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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The FDA has a few target action dates for the end of the month, although PDUFA dates can sometimes seem like a moving target.
Zealand Pharma shared positive top-line results for its second Phase III clinical trial of its congenital hyperinsulinism (CHI) drug, dasiglucagon, in pediatric patients.
Janssen’s Tremfya, an IL-23 inhibitor, is showing an ability to separate itself from AbbVie’s Skyrizi in preventing the activation of cells that drive inflammation.
On Thursday, Mersana announced that the FDA granted an orphan drug designation to one of its lead assets, XMT-2056, which is intended to treat gastric cancer.
As the American Society of Gene & Cell Therapy’s 25th Annual Meeting wraps up, a host of life science companies touted their research and products. BioSpace looks at some of them.
Pfizer, Sarepta Therapeutics, Genethon and Solid Biosciences are working on gene therapies for Duchenne Muscular Dystrophy. Now, the four companies have teamed up.
U.K. researchers found that the first dose of any vaccine was linked with an initial 12.8% decrease in the odds of Long COVID.
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.