Government
A spokesperson for the Department of Health and Human Services refuted the claim, made Thursday on social media by ACIP Vice Chair Robert Malone, calling it “baseless speculation.”
Heath Secretary Robert F. Kennedy Jr.’s efforts to overhaul vaccine policy are likely illegal, a Massachusetts District Court Judge ruled; Structure’s GLP-1 weight loss pill succeeds in Phase 2 while Rhythm’s Phase 3 basket trial fails to find the beat; Eli Lilly warns of potential safety risks of taking compounded tirzepatide, and Novo Nordisk is hit with an FDA warning letter regarding adverse events potentially linked to Ozempic.
A Massachusetts judge called Kennedy’s efforts to reform the CDC’s vaccines advisory panel a “procedural failure,” adding that the new committee members do not “comport with governing law.”
Health Secretary Robert F. Kennedy Jr. has become increasingly unpopular among several government officials, largely as a result of his antivaccine rhetoric and actions. Other contentious issues reportedly include the approval of an abortion pill and other controversial FDA decisions.
Rare disease biotech stocks pop on the news that Vinay Prasad, the FDA’s chief biologics regulator, will depart the FDA at the end of April; Sen. Ron Johnson launches an investigation into recent rare disease drug rejections; and Roche and Zealand’s amylin analog fails to match investor expectations—and Eli Lilly’s rival candidate—in a mid-stage trial.
Some biotechs that had seen regulatory setbacks under Center for Biologics Evaluation and Research director Vinay Prasad experienced stock bumps Monday morning. Under Prasad’s leadership, the rare disease space has suffered a series of controversial rejections.
TrumpRX and DTC sales may expand prescription drug access, but they will not solve the affordability crisis by themselves.
Adam Urato, who is currently a vaccine advisor to the CDC, is closely associated with acting CDER director Tracy Beth Høeg and is a fellow skeptic of the use of selective serotonin reuptake inhibitors during pregnancy.
UniQure and REGENXBIO are both dealing with FDA setbacks for their respective gene therapies, as regulatory experts question the FDA’s decision-making processes; CBER director Vinay Prasad is under probe for allegedly fostering a toxic workplace; Sarepta CEO Doug Ingram is stepping down after several years of tumult at the top of the muscular dystrophy–focused company; and Eli Lilly again tops Novo Nordisk in a weight loss trial.
One of the two new members of the CDC’s Advisory Committee on Immunization Practices questioned the safety of COVID-19 vaccines before the Texas Senate in 2021.
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