On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This...more
7/24/2025
/ Artificial Intelligence ,
Biosimilars ,
Biotechnology ,
Clinical Trials ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements ,
Research and Development
FDA approves Omylco® (omalizumab), first biosimilar of Xolair®.
After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025....more
Although the Corporate Transparency Act (the “CTA”) is no longer halted by nationwide preliminary injunctions, U.S. companies and their beneficial owners are not required to report beneficial ownership information pursuant to...more
For the past few months, the beneficial ownership reporting obligations under the Corporate Transparency Act (the “CTA”) have fluctuated between being required pursuant to the CTA and being halted by nationwide preliminary...more
The U.S. stands at a crossroads in light of rising drug prices and it is unclear what the future will hold in answer to the rising drug costs. Biologic medicines have rapidly expanded available treatment options and accounted...more
2/19/2025
/ Biologics ,
Biosimilars ,
BPCIA ,
Clinical Trials ,
Competition ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Insurance ,
Healthcare ,
Intellectual Property Protection ,
Medicare ,
Patents ,
Pharmaceutical Industry ,
Regulatory Requirements
Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more...more
1/14/2025
/ Biosimilars ,
EU ,
European Medicines Agency (EMA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs ,
Regulatory Approval ,
Regulatory Requirements
Gene therapies have been the subject of tremendous scientific research and investment. With hundreds of clinical trials in progress and many target applications, the biotechnology, agricultural, and pharmaceutical fields are...more