Drug Development
The Phase 3 results are the first direct proof-of-concept for an ADC replacing platinum-based chemo in a first-line standard-of-care regimen for non-small cell lung cancer, according to Leerink Partners. The readout also represents the second late-stage win for the Merck and Kelun-Biotech asset, called sac-TMT.
FEATURED STORIES
Biogen touted an “unprecedented” drop in tau in a Phase 2 trial, backing the company’s decision to take diranersen to Phase 3 despite a missed primary endpoint and seemingly supporting the anti-tau approach.
As antibody-drug conjugates advance and move into earlier lines of treatment, drug developers have to build gentler therapies that don’t just extend survival but improve it.
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
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A second patient death has been linked to the Phase III clinical trial of Eisai and Biogen’s investigational Alzheimer’s drug lecanemab, according to the journal Science.
Shares of CinCor Pharma fell more than 50% in premarket trading Monday after its investigational blood pressure drug failed to meet the primary endpoint in a Phase II trial.
A Phase III trial of Axsome Therapeutics’ AXS-05 hit both the primary and secondary endpoints in patients with Alzheimer’s disease agitation, the New York-based company announced Monday.
BioMarin Pharmaceutical announced the FDA no longer plans to hold an advisory committee meeting to review its BLA for Roctavian an AAV gene therapy for adults with severe hemophilia A.
Novartis and Medicines for Malaria Venture are moving into Phase III for a combination treatment targeting the rise of artemisinin-resistant Malaria infection.
Late Monday, Arvinas Inc. was forced to divulge the contents of its upcoming breast cancer data presentation, slated for the 2022 San Antonio Breast Cancer Symposium (“SABCS”).
The FDA granted priority review to Takeda’s Biologics License Application for TAK-003, a dengue vaccine candidate. The vaccine to date is only approved for use in Indonesia.
Merck is eyeing another major label expansion for its flagship anti-PD-1 therapy Keytruda following an interim analysis of KEYNOTE-859 trial.
The FDA granted argenx Priority Review status for the company’s BLA for SC efgartigimod for generalized myasthenia gravis.
Following a request from the FDA, GSK is withdrawing its multiple myeloma drug Blenrep from the U.S. market while continuing to push other combination trial programs.