Webinar: Orange Book listing sheets under the microscope
Key Considerations for Reshoring U.S. Drug Manufacturing
Drug Pricing Initiatives During the Trump Presidency
Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
Patent law in Europe: What pharmaceutical companies need to know
EU excessive pricing laws
Polsinelli Podcast - Generic Drugs to Market - What's the Climate in 2014?
As previously reported, the Patented Medicine Prices Review Board (PMPRB) published a Discussion Guide for Phase 2 Consultations on New Guidelines as part of a three-phase consultation process that started in September 2023....more
On February 23, 2024, Health Canada announced that it will expand the information available on the Generic Submissions Under Review (GSUR) list to include the following...more
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
Compliance Today (August 2020) - On May 7, the Department of Justice’s Antitrust Division announced a deferred prosecution agreement, in which Apotex Corp. agreed to pay a $24.1 million criminal penalty for...more
The philosopher George Santayana is usually best remembered for the pithy saying, ‘Those who cannot remember the past are condemned to repeat it.” Santayana was an essayist, poet, professor and novelist. According to...more
The U.S. Environmental Protection Agency (EPA) has announced two new proposed hazardous waste rules that EPA believes would clarify and simplify requirements for health care facilities and retail pharmacies to manage their...more
Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more
Companies face lots of risks – the soup du jour has been anti-corruption enforcement and compliance. Like any consistent restaurant you might visit regularly, one risk continues to grow, quietly and significantly –...more
In an article, entitled “GSK China probe flags up wider worries”, in the Wednesday edition of the Financial Times (FT) reporters Andrew Jack and Patti Waldmeir discussed the ongoing bribery and corruption scandal involving...more