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Earlier this month, a federal district court denied the Outsourcing Facilities Association’s preliminary injunction motion, which sought to preclude FDA from taking enforcement action against compounded tirzepatide...more
Author’s Note: This is an updated version of the post to our blog dated October 30, 2024. Later that day, FDA announced the resolution of Novo Nordisk’s semaglutide shortage, which altered the conclusion of our original post...more
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
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
The COVID-19 pandemic has accelerated the globalization of the life sciences industry, driving cross-border collaborations to develop urgently needed treatments, scale up manufacturing and distribution, and fill raw material...more
Companies often enter into supply agreements for component parts that are covered by or produced using a supplier's intellectual property (IP) rights, but do not give enough thought to IP licensing. In the face of supply...more
As the global economy faces the third year of the pandemic, manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the past few years to become...more
The European Union (“EU”) and its Member States are struggling with the pace of their vaccination programs. This is partly due to shortages of vaccine availability. Germany, like the rest of the EU, is scrambling to obtain...more