Drug Development
HUTCHMED has completed the rolling submission of its New Drug Application to the FDA for fruquintinib, its candidate for refractor metastatic colorectal cancer.
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.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
A roundup of last week’s top clinical trial announcements and news, including updates from Pfizer, BioNTech, Ocugen and more.
Genentech announced new data related to its investigational CD20xCD3 T-cell engaging bispecific antibody intended to treat relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).
Zymeworks increased its stake in the company to 6.9%, slightly under 4 million shares, and options with shares popped 13% after the original bid and are up another 10%.
Axcella is prioritizing its clinical development portfolio to focus on its investigative assets for COVID-19 and non-alcoholic steatohepatitis (NASH) after abrupt leadership resignations.
Mirati Therapeutics’ adagrasib is going up against Amgen’s Lumakras in the KRAS race, and according to Friday pre-market trading, the results shared Thursday don’t seem to be enough for investors.
Two therapies for different cancers are moving forward in development following positive outcomes in their clinical trials ahead of the ASCO’s annual meeting in early June 2022.
On June 5, the FDA is expected to decide the fate of Acer Therapeutics’ experimental treatment for Urea Cycle Disorders (UCDs), ACER-001. CEO Chris Schelling spoke with BioSpace.
Two researchers affiliated with Northwestern University have discovered a new drug that may outperform existing treatments for amyotrophic lateral sclerosis (ALS).
ZYESAMI, (aviptadil), being assessed by NRx Pharmaceuticals, failed a review conducted by the Data Safety and Monitoring Board (DSMB), with the board recommending that arm of the trial cease.
Pfizer announced the FDA has granted its combinatorial therapeutic ervogastat/clesacostat Fast Track Designation that is intended for the treatment of NASH with liver fibrosis.