Recon: Advent in Talks to Buy Sanofi Generics Business

• Does FDA Need Statutorily Imposed Incentives for Regulatory Compliance Matters? (FDA Law Blog)
• Johnson & Johnson’s Q1 tops estimates (Mass Device) (Fierce)
• Marijuana-based drug gets positive review from FDA (AP) (Bloomberg)
• 2018 Meeting Materials, Peripheral and Central Nervous System Drugs Advisory Committee (FDA)
• Pharma's biggest concern is a Trump surprise (Axios)
• Evolving Payer Coverage Policies on Genomic Sequencing Tests (JAMA)

• Advent in talks to buy Sanofi generics business for €1.91bn (FT-$)
• Astellas to invest $1.8bn in M&A diversification bid (Nikkei Asian Review) (Endpoints)
• In encouraging sign, Ebola vaccine appears to provide long-lasting protection (Stat)
• UK pledges cash for Commonwealth education, urges malaria fight (Reuters)
• Novartis to invest $100m in new malaria treatments (Pharmafile)
• Rare human outbreak of monkey malaria detected in Malaysia (Nature)
• Notice: Release of Proposed IMDRF Document: Definitions for Personalized Medical Devices (Health Canada)

• GE rides gene therapy wave with ready-made viral drug factories (Reuters)
• BMS ties with Janssen on Factor XIa inhibitor programme (PharmaTimes)
• Bristol-Myers has Farther to Fall (WSJ-$)
• Broad launches tool to id vulnerabilities of cancer cells (BioCentury)
• U.S. Funding for Biomedical Research Takes an Encouraging Upturn (Xconomy)
• Arkansas Regulates Pharmacy Benefit Managers (Pew)
• NJ High Court Urged To Consolidate J&J Hernia Mesh Suits (Law360-$)
• Fed. Circ. Affirms IP Win For Sunovion On Generic Latuda (Law360-$)
• Oxford Uni, Boehringer, Lilly link to test Jardiance in kidney disease (PharmaTimes)

• FDA Grants Breakthrough Therapy Designation for Genentech’s Hemlibra (emicizumab-kxwh) in Hemophilia a Without Inhibitors (Press) (Reuters)
• Blueprint Medicines' Cancer Drug Impresses In Early Study (Forbes)
• Merck Announces First Phase Three Studies for PCV-15 (V114) Its Investigational Pneumococcal Disease Vaccine (Press)
• Novocure Reports Positive Top-line Results from STELLAR Phase 2 Pilot Trial in Mesothelioma (Press)
• Club drug spray ketamine can stop suicidal thoughts, study finds (NBC News)

• Battery Performance Alert and Cybersecurity Firmware Updates for Certain Abbott (formerly St. Jude Medical) Implantable Cardiac Devices: FDA Safety Communication (FDA)
• Nuvo launches pivotal trial for PregSense home maternity monitor (Mass Device)
• Researchers Release Instructions to Convert 3D Printers Into Bioprinters (Mass Device)
• Companion Diagnostics Space Warms Up with Collaboration (MDDI)

• These are the top priorities for the nation’s top cancer doctor (Washington Post-$)
• Senator Sanders introducing bill targeting opioid manufacturers (Reuters)
• DeLauro Urges FDA Action to Address Arsenic in Infants’ Food (Press)
• Miami Launches Suit Against Drug Cos. Over Opioid Abuse (Law360-$)
• Medicare Part D Opioid Prescribing Mapping Tool (CMS)

• FDA Advisory Committee Calendar

• Spain’s biggest-ever science petition decries ‘abandonment’ of research (Nature)
• First PQT Medicines Quality Workshop for Manufacturers (WHO)
• EMA’s PRIME Process Could Be A Model For Tackling Pediatric Development Issues, Says Industry (Scrip-$)
• Fimea to survey the views of pharmaceutical industry operators on the generic substitution of biological medicines (Fimea)
• Acupuncture needles with false CE marking (Danish Medicines Agency)

• No Prophylactic Antibiotic Use for Young Children’s Intussusception with Low-risk Infection after Successful Air Enema Reduction (Nature)

• India’s import of China-made medicines has increased 50 per cent in 4 years (The print)
• DIA and US FDA to organise multi-city workshop on 'Guidance and polices from US FDA, EMA and CDSCO (PharmaBiz)

• Medicare Advisers Recommend Payment Cuts To Many Free-Standing ERs (NPR)
• U.S. public may lack understanding of cancer screening (Reuters)
• Regulate artificial intelligence to avert cyber arms race (Nature)