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Recon: FDA Approves Novartis Combo Therapy

Posted 04 May 2018 | By Zachary Brennan 

Recon: FDA Approves Novartis Combo Therapy

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

In Focus: US
  • FDA approves Novartis combo therapy for aggressive type of thyroid cancer (Reuters)
  • Jury convicts four in CMS-Deerfield insider trading case (Mass Device)
  • Ex-Valeant Official Sought ‘Big Payday’ in Bribe Scam, Jury Told (Bloomberg)
  • Federal kickback law might be used to bring down drug prices, FDA commissioner suggests (Stat)
  • Sarepta adds muscular dystrophy gene therapies via Myonexus pact (Fierce)
  • HHS To Brief Congressional Staff On Drug Prices Friday (IHP-$)
In Focus: International
  • China’s CDH Investments counters Varian with unsolicited $1.4B bid for Sirtex (Mass Device)
  • European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (EMA)
  • Notice: Medical Device Single Audit Program (MDSAP) Reduction of Audit Times for Small-sized Enterprises – update (Health Canada)
Pharmaceuticals & Biotechnology Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Post-exposure treatments for Ebola and Marburg virus infections (Nature Reviews Drug Discovery)
  • Bio Roundup: IDO Fallout, Express Scripts Dumps Amgen, Isaly Out & More (Xconomy)
  • ICER Weekly Review (ICER)
Medical Devices
  • Class 2 Device Recall cobas b 2216Roche OMNI S6 system (FDA)
US: Assorted & Government
  • Dem senators urge FDA to remove powerful opioids from the market (The Hill)
Upcoming Meetings & Events Europe
  • Advertising investigations: April 2018 (MHRA)
General Health & Other Interesting Articles
  • The best medicine? What’s meaningful for our patients (NY Times-$)
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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