Takeda puts up $1B-Plus for Hutchmed’s colorectal cancer drug
Takeda entered into an exclusive licensing agreement with Hutchmed Limited to develop its colorectal cancer candidate, fruquintinib, beyond mainland China, Hong Kong and Macau.
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Entries by BioSpace
Sanofi and CytoReason target IBD in expanded collaboration
Sanofi licensed CytoReason’s inflammatory bowel disease model in a multi-million dollar bid to identify new therapies for IBD and Crohn’s and colitis.
Seagen snags accelerated approval in aggressive colon cancer
With the approval, Tukysa became the first FDA-approved treatment for RAS wild-type, HER2-positive metastatic colon cancer, a cancer with historically poor outcomes.
FDA green lights Astellas’ trial for Pompe disease therapeutic
Yesterday, Astellas announced that the FDA had lifted its clinical hold for the company’s experimental gene therapy trial for late-onset Pompe disease. The therapy was placed on clinical hold in June 2022 after a study participant experienced a severe adverse event.
Weeks after reverse merger, Disc expands hematologic pipeline
Disc Medicine inked an exclusive license agreement with Mabwell Therapeutics for the latter’s portfolio of monoclonal antibodies against the TMPRSS6 protein.
Innovative trial design may have cost Lilly’s Donanemab accelerated approval
The FDA issued a complete response letter refusing accelerated approval for Eli Lilly’s Alzheimer’s disease candidate donanemab, the Indianapolis-based company announced yesterday.
Roche’s Tecentriq/Avastin combo scores a first in liver cancer
According to data from the IMbrave150 study, the drug combo is the first treatment option in over a decade to confer significant overall survival benefit over standard of care in unresectable hepatocellular carcinoma.
Despite regulatory progress, delivery hurdles persist for neurodegenerative space
The past year has seen incremental victories in the neurodegenerative disease space with the approval of Amylyx’s Relyvrio, in ALS and Biogen and Eisai’s Leqembi (lecanemab) in Alzheimer’s disease. Despite these regulatory milestones, there are still hurdles to overcome, with delivery across the blood-brain barrier topping the list.
FTC seeks to ban non-competes nationwide, singles out BioPharma
While the FTC’s proposed rulemaking would affect every industry, the impact it could have on biopharma and biotech companies is unique due to the technologically advanced and secretive nature of the research and information gathered and its value to other companies.
Junshi’s Phase III PD-1 blocker shows promise in NSCLC
Junshi Biosciences’ Neotorch is the world’s first registered Phase III immuno-oncology trial for lung cancer to post positive EFS (event-free survival) data.
