Regulatory Recon: Novartis Admits South Korean Kickbacks, Denies it Paid Bribes in Turkey EMA Fires Back at IQWiG Over Adaptive Pathway Criticism (12 August 2016)

Posted 12 August 2016 | By Michael Mezher 

Regulatory Recon: Novartis Admits South Korean Kickbacks, Denies it Paid Bribes in Turkey EMA Fires Back at IQWiG Over Adaptive Pathway Criticism (12 August 2016)

Welcome to Regulatory Reconnaissance, your adaily 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

  • Valeant gives six months timeline for FL plant reinspection after eye drug CRL (InPharmaTechnologist
  • Will Embryonic Stem Cells Ever Cure Anything? (MIT Technology Review)
  • Aethlon claims 50% blood serum clearance of Zika virus in 5 hours (MassDevice)
  • FDA Corrects Statutory Error on Informal Hearings Linked to Banned Devices (Focus)
  • Statement of Principles on Industrial Hemp (Federal Register)
  • UPDATE: DOJ Subpoenas Alere Over Faulty Blood Testing Devices (POGO)
  • MedTech Associations Recognize Sen. Hatch for Leadership in MedTech Innovation (AdvaMed)
  • Obama Administration Counters Insurer View on Healthcare Law's Costs (WSJ-$)
  • Will biosimilar carve-outs put R&D for older MAbs on ice? (Bioworld)
  • CRISPR-Generated Neuronal Cells May Serve as Brain Disease Models (GEN)
  • FDA Establishes New Process for Preliminary Combination Product Classification (Focus)
  • The Anger of Cancer (NYTimes)
  • Biosimilars should slash up to 50% off reference product prices, says Oncobiologics' Pankaj Mohan (PharmaLetter-$)
  • US Government Shifts $81 Million to Zika Vaccine Research, Fauci Says More is Needed (Reuters) (Inside Health Policy) (Medpage)
  • Pediatric Study Compliance Could Face Scrutiny In PDUFA Renewal (Pink Sheet-$)
  • Allergan picks up ForSight Vision for $95m (MassDevice)
  • Gilead to get attorney fees in hepatitis C patent fight with Merck (Reutes) (Law360-$)

In Focus: International

  • Open data in drug discovery and development: lessons from malaria (Nature)
  • Novartis says bribe allegations in Turkey groundless, matter closed (Reuters)
  • Novartis says South Korea employees gave kickbacks, confirms indictment (Reuters)
  • NICE plans to charge for appraisals – but pharma wants reform first (PharmaPhorum)
  • Data Integrity: New Draft Guidance and Q&A (Focus)
  • Canada to allow medical patients to grow own cannabis (Reuters)
  • Novartis invests €100m to boost mAb production 70% at French biologics site (BioPharmaReporter)
  • Interview – Pharming's last chance lies with solo strategy (EP Vantage)
  • AstraZeneca wins UK cost approval for longer use of heart drug (Reuters)
  • European Regulatory Roundup: UK Lord Tries to Reassure Politicians on Brexit Life Science Strategy (Focus)
  • European Regulators Put Dow DuPont Deal Under Microscope (C&EN)
  • Samsung's biotech unit applies for IPO in South Korea's main bourse (Xinhuanet)
  • Hold Daiichi for contempt of court responsible for leak: RH Holdings (Economic Times) (SCRIP-$)
  • Malaysia Update: Labeling, Exemptions, Advertising Rules (Emergo)
  • EMA responds to IQWiG criticism of adaptive pathway (BioCentury) (SCRIP-$)
  • Novartis Upends Early-Stage Drug Research (Forbes)
  • AEMPS says Alcor's plan to fix problems at Spain plant is insufficient (InPharmaTechnologist)
  • Thousands to benefit with new anti-clotting drug recommendation, says NICE (Pharmafile)

