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.
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COVID-19 continues to generate surprises, such as a possible link between dementia and severe COVID-19. Continue reading for that and more research stories.
Ampio shares continue to fall following the company’s announcement that the FDA rejected proposed changes to a Phase III study of its treatment for osteoarthritis of the knee and other joints.
Ultragenyx and Mereo celebrated their first patient dosed in a Phase II/III study investigating the use of setrusumab as a treatment for osteogenesis imperfecta (OI).
The FDA noted that the EUA application for Novavax’s COVID-19 shot may take a while to be resolved, citing an “incredibly complex review process.”
RMAT designation means a faster, more streamlined approval process and frequent communication with FDA representatives. The FDA recently granted RMAT Designations to both Direct Bio and AlloVir.
Biopharma and life sciences organizations from across the globe provide updates on their businesses and pipelines.
The U.S. FDA’s Oncologic Drugs Advisory Committee is holding a meeting on April 21, 2022, to discuss safety findings across the entire class of PI3K inhibitors for hematological cancers.
Arcturus Therapeutics announced positive Phase III trial results for its mRNA vaccine candidate, ARCT-154, intended to prevent COVID-19 caused by the SARS-CoV-2 virus.
The FDA has issued a Complete Response Letter (CRL) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) to Teva Pharmaceuticals and MedinCell.
More than two years into the COVID-19 pandemic, some experts, business leaders and government agencies are starting to prep for the next potential pandemic.