JN.1 Subvariant SARS CoV-2 rS Vaccine(Novavax)

THURSDAY, Nov. 14, 2024 -- President-elect Donald Trump has chosen Robert F. Kennedy Jr. to head the U.S. Department of Health and Human Services. The department encompasses numerous key agencies, including the U.S. Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the National Institutes of Health, Medicaid, and Medicare. In a statement, Trump, who has already said he would let Kennedy "go wild on health," reinforced his would-be appointee's image as a maverick. "For too long, Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation, and disinformation when it comes to Public Health," Trump said in a post on his Truth Social site announcing the nomination. Kennedy, he said, would "Make America Great and Healthy Again!" It has been a dramatic arc for Kennedy, whose namesake father was assassinated in 1968 in the midst of a campaign to become the Democratic presidential nominee that year. Kennedy Jr. was himself a Democrat until he campaigned in this year's presidential campaign as an independent focused on health care. But he abandoned the race after receiving a pledge from the Republican Trump that he would be given a high-ranking position in health policy if Trump won the election. However, Kennedy's many controversial positions on various aspects of health have made him a target of critics. He has long claimed that the COVID-19 vaccines employed during the pandemic caused more harm than good -- a claim not borne out by science, most experts say. He has touted the long-discredited notion that childhood vaccines can cause autism. He is also a supporter of the safety of raw, unpasteurized milk (long linked to outbreaks of illness) and an opponent of fluoride in drinking water, something that for decades has been a mainstay of dental health. Kennedy has long cast himself as a fighter against Big Pharma and food conglomerates, something that may have bolstered Trump's appeal among voting blocks such as young mothers, the Associated Press noted. As such, Kennedy has pushed for tougher regulation of the food and drug industry, which could be at odds with Republicans' promises of deregulation in a second Trump term. Associated Press Article Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

EMERYVILLE, Calif.--( BUSINESS WIRE )--= Nutcracker Therapeutics, Inc. , a pioneering biotechnology company dedicated to enabling transformative RNA therapies through its proprietary technology platform, today announced its new contract research, development, and manufacturing organization (CRDMO) capabilities, which will provide next-generation design and biomanufacturing solutions for RNA drug developers. Nutcracker Therapeutics’ manufacturing solutions can be scaled for an array of drug discovery needs, from small quantities of many RNA constructs, to large-scale applications, such as GMP-grade personalized RNA-based medicines for tens of thousands of patients every year, or larger amounts of a single RNA-based drug product. “Speed to clinic for personalized RNA therapies will propel the next wave of growth for emerging RNA medicines,” said Igor Khandros, CEO. “In response to the need for mRNA COVID-19 vaccines during the pandemic, the manufacturing capacity for RNA was designed on an enormous scale with traditional technologies. In our view, the future of RNA is increasingly personalized, making the need for flexible and scalable biochip-based manufacturing all the more clear. “Through the combination of our advanced manufacturing system, best-in-class design capabilities, and end-to-end RNA expertise under one roof, Nutcracker Therapeutics’ CRDMO services provide accelerated speed to the clinic for various RNA treatments, as well as to high quality, low-cost personalized medicines with on-demand capacity scale-out,” Khandros continued. “Our ambition is to contribute to the proliferation of RNA medicines with our advanced technologies for the sake of patients in need.” Nutcracker Therapeutics’ CRDMO capabilities harness the power of the Nutcracker Manufacturing Unit (NMU), which is designed to support the broad development of RNA drugs from discovery and late-stage clinical trials, to commercialization – with minimal change in manufacturing protocol across each phase. The NMU is 21 CFR Part 11 compliant. The company’s Current Good Manufacturing Practice (cGMP) facility includes semiconductor-like, automated end-to-end manufacturing capabilities that enable a “scale-out” approach for expansion, which can be achieved by NMUs working in tandem. Based in Emeryville, CA, the 8,000 sq. ft. facility is capable of manufacturing personalized cancer vaccines (PCVs) for 2,000 patients annually, with a rapid turnaround time of three weeks from sequence to completed drug product. At the heart of the NMU are biochips, which leverage microfluidics to compress an entire bioreactor, purification column and in-process monitoring into a mere 9 square inches. The biochips – which are single-use disposables for processing individual patients’ PCVs, hence minimizing the risk of cross contamination – have a flexible design to support customization, allowing for the development of PCVs. A single NMU can manufacture different drugs with minimal downtime by simply changing the biochip. The manufacturing advantages of the NMU specifically designed for RNA include the precise control of reagent concentrations throughout reactions, maximizing yield and quality, while minimizing reagent wastage. Furthermore, the NMU is primed for the production of research-, clinical-, and commercial-grade materials that are high in purity and reproducibility. Nutcracker Therapeutics has compiled and reviewed manufacturing data from the NMU for over 2,000 RNA production cycles, and has received favorable feedback from the U.S. Food and Drug Administration. To learn more about Nutcracker Therapeutics’ CRDMO capabilities and offerings, visit https://www.nutcrackerx.com/crdmo-services/ . For more information on the NMU, visit here . About Nutcracker Therapeutics, Inc. Nutcracker Therapeutics, Inc. is a biotechnology CRDMO company that combines advanced engineering with high-precision biosynthesis to unlock the promise of RNA. The company’s mission is to drive forward the development of safe and effective RNA drugs and personalized cancer vaccines through its complete technology platform, which encompasses the design, delivery, and manufacturing of RNA molecules. Armed with this high-tech advantage, Nutcracker Therapeutics’ unique scalable RNA platform significantly reduces costs and cycle times, while keeping the highest quality. For more information, visit www.nutcrackerx.com .