Regulatory Focus™ > News Articles > 2019 > 7 > Recon: Novartis Sets Aside $700M to Settle US Bribery Suit

Recon: Novartis Sets Aside $700M to Settle US Bribery Suit

Posted 18 July 2019 | By Michael Mezher 

Recon: Novartis Sets Aside $700M to Settle US Bribery Suit

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Novartis Sets Aside $700 Million to Settle Bribery Allegations (WSJ) (STAT) (Reuters)
  • Fraud conviction of ‘pharma bro’ Martin Shkreli upheld by federal appeals court (CNBC)
  • Kronos, a startup led by Gilead alumni, raises $105 million in latest mega-round (STAT)
  • Elizabeth Holmes Wins Judge’s Backing in Getting FDA Documents Faster (Bloomberg) (Law360-$)
  • US overdose deaths post annual drop for first time in two decades (Reuters)
  • Car Shopping, Handbags And Wealthy Uncles: The Quest To Explain High Drug Prices (NPR)
  • House Votes to Repeal Obamacare Tax Once Seen as Key to Health Law (NYTimes) (Politico)
  • Protect at All Costs: How the Maker of the World’s Bestselling Drug Keeps Prices Sky-High (Fortune)
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In Focus: International
  • WHO declares Ebola outbreak is international health emergency (Reuters) (NYTimes) (Science) (WHO)
  • Congo Ebola victim may have entered Rwanda and Uganda, says WHO (Reuters)
  • Bristol-Myers Squibb, Bayer team up on Opdivo-Stivarga combo in colorectal cancer (Fierce) (Press)
  • Big Pharma’s First Female CEO Disrupts Glaxo From Within (Bloomberg)
  • "Little to no progress" made in achieving gender representation within top pharma firms, report says (Pharmafile)
  • Novartis's Pure Play in Pharma Works, for Now (Bloomberg) (PMLive)
  • Exclusive: Woodford biotech stakes first off block in asset sale – source (Reuters) (Endpoints)
  • Takeda Kicks Off Sale of Western European Drugs: Sources (Reuters) (Endpoints)
  • Intensive Anti-HIV Efforts Meet With Mixed Success in Africa (NYTimes)
  • Menstrual Cups: Study Finds They're Safe To Use — And People Like Them (NPR)
  • Final ICH Q12 Post-Approval Changes Guideline Expected In November (Pink Sheet-$)
Pharmaceuticals & Biotechnology
  • FDA, EMA Advise on Risk-Based Monitoring in Clinical Trials (Focus)
  • Amarin Plans Citizen Petition to Block Synthetic EPA in Supplements (Focus)
  • FDA Drafts Guidance on Developing GnRH Analogues to Treat Advanced Prostate Cancer (Focus)
  • Pharma's top jet-setting executives of 2018 (Fierce)
  • Drug-Induced Liver Injury — Types and Phenotypes (NEJM)
  • Common Medications Can Masquerade As Dementia In Seniors (KHN)
  • MyoKardia cuts all ties to Sanofi (BioPharmaDive)
  • A bird’s-eye view of clinical trials provides new perspectives on drug research and development (STAT)
  • Personalized treatments may be threatened by drug cost-containment proposals (STAT)
  • Denmark's Genmab hits the jackpot with $500M+ US IPO as smaller biotechs rake in a combined $147M (Endpoints)
  • On a global romp, Boehringer BD team picks up its third R&D alliance for July — this time focused on IPF with $50M upfront (Endpoints)
  • US Food and Drug Administration Reports of Pregnancy and Pregnancy-Related Adverse Events Associated With Isotretinoin (JAMA)
  • Servier scoots out of another collaboration with MacroGenics, writing off their $40M (Endpoints)
  • As Acthar troubles persist, Mallinckrodt invests in RNAi and Silence Therapeutics (Endpoints)
  • Biotech building facility to make genome-edited, off-the-shelf CAR-T therapies (Fierce)
  • Walgreens, CVS, and Walmart Lead the 25,000 Pharmacies Now Profiting From the 340B Program (Drug Channels)
