Regulatory Recon: Panel Recommends Probuphine Implant for Opioid Addiction, Survey Shows Fewer CE Marks Since 2010 (13 January 2016)

Posted 13 January 2016 | By Michael Mezher 

Regulatory Recon: Panel Recommends Probuphine Implant for Opioid Addiction, Survey Shows Fewer CE Marks Since 2010 (13 January 2016)

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

  • Samsung Bioepis faces patent suit by Amgen (Korea Herald)
  • French Regulator Plans Tighter Drug And Device Monitoring, Patient Links (SCRIP-$) (ANSM)
  • Team NB Survey Shows Fewer CE Mark Certifications, More Withdrawals since 2010 (Emergo)
  • Italy's AIFA explains importance of generics and biosimilars for healthcare (PharmaLetter-$)

Sponsored Content: The Regulatory Affairs Landscape has Evolved. Will You?

US: Pharmaceuticals and Biotechnology

  • 2015 Life Sciences Deal Trends – Year End Review (Thomson Reuters)
  • FDA Likely to Require Substantial Clinical Data for Interchangeable Biosimilars, Lawyers Say (Focus)
  • Valeant Pharmaceuticals' Novel Business Approach Made it a Wall Street Darling, Then a Pariah (New York Mag)
  • Drugmakers Dismiss Outrage Over High Prices as 'Abomination' (STAT)
  • Big Pharma Doubles Down on CRISPR for New Drugs (MIT Technology Review)
  • New NIH awards will support development of therapeutic alternatives to traditional antibiotics (NIH)
  • CDER Launches Clinical Outcomes Assessment Compendium, Seeks Input on Future Expansions (FDA Law Blog) (FDA)
  • One by one: Continuous manufacturing gets broad support (In-PharmaTechnologist)
  • Stem Cell Centers Hit with GMP Warning Over Lack of Licenses (FDANews-$)
  • Avoid anticholinergics in Parkinson's, say researchers, despite study findings (Pharmaceutical Journal-$)
  • 6 Ways Quality Managers Can Build a Culture of Quality (GxP Lifeline)
  • Vaccine contract manufacturing market to undergo shift, says analyst (Outsourcing-Pharma)
  • Taking drugs for depression linked to better diabetes control (Reuters)
  • FDA Warning Wire: China Drugmaker Accused Of Data Deceit (Law360-$) (Focus)
  • In fecal matter transplants, frozen is as good as fresh (Washington Post)
  • Orthocell granted US patent for regenerative growth factor production (BioPharma-Reporter)

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

  • Roche, AbbVie get U.S. priority review status for leukemia drug (Reuters)
  • Merck, BioLineRX to study drug combo to fight pancreatic cancer (Reuters)
  • Coherus and Baxalta announce etanercept biosimilar met primary endpoint in Phase 3 study (Biosimilar News)
  • Tricida Announces FDA Acceptance of Investigational New Drug Application for Lead Candidate TRC101 (Press)
  • GTx Announces Initiation of Phase 2 Clinical Trial of Enobosarm in Stress Urinary Incontinence (Press)
  • Anavex announces positive dose-response data for ANAVEX 2-73 in Alzheimer's disease patients (MNT)
  • ABIVAX announces positive top-line clinical Phase IIa data for novel HIV drug-candidate ABX464 (MNT)
  • Jama Neurology Releases Highly Promising Data From ALS Clinical Trial Conducted By Hadassah Medical Organization Jerusalem And Brainstorm Cell Therapeutics (Press)

US: Medical Devices

  • Between Openness and Privacy in Genomics (PLoS)
  • Comment Request: Cancer Genomics Cloud Pilots Survey (NIH)
  • What's Ahead for Medical Device Cybersecurity in 2016? (MDDI)
  • Stryker pleural drainage device recall is Class I (MassDevice)
  • One-hour diagnosis of heart attack possible with troponin T test from Roche Novel strategy shortens time to heart attack diagnosis drastically (Press)

US: Assorted and Government

  • March-In Rights Alone Won't Solve Our Drug Pricing Problems (Harvard Bill of Health)
  • Candidate to Run FDA Is Approved, but Likely to Be Blocked (NYTimes) (Washington Post)
  • State Measures to Slash Drug Prices Face Big Hurdles (STAT)
  • California Lawmakers To Revive Rx Drug Cost Transparency Bill (California Healthline)
  • Wyeth's 'Clear Evidence' Language: Clearly Misunderstood (Law360-$)
  • Off-Label Promotion Not Dispositive in Qui Tam Action (Drug and Device Law)
  • Reed Smith Atty's Widow, GSK Headed To Trial In Suicide Suit (Law360-$)
  • Takeda Execs Admitted To Actos Scheme, Relator Claims (Law360-$)
  • Why Apple and Google are good for healthcare… and Uber is not (MedCityNews)

Upcoming Meetings and Events              


  • EMA Carries 2014 Momentum, Recommends 39 New Drugs and Sets Orphan Record (Focus)
  • NICE develops sepsis guideline to accelerate diagnosis (PharmaTimes)
  • Glaxo May Consider Spinoffs After Novartis Deal Integration (Bloomberg)
  • Medtronic earns CE mark to use its drug-eluting balloon to help hemodialysis patients (FierceMedicalDevices)
  • HeartWare shares plunge 30% as company further delays key CE mark trial (FierceMedicalDevices)
  • Marksman Pharma's Goa plant comes under UK regulator's scanner (Economic Times)
  • Eisai submits Lenvatinib's new application in Europe ( BioSpectrum)


  • Over 200 drugs under development, top 50 with $30 billion potential: Cipla (Economic Times)
  • Approval Of Novel Dosage Form Of Sildenafil Subject To Phase 4 Clinical Trial (24 Insight)
  • Indian pharma sees need to create an environment of trust to offset unprecedented compliance challenges (PharmaBiz)
  • Govt to promote 10% technical manpower at ADR monitoring centres (PharmaBiz)


  • Sensor may detect cancer from breath (The Japan News)
  • Occlutech' ASD Occlusion Device secures Japanese MHW approval (BioSpectrum)

Other International

  • West Africa Ebola Outbreak Expected to be Declared Over at Last (STAT)

General Health and Other Interesting Articles

  • First US case of Zika virus infection is identified in Texas (BMJ-$) (Reuters)
  • Warning over growing opioid prescribing in pregnant women (OnMedica)

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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