Tag Archives: FDA

Research Preview: Science Magazine – Jan 23, 2023

Science Magazine – January 13, 2023 issue:

NASA unveils initial plan for multibillion-dollar telescope to find life on alien worlds

Habitable Worlds Observatory would be designed for robotic servicing

Illegal mining has muddied tropical rivers worldwide

Silt overload and mercury pollution endanger river ecosystems—and the people who depend on them

FDA approves new antibody to slow Alzheimer’s disease, even as safety concerns linger

Agency warns about brain swelling and bleeding on drug’s label, but imposes few restrictions on lecanemab’s use

Reports: Tufts Health & Nutrition – December 2022

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December 2022 Issue:

Beware of “Health-Washing”

Front-of-package health claims can be helpful—but they can also be misleading. Learn how to tell the difference.

Habitual Coffee Consumption Associated with Health Benefits

A study that followed nearly 400,000 middle-aged individuals in the U.K. for a median of over 10 years found that, compared to individuals who reported drinking less than one cup of coffee a day, drinking four or more eight-ounce cups a day was associated with lower risk of 30 medical conditions.

FDA Proposes New Definition of “Healthy” on Food Packages

The U.S. Food and Drug Administration (FDA) recently proposed new draft guidelines for food manufacturers who want to label their products as “healthy.” This term was last defined in the 1990s. According to the FDA, “our current definition permits manufacturers to use the claim ‘healthy’ on some foods that, based on the most up-to-date nutrition.

Covid-19 Podcast: Latest On Vaccine Rollout, New Mutation & FDA Approvals

Stephen Hahn, U.S. Food and Drug Administration Commissioner, Sigal Atzmon, founder and chief executive officer of Medix Global, and Roche CEO Severin Schwan, on the pandemic, Covid-19 vaccines and the new mutation.

World News Podcast: U.S. Approves Vaccine, German Covid-19 Fatalities Surge

Radio News 24/7 reports: Pfizer vaccine approved by FDA, Germany faces surging Covid-19 fatalities, and other top world news.

Morning News Podcast: FDA Covid Vaccine Review, Facebook Lawsuits

U.S. nears final vaccine review as daily national deaths top 3,250, Facebook hit with antitrust lawsuits, and Florida sheriff deputies deliver meals to kids doing virtual school.

Top New Science Podcasts: Clinical Trial Failures At The FDA, AI Wins At Curling

Investigative journalist Charles Piller joins host Sarah Crespi to discuss his latest Science exclusive: a deep dive into the Food and Drug Administration’s protection of human subjects in clinical trials. Based on months of data analysis and interviews, he uncovered long-term failures in safety enforcement in clinical trials and potential problems with trial data used to make decisions about drug and device approvals. 

Sarah also talks with Klaus-Robert Müller, a professor of machine learning at the Technical University of Berlin, about an artificial intelligence (AI) trained in the sport of curling—often described as a cross between bowling and chess. Although AI has succeeded in chess, Go, and poker, the constantly changing environment of curling is far harder for a nonhuman mind to adapt to. But AIs were the big winners in competitions with top human players, Müller and colleagues report this week in Science Robotics. 

Health News Video: FDA Launches (And Explains) New Nutrition Facts Label

What’s new about the new Nutrition Facts label? Watch this Q&A with Susan T. Mayne, Ph.D., Director of FDA’s Center for Food Safety and Applied Nutrition. 

New FDA Nutrition Facts Label March 2020

For more information

Top Medical Podcasts: Lung-Cancer Screenings, Placebo Effects (NEJM)

Lung-Cancer Mortality with Volume CT Screening NEJM February 2020Featuring articles on lung-cancer screening in the NELSON trial, ribociclib and fulvestrant in metastatic breast cancer, vitamin D in pregnancy and asthma, treatment thresholds for neonatal hypoglycemia, and CAR-NK cells in anti-CD19 lymphoid tumors; a review article on placebo and nocebo effects; a Clinical Problem-Solving describing a rapid change in pressure; and Perspective articles on altruism in Extremis, on abuses of FDA regulatory procedures, and on joining forces against delirium.

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Healthcare: “10 Drugs And Medical Devices Approved By FDA In Dec. 2019 (BHR)

From a Becker’s Hospital Review (BHR) online release article:

10 drugs and medical devices approved by the FDA since Dec. 6:

  1. Enhertu is Japanese drugmaker Daiichi Sankyo’s drug designed to treat HER2-positive breast cancer.
  2. Padcev is Astellas Pharma’s drug designed to target specific cancer cells to treat urothelial cancers.
  3. Control-IQ Technology controller is Tandem Diabetes Care’s insulin device, designed to help diabetes patients tailor their treatments to their individual needs.
  4. Vascepa is Amarin Pharmaceuticals’ drug, a fish oil-derived pill designed to treatVascepa benefits cardiovascular events.
  5. EXALT Model D is Boston Scientific’s device, the first fully disposable duodenoscope, designed to reduce the risk of infections in patients treated with the device.
  6. Vyondys 53 is Sarepta Therapeutics’ drug designed to treat Duchenne muscular dystrophy, which the FDA had previously rejected.
  7. GSP Neonatal Creatine Kinase-MM kit is PerkinElmer’s device, used to detect Duchenne Muscular Dystrophy in newborns.
  8. Unidose liquid system is AptarGroup’s device that uses a nasal spray to treat seizures. It is the first and only nasal treatment for patients with epilepsy.
  9. Avsola is Amgen’s drug, a biosimilar of Johnson & Johnson’s Remicade. It is designed to treat rheumatoid arthritis, Crohn’s disease, plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.
  10. cobas vivoDx is Roche Molecular Systems’ device, designed to diagnose MRSA hours faster than traditional tests.

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To read article at Becker’s Hospital Review