Regulatory Focus™ > News Articles > Regulatory Recon: Pacira Sues FDA Over Marketing of Pain Drug (9 September 2015)

Regulatory Recon: Pacira Sues FDA Over Marketing of Pain Drug (9 September 2015)

Posted 09 September 2015 | By Zachary Brennan 

Regulatory Recon: Pacira Sues FDA Over Marketing of Pain Drug (9 September 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

  • Pharma leaders urge UK Government not to cut spending (Pharmafile)
  • Toads Skin, Herbs Feed China’s $2.7 Billion Cancer Fight (Bloomberg)
  • New EC health director general takes office (PMLive)
  • EU clears first mitochondrial disease therapy (PharmaTimes)

US: Pharmaceuticals and Biotechnology

  • VC Returns Revisited: Biopharma’s Outperformance (Life Sci VC) (Forbes)
  • Biogen inks a $544M autoimmune drug deal (FierceBiotech) (Xconomy)
  • Agenus mortgages some vaccine royalties for $115M in R&D cash (FierceBiotech)
  • Is Fabre-Kramer’s Gepirone Antidepressant Rising From The Dead After 8 Years? (Pink Sheet-$)
  • Bristol’s Opdivo/Yervoy Combo In Lung Cancer: Dosing Tweaks Improve Safety (Pink Sheet-$)
  • Patent Challenge Winds Now Blowing Against Kyle Bass' Assault On Biotech Firms (Pink Sheet-$)
  • On the ropes, GlaxoSmithKline admits to another PhIII debacle (FierceBiotech)(Reuters) (WSJ)
  • Bristol-Myers' latest PD-1 win could pave the path to earlier use (FierceBiotech)
  • FDA Clears Nanosphere's Respiratory Pathogen Test (GenomeWeb)
  • Compounded or Repackaged Drugs Stored in Becton-Dickinson Syringes: FDA Expands Warning (FDA)
  • AstraZeneca nabs priority review voucher as Wellstat bags FDA OK (FierceBiotech)
  • EPIRUS Expands Biosimilar Pipeline and Capabilities Through Acquisition of Bioceros (Benzinga) (Press)
  • Impax Resolves Issues in 2011 FDA Warning Letter (FDANews-$)
  • Lawsuit, Website Undermine FDA Off-Label Promotion Concerns (FDANews-$)
  • FTC Says AbbVie Can't Shield Docs In Pay-For-Delay Fight (Law360-$)
  • Pharma Reps Slam PTAB Over 'Skewed' Procedural Rules (Law360-$)

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

  • Tuesday's Clinical Trial Scorecard: Akebia Wins, Tetraphase, Flexion, Theravance Lose (TheStreet)
  • Tetraphase's bowel drug fails late-stage study, shares slump (Reuters)
  • Flexion routed as lead pain drug flops in first pivotal study (FierceBiotech)
  • Marinus Pharmaceuticals Announces Positive End-of-Phase 2 Meeting With FDA for Ganaxolone in Focal Onset Seizures (Press)
  • Breakthrough's Achilles Heel: Alexion’s Newly Acquired Kanuma Delayed By Manufacturing (Pink Sheet-$)
  • New Haven Pharmaceuticals Receives FDA Approval for Durlaza Extended Release Capsules for Secondary Prevention of Stroke and Acute Cardiac Events (Press)
  • First Patient Enrolled in Ocata Therapeutics’ Phase 2 Study for Dry AMD (Press)
  • Udenafil Granted Orphan Designation For Use In Patients With A Single Functional Ventricle That Have Undergone Fontan Surgical Palliation (Press)
  • Clinical Research, Firsthand (Eli Lilly Blog)
  • Gain-of-function study finding may accelerate flu vaccine production (BioPharma-Reporter)
  • First patient enters phase III trial of Biogen's Alzheimer's drug (PharmaPhorum)
  • Aduro Biotech Announces Clinical Trial Agreement to Evaluate Combination of Two Novel Cancer Immunotherapies for the Treatment of Ovarian Cancer (Press)
  • After FDA pushback, AcelRx hopes second run at pain is a gain (SF Business Times)
  • Valeant And Progenics Announce FDA Acceptance Of NDA Submission For Oral RELISTOR (Press)

