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A federal judge has granted Eli Lilly’s request to halt an HHS final rule for its 340B drug discount program, siding with the drugmaker in finding that the department didn’t follow rulemaking requirements or give enough time for comment. Read More
In another blow to AstraZeneca’s (AZ) COVID-19 vaccine, a peer-reviewed study has found that it failed to protect against mild-to-moderate infections caused by the virus’ South African variant. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) issued a warning letter to Foshan Biours Biosciences, an over-the-counter (OTC) drugmaker in Guangdong, China, following a records-based inspection that revealed inadequate testing and cleaning validation for the company’s biomedical patch. Read More
A U.S. District Court has dismissed major accusations made in a high-stakes lawsuit brought by Minnesota Attorney General Keith Ellison alleging that three big drugmakers engaged in price gouging of diabetes drugs, thus violating the Racketeer Influenced and Corrupt Organizations (RICO) Act. Read More
In a revision of its Emergency Use Authorizations (EUAs) for Eli Lilly’s and Regeneron’s antibody combination therapies for COVID-19, the FDA is requiring the companies to assess the therapies against the mutant strains of the SARS-CoV-2 virus. Read More
Moderna is working to widen the utility of its COVID-19 vaccine and, over the past week, announced that it has begun to study its vaccine in kids aged six months to 11 years old, that it is testing a version of its vaccine that can be stored at warmer temperatures and that it launched a study of a modified COVID-19 vaccine to target the variant strain first identified in South Africa. Read More
The European Commission has announced that it expects to receive approximately 200 million doses of Pfizer/BioNTech’s two-dose COVID-19 vaccine in the second quarter, giving hope that the EU may reach its inoculation goals on time despite serious setbacks to vaccine deliveries. Read More
Nearly two dozen attorneys general (AG) have come out against a $10 billion bankruptcy proposal put forth by Purdue Pharma to settle thousands of opioid lawsuits, calling it an improvement over the original plan but still inadequate in the compensation it provides. Read More