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HHS has released its latest semiannual regulatory agenda with just four planned drug-related actions by the FDA — three proposed rules and one final rule. Read More
An independent investigation has shown that uniQure’s hemophilia B gene therapy (etranacogene dezaparvovec) was not responsible for a reported case of liver cancer that led to a clinical hold by the FDA on its entire clinical development program for the gene therapy, the company said. Read More
The FDA has not wavered on its October 2020 call for AMAG Pharmaceuticals to withdraw its preterm birth progestin drug Makena and generic versions of it even after a meta-analysis from multiple trials found that it reduced preterm birth before 34 weeks. Read More
The HHS announcement follows the department saying in mid-March that it would stop distributing bamlanivimab in California, Arizona and Nevada. Read More
The Pfizer/BioNTech and Moderna vaccines are highly effective at preventing SARS-CoV-2 infections among healthcare and essential workers, a real-world study by the Centers for Disease Control and Prevention (CDC) has confirmed. Read More
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