Regulatory Recon: FDA Approves UCB Seizure Drug Briviact, IQWiG Denies Added Benefit of Praluent (19 February 2016)

Posted 19 February 2016 | By Michael Mezher 

Regulatory Recon: FDA Approves UCB Seizure Drug Briviact, IQWiG Denies Added Benefit of Praluent (19 February 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

  • Novartis wins FDA breakthrough therapy for AML treatment (Reuters)
  • FDA approves Briviact to treat partial onset seizures (FDA)
  • Zika-hit Puerto Rico prepares to import all of its blood supplies (Reuters)
  • FDA panel recommends deep, long-term monitoring for leadless pacemakers (MassDevice) (Press)
  • PDUFA Negotiations: Early Communications, Breakthrough Still On Docket (Pink Sheet-$)
  • Dear FDA: The Daraprim Website Lacks Important Safety Information! (Pharma Marketing Blog)
  • FDA Offers Free, Continuing Edu Course to Help Healthcare Providers Understand 'Biosimilars' (FDA Voice)
  • In First Human Test of Optogenetics, Doctors Aim to Restore Sight to the Blind (MIT Technology Review)

In Focus: International

  • Added benefit of Praluent not proven, says IQWiG (PharmaLetter-$) (IQWiG)
  • South Korea Continues to Boost Biopharma Sector, Tightening Review Process (Thomson Reuters)
  • Diverging Opinions Persist On Thorny EU Regulatory Trilogue Subjects (Clinica-$)
  • Unnecessary antibiotics prescriptions reduced in new trial (MHRA) (Study)
  • Differences between biosimilars and reference products (GaBI)

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US: Pharmaceuticals & Biotechnology

  • How drug ad narrators take the scariness out of side effects (STAT)
  • FDA Allows Banned Chinese Firm to Ship Chemotherapy to US as Shortage Threat Looms (Focus)
  • FDA Finalizes Guidance on Safety Data Collection for Late-Stage and Postapproval Trials (Focus)
  • Guidance for Industry on Immunogenicity-Related Considerations for Low Molecular Weight Heparin (FDA)
  • When Cancer Treatment Offers Hope More Than Cure (NYTimes)
  • Evolution of strategies to improve preclinical cardiac safety testing (NEJM-$)
  • FDA Meets With Clinical Decision Support Firms To Address Challenging Cases (Pink Sheet-$)
  • Drug Labeling With Tiered Evidence Levels Eyed As Fix For Off-Label Promotion (Pink Sheet-$) (Duke-Margolis)
  • FDA must focus on drug safety and effectiveness, not patients' life outcomes (The Hill)
  • Targeting the 'gene next door' to fight hard-to-treat tumors (Boston Globe)
  • New drug for severe form of MS generates glimmer of hope — and tempered expectations (STAT)
  • Editorial: Call the Pharma Executive  (SCRIP-$)
  • Generics will cut into bipolar disorder market to $4.2 billion by 2024, report (PharmaLetter-$)
  • Common Antibiotics May Cause Delirium, Confusion And Hallucinations (Forbes)
  • Blood From Ebola Survivor Yields Clues For New Vaccines And Antibody Drugs (Forbes) (BioWorld)
  • Benzodiazepine-Related Overdose Deaths Soar, Study Suggests (Forbes)
  • 2016 The Year of Pharmacy Enforcement (Policy and Medicine)
  • Key hurdle overcome in the development of a drug against cystic fibrosis (MNT)
  • Wall Street Horizon Partners with Informa's BioMedTracker to provide FDA Drug Approval Dates and Pharmaceutical Intelligence to Investment Professionals (Press)
  • Baxter Issues Voluntary Nationwide Recall of One Lot of 0.9% Sodium Chloride Solution for Irrigation Due to Presence of Particulate Matter (FDA)
  • Expanding the Science of Patient Input: Building Smarter Patient Registries (Faster Cures)
  • FDA Removes 771 Drug Facilities from Registration Database (Registrar Corp)

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

  • Nivalis Therapeutics Announces FDA Fast Track Designation for N91115 in Patients With Cystic Fibrosis (Press)
  • Strategia Therapeutics Initiates a Phase 1 Clinical Trial of the Anti-cancer Agent "FF-10502" For FUJIFILM in Patients with Advanced Cancers (Press)
  • Spectrum Pharmaceuticals Announces FDA's Acceptance of NDA Filing for EOquin (apaziquone for intravesical instillation) (Press)
  • Shape-shifting engineered nanoparticles for delivering cancer drugs to tumors (Press)

US: Medical Devices

  • Sure Genomics Gets FDA Letter (GenomeWeb)
  • Setting non-sales targets in medical device distribution agreements (Emergo)
  • Bayer Refutes Congressman's Claims on Essure Safety (Focus)
  • ISO 80369 is Coming—Will You Be Ready? (MDDI)
  • Post-Approval Studies: Similarities and Differences from Pivotal Studies (Medical Device CRO Blog)
  • The Case for Quality: Working with Stakeholders to Improve the Safety of Medical Devices for Patients (GxP Lifeline)
  • Cheap Plasmonic Interferometer Could Enable Prickless Glucose Monitor (IEEE Spectrum)
  • AdvaMed confirms ex-BIO COO Whitaker is new CEO (MassDevice)
  • ScandiDos Obtains FDA 510(k) for Delta4 Discover in US (Press)

