Recon: Jazz, Lundbeck and Alexion Pay $123M to Settle Kickback Probe; Novartis Sues Amgen Over Aimovig

• Drugmakers pay $123 million to resolve US charity kickback probe (Reuters) (STAT) (DoJ)
• Novartis sues Amgen over migraine treatment Aimovig (Reuters)
• FDA’s Gottlieb heads back to AEI to tackle drug prices (Washington Post) (The Hill) (Endpoints)
• Outgoing FDA chief Gottlieb raises 'concern' over Walgreens, CVS selling CBD products (CNBC)
• US to wrap case against drug company executives tied to opioid crisis (Reuters)
• The questions Alex Azar will face today (Politico)
• A small drug maker accuses Soon-Shiong of masterminding a ‘catch-and-kill’ scheme (STAT) (Endpoints) (Financial Times)
• Sanofi plans sales layoffs—again—in primary care, diabetes (Fierce)
• Jeff Bezos teams with Bill Gates to fund new and better ways to diagnose Alzheimer’s (Endpoints)
• ICER finds Biogen SMA drug price, Novartis estimates for its treatment far too high (Reuters) (Endpoints) (ICER)
• House Committee Plans Second Hearing on Insulin Costs (House E&C)
• Daiichi's Xospata rival pushed back by FDA as it combs through new data (Fierce)
• People Living With Incurable Cancers Urge More Research (AP)
• Opioid epidemic is increasing rates of some infectious diseases (NIH)

• The IVD industry is undergoing significant change. Join BSI experts at their In-Vitro Diagnostic Regulation Workshop to learn about the most significant changes to the European Regulatory and Compliance Expectations for CE marking. Topics such as an IVDR Overview including Classification and Grouping Devices, interacting with the Notified Body, Technical Documentation Requirements, New Requirements for Performance Evaluation and Using the Remaining Transition Period Effectively will be covered. Register here.

• Bayer contains cyber attack it says bore Chinese hallmarks (Reuters) (DW) (Fierce)
• EMA grants PRIME designation to Janssen’s investigational CAR-T therapy (PharmaTimes) (Endpoints) (Press)
• Korea Suspends First Approved Gene Therapy Pending Component Discrepancy Probe (Pink Sheet-$)
• Pfizer gets EU nod for Tagrisso rival Vizimpro (PMLive)
• AVEO warns EU approval of Fotivda could be at risk (PMLive)
• Vivek Ramaswamy launches yet another Vant, this time in Asia with a TCR-focused Medigene partnership (Endpoints)
• Lupin’s Etanercept Biosimilar Gains Approval in Japan (Big Molecule Watch)
• Scotland Releases Drug Supply Plans to Prepare for Possible No-Deal Brexit (BioCentury)
• Scientists Thought They Had Measles Cornered. They Were Wrong. (NYTimes)
• Big Pharma come together for better drug side effect detection (PharmaTimes)
• Innovative Cancer Drugs Get Funding In Australian Govt’s Pre-Election Budget (Pink Sheet-$)
• Uneven access to health services drives life expectancy gaps (WHO)
• One in five deaths worldwide linked to unhealthy diet (Reuters)

• Gottlieb, Abram Statement on new efforts to improve the quality of compounded drugs (FDA)
• Industry Calls on FDA to Streamline Process of Providing Marketing Status Updates (Focus)
• FDA to Step Up Stem Cell Enforcement, Look Into Pathway for Low-Risk Treatments (Focus)
• Gottlieb Suggests Human Germline Gene Editing Moratorium (BioCentury)
• Dozens of clinics market risky cell therapies to treat eye disorders (Reuters)
• Generics Will Find it Harder to Implement REMS Reforms, AAM Says (FDANews-$)
• FDA's Pazdur Encourages Chinese Companies To Bring Low-Cost PD-1 Drugs To US Market (BioCentury)
• CVS expands same-day prescription delivery nationwide (CNBC)
• ‘Predatory’ Scientific Publisher Is Hit With a $50 Million Judgment (NYTimes) (FTC)
• FDA-approved drug effectively treats rare chronic immune disorder (NIH)
• The biotech scorecard for the second quarter: 18 stock-moving events to watch (STAT)
• Esketamine and psychedelics will require restructuring mental health care visits (STAT)
• NIH unveils a vaccine candidate for universal flu jab as first-in-human studies get underway (Endpoints)
• NGM bags $107M from an IPO designed to back their play in the big NASH R&D race (Endpoints)
• Determination That QVAR 40 and QVAR 80 (Beclomethasone Dipropionate HFA) Inhalation Aerosol, 40 Micrograms and 80 Micrograms, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)

