Regulatory Focus™ > News Articles > Regulatory Recon: Application for Biosimilar Remicade to go Before FDA AdComm (9 February 2015)

Regulatory Recon: Application for Biosimilar Remicade to go Before FDA AdComm (9 February 2015)

Posted 09 February 2015 | By Alexander Gaffney, RAC

Regulatory Recon: Application for Biosimilar Remicade to go Before FDA AdComm (9 February 2015)

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

In Focus: US

  • FDA AdComm to Discuss Celltrion Application for Biosimilar Remicade (FDA)
  • FDA approves Lucentis for diabetic retinopathy (BioCentury) (PharmaTimes) (SCRIP-$) (FDA) (Press)
  • With FDA Input, Some Companies Moving Toward Continuous Manufacturing (WSJ-$)
  • GPhA President Neas Apologizes To Upton Over Initial Response To 21st Century Cures Draft Bill (IHP-$)
  • Guidance: Complicated Intra-Abdominal Infections--Developing Drugs for Treatment (FDA)
  • FDA Gets a New leaders for its Office of Criminal Investigations (Main Justice)
  • 2015 Policy Landscape: A Biomedical R&D Planning Guide (FasterCures)
  • Knee Replacement Device Unapproved, but Used in Surgery (NYTimes)
  • Guidance: Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices (FDA)
  • 6 Emerging FDA Inspection Trends for Devices (MDDI)
  • FDA called test used by New York AG invalid a year before recall (NewHope) (Tan Sheet-$)
  • Herbal supplements industry lashes out at fraud claims (CBS) (NI-USA) (NPI) (AP)
  • What are the Last 6 FDA Commissioners Up to These Days, and What Does That Mean for Margaret Hamburg's Future After FDA? (Pink Sheet-$)
  • Who is Dr Stephen Ostroff? (SCRIP-$)

In Focus: International

  • Guinea to expand use of experimental anti-Ebola drugs (Reuters)
  • Pharma files complaint to stop Italy off-label law (PharmaTimes)
  • Who’s Doing What On EMA Call For GVK Suspensions (PharmAsia-$)
  • India may finally usher in pharma data protection (Financial Express)
  • Canada Wants Alexion to Repay Sales Generated by ‘Excessive Pricing’ (Pharmalot)

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  • Join RAPS, Wednesday, 18 February for New China Medical Device Regulations: Best Practices for Clinical Trials.

US: Pharmaceuticals and Biotechnology

  • FDA AdComm to Discuss Celltrion Application for Biosimilar Remicade (FDA)
  • FDA approves Lucentis for diabetic retinopathy (BioCentury) (PharmaTimes) (SCRIP-$) (FDA) (Press)
  • With FDA Input, Some Companies Moving Toward Continuous Manufacturing (WSJ-$)
  • GPhA President Neas Apologizes To Upton Over Initial Response To 21st Century Cures Draft Bill (IHP-$)
  • Guidance: Complicated Intra-Abdominal Infections--Developing Drugs for Treatment (FDA)
  • Bye, Bye ‘Breakthrough’: Bristol, Merck HCV Drugs Face Loss Of Special Designation (Pink Sheet-$)
  • FDA Gets a New leaders for its Office of Criminal Investigations (Main Justice)
  • FDA AdComm to Discuss GSK's Breo Ellipta Application (Tarius) (Press) (FDA)
  • Huge Prescriber of Risky Antipsychotic Drug to Plead Guilty to Taking Kickbacks from Teva (ProPublica)
  • Virginia Senate Panel Combines Three Right-to-Try Bills (Thompson-$)
  • Indiana Right-to-Try Bill Receives House Committee Do Pass Nod (Thompson)
  • Growth Concerns Loom For Daiichi Sankyo on Drug Warning (Bloomberg)
  • FDA’s Role in Preventing Influenza and Protecting the American Public Through Vaccination (FDA)
  • Amgen Demands Injunction In Biosimilar Suit (Law 360-$)
  • Why the FDA wants to double inspectors at Indian manufacturing facilities (BioPharma Dive)
  • Movantik No Longer Controlled Substance, DEA Rules (MPR)
  • Reagan-Udall Foundation Releases 2015 Research Agenda (IMEDS)
  • Interoperability And The DSCSA (RxTrace)
  • GFR decline as an end point in trials of CKD: a viewpoint from the FDA. (PubMed)
  • Early biomarkers of doxorubicin-induced heart injury in a mouse model. (PubMed)
  • Utah Introduced Biosimilars Notification Bill (Scout)

