Recon: Gilead Wins Reversal of Hep C Patent Verdict; Merck CEO Speaks Out on Trump

Posted 19 February 2018 | By Zachary Brennan 

Recon: Gilead Wins Reversal of Hep C Patent Verdict; Merck CEO Speaks Out on Trump

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

In Focus: US
  • Gilead wins reversal of $2.54 billion hepatitis C drug patent verdict (Reuters) (Stat)
  • Novartis readies to auction U.S. generic pills business: sources (Reuters)
  • FDA Okays First Concussion Blood Test--but Some Experts Are Wary (Scientific American)
  • FDAAA TrialsTracker: A live informatics tool to monitor compliance with FDA requirements to report clinical trial results (Paper) (Tracker)
  • The C.E.O. Who Stood Up to President Trump: Ken Frazier Speaks Out (NY Times-$)
  • AstraZeneca's immunotherapy drug wins key lung cancer approval (Reuters) (Focus) (FT-$)
  • Targeted protein degraders are redefining how small molecules look and act (C&EN)
  • Did Pox Virus Research Put Potential Profits Ahead of Public Safety? (NPR)
  • Is California Turning Stem Cells Into Dollars or Debts? (Bloomberg)
  • Apple’s Move to Share Health Care Records is a Game Changer (Wired)
In Focus: International
  • Europe’s chemical makers look back fondly on 2017 (C&EN)
  • WHO warns over measles immunisation rates as cases rise 400% across Europe (Guardian)
  • Lessons from Ranbaxy: Suffocating Silence Prevented Us From Questioning the Rot in the System (The Wire)
  • Greek judges call for calm over Novartis scandal (Euractiv)
  • Japanese firms push into cell therapy (C&EN)
  • NICE gives three nods in thyroid cancer (PharmaTimes)
  • Malawi cholera cases pass 500, eight people dead (Reuters)
  • World leaders join new drive to beat noncommunicable diseases (WHO)
  • Maha FDA urges CDSCO to consider industry plea towards easing out repeated joint inspections on loan licenses (PharmaBiz)
Pharmaceuticals & Biotechnology
  • Eli Lilly shutters a failed PhII for rheumatoid arthritis, clouding $690M Hanmi pact (Endpoints)
  • Tetraphase and Their Troubles (In the Pipeline)
  • The Deeply Human Core of Roche's $2.1B Tech Acquisition - And Why They Did It (Forbes)
  • Allergan, Others Cough Up $9M In Product-Hopping Suit (Law360-$)
  • Momenta, Sandoz Can't Nix Drug Antitrust Suit, Court Told (Law360-$)
  • Vertex offers ‘portfolio approach’ to secure access to CF meds (PharmaTimes)
Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations
  • New Data Demonstrates Long-Term Skin Clearance in Patients with Moderate to Severe Plaque Psoriasis Treated with Janssen’s Tremfya (guselkumab) (Press)
  • Otezla (Apremilast) Phase III Data Showed Significant Improvements in Patients with Active Behçet’s Disease with Oral Ulcers (Press)
  • AbbVie Presents New Positive Late-Breaking Data from Two Phase 3 Psoriasis Trials of Risankizumab at the 2018 American Academy of Dermatology Annual Meeting (Press) (PMLive)
  • Scientists Explore Ties Between Alzheimer's And Brain's Ancient Immune System (NPR)
  • Major Threat to Malaria Control Programs by Plasmodium falciparum Lacking Histidine-Rich Protein 2, Eritrea (CDC)
  • New C diff guidelines incorporate fecal transplant (CIDRAP)
Medical Devices
  • FDA's Root Causes and Use Error (MDDI)
  • BD Accuses Cytek of Stealing Trade Secrets (MDDI)
  • Boston Scientific IP Attys Must Defend Doc-Redact Request (Law360-$)
US: Assorted & Government
  • FDA’s bigger piggy bank (BioCentury)
  • FTC Nominees Open To Reviewing Past PBM Mergers; Simons Wants Task Force To Monitor Drug Prices (InsideHealthPolicy-$)
Upcoming Meetings & Events General Health & Other Interesting Articles
  • Breakthrough over growing human organs in animals (Financial Times-$)
  • Grandmother loses life-savings for stem cell 'cure' at St. Louis clinic (KSDK)
  • Tango classes, ukulele lessons: the rise of “social prescriptions” (The Economist)
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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