Category Archives: Industry Insights

Migraine is a debilitating disorder that affects millions of people in the United States. Migraine has the ability to affect individuals in a way that deprives them of their normal, daily activities, and often results in pain, physical impairment, lost productivity, and increased financial cost. Erenumab (Aimovig™, AMG-334) is a fully human monoclonal antibody being […]

In April there were a total of five new drug approvals by the FDA we deemed specific to the specialty market. One of these approvals was a first-time generic approval for Zavesca®. In addition, there were six supplemental drug approvals. The FDA had assigned seven new products for review. Finally, there were six potential specialty […]

Day 2 AMCP 2018 presentations provided continuing opportunities for learning, networking and the sharing of ideas. Today’s headline session presented by Douglas Long, BS, MBA focused on pharmacy marketplace trends.  Of note was that Hepatitis is no longer a key topic, demonstrating a trend towards successful treatment of this patient population.  While the data presented […]

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 […]