Category Archives: Industry Insights

In March there were a total of seven drug approvals by the FDA we deemed specific to the specialty market.  In addition to these approvals, the FDA had assigned five new PDUFA dates. Finally, there were fifteen potential specialty products with PDUFA dates in April, although two of those products received a complete response letter […]

INSIDE THIS ISSUE Code Updates: Large Price Changes Reminder – New HCPCS C-Codes Effective April 1, 2018 Reminder – New HCPCS Q-Codes Effective April 1, 2018 Reminder – HCPCS Q-Code Description Change Effective April 1, 2018 Reminder – Deleted HCPCS Q-Code Effective April 1, 2018 CMS News: Reminder – Part B Biosimilar Biological Product Payment […]

X-Linked Hypophosphatemia (XLH) is a rare genetic musculoskeletal disorder that is characterized by low levels of phosphate and has the potential to lead to bone abnormalities or rickets. Current conventional treatment of XLH includes daily phosphate and active vitamin D doses to serve as replacement therapy, but this does not treat or correct the underlying […]

Review of Herceptin biosimilars in the drug pipeline Herceptin® (trastuzumab) is a recombinant monoclonal antibody used for the treatment of breast cancer and gastric cancer in combination with other chemotherapy agents. In 2017, it gained $2,804 million in sales in the United States, which has made it a target for the development of biosimilars. Currently, […]

The Power of Data in the Healthcare Ecosystem Advances in technology and data are shifting the tides of nearly every industry today. Data that is vital to business success, improved patient care, and pharmaceutical advancement is within fingertip reach. We have only experienced the very tip of the iceberg of the power of data in […]

Enacted in 1992, the Prescription Drug User Fee Act (PDUFA) was created to authorize the Food and Drug Administration (FDA) to collect fees from companies that produce certain human drug and biological products. These fees serve as a secondary source of funding for the FDA and serve to expedite the review process. The FDA establishes […]

Where will tildrakizumab be positioned in the psoriasis marketplace once approved by the FDA? Plaque psoriasis (psoriasis vulgaris) (ICD-10 L40.0), which is commonly referred to simply as psoriasis, is the most common form of the skin disease with a prevalence of 2-3% worldwide.  GlobalData estimates that the biologics total drug sales for psoriasis in 2012 […]

INSIDE THIS ISSUE Code Updates:         • Large Price Changes         • New HCPCS C-Codes Effective April 1, 2018         • New HCPCS Q-Codes Effective April 1, 2018         • HCPCS Q-Code Description Change Effective April 1, 2018         • Deleted HCPCS Q-Code Effective April 1, 2018 CMS News:         • Part B Biosimilar Biological Product Payment Effective April 1, 2018         • Implementation of the Transitional Drug Add-On […]

Review of ibalizumab-uiyk (TrogarzoTM) a novel biologic for patients with multi-drug resistant HIV-1 Multi-drug resistant HIV (MDR-HIV) carries a greater risk of disease progression and leaves HIV patients with limited treatment options. There are currently 10,000 people living with MDR-HIV in the United States, and due to this prevalence, it has become necessary to consider drug […]

RJHS – Drug Alert FDA Drug Approval – Ibalizumab-uiyk (TrogarzoTM) On March 6, 2018, the U.S. Food and Drug Administration (FDA) approved a first in class treatment for adults with multi-drug resistant (MDR) HIV-1 infection, with a manufacturer’s initial estimated annual treatment cost of $118,000. An initial overview is listed below.  For additional Information on […]