Clinical research
The biopharmaceutical company announced the final overall survival analysis of its drug MARGENZA in SOPHIA Phase III study in adults with metastatic breast cancer.
The analysis showed tezepelumab achieved an 86% reduction in the annualized asthma exacerbation rate with patients having nasal polyps, and 52% in patients not having nasal polyps.
Sometimes the U.S. Food and Drug Administration (FDA) runs ahead of schedule. In the case of this week’s two PDUFA dates, that was completely true. Here’s a look.
Novartis announced that it is discontinuing the trial in kidney transplant patients after conducting an interim analysis from its CIRRUS-1 trial of CFZ533 (iscalimab).
There were a fair number of clinical trial announcements last week. Here’s a look.
Shares of Forte Biosciences plunged more than 80% in premarket trading after the company announced failure to demonstrate statistical significance of Phase II atopic dermatitis trial.
The approval was built on data from the Phase III ASPEN trial that compared Brukinsa to ibrutinib in a total of 201 patients. Here’s more about the drug.
Pfizer dosed its first patients in a Phase III trial assessing a single dose of its investigational RSV bivalent prefusion F subunit vaccine candidate (RSVpreF) in adults ages 60 and above.
Shares of Assembly Biosciences have fallen more than 20% in premarket trading after the company discontinued the development of a hepatitis B therapeutic candidate.
Takeda said that Phase III PANTHER, which studied the effectiveness of pevonedistat for different types of leukemia, did not produce significant results in terms of event-free survival.
PRESS RELEASES