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A foundation representing German vaccine maker BioNTech has been accused of trying to undermine the World Health Organization’s (WHO) initiative to bring COVID-19 vaccine manufacturing to the African continent. Read More
Democrats in the U.S. House of Representatives and eight advocacy groups are pressing Department of Health and Human Services (HHS) head Xavier Becerra to use either “march-in” or government use rights for the prostate cancer drug Xtandi, which is marketed by Pfizer and Japanese company Astellas but was developed using grant funding from the U.S. Army and the National Institutes of Health (NIH). Read More
President Biden sought yesterday to revive his massive spending package lying dormant in the Senate by highlighting a popular component of the bill — prescription drug pricing reform. Read More
Members of FDA’s Oncologic Drugs Advisory Committee voted 14-1 yesterday to require a U.S. study for sintilimab, Lilly’s investigational lung cancer drug that — so far — only has Chinese trial data. Read More
Seventy-eight Republicans have thrown down the gauntlet in front of the Centers for Medicare & Medicaid Services (CMS), charging that limiting payments for Biogen’s Aduhelm pressures people with Alzheimer’s disease — especially minorities, the poor and the disabled — to participate in clinical trials if they want the drug. Read More
The FDA has issued a warning letter to Innoveix Pharmaceuticals arising from an inspection of the company’s drug compounding facility in Addison, Texas, last May in which an agency official observed serious deficiencies in the plant’s sterile production practices. Read More
The European Medicines Agency (EMA) has announced a new center that will deliver a network of real-world data (RWD) sources across the EU for use in drug reviews. Read More
Opdivo, Bristol Myers Squibb’s checkpoint inhibitor, increased survival time in patients with inoperable advanced esophageal cancer, both alone and in combination with the company’s T-cell booster Yervoy (ipilimumab). Read More