US: Assorted & Government

  • Amarin, FDA Seek One More Month to Hash Out Off-Label Promotion Settlement (Focus) (SCRIP-$)
  • US Congress Targets FDA Premarket Reviews, Clinical Trials for Medical Devices (Emergo)
  • NuVasive Didn't Infringe Medtronic Patent, Judge Says (Law360-$)
  • Sandoz Asks Supreme Court To Reverse Biosimilar Decision (National Law Review)
  • Guest Post - Narrowing the Scope of What Constitutes Off-Label Promotion (Drug and Device Law)
  • Something Fishy in the Appropriations Act: With GE Salmon, A Side of Smoke and Mirrors (FDA Law Blog)
  • 51 More Hospitals Join Federal ICD Settlement (Gray Sheet-$)
  • SEC Takes Shot At Kaye Scholer Atty In Shkreli Civil Case (Law360-$)
  • Johnson & Johnson loses another pelvic mesh suit (MassDevice)
  • U.S. securities regulator levels new charges in press release hacking case (MassDevice)
  • Rosetta Receives Conditional Approval for Thyroid Test in NY State (GenomeWeb)

Upcoming Meetings & Events


  • European Regulatory Roundup: EMA Looks to Cut PML Risk in Patients Taking MS Drug Tysabri (18 February 2016) (Focus)
  • Teva Makes Concessions in EU Review of Bid for Allergan Unit (Bloomberg) (Reuters)
  • Boehringer's Praxbind reimbursed in England, Ireland and Wales (PharmaLetter-$)
  • EC approves AstraZeneca's Brilique at a new 60mg dose (EPR)
  • European generics and biosimilars makers adopt disclosure rules (GaBI)
  • Measures to increase generics use in Greece (GaBI)


  • Asia Regulatory Roundup: Drug Safety, Traceability at Forefront of China's Health Reform Plan (16 February 2016) (Focus)
  • China tests marketing authorization holder system and Boehringer gets the first deal (PharmaLetter-$)
  • Korea Accelerating Efforts To Develop, Launch Orphan Drugs (PharmAsiaNews-$)
  • New Singapore Rules Will Impact Drug Licensing, Trials, Surveillance (PharmAsiaNews-$)


  • AP govt to create SPV for setting up Medical Devices Park near Vizag (PharmaBiz)
  • Indian pharma putting in place effective corrective and preventive action practices to stall drug recalls (PharmaBiz)
  • DFDA Myanmar keen to adopt Gujarat FDCA's e-governance model to improve regulatory mechanism (PharmaBiz)
  • IPC adds 8 New Impurities Standards & 10 New Indian Pharmacopoeia Reference Substances (PharmaBiz)
  • Biotech Institute in Cuba Refused Patent India Despite Grants in US & EU (24 Insight)
  • Zydus Cadila gets US FDA nod for Doxycycline capsules (Economic Times)
  • Divis Labs Visakhapatnam Unit-2 has successful US FDA inspection (Economic Times)


  • Guidance for Health Care Professionals on Special Access and Custom-Made Medical Devices (Health Canada)
  • Canadian provinces close the door on Alexion over price of rare disease drug (STAT)
  • Consultation: Draft Guidance for Industry - Preparation and Submission of Summary Reports for Marketed Health Products - Annual Summary Reports and Issue-Related Summary Reports (Health Canada)


  • Prepare For Update To Over 300 Ingredient Names: Australia Tells Pharma (SCRIP-$)

Zika Virus

  • How One Brazilian City Is Tackling Mosquitoes (MIT Technology Review)
  • Keeping the Zika Outbreak in Perspective (Forbes)
  • Obama Administration Pushes Steps to Aid Puerto Rico With Zika Virus (WSJ-$)
  • Zika Outbreak Could Be an Omen of the Global Warming Threat (NYTimes)
  • World Bank offers $150 million in financing to Zika-affected countries (Reuters)
  • Experts question assumption that Zika sickens just 1 out of 5 (Reuters)
  • Brazil's Rousseff guarantees resources for Zika vaccine (Reuters)
  • Zika crisis pressures Vatican to soften contraception stance (Reuters)
  • Zika May Increase Risk of Mental Illness, Researchers Say (NYTimes)
  • US, Brazil researchers join forces to battle Zika virus (Reuters)
  • WHO Recommends Contraception in Countries With Zika Virus (NYTimes)
  • CDC adds 2 destinations to interim travel guidance related to Zika virus (CDC)
  • Scientists Doubt Rise In Microcephaly Along With Zika Is Coincidence, But They Haven't Yet Proved It (Forbes)

Other International

  • Patients left in lurch as Bayer pulls free anti-coagulant (RadioNZ)
  • Transition Successfully to ISO 9001:2015 (Quality Digest)
  • Ex-NAFDAC DG hands over to Director of Administration (PulseNG)

General Health & Other Interesting Articles

  • New HIV Diagnoses Have Declined, But Not For Black Gay And Bisexual Men (Health Affairs Blog)
  • 1 in 3 adults don't get enough sleep (CDC)
  • Lengthy Hospice Care Boosts Medicare Bills (WSJ-$)
  • Drinking more coffee may undo liver damage from booze (Reuters)
  • Wounded US soldier soon to receive first US penis transplant (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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