Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Major Device Firms Hacked (10 February 2014)

Regulatory Reconnaissance: Major Device Firms Hacked (10 February 2014)

Posted 10 February 2014 | By Alexander Gaffney, RAC 

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In Focus: US

  • Hackers break into networks of 3 big medical device makers (SF Chronicle)
  • FDA Health IT Deregulation Bill Coming To The Senate (Gray Sheet-$)
  • Sunshine Reporting Registration to Open February 18 (FDA Law Blog) (Policy and Medicine) (Porzio)
  • Most stem cell lines registered with the NIH don't comply with the FDA's guidelines for human use (The Scientist)
  • Merck to pay $100 million in NuvaRing contraceptive settlement (Reuters) (NPR)
  • US Attorney Discusses Factors in Determining Potency of Prosecution (Policy and Medicine)
  • Sanofi CEO backs structured data disclosure (Pharma Times)
  • FDA's Bob Temple: Industry Shouldn't Exclude Patients With Multiple Diseases From Trials (BioCenturyTV)

In Focus: International

US: Pharmaceuticals/Biotechnology

  • PhRMA, BIO, Amgen, Others Sound off on Biosimilar INNs in Nature (Nature)
  • Most stem cell lines registered with the NIH don't comply with the FDA's guidelines for human use (The Scientist)
  • Merck to pay $100 million in NuvaRing contraceptive settlement (Reuters) (NPR)
  • Sex matters: Drugs can affect sexes differently (CBS)
  • US Attorney Discusses Factors in Determining Potency of Prosecution (Policy and Medicine)
  • Sanofi CEO backs structured data disclosure (Pharma Times)
  • FDA's Bob Temple: Industry Shouldn't Exclude Patients With Multiple Diseases From Trials (BioCenturyTV)
  • Advisory Semantics: When Words Get In The Way Of Science At FDA Panels (Pink Sheet-$)
  • FDA Panel to Weigh Painkillers' Cardiac Risk (WSJ-$) (MedPage Today) (Fierce)
  • Official: FDA Needs More Than Outsourcer Fees To Fund Compounding Law (IHP-$)
  • DEA Representative States it has Received the HHS Recommendation on Rescheduling of Hydrocodone (FDA Law Blog)
  • Biosimilar Naming Fight: Could Brand Names For All Resolve The Problem? (Pink Sheet-$)
  • FTC Biosimilars (Follow-On Biologics) Workshop Tackles State Substitution Legislation and Naming Proposals on Competition (FDA Lawyers Blog)
  • Pre-emptive state legislation may hinder biosimilar adoption in US (BioPharma Reporter)
  • India to press for simplification of laws on generics during meeting with US FDA commissioner (PharmaBiz)
  • How adaptive I-SPY 2 breast cancer study silenced critics (BioCentury-$)
  • Forest Sues Glenmark Over Generic Fibromyalgia Treatment (Law 360-$)
  • DOJ declines to join whistleblower lawsuit against Celgene (Fierce) (Pharma Marketing Blog)
  • Drug Recalled for Microbial Contamination (FDA)

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

  • Androxal Vs. Testosterone Gel Head-To-Head Trials Get FDA Pumped (Pink Sheet-$)
  • FDA grants Spectrum's Beleodaq priority review (SCRIP-$)
  • Ipsen posts top results for Phase III study of Decapeptyl in prostate cancer (Pharma Letter-$)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • Hackers break into networks of 3 big medical device makers (SF Chronicle)
  • FDA Health IT Deregulation Bill Coming To The Senate (Gray Sheet-$)
  • Device Center Moves To Better Prioritize Its Scientific Work (Gray Sheet-$)
  • Gene-by-Gene Cries Uncle, Settles with Myriad Genetics (Patent Docs) (MedCity News) (BioCentury)
  • Covidien's Endo Gia stapler wins FDA nod (Mass Device)
  • Feds: Draft med device interoperability standards could come this spring (Fierce)
  • J&J Wants Discovery Mishaps Barred From Vaginal Mesh Trial (Law 360-$)
  • FDA/AGS Workshop on Supporting Innovation for Safe and Effective Minimally Invasive Glaucoma Surgery, February 26, 2014 (FDA)
  • January 2014 510(k) Clearances (FDA)
  • AliveCor Receives FDA Over-the-Counter Clearance for Its Heart Monitor (Press)

US: Assorted And Government

  • Researchers Debate Costs Of Clinical Trial Data Sharing At IOM Gathering (Gray Sheet-$)
  • US Capitol Capsule: BIO 'ever vigilant' on legislative, regulatory moves affecting investment (SCRIP-$)

Upcoming Meetings And Events

  • 10 February 2014: E&C Committee on Drug Shortage Problem (E&C)
  • 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • European Medicines Agency updates guidance for annual strain change of seasonal influenza vaccines (EMA)
  • UK plans to reduce use of animals in research (PMLive)
  • Why companies will need EMA advice on CV requirements for lipid disorders (BioCentury-$)
  • NBRG Call for Industry Participation - Survey Understanding Annex Z EN ISO 14971:2012 (Eisner)

India

Japan & China

  • November enforcement date for new pharmaceutical affairs law in Japan (Mass Device)
  • AHWP Announces 2014 Meeting Details (AHWP)

Other International

  • Saudi Arabia's March declaration deadline nears for foreign device makers (SCRIP-$)
  • SA industry body ousts executive committee in wake of ''Pharmagate'' (SCRIP-$)

General Regulatory And Interesting Articles

  • Gilead, Maker Of $1,000 Hepatitis C Pill, Looks To Cut Its Cost Overseas (NPR)
  • New Theory of Antidepressants Could Help Predict Patients' Response (Scientific American)
  • Flu Shot Fail: Why Doesn't the Vaccine Always Work? (NBC)
  • The DOD wants a memory-restoring brain implant, a potential device industry boon (Fierce)

Regulatory Reconnaissance #253 - 10 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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


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