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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
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
The FDA has launched a new online dashboard for adverse event reporting of COVID-19 products that have received Emergency Use Authorizations (EUAs). Read More
HHS announced that it will restrict distribution of Eli Lilly’s COVID-19 antibody therapy, bamlanivimab, in three states because of concerns about its effectiveness against a variant strain of the virus first identified in California. Read More
A study by researchers at the University of Utah and other universities found that payments for neurology drugs under Medicare Part D saw a substantial hike over five years despite only a small bump in the number of claims. Read More
The U.S. Senate has unanimously passed two bipartisan bills aimed at lowering prescription drug prices by elevating generics and biosimilars that are now awaiting consideration in the House. Read More
India’s and South Africa’s proposal to temporarily waive intellectual property rights for COVID-19 vaccines and medicines was stopped once again by opposition from wealthy Western nations, including the U.S., during the World Trade Organization (WTO)’s meeting last week, in a victory for the pharma industry. Read More
As part of an industry-wide FDA review, the agency’s Oncologic Drugs Advisory Committee will convene next month to discuss six cancer indication approvals given under the agency’s Accelerated Approval program that haven’t verified their clinical benefit in confirmatory trials as required. Read More
The European Commission (EC) granted Johnson & Johnson (J&J)’s COVID-19 vaccine a conditional marketing authorization yesterday, giving the 27-member bloc a desperately needed alternative as the region faces serious supply delays for previously authorized shots. Read More