As U.S. pharmacy benefit companies face scrutiny from lawmakers and regulators, the main group representing them in Washington has nearly doubled its lobbying spend to over $15 million in 2023, a Reuters review of congressional disclosures shows.
ReutersThe FDA was expected to make its decision by Wednesday, but it is still reviewing Liquidia’s marketing application for possible approval, although it has not asked for any additional clinical data to support the application.
According to the FDA’s website, the limit, which is in place through February, is due to an increase in demand.
The regulator’s Complete Response Letter flagged issues with the new formulation of tesamorelin’s chemistry, manufacturing and controls and sought more information about its immunogenicity risk.
At the beginning of January, the FDA announced that it was authorizing Florida’s Agency for Health Care Administration to import certain prescription drugs from Canada. Leslie Isenegger, practice leader, corporate pricing and public affairs at Real Chemistry, answers some key questions about the implications the program could have on the pharma industry.
In a Phase I/II trial, an 11-year-old boy gradually regained hearing—eventually reaching normal range for some frequencies at 30 days—following treatment with Eli Lilly’s dual adeno-associated viral vector-delivered gene therapy.
An FDA advisory committee will meet to review J&J and Legend Biotech’s supplemental BLA for Carvykti for the treatment of relapsed or refractory multiple myeloma patients who have undergone at least one prior line of therapy.
Under the agreement, Novo Nordisk has obtained all exclusive rights to develop and commercialize EraCal’s oral small molecule asset to control appetite and body weight with an eye toward treating obesity.
The U.S. pharmacy chain is working with advisers to assess the level of interest in Shields Health, the report said, adding that the specialty pharmacy company is expected to draw interest from private equity firms and healthcare companies.
A three-judge panel of the 2nd U.S. Circuit Court of Appeals in Manhattan said a lower court judge acted properly in imposing the ban and ordering Shkreli to repay $64.6 million because of his antitrust violations.
