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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five medicines for approval at its monthly meeting last week — and issued a positive review of Celltrion’s monoclonal antibody, regdanvimab, for treatment of COVID-19. Read More
The Pfizer/BioNTech COVID-19 vaccine is seeing progress on multiple fronts, including a newly launched study in children as young as six months old, a billion-dose a year manufacturing facility that will come on stream in Germany next month and less onerous storage temperatures expected soon in the EU. Read More
A group of academics, policy experts and nonprofits has penned a letter to HHS and the National Institutes of Health (NIH) urging the government to draw up provisions that improve global access to Moderna’s COVID-19 vaccine as part of any patent-licensing agreement for the drugmaker. Read More
Novartis is free to pay for low-income patients to receive its pricey CAR-T therapy Kymriah (tisagenlecleucel), and those payments will not be considered illegal. Read More
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