Regulatory Recon: Following MHRA Lead, Brazil Halts Use of Silimed Implants (5 October 2015)

Posted 05 October 2015 | By Michael Mezher 

Regulatory Recon: Following MHRA Lead, Brazil Halts Use of Silimed Implants (5 October 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

  • Why Partnerships are Key to the Science of Patient Input (FDA Voice)
  • The FDA Tiptoes – and Congress Splashes Into – the 21st Century (Drug and Device Law)
  • The NPRM for the Common Rule: 88 Questions to Answer in 90 Days (FDA Law Blog)
  • The Senate’s Painkiller Investigation Is Dead In The Water (BuzzFeed)
  • Valeant’s Drug Price Strategy Enriches It, but Infuriates Patients and Lawmakers (NYTimes)

In Focus: International

  • Beating parasites wins three scientists Nobel prize for medicine (Reuters)
  • Welsh stem cell firm wins fast-track filing path in Europe (Reuters)
  • Brazil halts use of Silimed silicone breast implants, follows Europe (Reuters)
  • Russia may start compulsory licensing of foreign drugs (PharmaLetter-$)

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US: Pharmaceuticals and Biotechnology

  • Characterizing the US FDA's approach to promoting transformative innovation (Nature-$)
  • FDA approves Keytruda for advanced non-small cell lung cancer (FDA) (Reuters) (NYTimes) (WSJ-$)(SCRIP-$) (Press)
  • Women are missing from HIV drug trials (Reuters)
  • Editorial: Drug pricing realities (Boston Herald)
  • FDA Recommendation to Screen Blood for Babesia Cited in RI Blood Center Layoff (Providence Journal)
  • Pharma outsourcing more med affairs and post approval work say experts (Outsourcing-Pharma)
  • FDA Says Sun's Elepsia Approval Was Erroneous (SCRIP-$)
  • 'Often Reserved' FDA Biologics Chief Midthun To Depart (SCRIP-$) (BioCentury) (Job Posting)
  • Want to get a warning letter from OPDP? Omit drug risks from your promos (FiercePharmaMarketing)
  • Promoted tweets negatively impacting medical conferences (PharmaPhorum)
  • Sandoz’s Enbrel Biosimilar Filing May Spur New Litigation (Pink Sheet-$)
  • FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept (Biosimilar News) (BioPharma-Reporter)
  • International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Ketamine and Nine Other Substances (FDA)
  • Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation (FDA)
  • Drug Products Intended to be Sterile by Chen Shwezin Inc., dba Park Compounding Pharmacy: FDA Statement - Lack of Sterility Assurance (FDA)

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

  • HHS Advances Development of a Novel Drug to Treat Influenza (ICT)
  • Amicus Sees Delay in U.S. Approval of Drug (WSJ-$) (Reuters)
  • FDA Approves New Treatment Combination of Gilead’s Letairis® with Tadalafil for Pulmonary Arterial Hypertension (WHO Group 1) (Press)
  • Teva's Next Blockbuster? Its Anti-CGRP Antibody Prepares For Phase III In Difficult-To-Treat Migraines (SCRIP-$)
  • Clinical Data from Merz Neurosciences’ Phase III Extension Study of XEOMIN (incobotulinumtoxinA) for Spasticity to Be Presented at 2015 AAPM&R Annual Meeting (Press)
  • Dako Announces FDA Approval of New Companion Diagnostic for Lung Cancer (Press)
  • Inspirion Delivery Technologies Receives FDA Approval for MorphaBond™ (morphine sulfate) extended-release tablets CII, an Opioid Analgesic Formulated with Abuse-Deterrent Properties (Press)

