Drug Development
Late-stage data from two studies showed Novartis’ BTK inhibitor remibrutinib improves symptoms of chronic spontaneous urticaria. The company will file for regulatory approval in 2024.
FEATURED STORIES
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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THE LATEST
Centessa halted ZF874 following the report of an adverse event that involved elevated liver enzymes in a Phase I study. This is the second development program the company has stopped in as many months.
A new study on Alzheimer’s disease ties the brain’s immune response to the condition, while scientists have identified a better antibody treatment for cancer and more research news.
Panacell Biotech plans to initiate a program to investigate the use of natural killer (NK) immune cells, exosomes and brown adipose-derived stem cells to treat Long COVID.
Vyne Therapeutics’ combination therapy for atopic dermatitis failed to meet the primary endpoint in a Phase II trial, leaving the company evaluating its priorities and pipeline.
MaaT Pharma announced that the U.S. FDA has maintained the clinical hold on MaaT013, its candidate for patients with steroid-resistant acute graft-versus-host disease.
Monkeypox is spreading, COVID-19 stubbornly persists and on Tuesday, news broke of a Langya henipavirus outbreak in China.
Using Cerevance’s proprietary NNETSseq technology platform, Merck and Cerevance have partnered to identify new targets for the treatment of Alzheimer’s disease.
BeiGene and Novartis’ unresectable hepatocellular carcinoma treatment, Tislelizumab, is gaining ground as a potential treatment for advanced liver cancer.
The week started off with a clinical bang for Verona Pharma, Kodiak, AstraZeneca and Daiichi Sankyo with wins in COPD, lung cancer and macular edema respectively.
Industry executives often lament the fact that clinical trials take a long time to complete and often fail. BioSpace spoke with Tufts’ Ken Getz about possible reasons and solutions.