“The FDA Fast Track Designation for AB-1002 is an important accomplishment for the clinical development of this program and highlights our goal of bringing potentially effective treatments to patients with advanced congestive heart failure,” said Canwen Jiang, MD, PhD, Chief Development Officer and Chief Medical Officer, AskBio.
Tag Archive for: Drug development
An FDA advisory committee agreed that using minimal residual disease could be a viable surrogate endpoint for accelerated approval for drug development in multiple myeloma.
Neumora Therapeutics said the U.S. Food and Drug Administration (FDA) had placed a clinical hold on early-stage study of its experimental schizophrenia drug, sending its shares down more than 23% in premarket trading.
Novartis is to cut up to 680 jobs in its development organization, which helps bring its drugs to market, the Swiss pharmaceuticals company said on Tuesday.
Recent U.S. policy changes and the introduction of the Inflation Reduction Act (IRA) have injected a sense of urgency within pharma companies for greater cross functional cooperation. The traditional route that drugs take through the development process from bench to patient needs a radical rethink. Any pressure on how drugs are assessed through the AA route will further ramp up the urgency within pharma to align internally.
Now in Phase III with its small molecule orforglipron, Eli Lilly is leading the oral GLP-1 race against Novo Nordisk, Pfizer, Roche and others.
While disease-modifying therapies largely steal the spotlight in Alzheimer’s drug development, several companies are working to solve this less-discussed but disruptive facet of the illness.
According to its SEC filing at the time, Boundless will use the IPO proceeds to fund the development of its extrachromosomal DNA (ecDNA) programs, being developed for cancer indications.
Moderna has entered into a development and commercialization funding agreement with asset management firm Blackstone Life Sciences to help advance its pipeline of flu vaccine candidates.
Axsome Therapeutics said on Monday its experimental therapy cut the frequency of disruptive episodes of muscle weakness tied to a sleep disorder called narcolepsy in a late-stage trial.