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

  • Achillion, Gilead drug cocktail cures hepatitis C in six weeks (Reuters)
  • GSK announces positive overall survival results from phase III COMBI-d study of dabrafenib (Tafinlar) and trametinib (Mekinist) combination (Press)
  • Upcoming events: Antidote data from Portola and US action on Actavis antibiotic (EP Vantage)
  • Advanced Inhalation Therapies Receives Orphan Drug Designation of its Proprietary High Dose Formulation of Nitric Oxide for Adjunctive Treatment of Cystic Fibrosis (Press)
  • La Jolla Pharmaceutical Company Announces Special Protocol Assessment for Planned Phase 3 Trial of LJPC-501 in Catecholamine-Resistant Hypotension (Press)
  • Universal Flu Vaccine Shown ‘Feasible’ And Safe In Phase I Study, NIH’s Fauci Says (Pink Sheet-$)
  • Alkermes says trial results of reformulated Tecfidera show fewer side effects (BizJournal)

US: Pharmaceuticals and Biotechnology: General

  • 2015 Policy Landscape: A Biomedical R&D Planning Guide (FasterCures)
  • John Oliver returns with a devastating message about pharmaceutical marketing (Vox)
  • A Look at Some Vaccine-Related Legislation in Several States (AP)
  • Drug price wars 'drive value': Medical exec (CNBC)

US: Medical Devices

  • Knee Replacement Device Unapproved, but Used in Surgery (NYTimes)
  • Guidance: Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices (FDA)
  • CDRH Releases Draft Guidance on Trials For Nail Fungus (Thompson)
  • FDA Authorizes use of new Ebola Test (FDA)
  • 6 Emerging FDA Inspection Trends for Devices (MDDI)
  • FDA Inspections: Hope is Not a Strategy (MDDI)
  • FDA approves the first 3-D breast CT scanner without tissue compression from Koning (Fierce)
  • Judge: Come to an agreement over transvaginal mesh in two days, or else the barrage of lawsuits will commence (Fierce)
  • Medtronic settles another whistleblower suit for $2.8m (Mass Device)
  • Positive data for Neovasc study of stent-like angina device (Mass Device)
  • Class 1 Recall for Maquet Humidifier (FDA) (FDA)

US: Dietary Supplements

  • FDA called test used by New York AG invalid a year before recall (NewHope) (Tan Sheet-$)
  • Herbal supplements industry lashes out at fraud claims (CBS) (NI-USA) (NPI) (AP)
  • Class-action suit filed for 'phony' herbal supplements (NewHope)  (Strasburger) (Law 360-$)
  • FDA Gets Supplement Co. Shut Down For Treatment Claims (Law 360-$)

US: Assorted And Government

  • What are the Last 6 FDA Commissioners Up to These Days, and What Does That Mean for Margaret Hamburg's Future After FDA? (Pink Sheet-$)
  • Who is Dr Stephen Ostroff? (SCRIP-$)
  • FDA’s Rent Is Too Damn High: Consolidated Labs Cost More Than Off-Campus Space (Pink Sheet-$)
  • FDA Field Operations Would Endure Reductions Under Budget (Pink Sheet-$)

Upcoming Meetings

Ebola Outbreak

  • Guinea to expand use of experimental anti-Ebola drugs (Reuters)
  • FDA Authorizes use of new Ebola Test (FDA)
  • German drugmaker Stada to launch rapid test for Ebola (Reuters)

Europe

  • Pharma files complaint to stop Italy off-label law (PharmaTimes)
  • Who’s Doing What On EMA Call For GVK Suspensions (PharmAsia-$)
  • EU Team Willmott: ready for regulatory action, but will new team bring new ideas for change? (Clinica-$)
  • MDD Harmonized List of Standards Website Moved (Elsmar)
  • Work plan for the Biosimilar Medicinal Products Working Party (BMWP) 2015 (EMA)
  • EUCROF Congress Focus on Clinical Trial Regulation (EFPIA)
  • Swissmedic examines drugs trialled by GVK Biosciences (Business Line)
  • GSK seeks EMA approval for additional indication of eltrombopag to treat ITP (PBR)

India

  • India may finally usher in pharma data protection (Financial Express)
  • CDSCO working to bring in new norms related to online medicine sales (CDSCO)
  • Insight On India – Highlights For The Week Of Feb 1-7, 2015 (Two-Four Insight)

Japan

  • Sorin wins MRI-safe pacemaker approval in Japan (Mass Device)

Canada

  • Canada Wants Alexion to Repay Sales Generated by ‘Excessive Pricing’ (Pharmalot)
  • Canadians Have A Right To Assisted Suicide, High Court Says (NPR) (MedPage Today) (Vox)
  • Recalled Drugs Still on Store Shelves (The Star)

Australia

  • TGA Regulators Recall Oxygen Concentrator Over Fire Risk (TGA)

General Regulatory And Interesting Articles

  • Drug Combinations a Good Approach for Infectious Fungus, Research Shows (Press)
  • Estimating the Economic Costs of Antimicrobial Resistance (RAND)
  • Testosterone Drop May Be Result, Not Cause, of Decline in Sexual Activity (Reuters)
  • Dizziness Can Be a Fatal Side Effect of Many Medications (SciAm)
  • Why are there deadly drugs? (BMC Medicine)
  • Common antibiotic taken with a diuretic linked to sudden death (PharmJournal)

Regulatory Reconnaissance #489 – 9 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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