Check out this list of our top 10 most read stories from June 2024.
FDA Grants EUA to OTC COVID-19, Flu Combination Test
The FDA has granted emergency use authorization (EUA) to an over-the-counter (OTC) 3-in-1 flu and COVID-19 test, biotechnology company Watmind announced in a news release. The test, which is intended for at-home and point-of-care use, can simultaneously detect COVID-19, influenza A, and influenza B in 15 minutes.
FDA Approves 2 New OTC Continuous Glucose Monitors
The FDA has provided clearance to 2 over-the-counter (OTC) continuous glucose monitor (CGM) systems, health care technology company Abbott announced in a release. The new OTC devices are based on the company’s FreeStyle Libre sensing technology, which is the most widely used CGM system in the world.
After DOJ Indictment, CDC Urges Caution Around ADHD Medications
The Department of Justice has announced the indictment of 2 individuals associated with a California-based digital health company for alleged participation in an Adderall distribution scheme, conspiracy to commit healthcare fraud, and obstruction of justice.
Q&A: CVS Pharmacy Technician on Rhode Island Unionization Efforts
Drug Topics spoke with Chris DesRochers, a pharmacy technician who works at the CVS Wakefield location and is active in the recent organizing, about what motivated him and his coworkers to unionize, some of the challenges they faced that led to the decision, and what he hopes to achieve through unionizing.
Moderna: Combination COVID-19–Flu Vaccine Trial Meets Primary Endpoints
The phase 3 trial of an investigational combination influenza-COVID-19 vaccine mRNA-1083 has met its primary endpoints. Investigators found that the immune responses from a single mRNA-1083 dose were noninferior to the coadmininstered comparators. In both cohorts, mRNA-1083 also “elicited statistically significantly higher immune responses” against 3 strains of influenza virus—H1N1, H3N2, and B/Victoria), as well as against SARS-CoV-2.
CGM, Wearable Device Data to Improve Mortality, Establish Lifestyle Changes
The use of continuous glucose monitoring (CGM) has created a large-scale model for tracking lifestyle data and improving mortality in patients with diabetes. With the use of CGM data, patients can track blood glucose levels and adjust lifestyle behaviors in real time.
FDA Advisory Panel Votes Against MDMA-Assisted Therapy for PTSD
An independent FDA advisory panel voted against the use of midomafetamine (MDMA)-assisted therapy to treat post-traumatic stress disorder (PTSD) during a meeting held Tuesday, saying the treatment was not effective at treating the condition and that the benefits don’t outweigh risks associated with the drug.
FDA Approves Pneumococcal 21-Valent Conjugate Vaccine Capvaxive
The FDA has approved Merck’s Capvaxive (V116), Merck’s pneumococcal 21-valent conjugate vaccine, for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults aged 18 years and older.
Boehringer Ingelheim Inhaler Cost Cap Program Launches
A first of its kind program from Boehringer Ingelheim capping the cost of inhalers for chronic obstructive pulmonary disease (COPD) and asthma at $35 launched on June 1, 2024. The program was originally announced in March 2024.
Can ChatGPT Be Trusted to Provide Medication Information to Patients?
Using ChatGPT to answer commonly asked questions about a new medication can be helpful but may provide inaccurate information to patients, according to research published in the Journal of the American Pharmacists Association.Based on these results, investigators advise against using the technology to replace consulting a health care professional.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.