Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA bans two more IPCA plants

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.

Actelion's PAH drug Opsumit gets Japan marketing nod, GSK's Encruse approved

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 MHLW approves Gilead's Sovaldi for genotype 2 chronic hep C

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 API manufacturers get CDSCO nod to supply to local R&D

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 CEO testifies before Congress, talks up device industry

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.

Emergent Bio bags FDA approval for another anthrax treatment

Maryland's Emergent BioSolutions won FDA approval for an injected treatment for anthrax infection, padding the company's stable of biodefense products.

Human albumin shortage in India may prompt emergency measures

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 set to train food and drug inspectors in first state effort

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.

India's Wockhardt faces mass of lawsuits in U.S. over generic Reglan

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.