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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
A large study has found that the Medicare Part D program could have saved almost $1.7 billion in one year if prescribers and patients had chosen generic drugs over their brand-name equivalents. Read More
The FDA has challenged a lawsuit filed by pharmacies against its compounding drug distribution regulations issued last year, contending it is too early to take the matter to court. Read More
An FDA expert panel on vaccines met on Friday to review strains to include in influenza vaccines for the next flu season and heard that the COVID-19 pandemic has changed the production landscape. Read More