US: Medical Devices                            

  • St. Jude gets FDA warning letter for Atlanta facility (Reuters)(MDDI)
  • Tyvek Is Tyvek, FDA Affirms In Letter To DuPont (Gray Sheet-$) (FDA, Letter)
  • FDA approves Boston Scientific’s Synergy absorbable stent (MassDevice)
  • Intersect ENT files for expanded Propel PMA (MassDevice)
  • ReVision Optics files final PMA module for Raindrop inlay (MassDevice)
  • SurModics Receives FDA IDE Approval for Early Feasibility Study of the SurVeil™ Drug-Coated Balloon (Press)
  • Micro/Optofluidic Chip Detects Ebola Faster, Easier Than PCR (medGadget)
  • Medtronic's Valiant® Thoracic Stent Graft System Demonstrates Durability After Five Years (Press)
  • Class I Recall: PROFEMUR Neck Varus/Valgus CoCr 8 Degree - Unexpected Rate of Fractures After Surgery (FDA) (FDA)

US: Assorted and Government

  • Hillary Clinton: ‘Absolutely incomprehensible’ that FDA approved OxyContin for children (Washington Post)
  • Senators Urge Slowdown on Meaningful Use Rule (Medpage Today)
  • Supreme Court's New Term: What Biopharma Should Expect (SCRIP-$)
  • Jury Asked To Award $9.5M Damages In J&J Pelvic Mesh Case (Law360-$)
  • Opinion: The Candidates on Heath Care (NYTimes)
  • Cipher, Ranbaxy settle patent litigation with Actavis (Economic Times)
  • Vascular Solutions Alleges Misconduct In Off-Label Case (Gray Sheet-$)
  • Making Sense of the Daubert and Summary Judgment Orders in A Metal-on-Metal Hip Implant Bellwether Case (Drug and Device Law)

Upcoming Meetings and Events              


  • UK Awaits MHRA Medical Device Fee Consultation While Regulatory Costs Mount (SCRIP-$)
  • Cell Therapy Plots European Conditional Approval For Heart Regeneration Product (SCRIP-$)
  • Europe grants its first CE mark for leadless pacemaker to treat left ventricle (FierceMedicalDevices)
  • Prevention better than cure, NICE chair tells GPs (OnMedica)
  • Pressure group seeks compulsory license for biosimilar of Roche's Kadcyla in UK (PharmaLetter-$)
  • NHS missing out on vital cost-savings due to slow uptake of new biosimilar medicines (MNT)
  • Protalex Announces Regulatory Approval to Initiate Phase Ib Trial of PRTX-100 to Treat Immune Thrombocytopenia in France (Press)
  • EMA to review Ultragenyx's Ace-ER to treat HIBM (BioCentury)
  • Revealed: how AstraZeneca avoids paying UK corporation tax (The Guardian)


  • India says EU ban on generic drugs 'unwarranted' (Reuters)
  • Health ministry to do away with repeat animal testing for permission for new drug or clinical trial (PharmaBiz)


  • Japan’s Sakigake Approval Pathway Aims to Cut Drug Lag (FDANews-$)


  • Australian industry toughens up code on financial ties to doctors (SCRIP-$) (Medicines Australia)
  • Codeine-related deaths in Australia doubled in a decade, study finds (The Guardian)

Other International

  • Brazil Suspends Pharma Serialization And Tracing Requirements (RxTrace)
  • New Medical Device Classification Tool from Singapore HAS (Emergo)
  • Eisai to Provide Diethylcarbamazine Citrate Tablets Free of Charge for Use in National Lymphatic Filariasis Elimination Campaign in Indonesia (Press)
  • Grünenthal receives Brazilian ANVISA certification for Tecnandina production plant in Ecuador (PharmaLetter-$)
  • WHO Committee Says Ebola Remains a Public Health Emergency of International Concern (ICT)
  • Ebola is all but over, but the postmortem is just getting started (The Guardian)

General Health and Other Interesting Articles

  • Hit and lead criteria in drug discovery for infectious diseases of the developing world (Nature-$)
  • Chagas: An Emerging Infectious Disease Threat In US (Forbes)
  • Scientists trace the origins of extreme drug-resistant TB (Health24)

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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