FDA Roundup: Updated Label for Altuviiio, CRL Given to Heplisav-B
Check out important updates from the FDA for the week of May 13.
FDA Approves Tarlatamab-dlle for Extensive-Stage Small Cell Lung Cancer
Amgen’s Tarlatamab-dlle (Imdelltra) is the first and only approved DLL3-targeting bispecific T-cell engager therapy for the aggressive form of lung cancer.
Once-Weekly Insulin for T2D Shows Positive Topline Results in Phase 3 Clinical Trial Program
Efsitora (efsitora alfa) from Eli Lilly met its primary endpoint of non-inferior A1C reduction compared to insulin degludec and insulin glargine in 2 phase 3 studies.
Walgreens to Start Selling its Own OTC Naloxone Nasal Spray
The company’s version of the opioid overdose medication will be $10 cheaper than branded products and is set to be available in stores later this month.
Reviewing Efficacy, Safety of Weight Loss Therapies in T1D
Different weight loss therapies provide a wide range of benefits to patients with T1D—but they have some potential adverse effects.
COVID-19 Vaccine Booster Dose Beneficial to Immunocompromised Patients
A recent study found that, of 423 participants who were initially low responders, 90% increased their antibody concentrations to more than 400 AU/mL.
FDA Roundup: Myhibbin for Prophylaxis of Organ Rejection, Insulin App Recall
Check out important updates from the FDA for the week of May 6.
FDA Delays Decision on Moderna’s RSV Vaccine
The federal agency said the delay was due to administrative constraints and did not cite any vaccine safety, efficacy or quality issues.
Psilocybin Treatment for PTSD Shows Positive Topline Results in Phase 2 Study
A single dose of Compass Pathways’ investigational COMP360 was well tolerated and showed durable improvements in CAPS-5 and SDS total scores compared to baseline.
Slideshow: Exercise May Fight Depression, Mindfulness Could Help Reduce Drug Use
With the mental health crisis worsening in the United States, recent research explores novel treatments and underlying causes.
Fentanyl Education, Prevention Key to Ending Crisis in US
For National Fentanyl Awareness Day, Drug Topics talked with Scott H. Silverman about how public health leaders can address the fentanyl crisis and the best ways to educate the public on the dangers of fentanyl use.
FDA Advisory Committee Will Soon Meet to Discuss MDMA-Assisted Therapy for PTSD
The Psychopharmacologic Drugs Advisory Committee will meet June 4 to review a new drug application from Lykos Therapeutics.
FDA Roundup: Humira Biosimilar, WHIM Syndrome Treatment
Check out important updates from the FDA for the week of April 29.
Pharmacogenetic Testing Recommendations Needed in Clinical Guidelines to Increase Consistency
A review found that many guidelines that recommended pharmacogenetic testing were inconsistent between clinical associations.
NCPA Says AI Can Help Pharmacies Optimize Cash Pricing
The organization has renewed its recommendation of Prescryptive Health’s artificial intelligence pricing system, stating it can help independent pharmacies stay competitive.
Slideshow: COVID-19 Vaccines, Booster Immunity and Emerging Variants
Recent research on COVID-19 vaccination shows that vaccines help fight variants, led to lower cases among children in California, and that boosters provide longer lasting protection.
FDA Approves Mavorixafor for Treatment of WHIM Syndrome
WHIM syndrome is characterized by low levels of neutrophils and lymphocytes in the blood due to dysfunction in the CXCR4 receptor, which results in serious and frequent infections.
FDA Roundup: Generic Naloxone, Pediatric Low-Grade Glioma Treatment
Check out important updates from the FDA for the week of April 22.
FDA Approves Pfizer’s Gene Therapy for Hemophilia B
Fidanacogene elaparvovec-dzkt (Beqvez) is a 1 time treatment that allows patients with hemophilia B to produce factor IX themselves.
FDA Approves Generic OTC Naloxone Nasal Spray
Amneal Pharmaceuticals said its generic naloxone hydrochloride nasal spray is now available in the US following FDA approval.
Community Pharmacists Could Help Patients Control Diabetes Through Remote CGM Monitoring
A new study found that cloud-based CGM monitoring services provided statistically significant improvements in high time above range, time in range, and average glucose.
Accreditation and Value-Based Care: Leveraging Operational Excellence and Clinical Services for Patients and Your Pharmacy
Sandra C. Canally, RN, found and CEO of the Compliance Team, discusses the goals, benefits, and opportunities of value-based care in pharmacy.
Independent Pharmacies Must Look Out For Deceptive PBM Practices
A Q&A with Douglas Hoey, CEO of NCPA, on ways to change the pharmacy payment model and deceptive practices being employed by PBMs.
FDA Issues CRL for Epidermolysis Bullosa Gene Therapy
Abeona Therapeutics’ pz-cel is an investigational autologous, COL7A1 gene-corrected epidermal sheet therapy for the treatment of recessive dystrophic epidermolysis bullosa.
How Pharmacies Can Effectively Transition to a Wellness-Focused Model
At AAP 2024, Kathy Campbell, PharmD, discussed obstacles that pharmacies may face when transitioning to a wellness-focused approach.
Therapeutic Relationship Plays Key Role in Psychedelic Treatment
A higher patient-rated therapeutic alliance was associated with improvements in depression outcomes up to 1 year after treatment.
FDA Roundup: Biosimilars, Boxed Warning Added for CAR T-Cell Therapies
Check out important updates from the FDA for the week of April 15.
Medicare-Focused Insurance Agency Could Benefit Independent Pharmacies
A Q&A with Joe McKamey, general manager at Marcrom’s Pharmacy in Manchester, Tennessee.
CVS Pharmacists in Rhode Island Petition to Unionize
Nine pharmacists from 2 corporate locations in Wakefield and Westerly are seeking to join the Pharmacy Guild in an attempt to improve working conditions.
Pharmacies Should Adopt Proactive Health, Wellness to Help Patients
Kathy Campbell, PharmD, discusses why she believes wellness and proactive health are the future of pharmacy and the unique value they offer compared to traditional models.