The Pharmacy Times® Pharmacy Technician Clinical Role section is a comprehensive resource for clinical news and expert insights on issues pertaining to specialty pharmacists.
May 1st 2025
The Inflation Reduction Act's (IRAs) drug negotiation provisions will fundamentally reshape Medicare drug pricing, provider reimbursement, and healthcare delivery dynamics across Part B and commercial markets, according to panelists at Asembia’s AXS25 Summit.
FDA Approves First Ophthalmology Biosimilar for Neovascular Age-Related Macular Degeneration
September 20th 2021An anti-vascular endothelial growth factor therapy, ranibizumab prevents vision loss in patients with retinal vascular disorders, which can cause irreversible blindness or visual impairments in adults.
Read More
An Overview of FDA Risk Evaluation & Mitigation Strategies
September 20th 2021REMS are not intended to minimize all harmful effects of a drug, but instead focus on preventing, tracking, and handling a specific serious risk by informing, educating, and/or enforcing measures that reduce the frequency and/or intensity of the event.
Read More
Apalutamide Demonstrates Strong PSA Response in Patients With Advanced Prostate Cancer
September 20th 2021Apalutamide (Erleada, Johnson & Johnson) demonstrated a strong prostate-specific antigen response and high adherence rates in patients with non-metastatic castration-resistant prostate cancer.
Read More
Oncology Overview: Tucatinib for Advanced Unresectable or Metastatic HER2-Positive Breast Cancer
September 16th 2021Tucatinib is indicated to treat adults with advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who have already received at least 1 anti-HER2-based regimen in the metastatic setting.
Read More
Expert: FDA to Continue Efforts to Address Disparities in Cancer Drug Trials
September 10th 2021Lola Fashoyin-Aje, MD, MPH, associate director of Science & Policy Program to Address Disparities at the FDA’s Oncology Center of Excellence, discusses the importance of promoting inclusion of members of racial and ethnic minority groups in cancer drug trials.
Watch
Specialty Drug Commercialization Process and Considerations
September 7th 2021As specialty drugs move through clinical trials and preparations for commercialization begin, significant attention is warranted to this process considering the massive investments that would have been already made in the product up to this point.
Read More
Subcutaneous Immunoglobulin Shows Quality of Life Improvement in Patients With CIDP
August 25th 2021Patients with chronic inflammatory demyelinating polyneuropathy who transitioned from intravenous immune globulin to subcutaneous immune globulin showed significantly improved quality-of-life measures.
Read More
How New FDA Guidance Project Optimus May Affect Future of Oncology Clinical Trials, Drug Pipeline
August 16th 2021Julie Bullock, VP, global head of clinical pharmacology and translational medicine at Certara, discusses the FDA’s new guidance Project Optimus, which addresses issues relating to dose optimization in clinical trials assessing oncology drugs.
Watch