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Predicting mRNA degradation to improve vaccine stability

Medical Xpress

Messenger Ribonucleic Acid (mRNA) as a therapeutic approach is gaining momentum due to its ability to be rapidly manufactured and its promising outcomes. mRNA-based vaccines, for instance, played a crucial role in the fight against COVID-19 in many parts of the world.

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Key Bills in the 2025 Legislative Session AAFP is Watching Closely

Alabama Academy of Family Physicians

Running from February 4 to May 15, this session promises to bring substantial changes to medical consent laws, Medicaid coverage, rural hospital funding, taxation on essential goods, and the transparency of healthcare costs. HB 2 – Vaccine Consent What’s in the Bill: Sponsored by Rep.

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A Reversal on Sequencing? Proposed Legislation Would Allow Patenting of Naturally Occurring Genes

FDA Law

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. They argued that the legislation was necessary to spur innovation of new vaccines and therapies in response to emerging health threats.

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Animals Need Drugs Too, But Not Without CVM Approval

FDA Law

CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA). The unapproved drug claims are not, in and of themselves, notable, but it is always interesting when FDA takes a stand against such a large swath of manufacturers and distributors at the same time.

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CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

FDA Law

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices.

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Commissioner Makary Charts a New Course for FDA at FDLI Annual Conference

FDA Law

He spoke with obvious enthusiasm about the recently announced pilot AI-assisted review and its potential to shave weeks off approval timelines, as he described hearing from one reviewer in the pilot project who said the pilot AI tool completed three days work in gleaning salient facts from medical literature in six minutes.

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The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law

There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns. complex public health issues within 100(!)