  • Sanofi says Cerdelga trial shows promise (Reuters) (Press)

US: Pharmaceuticals and Biotechnology: General

  • CVS Says New Cholesterol Drugs Would Severely Strain the Healthcare System (Health Affairs)
  • Gilead’s Pill Can Stop HIV. So Why Does Almost Nobody Take It? (Bloomberg)
  • To Pfizer's Chantix, a new JAMA study sounds like 14M potential patients (Fierce) (Reuters) (NYTimes)
  • In whooping cough, an epidemic but different vaccine issues (Politico)
  • John Oliver's Big Pharma Rant Is Amusing -- But Misleading (Forbes)
  • MD Anderson doctor planning online petition against cancer drug costs (Houston Chronicle-$) (Fierce)
  • AbbVie Says FTC Withholding Key Docs In Pay-For-Delay Suit (Law 360-$)
  • Pharma polluter gets probation, not prison as feds sought (Fierce)
  • VaxInnate snags $53m under BARDA contract extension (SCRIP-$)

US: Medical Devices

  • Cutting the Gordian Helix — Regulating Genomic Testing in the Era of Precision Medicine (NEJM)
  • FDA's Whitepaper on Next-Generation Sequencing Tests (FDA)
  • Pelvic Mesh lawsuits: J&J drops claim that women were asked to lie for payouts (Mass Device)
  • Industry Urges FDA To Downclassify PEEK Rods For Spinal Fusion (Gray Sheet-$)
  • Materials Posted for 20 February 2015 Meeting of the Orthopaedic and Rehabilitation Devices Panel (FDA)
  • Miraculins Provides Pre-Submission De Novo Documentation to the FDA for Its Scout® Diabetes Technology (Press)
  • Seegene Receives FDA Clearance for its Herpes Simplex Virus Molecular Test (Seegene)

US: Assorted And Government

  • FasterCures Responds to 21st Century Cures Discussion Document (FasterCures)
  • Is Regulation to Blame for the Decline in American Dynamism? (Marginal Revolution)

Upcoming Meetings

Europe

  • Safety signals: EMA recommendations now available in all EU languages (EMA)
  • Pharma firms violate marketing regulations every week, claims study (PMLive) (MNT) (PLos)
  • Off-label law undermines regulatory integrity: EFPIA chief (PharmaTimes)
  • How companies, EMA hope to improve dose-finding in Phase II (BioCentury-$)
  • Matrix compares old vs new EU GMP Guide Part I, Chapter 8 - effective as of 1 March 2015 (ECA)
  • EC withdraws investigation of UK’s Patent Box scheme (PharmaLetter-$)
  • New chair appointed for MHRA's newly-formed Devices Expert Advisory Committee (MHRA)
  • MHRA licensing time-based performance measures (MHRA)
  • MHRA: Electronic instructions for use of medical devices: guidance on regulations (MHRA)
  • Simplify Medical wins CE Mark for MRI-safe cervical disc (Mass Device)
  • Too broad vs. too limited: Can the sports nutrition industry climb out of regulatory purgatory? (NutraIngredients)
  • NICE unveils guidelines to monitor antibiotic prescribing (Pharmafile)
  • The 3rd pilot rapid assessment on ‘Balloon Eustachian Tuboplasty for the treatment of Eustachian tube dysfunction’ is available (EUnetHTA)

India

  • Indian Government to come with plans to improve bulk drug manufacturing capacities (India Times)

China

  • China FDA issues draft revisions to GCPs (BioCentury)

Canada

  • Health Canada approves new, more potent HPV vaccine (CTV)

Australia

  • Australian Government funding for biologicals (TGA)
  • Donor screening tests: information requirements (TGA)

Clinical Trials

  • Differences and Similarities in Investigator Selection Between the US and EU (NAMSA)

General Regulatory And Interesting Articles

  • We have a big superbugs problem. This is what researchers think will solve it. (Vox)
  • Swiss developers debut telescopic contact lens triggered by blinking (Fierce)
  • Biodefense Aims to Simulate Human Bodies by Linking Mini "Organs on Chips" (SciAm)
  • Reducing Biofilm Buildup On Implanted Devices With Liquid-Infused Polymers (MedDeviceOnline)

Regulatory Reconnaissance #496 – 18 February 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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