Drug Development
The companies will evaluate Moderna’s investigational Claudin18.2 mRNA cancer vaccine in combination with CARsgen’s Claudin18.2 CAR T cell candidate.
FEATURED STORIES
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.
The cholesterol-lowering drug is part of a suite of medicines that also includes MariTide and that Amgen Chief Medical Officer Paul Burton hopes will make the company the “undisputed leader in the management of cardiometabolic risk for patients” by 2030.
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The FDA is busy accepting drug applications, granting specialty designations and approving drugs for market. Here’s a look at this week’s FDA activity.
Novartis’ canakinumab failed again in non-small cell lung cancer while Anixa Biosciences, Palisade Bio and Genexine kicked off new trials.
HHS found nearly half of NIH clinical trials were reported incorrectly, in violation of federal standards, according to a new report issued Friday by the agency.
New study supports link between Alzheimer’s and other diseases and points out potential risk factors for developing Alzheimer’s later in life.
Lundbeck revealed that its migraine drug Vyepti failed to demonstrate statistical superiority over placebo at reducing the number of monthly migraine days.
The regulatory path for companies developing drugs for rare diseases is often fraught with challenges. KemPharm CEO Travis Mickle discussed just some of these with BioSpace.
Curis announced that the FDA has allowed patient enrollment to resume in the monotherapy phase of its TakeAim Leukemia Phase I/II trial studying emavusertib.
A trial evaluating generic drugs against severe COVID-19 provided data showing their overall ineffectiveness, and COVID-19-related lawsuits continue to pile up.
South Korea-based Genuv Inc. announced the publication of a preclinical study showing the potential of Mekinist, approved by the FDA for melanoma, in Alzheimer’s disease.
Jazz Pharma is breaking new ground with its cannabidiol epilepsy treatment Epidiolex, taking the drug into a Phase III study in children and adolescents.