Drug Development
The company also stands to gain from recent regulatory FDA guidance aimed at streamlining the development of non-opioid painkillers, Jefferies analysts suggested.
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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In a Phase IIb study, data showed that Prota Therapeutics’ oral immunotherapy led to 51% of children reaching clinical remission of their peanut allergy compared to placebo. See inside for this and more!
GeNeuro is developing therapeutics that tackle the viral proteins that potentially contribute to neurodegeneration seen in patients with MS, amyotrophic lateral sclerosis (ALS) and even COVID-19.
Applied Molecular Transport (AMT) provided a strategy update on Wednesday. Part of the update includes reducing its workforce by about 40% and funneling resources into its lead program.
Pfizer apparently hasn’t begun any combination trials in human beings of Paxlovid, and no reported human tests are using the drug in combination with other therapies.
The American Society of Gene and Cell Therapy annual meeting continues to see companies showcasing promising therapeutics for multiple disease indications.
Axsome Therapeutics announced that it published the results of its Ascend Phase-II clinical trial of AXS-05 to treat Major Depressive Disorder in The American Journal of Psychiatry.
Scientists in New Zealand have found that mRNA-based COVID-19 vaccines produce greater antibody levels compared to adenovirus vector-based ones across major COVID-19 variants.
ShouTi believes many targets addressed by biologic and peptide therapeutics can be reached by innovative, rationally-designed, best-in-class small molecules that don’t need refrigeration or injection.
Cytokinetics filed with the SEC reporting that the FDA planned to hold an advisory committee meeting to review its New Drug Application (NDA) for omecamtiv mecarbil.
Avrobio presented clinical data on Tuesday at the 25th Annual Meeting of the American Society for Gene and Cell Therapy (ASGCT) from its trial of AVR-RD-04, and preliminary results are promising.