Drug Development

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Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
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Enanta Pharmaceuticals’ attempt to find an effective treatment for respiratory syncytial virus (RSV) met a roadblock after its candidate failed to meet the primary endpoint in Phase II.
Following reports that Pfizer has declined study requests for Paxlovid, the company and NIH are said to be in conversation about potential studies assessing a longer treatment period of the antiviral.
Spruce Biosciences is developing what could be the first new therapy treating congenital adrenal hyperplasia (CAH) since the 1960s, and a new therapy for women with polycystic ovary syndrome.
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.