Regulatory Focus™ > News Articles > Regulatory Recon: FDA Settles Free Speech Suit Over Pacira Drug’s Label (15 December 2015)

Regulatory Recon: FDA Settles Free Speech Suit Over Pacira Drug’s Label (15 December 2015)

Posted 15 December 2015 | By Zachary Brennan 

Regulatory Recon: FDA Settles Free Speech Suit Over Pacira Drug’s Label (15 December 2015)

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

In Focus: International

  • Consultations on adoption of EU guidelines in Australia (TGA)
  • EMA guideline on the clinical investigation of medicinal products for the treatment of asthma (EMA) (Overview of Comments)
  • MHRA Drug Safety Update December 2015 (MHRA)
  • As combination drugs engulf India, an American pharmaceutical giant profits (Reuters)
  • Swissmedic approves Helsinn’s Akynzeo for CINV (PharmaLetter-$) (Press)

US: Pharmaceuticals and Biotechnology

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

  • Atara tanks after its kidney drug comes up short in Phase II (Press Release) (FierceBiotech) (SCRIP-$)
  • Amgen Reclaims Rights From GSK To Grow In Ex-US Markets (SCRIP-$) (PharmaLetter-$) (Reuters)
  • Neon Therapeutics and Bristol-Myers Squibb Enter Clinical Trial Collaboration (Press)
  • Pfizer declares Q1 dividend (Press)
  • Regen BioPharma, Inc. Receives FDA Clearance to Initiate Clinical Trial of HemaXellerate (Press)
  • Bellicum to be Added to the NASDAQ Biotechnology Index (Press)
  • Kyoto University's Center for iPS Cell Research Application and Takeda Launch the Joint Program for iPS Cell Applications Research (Press)
  • Evotec and Spero Therapeutics Extend Collaboration to Develop Novel Antibacterials (Press)

US: Medical Devices

  • Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical Devices; Guidance for Industry and FDA Staff (FDA)
  • Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy; Public Workshop; Request for Comments (FDA)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; Trivascular Ovation Abdominal Stent Graft System (FDA)
  • 3M Warming Device Infection Suits Grouped In Minn. (Law360-$)

US: Assorted and Government

Upcoming Meetings and Events              

Europe

  • Svelte Medical Systems Announces CE Mark Certification of SLENDER IDS (Press)
  • Dutch VC Aglaia BioMedical Ventures Invests in Swiss Biotech Inthera Bioscience (Press)

India

  • Govt plans to boost production of active pharma ingredients (Economic Times)
  • ART Bill seeking to regulate research on human embryos may be passed during current session (Pharmabiz)

China

  • China's Yisheng Bags Ebola Collab In US (SCRIP-$)

General Health and Other Interesting Articles

  • Don’t criticize what you can’t understand: Bob Dylan pops up throughout medical literature (Washington Post) (BMJ)
  • The Experts Were Wrong About the Best Places for Better and Cheaper Health Care (New York Times)
  • We Know Almost Nothing About the Animals That Live on Our Faces (Atlantic)

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? Send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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Categories: Recon, Regulatory News

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