Phase III
It proved itself superior to AZD1222 (ChAdOx1-S), the vaccine by Astrazeneca-Oxford, in terms of geometric mean titer for neutralization antibodies.
The U.S. FDA greenlit a new indication for Gilead Sciences’ drug Biktarvy for pediatric patients with HIV who are virologically suppressed or new to antiretroviral therapy.
Phathom announced positive results from its Phase III trial, PHALCON-EE, comparing vonoprazan against lansoprazole in patients with moderate to severe erosive esophagitis.
Biogen announced topline results from the Phase III VALOR trial of tofersen for superoxide dismutase 1 amyotrophic lateral sclerosis.
The FDA reviewed Tecentriq under Project Orbis, allowing the simultaneous submission and review of potential oncology treatments to international regulatory bodies.
It was yet another busy week for clinical trial announcements. Take a look.
The FDA and Regeneron are reportedly in talks to set up an advisory committee meeting to discuss the BLA ahead of the target action date.
They are calling the combination of tremelimumab and Imfinzi the STRIDE regimen for Single Tremelimumab Regular Interval Durvalumab.
Today’s approval was based on the Phase III KEYNOTE-826 trial that evaluated Keytruda and chemotherapy with or without bevacizumab compared to the same chemotherapy treatment.
Modern radiation therapy is tightly targeted to dramatically reduce toxicity and side effects and often can be administered on an outpatient basis.
PRESS RELEASES