Regulatory Recon: MHRA Cautions Against Brexit WHO Says World Not Prepared for Pandemics (24 May 2016)

Posted 24 May 2016 | By Michael Mezher 

Regulatory Recon: MHRA Cautions Against Brexit WHO Says World Not Prepared for Pandemics (24 May 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

  • Samsung Targets US Drug Market With Remicade Biosimilar (WSJ-$) (Reuters) (Press)
  • Republican Senators Lobby FDA Ahead of Decision on Sarepta's DMD Drug (Focus) (STAT)
  • Our Current Pharmaceutical Payment System Isn't Neutral (Harvard Bill of Health)
  • Don't Let Cancer Immunotherapy Hope Give Way To Hype (Forbes)
  • House Zika Bill Would Raid HHS Fund for New Medicare Payment System (Morning Consult)
  • Health policy: The right to try is embodied in the right to die (Nature-$)
  • Legal dimensions of Big Data in the Health and Life Sciences (Harvard Bill of Health)
  • Inventing A Machine That Spits Out Drugs In A Whole New Way (NPR)
  • FDA Outlines Medical Device Real-World Evidence User Fee Proposal (Focus)

In Focus: International

  • Behind the World's Top Drugmakers' Approach to Zika Vaccine (Bloomberg)
  • UK medicines regulator warns of Brexit hit (Financial Times) (The Guardian)
  • China cuts Astrazeneca, Glaxosmithkline and Betta drug prices (BioWorld)
  • Regulatory updates in Brazil you should know about (Emergo)
  • China and Russia teams join WHO's Emergency Medical Team Initiative (WHO)
  • WHO's Stern Warning: The World 'Is Not Prepared To Cope' With Pandemics (NPR)
  • Off-Label Drug Use and Pharmacovigilance: EMA Outlines What MAHs Need to Collect and Report (Focus)
  • Product liability for devices under MDR and IVDR (MedicalDevicesLegal)
  • NICE recommends NHS use of Zykadia for lung cancer (PharmaTimes)
  • Janssen's Darzalex gets conditional EC Approval (Pharmafile) (BioCentury)

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US: Pharmaceuticals & Biotechnology

  • Pharmacovigilance checklist: resolving common problems (PharmaPhorum)
  • Personalized medicine called not quite ready for primetime (MedCityNews)
  • Building An Antibiotic To Kill Bad Microbes While Sparing Good Ones (NPR)
  • Industry talks patient centricity in clinical trials (Outsourcing Pharma)
  • Patient can't always access complete medical records, doctors say (Reuters)              
  • UCB faces U.S. patent challenge for epilepsy drug (Reuters)
  • Novel trial approaches may help to make cancer treatments more precise (MNT)
  • FDA Orphan-Only Review Division Could Speed Access, Gottlieb Suggests (Pink Sheet-$)
  • Kite Pharma names Paul Jenkinson CFO (Pharmafile)
  • Market Access Restrictions To Entresto Are 'Frustrating,' ICER Official Says (Pink Sheet-$)

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

  • GSK lung drug succeeds in big UK study, after earlier miss (Reuters) (Pharmafile)
  • PhIII data puts AZ one step closer to severe-asthma showdown with GSK (Fierce)
  • Seqirus receives FDA approval for FLUCELVAX QUADRIVALENT (Influenza Vaccine) for people four years of age and older (Press)
  • Ipsen's partner Exelixis announced results from randomized phase 2 trial CABOSUN that demonstrate that cabozantinib significantly improved progression-free survival versus sunitinib in previously untreated advanced renal cell carcinoma (Press)

US: Medical Devices

  •  Five hurdles to overcome when planning a medical device trial (MassDevice)
  • Abbott warns on Topera catheter spline fracture risk (MassDevice)
  • 'Real challenges on the practical level' to wearables in medicine (MedCityNews)
  • FDA approved high-risk women's health devices without proper data: Study (Fierce) (Abstract)
  • Cardiovascular Devices; Reclassification of External Cardiac Compressor; Reclassification of Cardiopulmonary Resuscitation Aids (FDA)
  • Tim Cook: Why the Apple Watch is key in the 'enormous' health care market (CNBC)
  • Reprocessed Medical Device Market Size to Triple by 2022 (MDDI)
  • Providence Medical touts 2-year cervical fusion data, $2.9m funding round (MassDevice)
  • Baxter touts data on Theranova Dialyser efficacy, toxin clearance (MassDevice) (Press)
  • EndoChoice wins FDA 510(k) for Orca endoscope valves, announces multi-product launches (MassDevice) (Press)
  • Interventional Spine, Inc. announces FDA Clearance of Lordotic Opticage (Press)
  • Perimeter Medical Imaging Receives FDA Clearance for OTISTM Optical Tissue Imaging System (Press)
  • Cynosure Receives FDA Clearance to Market New PicoSure Energy Delivery System for Tattoos and Pigmented Lesions (Press)
  • FDA Approves Medic Vision SafeCT-29 that Helps Achieve Radiation Safety (Press)

US: Assorted & Government

  • Health Insurers Ratchet Up Scrutiny Of Opioid Prescription Approvals (Forbes)
  • Second Circuit Affirms Dismissal of Off-Label Promotion Case That was Brought under the False Claims Act, Relying on Caronia (FDA Law Blog)
  • Implementing MACRA: Implications for Physicians and for Physician Leadership (JAMA)
  • Lawsuits Over Baby Powder Raise Questions About Cancer Risk (NYTimes)
  • FTC Approves Final Order in Henry Schein Practice Solutions Case (FTC)

Upcoming Meetings & Events


  • Will fast-tracking medicines improve affordability? (PharmaLetter-$)
  • Witz among departing Sanofi execs (BioCentury)
  • Lessons To Learn From Borderline Barrier Products' Advertising Setbacks (Clinica-$)


  • USFDA Puts Yunnan Hande Bio-Tech On Import Alert (24 Insight)
  • Teijin Pharma's Feburic approved in Japan for chemo-induced hyperuricemia (PharmaLetter-$)
  • INTERVIEW: Cook MyoSite Eyes Japan As Cell Therapy Trials Progress (PharmasiaNews-$)
  • UPDATED: GSK expects deep discount for Viread in China to boost sales (Fierce)


  • PM Modi takes pledge to support AMR; economic cost could hit $100 tn by 2050 (Economic Times)
  • Ajanta Pharma gets USFDA nod for migraine pain relief drug (Economic Times)
  • Accord Receives ANDA Approval For Treanda (24 Insight)


  • Cerus wins Health Canada approval for Intercept blood system (MassDevice)


  • Australian Government grants Mesoblast $6.2 million to further R&D activities (BioSpectrum)


  • Biotron identifies compounds that demonstrate activity against Zika Virus (BioSpectrum)

General Health & Other Interesting Articles

  • At least seven sickened by chemicals at Florida Planned Parenthood (Reuters)
  • Sexism in Biotech: Be Aware, and Stay Vigilant (Forbes) (STAT)
  • Young female cancer survivors not clear on infertility risks (Reuters)

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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