Astellas Pharma US, Inc.
NEWS
The Japanese pharma contends that an analysis of the four deaths in its AT132 gene therapy clinical trial shows it is still viable as a potential treatment for a fatal, rare genetic disease.
While Astellas did not say why it withdrew its suit, it was the only company to file a legal complaint that wasn’t on the initial IRA drug price negotiations list and may not have had any grounds to sue.
ARS Pharmaceuticals, Intarcia Therapeutics and Taysha Gene Therapies this week got stark reminders of the difficulties in getting treatments through the regulator’s approval process.
The companies, which are collaborating on a drug combination to treat locally advanced and metastatic urothelial cancer, announced Friday that their Phase III trial met dual primary endpoints.
In honor of World Cancer Research Day, BioSpace takes a deep dive into 10 therapeutic candidates with the potential to change the treatment landscape in lung, breast, colorectal cancer and more.
The company has dropped its gene therapy candidate TSHA-120 for giant axonal neuropathy after the FDA reiterated the need for a randomized, double-blind, placebo-controlled trial.
The latest data show Izervay is safe and effective in a two-year trial. Just six weeks after securing FDA approval, Astellas plans to submit it to the regulator to expand its label for a longer treatment timeframe.
After its prostate cancer therapy was not included in Medicare’s initial drug price negotiation list, Astellas dismissed its Inflation Reduction Act lawsuit this week, while Illumina got new leadership.
The company has withdrawn a suit against the Department of Health and Human Services after its prostate cancer therapy was not included in Medicare’s initial drug price negotiation list.
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