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The FDA released a straight-to-final guidance yesterday on steps drugmakers should take to prevent high levels of nitrosamine impurities in their products. Read More
When the FDA is reviewing products that include both drugs and devices in combination, a stumbling block that sometimes causes delays is poor communication between the agency's Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH), according to an independent assessment by Lexington, Mass.-based Eastern Research Group (ERG). Read More
Generics company Mylan along with Biocon Biologics launched their diabetes drug Semglee, a version of Lantus, this week, touting it as 65 percent less expensive than other long-acting insulin products on the market. Read More
The chair of the House Committee on Oversight and Reform has told her colleagues that she is issuing a subpoena to AbbVie as part of the committee’s ongoing investigation into how companies set drug prices. Read More
Sanofi and Regeneron Pharmaceuticals said they have no plans to conduct further trials of their rheumatoid arthritis drug Kevzara for COVID-19 after it failed in a late-stage study. Read More
In a widely reported interview over the weekend, FDA Commissioner Stephen Hahn said the agency is prepared to issue an Emergency Use Authorization for a COVID-19 vaccine before phase 3 trials are complete if the benefits outweighed the risks. Read More
The FDA has been accused of potentially fouling up its Aug. 23 Emergency Use Authorization (EUA) of convalescent plasma (CCP) for the treatment of COVID-19 by adding a requirement that each unit of plasma include information on the concentration of antibody titres. Read More
The European Commission announced Monday that it is participating in the World Health Organization’s international COVAX program for COVID-19 vaccines and is contributing $478 million. Read More
In applications for patents — including some generally relevant to its COVID-19 vaccine candidate — Moderna failed to disclose millions of dollars it got from the Defense Advanced Research Projects Agency (DARPA), alleges an advocacy group that wants the Department of Defense (DOD) to investigate. Read More