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As 2020 comes to a close, Big Molecule Watch once again reviews the top developments in the biologics and biosimilars space for 2020. Please keep an eye out this week for posts identifying the most important regulatory, market, and legal developments impacting biosimilars....

Late last night, President Trump signed the newest COVID relief bill into law. The new law amends several federal relief laws, including the Families First Coronavirus Response Act (“FFCRA”)....

On December 18, 2020, the US Department of Labor (DOL or Department) adopted with limited changes its Proposal 3.0 regarding ERISA fiduciary investment advice, focused on the fiduciary status of rollover advice and a “best interest” prohibited transaction exemption (PTE) for conflicted advice ali

On December 18, 2020, the Interagency Food Safety Analytics Collaboration (IFSAC) issued its 2018 Annual Report on the Sources of Foodborne Illness.  The report collects and analyzes foodborne-illness outbreak data for four pathogens - Salmonella, Escherichia coli O157, Listeria monocytogenes, a

This advanced-level virtual training course takes a deeper dive into the formal grievance process, including mechanics of conducting an investigation. This session includes interactive training with discussion of real-world scenarios....

On December 27, President Trump signed the Economic Aid to Hard Hit Small Businesses, Nonprofits and Venues Act into law.

With many workforces continuing to work remotely, companies have had to reshape the ways in which important business functions are executed, including the ways in which workplace investigations are conducted.

In the early days of the COVID-19 pandemic, dozens of class action lawsuits were filed across a variety of industries in the United States – with theories of liability ranging from hand sanitizer false-labeling allegations, cruise-line negligence claims, and airline ticket refund demands, to comp

In its 2019 Concept Release on Harmonization of Securities Offerings,1 the US Securities and Exchange Commission (SEC) included a section requesting comment regarding resale exemptions, including Rule 144.

Just before midnight on December 21, 2020, Congress passed the Consolidated Appropriations Act of 2021 (the “Act”), a nearly 5,500 page stimulus bill allocating roughly $900 billon of much needed relief to United States businesses and individuals while funding the federal government until Septemb

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