The Orphan Drug Act of 1983 encourages the development of drugs for rare diseases, a process with unique clinical and commercial challenges. Although manufacturers of orphan drugs generally enjoy…
MARKET OUTLOOK The introduction of additional Crohn’s disease (CD) agents has shifted—and will continue to shift—market dynamics. The newer non-TNF biologics (Takeda’s Entyvio and Janssen…
Dyslipidemia refers to abnormalities in lipids and lipoproteins in the circulation and is a key modifiable risk factor for cardiovascular (CV) disease. The most common lipid abnormalities include…
MARKET OUTLOOK The increasing rates of resistance to antibiotics among gram-negative pathogens have driven the development of antibiotics that target specific mechanisms of resistance and/or…
The triptan drug class dominates the market for approved prescription acute treatments for migraine. Despite the array of approved triptan options, most of them generic, new reformulations have…
MARKET OUTLOOK The ulcerative colitis (UC) market landscape is constantly evolving. The TNF-α inhibitors have the longest tenure among all biologics for UC; however, the launch of Takeda’s…
Dyslipidemia is a key modifiable risk factor for cardiovascular (CV) disease. Current lipid-modifying therapies, including statins, ezetimibe, fibrates, omega-3 fatty acid compounds, and the novel…
Patient advocacy groups play many roles in orphan drug development, including funding and propelling early development and interacting with key stakeholders such as the patients, their caregivers,…
Market Outlook Despite the broad availability of antidepressants and atypical antipsychotics approved to treat major depressive disorder (MDD), approximately one-third of these patients are…
With the availability of multiple approved products for the treatment of diabetic macular edema (DME) in the EU5, including Bayer HealthCare’s Eylea, Novartis’s Lucentis, Allergan’s Ozurdex,…
MARKET OUTLOOK Progress in R&D and technology, regulatory and monetary incentives for advancing the development of treatments for rare diseases, and ongoing focus by the pharmaceutical market on…
Truxima (rituximab), Celltrion’s MabThera biosimilar, became the first oncology monoclonal antibody biosimilar to enter the European market in April 2017. Two months later, Sandoz’s Rixathon, a…
Celltrion’s Herzuma (trastuzumab) is the first biosimilar of Roche’s blockbuster HER2-targeted therapy, Herceptin, to launch in Europe. This series tracks uptake of Herzuma and medical…
The treatment landscape for colorectal cancer is based on chemotherapies and targeted agents, although the latter (e.g., Avastin, Erbitux, Vectibix) are currently confined to the metastatic setting…
MARKET OUTLOOK COPD is a progressive inflammatory respiratory tract and lung disease characterized by airflow obstruction and decreased lung function. The COPD market continues to suffer from…