Month in Review: Top 10 Articles From August 2023
Your monthly roundup of the top news from Drug Topics®.
GSK’s RSV Vaccine Now Available in Some US Pharmacies: What You Need to Know
A Q&A with Marc Ost, co-owner of Eric’s RX Shoppe, which was one of the first community pharmacies to receive the new vaccine.
FDA Delays Drug Supply Chain Security Act Deadline Until November 2024
The new deadline to be in compliance with the requirements will be November 27, 2024.
Moderna, Novavax Update Vaccines as COVID-19 Variants Cause Rise in Cases
The CDC and WHO are currently tracking several variants that are driving the majority of new cases around the world.
Chikungunya Vaccine for Adolescents Shows Positive Topline Results in Phase 3 Trial
PXVX0317 has received Fast Track and Breakthrough Therapy designation from the FDA.
Chronic Pain Prevalence High Among Women With HIV
Chronic pain is among the comorbidities for people diagnosed with HIV, but there has been a lack of data on the prevalence and risk factors in women.
Upcoming DIR Fee Changes Still Causing Concern for Pharmacists
New DIR fee rules eliminate clawbacks, but may create cashflow challenges for pharmacies in the first half of 2024.
Comparing Safety, Efficacy of COVID-19 mRNA Vaccines in Older Adults
Moderna’s mRNA-1273 vaccine was associated with a lower risk of diagnosed COVID-19 when compared to Pfizer’s BNT162b2.
FDA Gives 510(k) Clearance to COVID-19, Influenza A/B, RSV Combination Test
A 510(k) clearance, or a Premarket Notification, requires device manufacturers to notify the FDA at least 90 days ahead of registration with their intent to market a medical device.
What You Need to Know About the Drug Supply Chain Security Act Before November’s Deadline
A Q&A with Matt Sample, senior vice president of manufacturer and replenishment operations at AmerisourceBergen.
COPD Exacerbations Common in Patients Not Treated With Controller Medications
A study found that although the number of patients receiving a controller medication increased after their first exacerbation, the percentage given controller medications remained below 50% among the overall population.
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.
