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Just four months after Eli Lilly’s COVID-19 antibody therapy, bamlanivimab, received FDA Emergency Use Authorization (EUA), HHS is restricting nationwide distribution of it due to concerns about an increase in variants of SARS-CoV-2 that are resistant to the drug. Read More
The FDA is establishing an information-sharing network so states can provide information about compounding pharmacies to the agency — and to share notes among themselves. Read More
The FDA is proposing to add quinacrine hydrochloride to its 503B bulk substances list that outsourcing facilities may use in drug compounding. Read More
The European Commission (EC) aims to speed authorizations of vaccines adapted to fight new SARS-CoV-2 variants by giving the European Medicines Agency (EMA) fast-track authority. Read More
Pfizer’s monoclonal antibody tanezumab got a thumbs down for treating pain from osteoarthritis from two FDA advisory committees meeting in a joint session Thursday. Read More
In his first presidential news conference yesterday, President Biden set a new goal of 200 million COVID-19 vaccinations by his 100th day in office — doubling his initial goal. Read More
The FDA has revised its fiscal 2021 user fee rates for the Over-the-Counter (OTC) Monograph Drug User Fee Program to reflect exemptions for alcohol-based hand sanitizer makers, noting that OTC drugmakers will see an increase in facility fees. Read More
As Europe continues to face challenges and setbacks in its COVID-19 vaccination efforts, the European Commission (EC) has proposed new criteria for vaccine export authorizations to conserve its supplies. Read More
Democrats are reportedly considering using budget reconciliation, a procedure that would allow them to bypass Republican opposition and filibustering, to get major drug pricing legislation to the president’s desk. Read More
Amy Abernethy, the FDA’s principal deputy commissioner and acting chief information officer, will depart from the agency in a matter of weeks, according to acting commissioner Janet Woodcock. Read More