07:00 , May 12, 2014 |  BC Week In Review  |  Company News

J&J, WHO infectious news

Johnson & Johnson's Janssen Pharmaceutica N.V. subsidiary partnered with the Stop TB Partnership's Global Drug Facility to provide access to J&J's Sirturo bedaquiline to treat tuberculosis (TB) to over 130 low- and middle-income countries outside...
07:00 , Mar 10, 2014 |  BC Week In Review  |  Clinical News

Sirturo bedaquiline regulatory update

The European Commission granted conditional approval to an MAA from Johnson & Johnson for Sirturo bedaquiline to treat pulmonary multidrug-resistant tuberculosis (MDR-TB) in adults. The approval covers use of bedaquiline as part of a combination...
08:00 , Dec 23, 2013 |  BC Week In Review  |  Clinical News

Sirturo bedaquiline regulatory update

EMA's CHMP issued a positive opinion recommending conditional approval of an MAA from Johnson & Johnson's Janssen-Cilag International N.V. unit for Sirturo bedaquiline to treat pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults. The recommendation covers...
07:00 , Jul 1, 2013 |  BC Week In Review  |  Clinical News

Bedaquiline regulatory update

The World Health Organization (WHO) issued interim policy guidance recommending the use of Johnson & Johnson's bedaquiline in combination therapy to treat multi-drug resistant tuberculosis (TB). The guidance said 5 conditions should be in place...
08:00 , Jan 7, 2013 |  BC Week In Review  |  Clinical News

Sirturo bedaquiline regulatory update

On Dec. 28, 2012, FDA granted accelerated approval to an NDA from Johnson & Johnson for Sirturo bedaquiline to treat adults with multi-drug resistant pulmonary tuberculosis (TB) as part of a combination therapy when other...
02:18 , Jan 3, 2013 |  BC Extra  |  Top Story

FDA approves bedaquiline

FDA granted accelerated approval on Friday to an NDA from Johnson & Johnson (NYSE:JNJ) for Sirturo bedaquiline ( TMC207 ) to treat adults with multi-drug resistant pulmonary tuberculosis as part of a combination therapy when...
08:00 , Dec 3, 2012 |  BC Week In Review  |  Clinical News

Sirturo bedaquiline regulatory update

FDA's Anti-Infective Drugs Advisory Committee voted 18-0 that efficacy data for Sirturo bedaquiline from Johnson & Johnson supported accelerated approval to treat multi-drug-resistant tuberculosis. The panel voted 11-7 that J&J provided substantial safety data. Panel...
01:57 , Nov 29, 2012 |  BC Extra  |  Company News

FDA panel backs accelerated approval of bedaquiline

FDA's Anti-Infective Drugs Advisory Committee voted 18-0 that efficacy data for Sirturo bedaquiline from Johnson & Johnson (NYSE:JNJ) supported accelerated approval to treat multi-drug-resistant tuberculosis. The panel voted 11-7 that J&J provided substantial safety data....
01:08 , Nov 27, 2012 |  BC Extra  |  Company News

FDA releases bedaquiline briefing docs

FDA's Anti-Infective Drugs Advisory Committee will discuss on Wednesday whether safety and efficacy data support accelerated approval of Sirturo bedaquiline from Johnson & Johnson (NYSE:JNJ) to treat multi-drug-resistant tuberculosis (TB). In briefing documents released ahead...
07:00 , Oct 1, 2012 |  BC Week In Review  |  Clinical News

Bedaquiline regulatory update

FDA's Anti-Infective Drugs Advisory Committee will meet on Nov. 28 to discuss an NDA from Johnson & Johnson's Janssen Research & Development LLC unit for bedaquiline to treat multi-drug-resistant tuberculosis (TB). The application is under...