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At least five drug developers working on COVID-19 therapeutics and vaccines with U.S. government funding have contracts that bypass laws that ensure taxpayer-funded drugs and vaccines are affordable, a new report says. Read More
FDA Commissioner Stephen Hahn said yesterday that he was “optimistic” that more than one COVID-19 treatment could be available by the fall in addition to Gilead Sciences’ remdesivir, which has already received Emergency Use Authorization from the agency. Read More
Any COVID-19 vaccine the FDA approves would have to be at least 50 percent more effective than a placebo, according to a new guidance it released yesterday. Read More
The FDA will allow sponsors to extrapolate efficacy results from adult studies to use in pediatric studies of anti-infective drugs, as long as the disease process and the effects of the drug are similar in both populations. Read More
Novartis has agreed to pay $345 million to the U.S. government to settle charges that it violated the Foreign Corrupt Practices Act (FCPA) by bribing doctors in Greece and Vietnam. Read More
As the race to develop an effective COVID-19 vaccine by year’s end gains momentum, the FDA said it plans to issue a guidance on developing and licensing them. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) yesterday recommended granting Gilead Sciences’ remdesivir a conditional marketing authorization as a COVID-19 treatment. Read More
Public Citizen has petitioned the FDA to require a black box warning for sodium-glucose cotransporter-2 (SGLT2) inhibitors used off-label for treatment of type 1 diabetes. Read More
Senior Democrats in the House unveiled a bill yesterday that would give HHS the authority to negotiate prices for hundreds of drugs and would tax noncompliant drugmakers up to 95 percent of their sales. Read More
Three high-ranking House Democrats have asked FDA Commissioner Stephen Hahn for more details of the agency’s review process for COVID-19 vaccines. Read More