  • Chardan's blank check company picks microbiome player BiomX for $70M reverse merger (Endpoints)
  • Bayer-backed Pyxis debuts with $22M to pursue new immuno-oncology targets (BioCentury)
  • Comparative Confusion: What Does FDA Intend For Opioid Comparative Efficacy Data? (Pink Sheet-$)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Transgene Receives MHRA Approval for a Clinical Trial of TG6002, a Next-generation Oncolytic Virus, Administered by Intrahepatic Artery Infusion in Patients with Colorectal Cancer with Liver Metastases (Press)
  • Horizon Therapeutics plc Announces U.S. FDA Acceptance of its New Drug Application to Make PROCYSBI® (Cysteamine Bitartrate) Available as Oral Granules in Packets (Press)
  • LifeMax Receives Rare Pediatric Disease Designation for LM-030 for the Treatment of Netherton Syndrome (Press)
Medical Devices
  • Philips acquires Boston start-up Medumo to help hospitals communicate with patients (CNBC) (MassDevice)
  • Electricity-Conducting Bacteria May Inspire Next-Gen Medical Devices (NIH)
  • Titan Medical on track for FDA, CE Mark bids this year (MassDevice)
  • BD updates infusion pump recalls (MassDevice)
  • Edwards Lifesciences warns on burst balloon risk with Sapien 3 Ultra heart valve (MassDevice)
  • Teleflex Recalls NEONATAL ConchaSmart Breathing Circuit Due to Circuit Cracks (FDA)
  • Ethylene oxide plant reopening won’t halt FDA plans to seek alternatives (MassDevice)
  • 3D-printed resorbable implant technology achieves ISO 13485 certification (MDDI)
  • Pear Therapeutics Announces FDA Submission for Somryst™, a Prescription Digital Therapeutic for the Treatment of Adults with Chronic Insomnia and Depression (Press)
  • Integrated Endoscopy Receives FDA Clearance for NUVIS Single-Use, HD, Battery Operated Arthroscope (Press)
US: Assorted & Government
  • FTC's First Product Hopping Complaint Targets Safety Claims For Suboxone Film Formulation (Pink Sheet-$)
  • Advocacy group pledges six-figure ad buy to support Trump drug price plan (BioPharmaDive)
  • Med Mal Case Dives Deep Into Device Regulation (Drug & Device)
  • Athena Diagnostics v. Mayo Collaborative Services -- The Dissents (Patent Docs)
Upcoming Meetings & Events Europe
  • State of flux: European Notified Body numbers decrease further ahead of MDR, IVDR (Emergo)
  • EU Regulatory Roundup: UK Politicians Tell Government to Grant Debates on No-Deal Drug, Device Legislation (Focus)
  • AstraZeneca to shell out £12M in severance dispute with workers at former England plant (Fierce)
  • Boots UK to offer cystitis test (PharmaTimes)
  • ‘World’s most accurate blood test’ launched in UK (PharmaTimes)
  • How to incorporate Article 88 into Post Market Surveillance (Qserve)
  • Aurora Cannabis wins contract to supply medical cannabis to Italy (Reuters)
  • Human Medicines Regulations 2012 Advisory Bodies annual report 2018 (MHRA)
  • Medicines and Healthcare Products Regulatory Agency Annual Report and Accounts 2018 to 2019 (MHRA)
  • A New Era For Human Genetic Resource Compliance In China (Law360-$)
  • Chinese regulators preparing medical device UDI pilot (Emergo)
  • Cyber security for medical devices and IVDs (TGA)
  • Submissions received: Medical device cyber security (TGA)
General Health & Other Interesting Articles
  • Arthritis Is Tied to Heart Disease Risk (NYTimes)
  • Medical mistakes harm more than 1 in 10 patients. Many are preventable. (NBC)
  • Recent cannabis use tied to memory deficits, slowed mental processing (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.
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