Category Archives: Drug Pipeline Data

In April there were four new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were five supplemental drug approvals. The FDA had acted on assignment of new PDUFA dates for six new products for review. Drugs included in this review are generally regarded by the industry as specialty […]

INSIDE THIS ISSUE CMS News Drug Reimbursement Code Price Updates Drugs/Devices New Clinical and Billing Information Software Updates Prioritize your Code Level Pricing CODE UPDATES Large Price Changes: We identify and report on the codes with the most substantial pricing increases or decreases each month and detail the rationale for the change. Of the 35 […]

Of about clinical 1,400 studies, 34% were tied to some sort of genetic test. This will only increase over time. Watch to learn more: VIEW THE FULL WEBINAR   [TRANSCRIPT] Now, the other piece is, okay, great, so we have these 27 products, pretty small compared to the hundreds or thousands of products that we’re […]

In February there were two new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were two supplemental drug approvals. The FDA had acted on assignment of new PDUFA dates for three new products for review. Finally, there was one complete response letter issued. Drugs included in this review […]

FDA Approval: 11/2/18 Febrile neutropenia is a complication that can occur in cancer patients receiving chemotherapy. Normally, neutrophils (a type of white blood cell) protect against infections; however, chemotherapy treatments may cause a reduction in neutrophils to abnormal levels in cancer patients, known as neutropenia. When significant neutropenia occurs in the presence of a fever, […]

FDA Approval: 10/5/2018 Familial amyloid polyneuropathy (FAP, also called transthyretin amyloidosis) is a hereditary neurodegenerative disease that is characterized by the accumulation and deposition of the transthyretin protein (TTR) in the tissues and peripheral nervous system, and often causes pain, muscle weakness, and autonomic dysfunction. Eventually, the disease progresses into a sensory and motor polyneuropathy. […]

FDA Approval: 9/28/2018 Cutaneous squamous cell carcinoma (CSCC) is the second most deadly skin cancer following melanoma. CSCC leads to about 3,900 to 8,800 deaths per year in the United States. Prior to Cemiplimab approval, there were no FDA-approved treatments for advanced CSCC which is metastatic or where surgery is not an option. The rarity […]

FDA Approval: 9/14/18 Migraine is a debilitating disorder that affects millions of people in the United States. Migraine can 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. Fremanezumab-vfrm, developed by Teva Pharmaceutical Industries Ltd., is a fully […]

FDA Approval: 9/13/2018 Hairy cell leukemia (HCL) is a rare, slow-growing cancer of the blood in which the bone marrow produces too many abnormal B cells or lymphocytes. This compromises the bone marrow’s ability to produce healthy blood cells and platelets. Patients with HCL may experience enlargement of the spleen, increased susceptibility to life-threatening conditions […]

Familial amyloid polyneuropathy (FAP, also called transthyretin amyloidosis) is a hereditary neurodegenerative disease that is characterized by the accumulation and deposition of the transthyretin protein (TTR) in the tissues and peripheral nervous system, and often causes pain, muscle weakness, and autonomic dysfunction. Eventually, the disease progresses into a sensory and motor polyneuropathy. Currently, the mainstay […]