After issuing an import alert last year for an IPCA Laboratories API plant in India where employees had been falsifying drug testing results and deleting failed tests, the FDA began looking at its operations further upstream and has now banned products from two of IPCA's finished product facilities.
Swiss-based Actelion Pharmaceuticals was granted marketing approval by Japan's Ministry of Health, Labour and Welfare for Opsumit (macitentan) for the treatment of pulmonary arterial hypertension (PAH).
Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Gilead's Sovaldi (sofosbuvir) for the suppression of viremia in chronic hepatitis C virus, marking the first all-oral, interferon-free treatment regimen for genotype 2 HCV infection and the first product to be marketed by Gilead in Japan.
Indian companies can supply active pharmaceutical ingredients to local research and development companies and institutes, the country's Central Drugs Standard Control Organization said.
Edwards Lifesciences CEO Michael Mussallem testified before Congress on March 24 at a hearing entitled "Continuing America's Leadership: Advancing Research and Development for Patients." His comments focused on improving the FDA's medical device regulatory process, strengthening R&D infrastructure and continued encouragement of innovation.
Maryland's Emergent BioSolutions won FDA approval for an injected treatment for anthrax infection, padding the company's stable of biodefense products.
India regulators are mulling whether to invoke emergency procedures and order drugmakers to produce and distribute more human albumin, which has been in short supply for nearly a year.
India's Gujarat state government has signed a memorandum of understanding with Underwriters Laboratories to train 60 food-and-drug inspectors to work under the Food and Drug Control Authority.
Wockhardt's U.S. affiliate must face a mass of suits in a state court over its generic version of the acid reflux drug Reglan (metoclopramide), developed by Wyeth before the firm was bought by Pfizer.
Edwards-backed CardioKinetix reports China heart failure data; U.S. pivotal results expected in 2016
Startup CardioKinetix has reported positive pivotal data from China on its catheter-based heart failure treatment, the Parachute Ventricular Partitioning Device. It expects these study results to support a regulatory submission with the China Food and Drug Administration.