JOHNS HOPKINS UNIVERSITY

Negotiations for FY 2025 appropriations are ongoing, impacting NIH funding; President-elect Trump's nominees for HHS, CMS, CDC, FDA, and Surgeon General spark concern in the medical research community; House Appropriations Subcommittee reviews NIH budget for FY 2025; AACR and FDA host workshops on DPD deficiency and clinical trials; U.S. Surgeon General highlights tobacco use disparities; FDA approves new drugs and updates product labeling.

Trump nominates Dr. Marty Makary as FDA commissioner, potentially easing biotech and pharmaceutical industry concerns. Makary, a Johns Hopkins surgeon, supports evidence-based medical intervention and may promote innovation. His nomination contrasts with Robert F. Kennedy Jr.'s, a vaccine skeptic, for HHS. Neuralink, Elon Musk's neurotech startup, gains approval for a new trial to assess brain implants controlling robotic arms.

Samsung Electronics appoints Samsung Bioepis CEO Ko Han-sung to lead its Future Business Planning Division, marking a strategic shift with his biotech expertise. Ko, with a Ph.D. in genetic engineering, has steered Samsung Bioepis for 13 years and will continue his role as KoreaBIO chairman. Samsung Bioepis also names Kim Kyung-ah, its first non-founder female CEO, as its new head, symbolizing innovation and diversity.

People with HIV can now receive kidneys or livers from HIV-positive donors, per new HHS rules, based on evidence of safety and effectiveness. This change eliminates prior research study requirements.

A prospective cohort study enrolled 105 hospitalized and 73 non-hospitalized COVID-19 patients from April 2020 to April 2021, approved by Johns Hopkins University IRB. Non-hospitalized patients provided oral consent over the phone, while hospitalized patients gave written consent. Blood plasma samples were collected at various time points post-enrollment, with hospitalized patients' samples collected until death or 100 days post-enrollment. SARS-CoV-2 RNA levels were measured via RT-PCR, and SARS-CoV-2 variant inference was based on sample collection dates. Plasma proinflammatory cytokines and chemokines were measured using a custom multiplex kit, and binding antibodies were determined via ELISA. ACE2 binding inhibition and complement activation assays were also performed. ADCC assays and flow cytometry confirmed spike surface expression. Multiplex antibody assays on mucosal samples determined IgG and sIgA responses. Statistical analyses included linear regression, ANOVA, Spearman correlation, and linear mixed-effects modeling. Random forest modeling assessed predictive power of sociodemographic and serological variables for intubation or death outcomes.

President-elect Donald Trump appoints Johns Hopkins surgeon Marty Makary as FDA commissioner, selecting a medical researcher who challenged COVID-19 vaccination policies. Makary, a pancreatic surgery specialist, differs from Trump's controversial HHS and CMS nominees, Robert F. Kennedy Jr. and Mehmet Oz. Trump cites Makary's need to restore trust in the FDA and refocus its regulatory goals. Makary, though pro-vaccine, opposed broad mandates and criticized COVID vaccination policies for young adults and children, potentially complicating his role balancing vaccine credibility with conservative skepticism.

Trump's health agency nominees, including Marty Makary for FDA, Dave Weldon for CDC, and Janette Nesheiwat for Surgeon General, raise concerns due to their controversial views on vaccines. Robert F. Kennedy Jr., a prominent vaccine skeptic, is tapped to lead HHS, signaling potential major changes in public health policy.

Trump's health team includes Dr. Marty Makary for FDA, Dr. Dave Weldon for CDC, and Dr. Janette Nesheiwat for Surgeon General, all trained physicians with varied backgrounds. Makary criticizes food processing, Weldon pushed for embryo patent ban, and Nesheiwat advocates for vaccinations, potentially conflicting with Robert F. Kennedy Jr., Trump's HHS nominee.

Donald Trump appoints Johns Hopkins surgeon Marty Makary as FDA commissioner, choosing a medical researcher who challenged COVID-19 vaccination policies. Makary, a pancreatic surgery specialist, differs from Trump's controversial HHS and CMS picks, Robert F. Kennedy Jr. and Mehmet Oz. Trump cites Makary's need to restore trust in the FDA. Makary, though pro-vaccine, opposed broad mandates and criticized COVID vaccination policies for young adults and children.