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
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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
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European Medicines Agency (EMA) ,
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Patent Litigation ,
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Regulatory Requirements
Only days after lifting the nationwide preliminary injunction, the Fifth Circuit Court of Appeals vacated their decision to stay the district court’s preliminary injunction enjoining enforcement of the Corporate Transparency...more
The Corporate Transparency Act (CTA) went into effect on January 1, 2024, and will impact millions of U.S. businesses by imposing requirements to file corporate transparency reports with beneficial ownership information...more
In a long-awaited milestone in the gene therapy space, the Food and Drug Administration (FDA) approved two gene therapies to cure sickle cell disease (SCD). Soon thereafter these approvals, a key licensing agreement was...more
Gene therapy is part of a new wave of medicine that approaches disease treatment by addressing the root causes rather than focusing on treating or reducing symptoms. Currently, gene therapies are being developed for treatment...more
On July 27, 2021, Amgen announced that it will acquire Bay area-based Teneobio, a privately held, clinical stage biotechnology company developing multispecific and bispecific molecules including biologics called Human...more