Witness Credibility Analysis
Platform Regulation and Privacy – Unpacking the EDPB’s New Guidelines
On 12 September 2025, the European Data Protection Board (EDPB) issued draft guidelines (Guidance) on the interplay between the EU Gene...
FDA Approves Genentech’s GAZYVA® (obinutuzumab)
On October 20, 2025, the FDA approved Genentech’s GAZYVA® (obinutuzumab) as a treatment for adults with lupus nephritis (LN). Gazyva is...
Teva and Prestige Biopharma Enter Licensing Agreement to Commercialize Their Trastuzumab Biosimilar
On October 20, 2025, Teva Pharmaceuticals International GmbH (“Teva”) announced a licensing agreement with Prestige BioPharma Ltd. (“Pr...
Hospital and Health Systems Reimbursement Check – October 2025
On September 17, 2025, Joint Commission (“JC”) and Coalition for Health AI (“CHAI”) jointly released Guidance on the Responsible Use of...
The Kitchen Sink for October 31, 2025: Legal Tech Trends
Here’s the kitchen sink for October 31, 2025 of ten stories that I didn’t get to this week – with another brand-new meme from Gates Dog...
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Streamlining The Studies: New FDA Draft Guidance Aims To Speed Up Biosimilar Development
On Wednesday, the FDA issued a new draft guidance proposing to reduce the need for sponsors to conduct a comparative efficacy study (CE...