The U.S. Food and Drug Administration have announced the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas. Dengue is endemic in…
FDA Accepts New Drug Application, Grants Priority Review for Darolutamide
Bayer today announced the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review to darolutamide for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). The NDA and Priority Review status were based on data from the Phase III ARAMIS trial in men with nmCRPC. Darolutamide is an…
Researchers Develop Blockchain Protocol to Prevent Counterfeit Pharmaceutical Sales
Portland State University researcher Nirupama Bulusu wants to prevent counterfeit pharmaceuticals from flooding the market. Bulusu recently published a blockchain protocol that could do just that. Bulusu, professor of computer science at the Maseeh College of Engineering and Computer Science, worked with PSU computer science doctoral student Naif Alzahrani to publish “A new product anti-counterfeiting…
FDA Approves New Treatment for Osteoporosis in Postmenopausal Women
The U.S. Food and Drug Administration approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture). These are women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies. More than 10 million people…
FDA Approves First Two-drug Complete Regimen for HIV-infected Patients
The U.S. Food and Drug Administration approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato. This is the first FDA-approved two-drug,…
Cancer Drug Shortages Result in Almost No Treatment Changes, USC Study Finds
FDA Approves New Oral Drug to Treat Multiple Sclerosis
Four Air Cargo Trends Shaping the Transport of Pharmaceuticals
The air cargo industry is at the nexus of supply and demand. Combined with its role in the services industry, the air cargo industry is heavily influenced by the latest technologies and market forces. As a result, making business plans one month, let alone one year, in advance is a tall order. As we look…
Converting to a “Batch-less” World: Quality Implications of Continuous Manufacturing
Pharmaceutical processing is typically handled in a “batch” system, which consists of a step-by-step process for manufacturing products. With this process, once one “batch” is completed, the next begins, so on and so forth. This means that to complete the process, each step must be complete for the next to commence. There can be up…
