Regulatory Focus™ > News Articles > Regulatory Recon: EC, EU, WHO Now Sharing More Drug Data (23 September 2015)

Regulatory Recon: EC, EU, WHO Now Sharing More Drug Data (23 September 2015)

Posted 23 September 2015 | By Zachary Brennan 

Regulatory Recon: EC, EU, WHO Now Sharing More Drug Data (23 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

  • EC, EU and WHO share 'need to know' private drug data (Focus) (InPharma-Technologist) (EMA)
  • China FDA Expands Clinical Data Witch Hunt To CROs, Study Sites (PharmAsia News)
  • New China biosimilars guidance favors local companies, experts say (BioWorld)
  • EU Court Suspends EMA Decision To Grant Access To Drug Data (Mondaq)

US: Pharmaceuticals and Biotechnology

  • Framing the US drug pricing debate – the key flashpoints (First Word Pharma)
  • Pharma 'is getting better at drug R&D' (Pharmafile)
  • Pfizer’s Bourla Defends Cancer Drug Pricing (Pink Sheet-$)
  • Patient Engagement Needs 'Regulatory Guardrails' To Encourage Firms, Advocates Say (Pink Sheet-$)
  • Stemming The Tide Of Prescription Opioid Overuse, Misuse, And Abuse (Health Affairs)
  • Biosimilars Naming: Why Terminology Matters and Where It Stands (PhRMA)
  • Real world evidence: Not just “big data” (PhRMA)
  • Mylan countersues Perrigo over 'misstatements' about tender offer (Reuters)
  • Nestle pushes further into medicine with planned Alzheimer's test (Reuters) (PharmaLetter-$)
  • Infusing patient perspectives into decision-making: Recommendations for FDA (FasterCures)
  • Here's Why Biotech Stocks Are Set for a Big Decline (TheStreet)
  • Costco Urges Court To Toss Generic Lipitor Labeling Suit (Law360-$)
  • Pfizer: Playing For Keeps (SCRIP-$)

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

  • CTI BioPharma To Submit NDA For Pacritinib In Q4 Based Primarily On Data From Single Pivotal Persist-1 Trial (Press)
  • Depomed Announces Two Favorable Decisions in Inter Partes Review Proceedings Versus Endo Pharmaceuticals (Press)
  • Bausch & Lomb Seeks FDA Approval for Glaucoma Treatment (FDANews-$)

US: Medical Devices

  • FDA Says Essure Birth Control Complaints Have Spiked (Law360-$)
  • App maker settles with the feds over charges of improper marketing (Fierce Medical Devices)
  • B. Braun wins FDA nod for Infusomat pump (Mass Device)
  • J&J’s Ethicon appeals $3m loss in pelvic mesh case (Mass Device)
  • Non-prescription device may ease urinary incontinence (Reuters)
  • Zynex, Inc. Announces FDA Filing for Blood Volume Monitor (Press)
  • Medtronic Initiates Global Study of Minimally Invasive Technology to Aid Lung Cancer Diagnosis (Press)
  •  Research and Markets: United States Market for Orthopedic Large Joint Replacement Devices 2012-2022 (Press)
  • GE Healthcare Announces $300 Million Commitment to Support Emerging Market Health (Press)
  • New Device Improves MDs’ Ability to Monitor Breast Cancer Patients after Surgery (Press)

US: Assorted and Government

  • State Dept. urged to press FDA to curb mercury dental fillings (McClatchy)
  • U.S. Government Shutdown Threatens Research, Patients (SCRIP-$) (FDA Atty)
  • Congressional Representatives Introduce Controlled Substance Analog Legislation to Weed Out Synthetic Drug Manufacturing, Distribution and Sales (FDA Law Blog)
  • FDA and the Department of Defense: A Joint Force to Reduce Tobacco Use in the Military (FDA Voice)

Upcoming Meetings and Events              



  • Guinea officials call on Canada to help expand Ebola vaccine program (Globe and Mail)



  • China's Zai inks global deal with UCB, adds first MAb to pipeline (BioWorld)

Ebola Outbreak

  • Mistakes by WHO hindered Ebola response in Sierra Leone: investigation (AP)

Other International

  • Malaysia Consults On Reducing Info Needed In GDP Certificates For Medical Devices (SCRIP-$)
  • Cases in Iraq cholera outbreak rise to 121, but no new deaths: ministry (Reuters)

General Health and Other Interesting Articles

  • A text message a day may keep the doctor away (Reuters)
  • New Virus Found in Blood Supply — But Don't Freak Out Just Yet (NBC)

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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