Timely Insights for Healthcare Experts
New Treatment for Paroxysmal Nocturnal Hemoglobinuria Approved by the FDA
The injection Ultomirus (ravulizumab) has been approved for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). Ultomiris is a long-acting complement inhibitor that prevents hemolysis. Richard Pazdur, M.D., director of the FDA’s Oncology...
FDA Approves Elzonris (tagraxofusperzs) Infusion to Treat Blastic Plasmacytoid Dendritic Cell Neoplasm
The FDA has approved Elxonris (tagraxofusperzs) infusion to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in patients two years and older. This is the first FDA approved therapy specifically for BPDCN. Elzonris is a targeted investigational therapy...
FDA Approves App-connected Digital Inhaler
FDA approved ProAir digihaler by Asthmapolis, the first app-connected digital inhaler. The ProAir Digihaler has built-in sensors to detect when the device is used and the strength of the user’s inhalation. This data is then sent via Bluetooth to its mobile app...
New Drug for People Suffering from Chronic Idiopathic Constipation (CIC)
There's a new drug for people suffering from Chronic Idiopathic Constipation(CIC) headed to the market in 2019. The US FDA has approved Motegrity with the active ingredient Prucalopride for the treatment of CIC presented by Shire Dev LLC. Motegrity is a selective...
First Successful Live Birth After Uterus Transplant
The Lancet reports the first successful live birth from a uterus transplant. In September 2016, a 32-year-old woman in Brazil with congenital uterine absence, or Mayer-Rokitansky-Küster-Hauser [MRKH] syndrome, underwent a successful uterine transplantation from a...
Mobile Medical App to Support Opioid Use Disorder Recovery Programs
FDA clears mobile medical app reSET-O to help opioid use disorder patients stay in recovery programs. This new method of treatment is a prescription cognitive behavioral therapy to be used in conjunction with treatment that includes buprenorphine and contingency...
FDA approved Aemcolo (rifamycin) for Travelers’ Diarrhea.
The FDA approved Aemcolo (rifamycin) yesterday for the treatment of travelers’ diarrhea. Aemcolo is an antibacterial drug to treat noninvasive strains of Escherichia coli (E. coli) not complicated by fever or blood in the stool. The FDA estimates 10-40% of travelers...
FDA Approves a New Version of OTC Inhaler Primatene Mist
FDA approves a new version of Primatene Mist, the only OTC metered-dose inhaler. Primatene Mist is approved by the FDA as an OTC drug to provide temporary relief for symptoms of mild, intermittent asthma. Primatene Mist is only approved for those who have been...
New Physical Activity Guidelines for Americans: “Move more, and sit less”
Monday, JAMA published a summarized report of the just-released U.S. Department of Health and Human Services (HHS) second edition Physical Activity Guidelines for Americans (PAG), which provides evidence-based recommendations to improve American individual and...
FDA Announces an Emergency Use Authorization for “Fingerstick” Ebola Test that Uses a Portable Battery Reader
The FDA announced emergency use authorization for a rapid, single-use test to detect the Ebola Virus (Zaire ebolavirus). The test, called the DPP Ebola Antigen System (Chembio Diagnostic Systems Inc), is novel for using a portable battery reader for accurate...
French Study finds Association with Organic Food Consumption and Reduced Risk of Cancer
A French study finds an association between a higher frequency of organic food consumption and a reduced risk of cancer. The study findings still need to be confirmed. In this population-based cohort study of 68,947 French adults, high organic food scores were...
ACE Inhibitors Linked to Lung Cancer
A cohort study by the United Kingdom Clinical Research Datalink associated the use of ACEIs with an increased risk of lung cancer. The association elevated among people using ACE Inhibitors for more than five years. The study consisted of 992,061 patients treated with...
CMS Publishes Final Rule for (CY) 2019 Physician Fee Schedule & QPP: 5 Key Changes
Yesterday, November 1st, the federal Centers for Medicare & Medicaid Services (CMS) published their final rule for the Physician Fee Schedule for CY 2019, and Quality Payment Program (QPP)—regarding the Patients Over Paperwork Initiative, E&M requirements,...
First DTC Genetic Test passed FDA approval for Personal Genome Pharmacogenomic Reports
23andMe is the first direct-to-consumer (DTC) genetic test to be permitted by the FDA to market their pharmacogenomic reports providing information regarding genetic variants that may be associated with a patient’s ability to metabolize some medications to help inform...
FDA Approves Xofluza, First New Treatment for Influenza in Nearly 20 Years.
Yesterday the U.S. Food and Drug Administration approved Xofluza (balorxavir marhboxil), a new influenza treatment for acute uncomplicated influenza in people age 12 and older who have been symptomatic for no more than 2 days. This new drug, developed by Genentech,...
Another Rise in Acute Flaccid Myelitis (AFM) in Kids
The CDC is baffled by the cause of polio-like disease, Acute Flaccid Myelitis (AFM), affecting children in the United States. A reoccurring outbreak of AFM has been affecting Americans 21 and under since 2014. The CDC has recorded spikes in cases of Acute Flaccid...
Red Tide Spreading Across Florida Coastline
Toxic dinoflagellates algal blooms known as “red tides” are spreading across the Florida coastline, killing thousands of marine animals, and causing respiratory and gastrointestinal distress in residents. People in effected areas are warned not to swim in the water,...
The FDA approved cemiplimab-rwlc (Libtayo)
The FDA approved cemiplimab-rwlc (Libtayo) for treatment of locally advanced, or metastatic, cutaneous squamous cell carcinoma (CSCC). This is the first drug treatment approved for advanced CSCC, the second most common cancer in the U.S. Please see the FDA website for...