Regulatory Affairs

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July 10, 2020
Amgen Prevails in Settlement With Roche Over Cancer Biosimilars
Amgen and Roche have settled their litigation related to Amgen’s biosimilars of Roche’s blockbuster cancer drugs Avastin and Herceptin.
July 10, 2020
AbbVie On Track to Win 10-Year Ban on a Botox Rival
In a win for AbbVie, a preliminary ruling from a U.S. International Trade Commission (USITC) judge could lead to a 10-year ban on a competitor’s Botox treatment.
July 9, 2020
FDA Releases Spring Regulatory Agenda
The FDA released its spring regulatory agenda Wednesday for proposed and final rulemakings, including the following planned actions:

July 7, 2020
EMA Posts Five-Year Drug Regulatory Strategy for Comment
July 6, 2020
Public Citizen Pushes for Boxed Warning on Type 2 Diabetes Drugs
July 6, 2020
FDA Predicts Agency’s Guidance Process Will Be Changed by Pandemic
July 6, 2020
Alexion Settles Bribery Charges for $21.5 Million
July 6, 2020
Novartis Pays DOJ $729 Million To Settle Kickback Allegations

July 6, 2020
Appeals Court Upholds Amgen’s Enbrel Patents
July 2, 2020
PhRMA Challenges Minnesota Insulin Law
July 2, 2020
DOJ Charges Glenmark In Ongoing Generic Price-Fixing Investigation
July 2, 2020
Some Government Contracts for COVID-19 Products Dodge Affordable Pricing Laws, Report Says
July 1, 2020
Hahn Predicts Multiple COVID-19 Treatments by Fall