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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
Bristol Myers Squibb (BMS) has announced that its phase 2/3 melanoma trial of the company’s anti-LAG-3 antibody combination therapy met its primary endpoint of extending progression-free survival for melanoma patients who had not received prior treatment. Read More
AstraZeneca (AZ) responded to National Institutes of Health (NIH) concerns over its interim vaccine trial data by releasing its primary analysis results yesterday, but the embattled company’s two-dose shot faces intense scrutiny, with the European Medicines Agency (EMA) holding an expert meeting on March 29 to review possible links to blood clots. Read More
The University of California, San Francisco and Johns Hopkins University have launched an online archive of documents associated with the numerous lawsuits filed against drugmakers alleged to have fueled the U.S. opioid epidemic. Read More