• AstraZeneca’s asthma drug Fasenra looks promising for a set of rare chronic immune diseases (Endpoints)
• Puma Biotechnology Expands Cohorts in Phase II SUMMIT Trial of Neratinib in Cancer Patients with Tumors with Activating EGFR or HER2 Mutations (Press)
• Kyowa Kirin Announces FDA Acceptance of Istradefylline (KW-6002) New Drug Application Resubmission in the US (Press)
• Viking Therapeutics to Present New Data from Phase 2 Study of VK2809 in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Elevated LDL-Cholesterol at The International Liver Congress™ 2019 (Press)

• IMDRF Works to Speed Entry of Devices Across Multiple Countries (Focus)
• US FDA identifies hundreds of device types affected by sterilization facility closures (Emergo)
• FDA Starts A Discussion About How To Regulate Artificial Intelligence / Machine Learning Software As A Medical Device (FDA Law Blog)
• Digital health startups want to help Medicare prevent diabetes, if only it will let them (STAT)
• Silk Road Medical prices $120m IPO (MassDevice)
• Avanos Medical wins FDA nod for ON-Q Bolus pump (MassDevice)
• TherOx Receives FDA Approval for First Heart Attack Treatment Since PCI to Reduce Infarct Size (Press)
• Cardiogenic Shock Survival Rates Improve Significantly in Three Years Since Impella FDA PMA Approval (Press)

• House E&C Passes CREATES, Pay-for-Delay Bill (Focus)
• Opioid Crisis ‘Kingpin’ Is Oklahoma’s New Target in Lawsuit (Pew)
• Roche Evades Cancer Study Stock-Drop Suit For Second Time (Law360-$)
• How Easy Are Vaccine Exemptions? Take A Look At The Oregon Model (KHN)
• Baseless Vaccine Autism Lawsuit Dismissed (Drug & Device Law)

• FDA Advisory Committee Calendar

• MHRA Offers Additional No-Deal Brexit Guidance (Focus)
• COCIR Pushes to Harmonize Device Standards (Focus)
• Recommendations on eligibility to PRIME scheme (EMA)
• Monitoring To Start As EU SPC Waiver Nears Finishing Line (Pink Sheet-$)
• NHS England threatened legal action against Oxford University hospitals trust (Pharmafile)
• Class 4 Medicines Defect Information: Zoledronic acid 5mg solution for infusion (MDR 51-03/19) (MHRA)

• Mandatory medical device registration coming to Hong Kong (Pacific Bridge Medical)
• Japan Cell, Regenerative Therapy Environment ‘Exciting’ But Ongoing Dialog Needed (Scrip-$)
• Meeting Agenda for 2019 AHWP TC Leaders Meeting (AHWP)
• Asia Regulatory Roundup: India Drops Interim Compensation Requirements From Proposed Clinical Trial Rules (Focus)

• Emcure to launch generic breast cancer medicine (Economic Times)
• IPC to set up 300 ADR monitoring centres by 2020 with focus on North Eastern states (PharmaBiz)

• Health Canada Implements ICH Guideline on Good Clinical Practice (Focus) (Health Canada)
• Notice: For Consultation: Draft (Step 2) ICH Guidance: M10 Bioanalytical Validation Method (Health Canada)

• Australia’s Generics Plan Could Hit Safety Standards, Warns R&D Industry Body (Pink Sheet-$)
• An Action Plan for Medical Devices (TGA)
• Submissions received: Fees and charges proposal 2019-20 (TGA)