MONTREAL, CANADA–(Marketwired – July 14, 2015) – Theratechnologies Inc. (Theratechnologies) (TSX:TH) is pleased to announce that COFEPRIS, Mexico’s health agency, has approved the 2mg/vial presentation of tesamorelin for the treatment of lipodystrophy. Theratechnologies’ partner, sanofi, will re-submit a file to COFEPRIS to seek approval of the 1mg/vial presentation of EGRIFTA™ which is the one currently […]

The U.S. Food and Drug Administration has banned drug imports from an India manufacturing unit of Emcure Pharmaceuticals Ltd over violations of standard manufacturing practices, the latest in a series of Indian firms to face such action. In an ‘import alert’ posted on its website on Monday, the FDA said it had barred imports from […]

The U.S. Food and Drug Administration (FDA) and the World Health Organisation have intensified investigations into India’s clinical research firms, industry officials said, after recent probes revealed two leading firms had violated standards. The scrutiny is likely to further hurt India’s reputation as a global pharmaceutical hub, as it follows sanctions imposed by the FDA […]

India’s program to fight tuberculosis is in disarray due to a shortage of funds and the government has failed to meet annual targets to control spread of the nation’s most fatal infectious illness, a leaked assessment report said. India records more than 300,000 tuberculosis-related deaths and 2.2 million new cases of TB each year, resulting […]

Novartis submitted an application to the European Medicines Agency (EMA) for the use of ofatumumab, branded as Arzerra, as maintenance therapy for patients with relapsed chronic lymphocytic leukemia, its co-developer Genmab said.  The application is based on interim results from a Phase III study. Arzerra is already approved in Europe for use in combination with […]