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?
In an effort to enhance collaboration, the Indian Pharmaceutical Alliance (IPA) recently proposed that a more formal preferred partnership between the U.S. and India can not only lower drug prices in the U.S. but can improve...more
We Americans pay more for prescription medications than just about anywhere else on the globe. And Big Pharma keeps jacking prices higher....more
In a recent opinion piece in Newsweek, Dr. Rahul Tiwari asserts that pharmaceutical companies in India have an opportunity to supplant China's dominant position in producing active pharmaceutical ingredients ("API's") and...more
I'm not saying that anyone from the Biden administration was reading my blog post last week on drug shortages, and maybe it's just a coincidence that the White House announced new efforts to strengthen supply chains less than...more
This Diagnosing Health Care episode dives into the key business operations and legal considerations for reshoring active pharmaceutical ingredient (or “API”) and finished drug product manufacturing to the United States. The...more
During the pandemic, businesses are asking about their potential price gouging liability in states that they do not sell into directly but where their products might end up. At least one federal circuit court addressed this...more
The coronavirus global pandemic has ushered in extraordinary roadblocks for the pharmaceutical industry. To help you carve out a path forward, in-house senior executives and industry leaders will convene virtually at ACI’s...more
Legislation - Biologics: Senate Health Committee Passes Bipartisan Legislation to Lower Health Care Costs - During the last week of June, the Senate Health, Education, Labor, and Pensions (HELP) Committee approved...more
• "American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs" outlines actions that the Administration proposes to lower prescription drug prices. • The plan includes...more
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years. Among others tackling...more
On Wednesday, November 8, 2017 the Federal Trade Commission (FTC) hosted a workshop seeking to explore the general question of why the cost of prescription drugs has risen greatly in recent history. The Workshop was framed...more
• Nearly a month after Hurricane Maria swept through Puerto Rico, roughly 80 percent of the U.S. territory is still without electrical power. • The island is home to multiple drug manufacturing facilities that are directly...more
Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more