Investigation & Intelligence Feeds
FDA Grants Interchangeability Designation to Fresenius Kabi’s and Celltrion’s Denosumab Biosimilars
This week the FDA granted interchangeability status to Fresenius Kabi’s and Celltrion’s respective denosumab biosimilars. Interchangea...
The Entrepreneur’s Paradox: Building an Asset, Not Just a Job
Many entrepreneurs achieve the dream: They build a profitable, established business from the ground up. Yet they often find themselves ...
Evolution of CIPA Tracking Claims
As readers of this blog know, companies continue to be targeted in lawsuits asserting California Invasion of Privacy Act (“CIPA”) track...
TikTok’s Privacy Blunders: A Wake-Up Call for Business Owners
New guidance from the offices of the Canadian Privacy Commissioner and the Quebec, British Columbia, and Alberta Privacy Commissioners ...
Streamlining The Studies: New FDA Draft Guidance Aims To Speed Up Biosimilar Development
On Wednesday, the FDA issued a new draft guidance proposing to reduce the need for sponsors to conduct a comparative efficacy study (CE...
Can Cyber Threat Intelligence Sharing Continue After CISA 2015’s Lapse?
The expiration of the Cybersecurity Information Sharing Act of 2015 (CISA 2015 or the Act) on September 30, 2025 has quietly reshaped h...
Part II: Does Your Patent Office Post-Grant Strategy Account for the Rise of Serial Challenges Flowing From the PTAB to the CRU?
In a March 2025 article, we provided strategy considerations for both parties handling ex parte reexaminations following denied inter p...
CA and DE AGs Secure Safety and Oversight Commitments, Will Not Oppose OpenAI Recapitalization
Delaware AG Kathy Jennings announced that her office has issued a Statement of No Objection to the proposed corporate recapitalization ...
[Webinar] The New Health Data Laws Every Retailer Must Know – November 12th, 10:00 am PT
State laws like Washington’s My Health My Data Act and Nevada’s SB 370 are redefining what counts as health data—casting a wide net ove...
Smarter, Faster, Riskier? The Legal Realities of AI in Finance
Artificial intelligence (AI) is reshaping U.S. banking and financial services, promising greater efficiency, precision, and innovation....