Regulatory Reconnaissance: Chealsea's Northera (Finally) Gets FDA Approval (19 February 2014)

Posted 19 February 2014 | By Alexander Gaffney, RAC 

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In Focus: US

In Focus: International

US: Pharmaceuticals/Biotechnology

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

  • Bayer to file long-acting Factor VIII as data ease infusion burden (SCRIP-$) (BioCentury) (Fierce) (AP)
  • Lilly Announces Ramucirumab Phase III Lung Cancer Trial Meets Primary Endpoint of Overall Survival (Press) (Reuters)
  • FDA Approves Orphan Status for Update Pharma's UPI-928 in Acute Myeloid Leukemia (AML) (Press)
  • Novartis skin cancer drug Sonidegib clears pivotal trial (PMLive)
  • FDA Accepts Filing of the Medicines Company's New Drug Application for Intravenous Antibiotic Oritavancin With Priority Review (Press)
  • Genfit up on Fast Track for NASH compound (BioCentury)

US: Pharmaceuticals and Biotechnology: General

  • Patent trolls and Bio/Pharma (Harvard BOH)
  • EU's stance forces US executioners to improvise (AP)
  • Ranbaxy, Teva to Settle with New York Attorney General over Anti-Compete Deal (WSJ-$)
  • Pradaxa most complained about U.S. drug (Pharma Gossip)

US: Medical Devices

  • The FDA Wants You for Sham Surgery (WSJ-$)
  • J&J Wins 1st Vaginal Mesh Bellwether Trial (Law 360-$) (Fierce) (Mass Device)
  • Will FDA Panel Be Inspired By Sleep Apnea Stimulation Data? (Gray Sheet-$)
  • Carmat artificial heart patient in satisfactory condition: hospital (Reuters)
  • Artery Zapping Little Better Than Drugs In Atrial Fibrillation Patients (Forbes)
  • Claret Medical lands FDA OK for U.S. trial of Sentinel cerebral protection device (Mass Device)
  • Carestream Receives Its First FDA Clearance for Reading Medical Images on Multiple Mobile Platforms (Press)
  • Pictures of Apple's sensor-packed health meter earbuds available (MedCity News)

US: Assorted And Government

Upcoming Meetings And Events

  • 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)



  • Indian regulator says his agency will not expect domestic drugmakers to hit FDA standards (Fierce)
  • India (Sort-of) Optimistic About FDA Assistance (Pharma Manufacturing)
  • If you want our market, meet our standards, says Margaret Hamburg, US FDA chief tells Indian Pharma Industry (India Times)
  • Govt makes nominal allocation in budget for helping SMEs to upgrade to WHO-GMP Standards (PharmaBiz)

Japan & China

  • Tokyo prosecutors raid Novartis Japan unit in probe (Rueters)
  • China FDA Likely To Change Pricing Mechanism Of Branded Generics (PharmAsia-$)

Other International

  • Australia Warns About Choking Risk of Capsule Gel Medications in Young Children (TGA) (TGA)
  • Australia Cancelling Certain GMDN Codes for Implanted Prostheses (TGA)

Regulatory Reconnaissance #259 - 19 February 2014

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.

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