Drug Development
When given hours ahead of an expected episode, a late-stage study showed the preventive benefits of Ubrelvy in safely reducing moderate or severe headaches within 24 hours of treatment.
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 LATEST
MBX Biosciences secured $115 million in Series B financing to advance its pipeline of Precision Endocrine Peptides for endocrine disorders.
Roche announced its investigational antibody gantenerumab failed to meet the primary endpoints in GRADUATE I and II - two Phase III studies in Alzheimer’s disease.
Early data from a combination of Cue Biopharma’s CUE-101 and Keytruda shows the treatment is effective in patients with recurrent/metastatic HPV16+ head and neck cancer.
PACT Pharma shared results of a first-of-its-kind trial using CRISPR technology to swap a gene in a patient’s immune cell to treat solid tumors.
At the FDA’s request, GSK has restricted the use of Zejula, a PARP inhibitor, to a specific population as a second-line maintenance treatment for ovarian cancer following updated data.
Seagen’s Adcetris has been given FDA approval for the treatment of children aged two years and above with high-risk classical Hodgkin lymphoma.
BrainStorm Cell Therapeutics ran into another stumbling block with ALS hopeful NurOwn Thursday as the FDA issued a Refusal to File Letter for its Biologics License Application.
The FDA’s Pulmonary-Allergy Drugs Advisory Committee voted against the potential Emergency Use Authorization of the company’s COVID-19 therapeutic candidate, sabizabulin.
AstraZeneca will give up on seeking approval for its COVID-19 vaccine in the United States. It is also abandoning three early-stage programs.
An anti-CD70 antibody drug conjugate developed by Ambrx, Inc. has been administered to the first patient in a Phase I study in China. It marks the first ADC in active development that targets CD70.