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The FDA issued a draft guidance answering commonly asked questions about the Orange Book, the agency’s reference book for generic drug substitutions, including how it deals with patent listings. Read More
Sixty percent of the public surveyed say they believe a treatment or vaccine for COVID-19 will be developed in just under a year. And once developed, 64 percent said they thought it would be less than a year before the public could begin receiving a COVID-19 treatment or vaccine. Read More
Two watchdog groups are pressing the U.S. Office of Government Ethics to reclassify the “vaccine czar” position President Trump recently filled, making it a government job requiring disclosure of all conflicts of interest instead of a private contractor position not bound by disclosure regulations and criminal ethics laws. Read More
The highly politicized debate over whether hydroxychloroquine is or is not useful to COVID-19 patients appears to be far from over. A coalition of more than 180 doctors and researchers have signed an open letter questioning the findings of a study showing that hydroxychloroquine and chloroquine have no benefit in treating COVID-19 patients. Read More
President Trump announced Friday that the U.S. will sever its financial ties to the World Health Organization (WHO), claiming the organization failed to implement requested reforms and was receiving an unfair proportion of its funding from the U.S. Read More
The FDA said it found unacceptable levels of NDMA (N-Nitrosodimethylamine) in extended-release versions of the type 2 diabetes drug metformin. Read More
PureTech Health said it will begin human trials on an experimental treatment for respiratory complications following recovery from COVID-19 infections. Read More
Novartis-subsidiary AveXis has entered into an agreement to manufacture a COVID-19 vaccine being developed by Massachusetts General Hospital and Massachusetts Eye and Ear. Read More
Top pharmaceutical executives pushed back yesterday against the World Health Organization’s plan for sharing patent rights and product data for COVID-19 countermeasures. Read More