Regulatory Recon: Valeant to Sell Pharma Unit for $930M South Korea to Fine Novartis Over Drug Promos (8 June 2017)

Posted 08 June 2017 | By Zachary Brennan 

Regulatory Recon: Valeant to Sell Pharma Unit for $930M South Korea to Fine Novartis Over Drug Promos (8 June 2017)

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

In Focus: US

  • Valeant to Sell iNova Unit for $930 Million (WSJ-$) (Reuters)
  • User Fee Reauthorization Bill Advances in House (Focus) (FDA Law Blog)
  • Value-based drug pricing makes sense, but is difficult to pull off (Stat)
  • Targeting Unconscionable Prescription-Drug Prices — Maryland’s Anti–Price-Gouging Law (NEJM)
  • Mylan, Others Rigged Generic Drug Prices, Suits Say (Law360-$)
  • California bill would end 'purely profit-driven' practice of drug-company coupons (LA Times)
  • Novartis’s Next Challenge: Pricing Breakthrough Cancer Treatment (Bloomberg)
  • Pharmacy groups warn of medicine import risks (Securing Industry)
  • High Risk Drug Domestic and Foreign Drug Inspections – Get Ready! (Lachman Consultants)
  • Good Review Practice: Clinical Consultative Review of Drugs Regulated Within OND (FDA)

In Focus: International

  • New Chinese VC leads $10M round for a Harvard spinout looking to industrialize platelet manufacturing (Endpoints) (Xconomy)
  • South Korea to fine Novartis unit over unfair drug promotions (Reuters)
  • Top EU court bars Dextrose tablet maker's glucose health claims (Reuters)
  • Public consultation launched on EU blood, tissues and cells legislation (European Commission)
  • UK Patients to get early access to Oxervate (Focus)
  • New WHO Designation for Oxygen Could Save Thousands of Lives Globally (PATH)
  • Novo Nordisk wins European approval for Refixia (PMLive)
  • Tekni-Plex invests $15m in a Chinese manufacturing facility (Manufacturing Chemist)
  • Yemen cholera cases pass the 100,000 mark: WHO (Reuters)
  • Medicines Evaluation Board: Annual Report: a leading player in Europe again in 2016 (MEB)
  • TGA presentations: International Regulatory Convergence for MTP GMP (TGA)
  • China FDA changes will speed up approval process, CRO says (Outsourcing-Pharma)

Pharmaceuticals & Biotechnology

  • In Biotech, No News Is Bad News (WSJ-$)
  • J&J woos Merck’s Mathai Mammen to helm of pharma R&D, Hait takes over on external innovation (Endpoints)
  • Hunting new deals, Eli Lilly buddies up on diabetes R&D with $55M pact (Endpoints)
  • Amgen Wants to Boost Label on Powerhouse Repatha (TheStreet)
  • A New Diabetes Approach? Small-Molecule Screening Wins Again
  • Roche ditches work on NewLink’s IDO cancer candidate (Fierce)
  • Actelion’s R&D group slammed with a setback as execs finalize $30B J&J deal (Endpoints) (Fierce)
  • Lilly Announces Strategic Collaboration with KeyBioscience AG (Press)
  • Sanofi Pasteur inks antibody discovery accord for influenza vaccine research (PharmaLetter-$)

Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Novartis’ CAR-T shows durable response in lymphoma patients (PharmaTimes)

Medical Devices

  • It’s time to get serious about the safety of medical devices (Stat)
  • Off-Label Use of Urine Assay Detects Zika in Semen (MedPage Today)
  • Hologic wins expanded FDA labeling for Genius 3D mammography system (Mass Device)
  • FDA clears AngioDynamics Solero MW tissue ablation system (Mass Device)
  • Device Maker, UPenn Sued For Heart Surgery Infection (Law360-$)

US: Assorted & Government

  • From the lab to Congress: A lawmaker wages a solo fight to shake up the NIH (Stat)
  • FBI raids offices of lab that pays doctors to promote genetic tests (Stat)
  • Examining the Role of the Department of Health and Human Services in Health Care Cybersecurity (E&C)

Upcoming Meetings & Events


  • European Parliament Committee on the Environment, Public Health and Food Safety Meeting (Video)
  • Commission Expert Group on Safe and Timely Access to Medicines for Patients (EC)

General Health & Other Interesting Articles

  • Creative Minds: A Transcriptional “Periodic Table” of Human Neurons (NIH)
  • They look like prescription drugs, but they’re actually deadly poison, Georgia authorities say (Washington Post-$)
  • Opening remarks at the Artificial intelligence for good global summit (WHO)
  • Average Pharmacist Salaries Hit $120,000, but Growth Again Lags Other Healthcare Professions (Drug Channels)

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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