Recon: Advent in Talks to Buy Sanofi Generics Business

Posted 17 April 2018 | By Zachary Brennan 

Recon: Advent in Talks to Buy Sanofi Generics Business

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • 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)
In Focus: International
  • 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 $100m in new malaria treatments (Pharmafile)
  • Rare human outbreak of monkey malaria detected in Malaysia (Nature)
  • Notice: Release of Proposed IMDRF Document: Definitions for Personalized Medical Devices (Health Canada)
Pharmaceuticals & Biotechnology
  • GE rides gene therapy wave with ready-made viral drug factories (Reuters)
  • BMS ties with Janssen on Factor XIa inhibitor programme (PharmaTimes)
  • Bristol-Myers has Farther to Fall (WSJ-$)
  • 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)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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)
Asia
  • No Prophylactic Antibiotic Use for Young Children’s Intussusception with Low-risk Infection after Successful Air Enema Reduction (Nature)
India
  • 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)
General Health & Other Interesting Articles
  • 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)
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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