Small Doses: March 11 to March 15
Check out a recap of important pharmacy news you might’ve missed this week, dispensed in small doses.
FDA Approves Resmetirom as First-Ever Treatment For MASH
The FDA has granted accelerated approval to resmetirom (Rezdiffra) for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) in adult patients.
3D illustration of liver / Rasi - stock.adobe.com
The decision makes resmetirom the first approved treatment for MASH, an advanced form of nonalcoholic fatty liver disease formerly known as non-alcoholic steatohepatitis.
Complementary Health Approaches for Pain Management Increasing in Popularity
The use of complementary health approaches among patients in the US increased between 2002 and 2022 parallel to an increase of reported pain prevalence.
Approaches such as acupuncture, massage, and yoga are designed to be used alongside standard medical care to further improve a patient’s overall health and wellbeing.
Psilocybin Analog for Treatment of Depression Receives FDA Breakthrough Therapy Designation
Cybin has received breakthrough therapy designation from the FDA for its psilocybin analog (CYB003) therapy for the treatment of major depressive disorder (MDD).
The phase 2 trial of CYB003 demonstrated promising results, with statistically significant improvements in depression symptoms sustained for up to 4 months.
California Wildfires in the 2010s Exacerbated Psychotropic Medication Prescriptions
In California areas affected by the 25 largest wildfires from 2011 to 2018, researchers of a new study found a significant increase in psychotropic medication prescriptions.
Of over 7 million participants in the study, the mean percent of individuals with at least 1 outpatient psychotropic prescription was 22%.
FDA Approves Lisocabtagene Maraleucel For Treatment of Relapsed or Refractory CLL, SLL
Lisocabtagene maraleucel (Breyanzi; liso-cel) has received accelerated approval from the FDA for the treatment of relapsed or refractory CLL or SLL in adult patients who have received at least 2 prior lines of therapy.
The approval was based on positive data from the phase 1/2 TRANSCEND CLL 004 study.
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.
