Regulatory Focus™ > News Articles > Regulatory Recon: FDA Accepts Amgen's Humira Biosimilar for Review, Sanders Blocks Califf Nomination

Regulatory Recon: FDA Accepts Amgen's Humira Biosimilar for Review, Sanders Blocks Califf Nomination (26 January 2016)

Posted 26 January 2016 | By Michael Mezher 

Regulatory Recon: FDA Accepts Amgen's Humira Biosimilar for Review, Sanders Blocks Califf Nomination (26 January 2016)

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

  • Sanders Places Hold on FDA Nominee (Sanders)
  • FDA accepts BLA for Amgen's Humira biosimilar (BioCentury) (Press)
  • Why the FDA shouldn't bow to parental pressure over Duchenne drug (STAT)
  • Generic User Fee 'Relief' For Small Firms Would Mean Bigger Bills For Large One (Pink Sheet-$)
  • Should clinical trial data sharing be mandated? (Outsourcing-Pharma) (BioPharmaDive) (ICMJE)
  • Big Pharma's bet on Big Data creates opportunities and risks (Reuters)
  • Calls intensify to get Medicare to pay for genetic sequencing of tumors (STAT)
  • Ethical and Societal Questions Loom Large as Gene Editing Moves Closer to the Clinic (JAMA)
  • Zika Virus: An Emerging Health Threat (NIH) (WAMU)
  • A New Prescription for Lower Drug Prices (WSJ-$)
  • Trump backs Medicare negotiating drug prices (Politico) (The Hill)

In Focus: International                    

  • Big Pharma's worst nightmare (The Guardian)
  • High-Risk Device Scrutiny On Agenda Of 2016's First EU Medtech Regulation trilogue (Clinica-$)
  • Glaxo evaluating possibility of using vaccine technology for Zika (Reuters)
  • ANVISA Recognizes Second MDSAP Auditor (Emergo)

US: Pharmaceuticals and Biotechnology

  • Medivation Decides That Their Drug Isn't What They Thought (In The Pipeline)
  • Vicodin Scripts Down After Tighter Controls (MedpageToday)
  • Safety Issues Spur Foundation-Backed Akashi to Suspend Duchenne Trial (Xconomy) (Boston Business Journal)
  • Broad Institute Genomic Services offers genomic insight into Ninlaro (EPR)
  • Commonwealth Informatics inks data deal with FDA (MassDevice)

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

  • FDA Accepts Filing of Cardiovascular Outcomes Data for Jardiance (empagliflozin) (Press) (MedpageToday)
  • Shire resubmits lifitegrast NDA (BioCentury)
  • OncoMed hits the brakes on PhII pancreatic cancer trial, shares plummet (FierceBiotech) (Press)
  • Keytruda and AFM13 to be investigated in Hodgkin lymphoma (EPR)
  • Ixchelsis announces positive Phase 2a results for IX-01 (EPR)
  • ImmunoGen Earns Milestone with Bayer's Initiation of a Phase 2 Clinical Study Designed to Support Anetumab Ravtansine Registration (Press)
  • Santalis Announces First Subject Enrolled in Phase 2 Trial of East Indian Sandalwood Oil to Treat Pediatric Molluscum contagiosum (Press)
  • Athenex Announces US FDA Allowance of the Investigation New Drug Application of Oradoxel, the Proprietary Oral Form of Docetaxel (Press)
  • Aratana Therapeutics Files for First FDA Approval (Press)

US: Medical Devices

  • FDA Emphasizes Risk Analysis, Labeling Details In Interoperability Draft Guidance (Gray Sheet-$) (Focus)
  • With genetic testing results, more may be better (Reuters)
  • Longtime CDRH Quality Systems Expert And International Regulatory Guru Kim Trautman Departs From FDA (Gray Sheet-$)
  • Nanopore Trap Sucks In DNA for Rapid Sequencing of Genetic Material (medGadget)
  • Fecal immunochemical test effective for annual colon cancer screening (MNT)
  • FDA identifies more problems at Invacare Corp (Cleveland Business)
  • Expert View: Wearable Technology And The FDA Adoption Curve (SCRIP-$)
  • Biogennix Utilizes ImageIQ for Preclinical Image Analysis for FDA 510(k) Marketing Approval (Press)

US: Assorted and Government

Upcoming Meetings and Events              


  • Novartis adds 100 jobs at Lek site in Slovenia as it muscles up on biosimilars (FiercePharma) (Press)
  • Galapagos bowel drug fails in research trial (Reuters)
  • Patients given hip implants made the wrong size(The Telegraph)
  • Why doctors delay switching to new drugs (PharmaPhorum)
  • New drug for advanced prostate cancer (OnMedica)
  • Baxalta's rare blood cancer drug Oncaspar approved in Europe (PMLive)
  • EFPIA Member Companies and Associations Prepare for Transfer of Value Disclosures in 2016 (EFPIA)
  • PHARNEXT Collaborates with OrphanDev in Europe for Its Phase 3 Clinical Trial PLEO-CMT in CHarcot-Marie Tooth Type 1A Disease (CMT 1A) (Press)


  • Curb imports of APIs to boost local production, says task force on pharma (Economic Times)
  • Can Indian Avastin Events Add To Roche's Take On Off-Label Use? (SCRIP-$)
  • AP showcases exclusive medical device park at Arab Health Expo (Economic Times)
  • Made-in-India heart valves tied in red tape (Economic Times)


  • China FDA HIV treatment nods for Xian Janssen, GSK show going local helps (FiercePharmaAsia)
  • Hepatitis C patients seek access to better drugs: survey (China Daily)
  • 'China is hungry,' as drug innovation push continues (Outsourcing-Pharma)


  • Japan's national immunization program still trails Europe (Japan Today)

Other International

  • HSA Alerts Public to Three Health Products Found to Contain Undeclared Western Medicinal Ingredients (HSA)
  • Generics to challenge GSK's prostate, hair loss drug in Korea (Korea Herald)
  • Global Fund rushes HIV drugs to Uganda amid shortage (Reuters)
  • Redemption in Liberia: a hospital's painful recovery from Ebola (Reuters)

General Health and Other Interesting Articles

  • Some colorectal cancers found before screening starts at age 50 (Reuters)
  • Heart attacks in women can be different — and more deadly — than in men (Washington Post)
  • Two Cases Suggest Zika Virus Could Be Spread Through Sex (NYTimes)
  • Most child and adolescent deaths still preventable (Reuters)
  • Number of obese and overweight children under five 'alarming', WHO says (Reuters)
  • Treatments for Guillain-Barré syndrome have expanded (Washington Post)
  • Down with the tyranny of the Fitbit (Washington Post)

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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