Regulatory Focus™ > News Articles > Regulatory Reconnaissance: J&J Wants Unique Names for Biosimilars (9 January 2013)

Regulatory Reconnaissance: J&J Wants Unique Names for Biosimilars (9 January 2013)

Posted 09 January 2014 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

In Focus: International

  • India and China top 2013's GMP failures, according to EMA data (In-Pharma)
  • France OKs Sales of Medicine Derived from Cannabis (AP)
  • Explanation of the Proposed Clinical Trials Regulation Overhaul (King & Spalding)
  • Novartis Faces Possible Criminal Inquiry in Japan (NYTimes) (Bloomberg)
  • WHO Endorses 8 Projects to Tackle Neglected Diseases (Scientific American)

US: Pharmaceuticals/Biotechnology

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

  • Catalyst boosted as 'breakthrough' PhIII drug clears safety hurdle (Fierce)
  • PaxVax Announces Positive Interim Results for Phase 3 Cholera Challenge Study; Clinical Trial Program to Proceed as Planned (Press)

US: Pharmaceuticals and Biotechnology: General

  • Generic Drug Price Spikes Demand Congressional Hearing, Pharmacists Say (NCPA)
  • The 'me toos' offer real benefits to many (AEI)
  • Roche's Genentech tells FDA to expect brief Tamiflu shortage (Fierce)

US: Medical Devices

  • Q&A: FDA's Alberto Gutierrez, Elizabeth Mansfield Discuss Personalized Medicine Efforts in 2013 (Genome Web-$)
  • Medtronic Symplicity System Misses Efficacy Goals in Study (WSJ-$) (Reuters) (Fierce)
  • U.S. FDA provides 510(k) communication timeline (Mass Device)
  • SkinRex issued FDA warning letter (Mass Device)
  • Siemens lands FDA clearance for new MRI system (Mass Device)
  • Kinsa lands 510(k) clearance for 1st smartphone thermometer (Mass Device)
  • Aggredyne Receives FDA Clearance of Its AggreGuide A-100 Instrument and AA Assay (Press)
  • EarlySense gets FDA device approval for patient monitor update to track staff performance (MedCity News) (Press)
  • K2M Expands Minimally Invasive Portfolio with 510(k) Clearance of CAYMAN Minimally Invasive (Press)
  • CADD-Solis Epidural Pump Wins Regulatory Approval in US (MedGadget)
  • Cardica Receives 510(k) Clearance For MicroCutter XCHANGE 30 Cutting/Stapling Device (Press)

US: Dietary Supplements

  • Supplement Trade Groups Focus On GMP Compliance, R&D in 2014 (Tan Sheet-$)
  • Dietary Supplements Under Closer Scrutiny (FDA Lawyers Blog)
  • Industry figures commend FTC's Operation Failed Resolution (NI-USA)
  • Marketers of genetically customized nutritional supplements agree to settle with FTC (NI-USA)

US: Assorted And Government

  • Video game maker partners with Pfizer for Alzheimer's clinical trial (MobiHealthNews)
  • Supreme Court schedules hearing on birth control mandate (NBC)
  • Warren, Coburn seek end of 'back-room' settlements (The Hill)
  • Liberal groups hit Obama for 'egregious' regulation delays (The Hill)
  • Obama regs have cost $500B, report finds (The Hill)

Upcoming Meetings And Events

  • 10 January 2013: National Biodefense Science Board Meeting (DHHS)
  • 28-29 January 2013: Workshop - Strategies to Address Hemolytic Complications of Immune Globulin Infusions (FDA)
  • 2014 FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • India and China top 2013's GMP failures, according to EMA data (In-Pharma)
  • France OKs Sales of Medicine Derived from Cannabis (AP)
  • Takeda's vedolizumab enters Ph III in Japan for UC and Crohn's disease (Pharma Letter-$)
  • Explanation of the Proposed Clinical Trials Regulation Overhaul (King & Spalding)
  • Pharma clinical trial agreement precedent is bonus for devices (Clinica-$)
  • Direct Flow Medical, Inc. Receives CE Mark for First Fully Repositionable 29 mm Transcatheter Aortic Valve System (Press)

Asia

General Regulatory And Interesting Articles

  • WHO Endorses 8 Projects to Tackle Neglected Diseases (Scientific American)
  • Roche 'brain shuttle' technology offers Alzheimer's hope (Reuters)

Regulatory Reconnaissance #232 - 9 January 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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