Regulatory Focus™ > News Articles > Regulatory Recon: Court Clears Path for Sale of US' First Biosimilar (20 March 2015)

Regulatory Recon: Court Clears Path for Sale of US' First Biosimilar (20 March 2015)

Posted 20 March 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: Court Clears Path for Sale of US' First Biosimilar (20 March 2015)

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

In Focus: US

In Focus: International

  • EU reg adoption set for 2016, says UK devices expert (Clinica-$)
  • MHRA to Issue Certificates of Free Sale for Medical Devices (MHRA)
  • India's Health minister okays plan to monitor medical devices (India Times)
  • Is peer-reviewed science too slow to track wearable accuracy? (MobiHealthNews)

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US: Pharmaceuticals and Biotechnology

  • U.S. judge rejects Amgen bid to block 'biosimilar' Neupogen (Reuters) (Bloomberg) (Law 360-$) (BioCentury) (FDA Law Blog) (Patent Docs) (Pink Sheet-$)
  • FDA panel backs Glaxo asthma drug for adults, not adolescents (Reuters) (Fierce) (Tarius) (BioCentury) (SCRIP-$) (Pink Sheet-$)
  • Fueling a Biotech Boom: FDA Approving Everything, and no Safety Scandals—Yet (The Street)
  • Antibiotics Development Down, Congress, FDA Catch Up (Bloomberg BNA)
  • BASF Asks FDA To Weigh Whole Sunscreen TEAs, Not Separate Parts (Tan Sheet-$)
  • FDA, DOJ Pursuing Prosecutions for Manufacturing Quality, Clinical Trials Fraud (FDAnews-$)
  • FDA Posts Advisory Committee Materials for a Review of Sedation in Pediatric Clinical Trials (Tarius)
  • Bristol-Myers Hits Mylan With Suit Over Generic HIV Drug (Law 360-$)
  • Don't Rely on OTC Homeopathic Asthma Products, Warns FDA (MPR) (FDA)

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

  • Biogen's Alzheimer's drug impresses in early study with Phase III on the way (Fierce) (CNBC) (WSJ-$) (Forbes) (NYTimes) (Press) (The Street) (BioFlash)
  • Amicus to seek Fabry disease drug approval (AP) (BioCentury) (SCRIP-$)
  • Galderma Announces Positive Phase 3 Trial Results of Investigational Adapalene 0.3%/Benzoyl Peroxide 2.5% (0.3% A/BPO) for the Treatment of Acne (Press)
  • Cell Medica granted Orphan Drug designation for novel cellular therapy (MNT)

US: Pharmaceuticals and Biotechnology: General

  • Hedge Funds Have Found a New Way to Attack Drug Companies and Short Their Stock (Bloomberg)
  • Blanket generalizations about biotech firms being more efficient are unfounded (WSJ)
  • Tricare to tighten compound drug rules (Military Times)

US: Medical Devices

  • FDA Approves BIOTRONIK Eluna Pacemaker System with Full-Body ProMRI Technology (Press)
  • Security must be baked into med devices, report stresses (Fierce)
  • AdvaMed Weighs in on Proposed Guidance Documents (FDA)
  • 7 steps to a successful first date with FDA (Mass Device)
  • January 2015 PMA Approvals (FDA)
  • December 2014 PMA Approvals (FDA)
  • Mammography Facility Adverse Event and Action Report - March 19, 2015 (FDA)

US: Dietary Supplements

  • FDA Confirms Senators’ Doubts About N.Y. Herbal Product Tests (Tan Sheet-$) (DSN)
  • AHPA encourages submissions to supplement label database (NewHope360)
  • The Legal Impact of the New York Attorney General’s Attack on Nutritional Supplements (NPI)

US: Assorted And Government

  • Hashing Out Patent Reform Options (MDDI)

Upcoming Meetings and Events

Europe

  • EU reg adoption set for 2016, says UK devices expert (Clinica-$)
  • MHRA to Issue Certificates of Free Sale for Medical Devices (MHRA)
  • Wockhardt's Daman unit gets UK drug regulator's clearance (DNA India)
  • EC Authorizes Prevtec's Coliprotec F4 (EC)

India

  • Health minister okays plan to monitor medical devices (India Times)

Japan

  • Astellas Submits Evolocumab to Japan's MHLW (Astellas)

Canada

  • Newborn eye drop treatment 'doesn't work,' say pediatricians who want law repealed (CBC)

Clinical Trials

  • Novo Nordisk On Diversity In Diabetes Trials: "We Could Do Better" (Forbes)
  • Audit: Serious ethical issues in drug trial suicide (AP) (Star Tribune) (MPR)

General Regulatory And Interesting Articles

  • Secondary pharmacology data to assess potential off-target activity of new drugs: a regulatory perspective (Nature)
  • Mice losing their allure as experimental subjects to study human disease (Guardian)
  • Why Medical Device Designers Should Care about Fasteners (MDDI)
  • Is peer-reviewed science too slow to track wearable accuracy? (MobiHealthNews)
  • Scientists Seek Ban on Method of Editing the Human Genome (NYTimes)

Regulatory Reconnaissance #518 – 20 March 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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