September 25, 2019 - CFIUS, Regulatory, United States

Foreign Investment 2020 (Part 1): Key Takeaways from the “Modernized” CFIUS Regulations

After more than a year of anticipation, the U.S. Department of the Treasury (“Treasury”) has released proposed regulations to implement the Foreign Investment Risk Review Modernization Act (FIRRMA). These proposed regulations follow an initial round of FIRRMA-implementing regulations issued in October 2018, which most …›

Artificial Intelligence and Pharma

Bethany Hills authored an article for PHARMAnetwork, covering how the pharmaceutical industry has been adopting artificial intelligence and machine learning. Bethany discusses that the pharmaceutical sector has been one of the more robust areas where private partnerships with artificial intelligence-based technology companies have developed. …›

China’s new administrative regulations on human genetic resources as applied to foreign persons

The Administrative Regulations of the People’s Republic of China on Human Genetic Resources (the “Regulations”), promulgated by China’s State Council, went into effect on July 1, 2019, superseding prior regulations on China’s human genetic resources (“China HGR”), particularly the 1998 Interim Methods of Human …›

Confidentiality of Documents: Only if Related to Court Proceedings or Commercial Interests

In particular for commercial reasons, pharmaceutical companies have an interest in the confidentiality of documents submitted in connection with the marketing authorization for medicinal products vis-á-vis its competitors as well as vis-á-vis the public. The Court of Justice of the European Union (“CJEU”) ruled in …›

Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR

On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.”[1] This report describes updates to FDA’s Medical Device Reporting (MDR) Program, namely the conclusion of the Alternative Summary Reporting (ASR) …›

The Diagnostics Dilemma: Securing and Protecting Diagnostic-Based Claims

While many life sciences companies are built on platforms involving the development of diagnostic products and methods that underlie personalized medicine allowing treatment that is customized to a patient’s unique biology, the U.S. Supreme Court dealt a blow to the industry with its decision …›