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
Carver Biosciences is developing next-generation gene editing technology using Cas13. By editing RNA, this method makes it possible to target and then edit or destroy RNA from viruses like SARS-CoV-2.
The data demonstrated that the drug, when given to the patients for more than seven days, offered a protection rate of 100%.
Biopharma and life sciences organizations from across the globe provide updates on their businesses and pipelines.
Evozyne inked a partnership with Takeda Pharmaceutical to develop next-generation gene therapies for up to four rare disease targets. Continue reading for that and more collaboration news from this week.
The AMR Action Fund financed two of this week’s money moves. Other moves ranged from medical devices to wearable sensor data companies. For that and more, continue reading.
Citius Pharmaceuticals has shared positive topline data from its Phase III clinical trial of I/Ontak. The company plans to file a biologics license application with the FDA later this year.
With the accelerated approval from the U.S. Food and Drug Administration, Vijoice becomes the first treatment approved in the United States for PROS
The FDA has stated that GSK and Vir’s COVID-19 treatment sotrovimab is no longer authorized to be used for the condition because of its low efficacy against Omicron sub-variant BA.2.
The U.S. Food and Drug Administration (FDA) has approved BioXcel Therapeutics’ Igalmi, a drug designed to reduce agitation episodes in bipolar disorder and schizophrenia patients.
Speakers at the 2022 Virtual Growth Conference’s session on pancreatic cancer acknowledged the exceptional challenges while extolling advances in immune-based therapies and combination approaches.