While the Centers for Medicare & Medicaid Services undergoes the comment period on its national coverage decision for Biogen’s controversial Alzheimer’s drug Aduhelm (aducanumab), Biogen and its partner company Eisai released additional details about the Phase IV post-marketing study of the drug.
Two weeks after AstraZeneca announced the company was withdrawing the use of Imfinzi as a treatment for bladder cancer in the United States, Swiss pharma giant Roche followed suit with the checkpoint inhibitor Tecentriq (atezolizumab).
Pfizer announced in a statement that the prespecified non-inferiority criteria for a post-marketing safety study of the rheumatoid arthritis drug Xeljanz (tofacitinib) were not met, but the company remains hopeful that future analyses of the study will be more promising.
Pfizer’s blockbuster rheumatoid arthritis drug Xeljanz has been a strong performer for the company, bringing in $1.77 billion in revenue last year, but now the company has indicated it intends to make a change in a post-marketing study due to safety concerns.
After the U.S. Food and Drug Administration took a hard line on the use of real-world evidence in clinical trials, industry leaders are beginning to back the idea, but with some minor changes.
Bayer AG disputed accusations in a new Netflix documentary that claims medical device makers and the U.S. Food and Drug Administration placed profits before patient safety.
Bayer AG’s Essure birth control implant should carry the strongest safety warning label, U.S. regulators said on Monday, following thousands of complaints about the device. The U.S. Food and Drug Administration also asked the German drugmaker to conduct a post-market study of the device. Essure, acquired by Bayer in 2013, has been the target of […]
Many high-risk therapeutic devices get Food and Drug Administration (FDA) approval with only one study proving their safety and efficacy before going to market. Studies of how the devices work once they are on the market are also few and far between, according to a new study that looked at all 28 high-risk devices approved […]