Phase II
It was a very busy week for clinical trial news, with much of it coming out of the American Association of Cancer Research Annual Meeting. Read on for details.
There are an estimated 2.3 million people living with Multiple Sclerosis and hundreds of thousands more undiagnosed, adding up to an annual cost of nearly $85 billion for care in the United States.
Pfizer, J&J and GSK indicate plans to file for regulatory approval by the end of this year for vaccines against RSV, which would see vaccines against the disease becoming available in 2023.
BioSpace looked at some of the efforts to improve the host system’s immune response, as well as others to improve allogeneic or autologous cell transplants.
CG Oncology presented positive interim Phase II results for its Core1 trial studying the use of CG0070 at the American Association for Cancer Research (AACR) Annual Meeting.
The FDA granted Merck’s investigational 21-valent pneumococcal conjugate vaccine (V116) for IPD and pneumococcal pneumonia Breakthrough Therapy Designation.
AbbVie and Genmab announced positive topline results from their Phase I/II trial for lymphoma treatment; Sanofi posted positive results from its Phase I/II trial for the treatment of ITP.
The revised operating plan also includes reductions in spending related to general and administrative expenses and investments in its research platform.
Drug pricing watchdog ICER issued a draft report on bluebird bio’s gene therapy betibeglogene autotemcel for beta-thalassemia. The report touted the therapy’s cost-effectiveness.
Pfizer and BioNTech will submit updated data to the FDA to support the Emergency Use Authorization (EUA) of COVID-19 vaccination boosters in children between the age of 5 and 11.
PRESS RELEASES