FDA’s Medical Device Chief To Leave Agency; Hospitals Struggling With Blood Culture Bottle Shortage
Read recent pharmaceutical developments in KFF Health News' Prescription Drug Watch roundup.
Stat:
Jeff Shuren, Medical Devices Head At FDA, To Leave Agency
Jeffrey Shuren, longtime chief regulator of medical devices at the Food and Drug Administration, announced to staff on Tuesday that he is leaving the agency, according to six sources and an email reviewed by STAT. (Lawrence, 7/23)
Stat:
Blood Culture Bottle Shortage Challenges Hospitals, Labs
Hospitals across the country are facing a severe shortage of supplies of blood culture bottles, critical tools for diagnosing serious and sometimes life-threatening bloodstream infections. (Branswell, 7/23)
Reuters:
Moderna Co-Founder Robert Langer To Step Down From Vaccine Maker's Board
Robert Langer, co-founder and a key figure behind Moderna's scientific success, will step down from the vaccine maker's board on Aug. 5, the company said on Tuesday. Langer played a crucial role in the development of Moderna's messenger RNA COVID vaccine, which is the biotech's only commercial product. (7/24)
CIDRAP:
Merck Announces Promising Findings For Its RSV Monoclonal Antibody For Infants
Merck today announced promising safety and efficacy results from a phase 2/3 clinical trial of a monoclonal antibody it is developing to protect infants from respiratory syncytial virus (RSV) infection. (Schnirring, 7/23)
CIDRAP:
HHS Announces Pharmacy-Based Clinical Trial Under Project NextGen
The Administration for Strategic Preparedness and Response (ASPR), part of the US Department of Health and Human Services (HHS), today announced $25 million in funding to Walgreen's through the Biomedical Advanced Research and Development Authority (BARDA) Project NextGen to support a COVID vaccine clinical trial featuring a decentralized approach to diversify the pool of study participants. (Schnirring, 7/23)