US: Medical Devices

  • IMDRF Participants Outline Plans for Next Week’s Meeting in Japan (Focus)
  • Crowdfunding medical devices raises money — and questions (Boston Globe)
  • Carlyle purchases 37% stake in diagnostics chain Metropolis  (Economic Times)
  • FDA Warning Wire: 'Adulterated' Devices (Law360 - $)
  • Novo collaborates with MIT on next-gen drug delivery devices (PMLive)
  • E&C Eyes September Hearing On Revised LDT Plan (InsideHealthPolicy - $)

US: Assorted and Government

  • House passes stem cell research reauthorization (The Hill)
  • Stakeholders Question Biosimilar Standards For 'Transition' Biologics (InsideHealthPolicy - $)
  • HELP’S ‘Cures' Coming later this fall (Politico)
  • FDA Taking Genomic Testing to the Next Level (FDA) (Focus)
  • FDA Issues Guidance on Evaluation of Drug Toxicity (Federal Register) (PharmaTech)
  • Proposed Legislation Seeks to Reform Mental Health Care (JAMA)
  • Congress Weighs Budget Cuts For Wide Range Of Health Programs (NPR)
  • Biosimilars Forum Presents More Reasons to Reject Common J-Codes (BioPharm International)

Upcoming Meetings and Events


  • Shazam CFO jumps to drug research app TrialReach (Financial Times)
  • Thermo Fisher Receives IVDD CE Mark for LC-MS System (GenomeWeb)
  • NICE hands Merck & Co’s Keytruda speedy recommendation (PMLive) (Pharmaceutical Journal)
  • EU: New GMP Implementing Act Published (ECA)
  • Committee for Orphan Medicinal Products meeting report (EMA)
  • Roche CEO lashes out at U.K.'s move to stop paying for a number of cancer meds (FiercePharma)
  • Scottish Medicines Consortium approves Sanofi's Toujeo insulin (PBR)
  • GDP non-compliance report for Czech company (ECA)


  • Updated information and transition form for Clinical Trial Notification scheme (TGA)


  • India’s CDSCO Looks to Crack Down on Online Drug Sales (Focus)
  • Indian drugs: not what the doctor ordered (Financial Times)


  • Roche CEO Hopes For Progress As China Tackles Approval Lag (PharmAsia News-$)
  • Simplified HIV Testing and Treatment in China: Analysis of Mortality Rates Before and After a Structural Intervention (PLOS Medicine)
  • Roche CEO Hopes For Progress As China Tackles Approval Lag (SCRIP-$)

Other International

  • Big Changes for ICH GCP and EU Regulations (Polaris Blog)
  • Putin: Industry must back Russia's 90% domestic drugmaking target (In-PharmaTechnologist)
  • MENA changing population dynamics: Prospects accelerating dealmaking (BioWorld)
  • TPP Negotiations Are No Walk On The Beach (LillyPad)
  • Middle East Respiratory Syndrome coronavirus (MERS-CoV) – Saudi Arabia Update (WHO)
  • Aspen Seeks Drugs Acquisitions as Overseas Deals Fuel Growth (Bloomberg)
  • Guidance: International Conference on Harmonisation; Q3D Elemental Impurities (Federal Register)

General Health and Other Interesting Articles

  • Chasing Cancer Stem Cells (In the Pipeline)
  • Genome Editing Writ Large (Chemical & Engineering News)
  • Overcoming the opioid crisis (Harvard)
  • Patients steered to fewer pharmacies may fill more prescriptions (Reuters)
  • ‘What’s a uterus?’ Health illiteracy could be the death of us (Guardian)
  • Stockpiles of critical snakebite anti-venom likely to run out next year, Doctors Without Borders warns (Washington Post)
  • NIH Conference Sounds the Alarm about the Dangers of Overdiagnosis (Oncology Times)
  • Fitbit Exec Says Smartwatches Still `More Hype Than Reality' (Bloomberg)

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 @Michael_Mezher or send him an email at
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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