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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LEXEO Therapeutics has announced positive initial data from its Phase I/II trial of LX1001, a gene therapy intended for the treatment of APOE4 homozygous Alzheimer’s disease (AD).
President Biden announced updates to the “Test to Treat” initiative that will allow people to get tested for COVID at a pharmacy and receive a treatment round of Pfizer’s Paxlovid at no cost.
After Karyopharm submitted Phase III data from its SIENDO study on Selinexor, the FDA said that it is unlikely to support an sNDA approval for the drug.
FibroGen is tangled up in a Securities Class Action Litigation and Derivative Litigation concerning clinical trial data for its drug Roxadustat.
First Moscow State Medical University has paused recruiting new patients for its ongoing clinical trials following a disruption in the university’s ability to receive clinical trial samples.
The FDA asked Finch to pause enrollment for the trial on CP101 in recurrent C. difficile infection, pending details on how SARS-CoV-2 donor samples will be shipped to the vendor.
The study, which has yet to be peer-reviewed, found the Pfizer-BioNTech vaccine was only about 12% effective for children ages 5 to 11 years against the Omicron variant.
AbbVie has bolstered its neuropsychiatric and neurodegenerative portfolio with the acquisition of Belgium-based Syndesi Therapeutics in a deal valued at up to $1 billion.
On Sunday, Boehringer Ingelheim tweeted a message of support for Ukraine, and announced it was standing in solidarity with the embattled Eastern-European country.
The FDA rejected Gilead’s New Drug Application, citing Chemistry Manufacturing and Controls (CMC) problems associated with the compatibility of the drug with the proposed container vial.