FDAnews Drug Daily Bulletin

An international coalition of pharma supply chain stakeholders is calling on the U.S.-based accreditor of internet domain name registrars (DNRs) to do more to combat illicit online sales of prescription drugs.

An Ohio District Court ruling that the FDA can approve generics on a withdrawn brand product could spell bad news for brand drugmakers trying to ward off generic competition.

The FTC again is asking for more information from Watson Pharmaceuticals on its proposed $5.6 billion merger with Actavis, delaying its attempt to become the world’s third largest generic-drug company.

Here’s an updated list of biotech and pharmaceutical companies with pending FDA drug approval decisions for the rest of 2012 and into early 2013.

Gilead Sciences said its elvitegravir, a component of the company’s important four-drug Quad HIV treatment currently awaiting an approval decision, demonstrated similar efficacy and tolerability to Isentress in difficult-to-treat patients.

French pharmaceutical giant Sanofi said the analysis of early data showed the ability of its vaccine against dengue virus to protect against the three of the four strains of the virus circulating in Thailand in the first ever efficacy study.

Global pharma giant Teva Pharmaceutical shall foray into India through a joint venture with U.S.-based Proctor & Gamble and will set up its first manufacturing facility at Sanand in Gujarat, a top state official said here.

German chemical and pharmaceutical company Bayer AG Wednesday said the UK’s regulator has confirmed its recommendation, allowing Xarelto to be used to treat blood clots.

Children coinfected with HIV and tuberculosis appear to suppress both infections when treated with standard TB regimens and an efavirenz-based HIV regimen, researchers said here at the International AIDS Conference.