Vinay Prasad, MD, former head of the FDA’s vaccine and gene therapy division who resigned under political pressure two weeks ago, is returning to the agency, The New York Times reported Aug. 9.  Dr. Prasad stepped down from the role…

AHA, along with other national hospital groups, urged the Health Resources and Services Administration to extend key deadlines for its recently announced 340B rebate model pilot program.  In a joint letter issued Aug. 8, the groups said the agency’s current…

The FDA has lifted its previously recommended pause on the use of the Chikungunya virus vaccine in individuals 60 and older, following a benefit-risk assessment.  The agency also approved updated labeling for the vaccine, which includes expanded warnings about adverse…

GSK said it will receive $370 million as part of the U.S. patent settlement involving CureVac and BioNTech over mRNA-based COVID-19 vaccines, The Wall Street Journal reported Aug. 8.  Under the deal, GSK will receive a $320 million cash payment.…

The American Society of Health-System Pharmacists has named Kim Benner, PharmD, as the organization’s next president.  Dr. Benner is a professor at Samford University’s pharmacy school in Birmingham, Ala., and a pediatric clinical pharmacy specialist at Children’s of Alabama in…

A growing number of health systems are investing heavily in centralized service centers to help reduce costs, address drug shortages and streamline operations. 

The 6th U.S. Circuit Court of Appeals upheld the dismissal of a lawsuit brought by the Chamber of Commerce challenging Medicare’s drug price negotiation program, ruling plaintiffs lacked standing to sue, The Hill reported Aug. 6.  The case centered on…

As the federal government pushes for lower drug prices and more domestic production, the FDA launched a “PreCheck” program Aug. 7 to expedite approval of new U.S. drug manufacturing facilities.  FDA PreCheck will provide drugmakers more frequent communication with the…

The FDA has granted accelerated approval to dordaviprone for the treatment of diffuse midline glioma with an H3 K27M mutation in patients one year old and older with progressive disease following therapy.  This is the first FDA-approved systemic therapy for…

Boise, Idaho-based St. Luke’s Health System named Josh Weber, PharmD, senior director of ambulatory, retail and specialty pharmacy services, he confirmed to Becker’s in an email.  In the new role, Dr. Weber will lead the strategic, financial and operational efforts…