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GlaxoSmithKline released positive topline results from five clinical studies of daprodustat, its investigational drug for treatment of anemia that occurs with chronic kidney disease (CKD). Read More
San Francisco biotech FibroGen’s investigational drug for anemia linked to chronic kidney disease (CKD) should not receive FDA approval, the agency’s Cardiovascular and Renal Drugs Advisory Committee said yesterday. Read More
The Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization’s COVAX program are launching a “marketplace” to make use of unused materials and idle stock to increase the global production of COVID-19 vaccines for underserved populations. Read More
Mount Sinai Hospital in New York and Cleveland Clinic are the latest large players in healthcare to flash a red light at Biogen’s controversial new Alzheimer’s drug Aduhelm. Read More
The Jan. 4 proposal by NIST would have weakened one of the few tools the federal government has to directly reduce the price of new prescription drugs. Read More
As state law is pre-empted by federal law, generics makers could not update their labeling or redesign their ranitidine products because the FDA had not approved those changes, the judge said. Read More
AstraZeneca’s acquisition of Boston-based Alexion Pharmaceuticals has been cleared by the UK’s Competition and Markets Authority — passing the final hurdle that will allow the $39 billion deal to close next week. Read More