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

• 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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• 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-$)

• 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 $22M to pursue new immuno-oncology targets (BioCentury)
• Comparative Confusion: What Does FDA Intend For Opioid Comparative Efficacy Data? (Pink Sheet-$)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• 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)