Tag Archives: FDA

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

Health Care System: Life-Saving Drug Shortages At U.S. Hospitals Reach “Unfathomable” Levels

From a Becker’s Hospital Review online release:

Massachusetts General Hospital“This is the fourth time in the last two years we’ve had to activate our hospital’s emergency operations plan for a major drug shortage,” Dr. Biddinger told NBC News. “It’s almost unfathomable in modern medicine. I never thought we would get to a point in the U.S. healthcare system where we wouldn’t have essential medicines to be able to treat patients.”

Drug shortages are increasing and lasting longer, according to an FDA report published Oct. 29. Of 163 drugs running low in 2013-17, over 62 percent were due to manufacturing or product quality problems.

Hospitals nationwide are facing shortages of crucial, lifesaving drugs, with 116 drugs currently running low, according to the FDA and cited by NBC News.

Boston-based Massachusetts General Hospital is a prime example, getting as close as two weeks away from canceling a lifesaving cardiac surgery due to a lack of herapin, a blood-thinner, according to Paul Biddinger, MD, chief of the division of emergency preparedness at Massachusetts General Hospital.

To read more: https://www.beckershospitalreview.com/pharmacy/it-s-almost-unfathomable-in-modern-medicine-us-hospitals-running-low-on-lifesaving-drugs.html?oly_enc_id=9129H5611090H0N