Drug Development
The mixed data from the Phase III COAST 2 trial follows an underwhelming data drop from COAST 1 in September that Leerink Partners said “fell well below expectations.”
FEATURED STORIES
Following the hard-won success of early anti-amyloid drugs, a new generation of Alzheimer’s modalities—from tau-targeting gene silencers to blood-brain barrier delivery platforms—is entering the pipeline to anchor future combination therapies.
Three years after the accelerated approval of its anti-amyloid Alzheimer’s therapy, Biogen—neck and neck in the market with Eli Lilly and its Kisunla offering—is focused on a near-term FDA decision for a subcutaneous induction dose of Leqembi, a presymptomatic readout in 2028 and a clutch of next-generation candidates.
BMO analysts say Eli Lilly is well-positioned to maintain its lead in the ballooning weight loss space, predicting “strengthening leadership in obesity and beyond” as portfolios expand and patient access improves.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
The Chinese government has halted the recommendation of Lianhua Qingwen used as a traditional Chinese treatment for mild cases of COVID-19.
There are very few ongoing clinical trials on treatments for Long COVID and there has been what appears to be a successful treatment using Pfizer’s Paxlovid. Read on for more details.
TG Therapeutics voluntarily withdrew its pending BLA and supplemental NDA for its treatment dubbed U2 for adults with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
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.
The U.S.Food and Drug Administration has granted Emergency Use Authorization to a breathalyzer that can detect COVID-19 within three minutes.
Regeneron announced that the U.S. FDA has extended its review of the BLA for monoclonal antibody REGEN-COV, which treats COVID-19.
The new facility is expected to bolster innovation across all facets of manufacturing to allow the company to fully develop and commercialize cancer treatments for patients in need.
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.