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The U.S. government is moving ahead of schedule on a vaccine partnership with pharmacies across the country to speed up inoculations with the Pfizer/BioNTech and Moderna vaccines and it will start the program this week, HHS Secretary Alex Azar announced yesterday. Read More
Wholesale price increases for brand-name drugs analyzed by the research group 46Brooklyn outpaced inflation for the past two years with a median increase of 5 percent in both years. Read More
Sponsors of human gene therapy (GT) products for neurodegenerative diseases affecting adults and children should initiate first-in-human clinical trials in adults before undertaking pediatric trials, according to new draft guidance the FDA released last week. When pediatric trials must be conducted first, sponsors should provide a rationale for why adult studies are not ethical or feasible, the guidance says. Read More
Effective Jan. 1, drugmakers can now seek accelerated drug approvals in the UK using the newly launched Innovative Licensing and Access Pathway (ILAP). Read More
HHS has made it known that pharma companies are required to offer 340B discounts for covered drugs even when they’re distributed by contract pharmacies, speaking out after several big drugmakers began withholding them. Read More
HHS has ordered the FDA to “cease further collection efforts” related to the Over-the-Counter Drug Monograph User Fee Program and has withdrawn the agency’s Dec. 29 Federal Register notice on user fee rates. Read More
The FDA made the right call in strongly advising against using a half-dose regimen of Moderna’s COVID-19 vaccine to stretch supply and vaccinate more Americans, members of the agency’s vaccine advisory panel told FDAnews. Read More