-
EYLEA® (aflibercept) and Soliris® (eculizumab) IPR Updates
On December 8, 2023, the PTAB instituted three of Samsung Bioepis’s pending IPRs against Alexion’s Soliris® (eculizumab), IPR2023-00933, IPR2023-00998, and IPR2023-00999. The challenged patents include composition of matter, formulation, and method of treatment claims. Samsung Bioepis filed two additional IPRs in June, IPR2023-01069 and IPR2023-01070, that are awaiting institution decisions….By: Venable LLP
-
The EU Reaches a Political Agreement on the AI Act
On December 8, representatives from the European Commission, the European Parliament, and the Council of the European Union (EU) reached political agreement on the shape and contents of the EU’s AI Act (the “Act”), setting the stage for the EU to implement the world’s first comprehensive AI law. As we have addressed in previous posts,…
-
Year-End Review – Data Privacy Insights To Take into 2024
Privacy and data protection has been a dynamic legal space in 2023. Throughout the year, our team at BakerHostetler worked with hundreds of clients on a wide range of challenging compliance issues. As the year ends, we want to take the opportunity to highlight some key areas we believe are worth particular attention moving into…
-
Celltrion Completes Application for FDA Approval of CT-P41, Biosimilar of Prolia® / Xgeva®
On November 30, 2023, Celltrion announced that it filed for an abbreviated Biologics License Application (aBLA) for FDA approval of CT-P41 (denosumab), a proposed biosimilar of Amgen’s Prolia® / Xgeva® (denosumab)……By: Venable LLP
-
Chinese Issuers See Progress on US Audit Issue and HKEX Reforms, but US Policies Could Impact Tech Companies
The past year presented a complex landscape for China-based companies seeking to access global capital markets. Against a backdrop of challenging macroeconomic conditions and escalating geopolitical tensions, regulatory authorities in the U.S., mainland China and Hong Kong introduced initiatives for China-based issuers that provide opportunities for those able to navigate the regulatory process successfully….By: Skadden,…
-
Nearly 70k Social Security Numbers Leaked in Kimco Staffing Services Data Breach
On December 19, 2023, Kimco Staffing Services, Inc. (“Kimco”) filed a notice of data breach with the Attorney General of Maine after discovering that an unauthorized actor was able to access the company’s IT network. In this notice, Kimco explains that the incident resulted in an unauthorized party being able to access consumers’ sensitive information,…
-
ESO Solutions Files Notice of Data Breach Affecting 2.7 Million Victims
On December 12, 2023, ESO Solutions, Inc. (“ESO”) filed a notice of data breach with the Attorney General of Maine following a September 2023 cyberattack. In this notice, ESO explains that the incident resulted in an unauthorized party being able to access patients’ sensitive information, which includes their names, Social Security numbers, dates of birth,…
-
Israel-Hamas War: U.N. Security Council Pushes Vote on Gaza Off for Second Day
The Council is seeking to avert a U.S. veto on a resolution calling for a pause in fighting to deliver significant amounts of aid. The United States and Israel object to handing over aid inspections to the U.N.
-
Migrants Crossing the Darién Gap Find Success on Social Media
TikTok, Facebook and YouTube are transforming global migration, becoming tools of migrants and smugglers alike.
-
Sudan’s Army Faces Scrutiny After Major City Falls to Rival Forces
The capture by paramilitary forces of Wad Madani, a strategic city in the country’s agricultural region, marks a watershed in the civil war that has upended life in the northeast African nation.
