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
An investigation into the estrogen-brain link will be led by the Tulane Brain Institute’s multidisciplinary team, whose expertise spans across the pharmacology, physiology and molecular biology industries.
The FDA has a full PDUFA calendar for the second half of March for New Drug Applications and Biologics License Applications. Here’s a look.
Across a range of indications, COVID-19-related and non-COVID-19-related, there was plenty of clinical trial news last week.
The discovery of a unique, inheritable resistance to Ebola infection has inspired the development of therapeutics that may not only be effective against Ebola but against COVID-19, as well.
The Russian invasion of Ukraine has hampered Ukrainian research to develop new treatments for infection from the SARS-CoV-2 virus and increased the risk of spreading virulent pathogens.
The death toll related to COVID-19 is more than 6 million, according to the Johns Hopkins COVID-19 dashboard, but it has long been suspected that the toll is significantly higher.
Capricor Therapeutics announced less-than-stellar Q4 2021 and full-year 2021 financial results and said the company stopped efforts on its COVID-19 vaccine.
The two companies will work closely to harness the abilities of dopamine receptor modulators to help patients living with complex neuropsychiatric conditions.
Selecta Biosciences is moving forward with development efforts for its gene therapy program for methylmalonic acidemia after the FDA lifted the hold on its clinical trial on March 9.
The identification of multiple genomic markers that are linked to specific mental health diseases is beginning to improve treatments and enable precision psychiatry.