US: Pharmaceuticals & Biotechnology

  • Lilly setback underlines Pfizer's strong lead in cyclin inhibition (EP Vantage)
  • Short of Cash, Northwest Bio Flirts With Insolvency (The Street)
  • Looking ahead to PDUFA VI (PhRMA)
  • Lilly announces Joshua Smiley, Anat Ashkenazi appointed to new roles, Thomas Grein retires (Press)
  • Biotech venture champion Bill Maris is exiting GV. What's next? (Endpoints)
  • Direct-to-Consumer Advertising of Prescription Drugs Can Inform the Public and Improve Health (JAMA Viewpoint)
  • Direct-to-Consumer Drug Advertising in Oncology Is Not Beneficial to Patients or Public Health (JAMA Viewpoint)
  • Cancer Research: Outside the Ivory Towers (Medpage)
  • Basket Trials – an Emerging Clinical Trial Design for Targeted Cancer Therapies (Citeline)
  • Google spinout Verily recruits another top psychologist for its mental health team (Fast Company)
  • Amarin, Omeros fall after follow-ons (BioCentury)
  • Do the new Merck HPV ads guilt-trip parents or tell hard truths? Both. (Washington Post)
  • ​Here's what we know about Shire's cost-cutting plans for the next three years (Boston Biz Journal)
  • Biophysics in drug discovery: impact, challenges and opportunities (Nature)
  • Electronic system for illegitimate drug FDA notifications launches (Securing Industry)
  • Catalent wins early-phase contract for Arch's inhaled orphan drug (InPharmaTechnologist)
  • FDA reinforces commitment to tackle opioid abuse with new Drug Facts Label (PharmaLetter-$)
  • Zurex Pharma's Antimicrobial Attracts $6.2M for Clinical Trial (Xconomy)
  • Beyond Traditional Marketing: What are the New Strategies for Pharma Sales? (Pharmaceutical Compliance Monitor)

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

  • Zealand takes PhII data to FDA after pitting diabetes drug against Novo's incumbent (Fierce)
  • Battered and bruised, ProNAi Therapeutics drops PNT2258 completely (Fierce)

US: Medical Devices

  • MedSun Newsletter – August 2016 (FDA)
  • Virtual reality, robots, feedback enable recovery of paraplegics (BioWorld)
  • Paralysis partly reversed using brain-machine interface training (Reuters)
  • Theranos' Emergency Authorization Bid for Zika Assay Raises Questions About Strategic Direction (GenomeWeb)
  • Cook Medical Issues Global Recall of Roadrunner® UniGlide Hydrophilic Wire Guides Due to Raw Materials Issue (Press)
  • Spectranetics releases final 1-year results for Stellarex drug-coated balloon (MassDevice)
  • How Mobile Access Drives Sales Performance (MassDevice)

US: Assorted & Government

  • DC Circuit Affirms MITIGARE 505(b)(2) NDA Approval, and Sidesteps COLCRYS Patent Certification Issue (FDA Law Blog)
  • New York Decision Not Good For Asbestos, But Not Bad For Drug/Device (Drug and Device Law)
  • CMS proposes cardiac rehabilitation plan (MassDevice)
  • Administrative Dispute Resolutions: 340B Drug Pricing Program (CMS)

Upcoming Meetings & Events


  • Accuray's Radixact Radiotherapy System Cleared in Europe (MedGadget)
  • Drug promotion: practical change in preflight (Swissmedic)
  • Saving antibiotics for when they are really needed: the Dutch example (The BJM)
  • New ERC Scientific Council members appointed (ERC)


  • Cipla names Samina Vaziralli as Executive Vice-Chairman (Economic Times)
  • Activists see red over easing of regulatory norms for clinical trials (Economic Times)


  • Prescription medicines: registration of new chemical entities in Australia (TGA)
  • Australia's TGA issues warning on denosumab and QT prolongation (PharmaLetter-$)


  • CDC adds Cayman Islands to interim travel guidance related to Zika virus (CDC)
  • Researchers Identify A Key Weapon of Zika Virus (KHN)

Other International

  • Nigeria reports first polio cases in two years: WHO (Reuters) (WHO)
  • How Worm Warriors Are Beating An Unbeatable Worm (NPR)

General Health & Other Interesting Articles

  • Lesbian, Gay, and Bisexual Adolescents: Population Estimate and Prevalence of Health Behaviors (JAMA)
  • The Twitter Debate Over Cholesterol Screening In Kids (CardioBrief)

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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