Regulatory Focus™ > News Articles > Regulatory Recon: FDA Accepts Submission for Enbrel Biosimilar (2 October 2015)

Regulatory Recon: FDA Accepts Submission for Enbrel Biosimilar (2 October 2015)

Posted 02 October 2015 | By Zachary Brennan 

Regulatory Recon: FDA Accepts Submission for Enbrel Biosimilar (2 October 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 , @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • FDA accepts Sandoz submission for proposed biosimilar entanercept (Press) (Reuters) (PharmaTimes) (BioPharma-Reporter)
  • FDA Approves Keytruda for advanced NSCLC (FDA)
  • FDA Approves Expanded Use of Trial System for Incontinence Therapy (Press) (Mass Device)
  • FDA Chief Nominee: Lines Must Divide Medical Product Review, Public Partnerships (InsideHealthPolicy-$)
  • FDA Urged To Simplify Device Labeling At Recent Gathering (Gray Sheet-$)
  • FDA to Address Advanced Companion Diagnostic Tests (BNA)
  • More Than The Rise In Biologics Prompts Reorg At FDA (Life Science Leader-$)
  • FDA Seeks Feedback on PDUFA User Fee Adjustment Mechanism (FDANews-$)(Report)

In Focus: International

  • Russian Drugs Pass as Supplements in U.S. (MedPage Today)
  • Pharmaceutical Associations Welcome MEDICRIME Convention, Landmark Tool to Curb Global Medicines Counterfeiting (IFPMA)
  • German physicians not pressured to switch to biosimilar infliximab (GaBI)
  • The Centre for Process Innovation Launches Open-Access Biologics Manufacturing Site (BioPharm International)

US: Pharmaceuticals and Biotechnology

  • Xenoport to seek partner to develop drug; CEO steps down (Reuters)
  • TEVA buys Mexico’s RIMSA for $2.3bn (PMLive) (PharmaLetter-$)
  • Biomarin grabs Kuvan from Merck for $380M cash up front (BioWorld-$)
  • Regeneron in deal with Mitsubishi Tanabe for pain therapy candidate fasinumab in Asia (PharmaLetter-$)
  • Amicus Therapeutics Provides U.S. Regulatory Update for Migalastat Monotherapy (Press)
  • Biotech Stock Mailbag: Akebia, Neuralstem, Arrowhead (TheStreet)
  • Houston Biotech DNAtrix Partners With Merck on Brain Cancer Treatment (Xconomy)
  • Elcelyx Raises $40M, Begins Late-Stage Trial of New Diabetes Drug (Xconomy)
  • Valeant Hits Apotex With Patent Suit Over Colitis Drug (Law360-$)
  • Eisai Loses Bid For Longer Exclusivity In FDA Delay Fight (Law360-$)
  • Professor Stephen Gough joins Novo Nordisk as senior principal clinical scientist (Pharmafile)
  • The Challenges Surrounding Immunology (Life Science Leader-$)
  • How You Can Boost Your Biopharma Commercial Profitability (Life Science Leader-$)
  • GSK Must Face Paxil Liability Suit (Law360-$)
  • Baxter Recalls More Sodium Chloride Injection Due to Sterility Issues (FDANews-$)
  • Mylan Infringed Cumberland's Acetadote Patent, Judge Rules (Law360-$)
  • Research Triangle Foundation Lands $50M to Jumpstart Park Center Plan (Xconomy)
  • Genzyme opts into gene silencing therapy for haemophilia (PMLive)
  • CPhI Report Predicts Switch to Continuous Manufacturing (PharmTech)

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

  • Merck takes novel immuno-oncology drug into clinical trials (PMLive)
  • Bayer Scores a Big Win in Action Involving Dietary Supplement Claim Substantiation (FDA Law Blog)
  • FDA approval for guaifenesin generics (GaBI)
  • Sanofi launches generic version of arthritis drug Arava in US (PharmaLetter-$)

US: Medical Devices

  • Apple is developing an electronic ring full of biosensors (FierceMedicalDevices)
  • Yale signs on to Apple's ResearchKit for heart disease study (FierceMedicalDevices)
  • Former US army physician sentenced to prison for medical device kickback scheme (BMJ-$)
  • EarLens wins FDA 510(k) for novel hearing aid (Mass Device)
  • Big Data and Medication Alerts: Interview With Dr. Gidi Stein, CEO of MedAware (MedGadget)
  • Device Firms Cheer ICD-10 Debut, While Providers Brace For Chaos (Gray Sheet-$)
  • How Mobile Health Data Can Boost Traditional Medtech (MDDI)
  • New Data On Smartinhaler Clinical Outcomes Shows Increased Adherence, Reduction In Severe Attacks (Med Device Online)
  • Philips And Massachusetts Institute Of Technology Team Up To Make Managing Brain Injuries Less Of A Headache (Press)

US: Assorted and Government

  • US plan to assess risky disease research takes shape (Nature)
  • In Boston, Clinton calls for more US regulation for painkillers (Boston Globe)
  • Kavli, NIH Invest $138m To Explore Brain's 'Frontier' (SCRIP-$)
  • CDC Supports New WHO Early Release HIV Treatment and PrEP Guidelines (ICT)
  • SEC Gets $7M Judgment In Pharma Pump-And-Dump Scheme (Law360-$)
  • FTC Returns Money to Consumers Who Bought Allegedly Bogus Weight-Loss Products (FTC)

Upcoming Meetings and Events              




Ebola Outbreak

  • Ebola data and statistics (WHO)

Other International

  • Hikma acquires Egyptian drugmaker (PharmaLetter-$)
  • Taiwan food and drug agency finds excessive pesticide residues in TWG Tea product, TWG Tea says issue overblown (Straits Times)
  • Nigeria: That NAFDAC-Media Partnership for Innovation (AllAfrica)

General Health and Other Interesting Articles

  • Don’t Repeal the Cadillac Tax (NY Times)
  • Human Genome Project: Twenty-five years of big biology (Nature)
  • Hospital Care Unaffected By Quality Payments, GAO Finds (Kaiser Health News)
  • Feds short insurers $2.5 billion on exchange plan losses (Modern Healthcare)
  • Senate HELP leader calls on CMS to delay and phase in next EHR rule (Modern Healthcare)
  • A tumor stole every memory I had. This is what happened when it all came back (Quartz)

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

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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