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Gilead Sciences’ daily oral HIV blockbuster Biktarvy has shown success as a long-term treatment, demonstrating continued high efficacy and strong viral suppression in two phase 3 trials that conducted years of follow-up. Read More
The European Commission (EC) will kick off a new pilot program later this month to collect information from drug sponsors to better understand why oncology and orphan drug products may be unevenly marketed across the 27-member bloc. Read More
Pfizer and French drugmaker Valneva have initiated a new phase 2 study evaluating VLA15, their experimental vaccine for Lyme disease — and say this is likely to be the last one before the candidate progresses to phase 3 trials. Read More
Merck and Ridgeback Biotherapeutics have said their experimental COVID-19 antiviral MK-4482 (molnupiravir) significantly reduced infection after five days of treatment in a clinical trial. Read More
More than two dozen PhRMA members have sent a letter to President Biden, imploring him to oppose India’s and South Africa’s proposal to the World Trade Organization (WTO) to waive intellectual property (IP) rights for COVID-19 innovations during the pandemic. Read More
A Pfizer plant that will produce the company’s COVID-19 vaccine has been observed by FDA investigators as having quality control lapses, but Pfizer says the problems will be resolved before the facility supplies any COVID-19 vaccine doses. Read More
The Senate passed a $1.9 trillion COVID-19 relief bill on Saturday in a 50-49 vote along party lines, including a $500 million appropriations injection for the FDA — equivalent to a 16 percent increase in the agency’s fiscal year 2021 funding. Read More