00:25 , May 12, 2018 |  BioCentury  |  Politics, Policy & Law

Getting reorganized

FDA is reorganizing the Office of New Drugs in its Center for Drug Evaluation and Research, seeking to make review oversight more consistent while encouraging senior staff to become thought leaders. The changes at OND...
14:44 , Aug 11, 2017 |  BC Week In Review  |  Company News

SPARKing data sharing

The Pew Charitable Trusts unveiled the Shared Platform for Antibiotic Research and Knowledge (SPARK), a cloud-based tool for data sharing and analysis in antibiotic research. The goal of SPARK is to help overcome difficulties in...
21:39 , Aug 7, 2017 |  BC Extra  |  Tools & Techniques

SPARKing data sharing

The Pew Charitable Trusts unveiled the Shared Platform for Antibiotic Research and Knowledge (SPARK), a cloud-based tool for data sharing and analysis in antibiotic research. The goal of SPARK is to help overcome difficulties in...
08:00 , Feb 18, 2013 |  BC Week In Review  |  Company News

Innovative Medicines Initiative (IMI) infectious news

The EU's Innovative Medicines Initiative said it launched two projects under its New Drugs for Bad Bugs (ND4BB) antimicrobial resistance research program. The Combating Bacterial Resistance in Europe (COMBACTE) program will receive €194.6 million ($260.4...
08:00 , Nov 29, 2012 |  BC Innovations  |  Strategy

Rediscovering antibiotics

The implementation of the Generating Antibiotic Incentives Now Act and other recent efforts to speed antibiotic development will only be successful if they encourage new chemical approaches that address the dearth of new chemical classes...
08:00 , Nov 19, 2012 |  BioCentury  |  Regulation

Antibiotics reset

There is a consensus among the U.S. government, industry and the medical community that the failure of antibiotic development to keep pace with the evolution of bacterial pathogens constitutes a public health crisis, and that...
07:00 , Jun 4, 2012 |  BioCentury  |  Strategy

Innovating antibiotics

Europe's Innovative Medicines Initiative is testing the boundaries of public-private collaboration by funding late-stage trials of pharma-backed compounds as part of a €223.7 million ($281.6 million) consortium supporting the development of new antibiotics. In return,...
01:19 , May 25, 2012 |  BC Extra  |  Company News

IMI launches antibiotic research program

The EU's Innovative Medicines Initiative launched the NewDrugs4BadBugs grant program to fund development of new antibiotics against antibiotic-resistant bacteria, including products from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and AstraZeneca plc (LSE:AZN; NYSE:AZN). The program will initially...
01:48 , Sep 11, 2009 |  BC Extra  |  Company News

NICE backs narrow Hycamtin use

The U.K.'s NICE issued a final appraisal determination (FAD) recommending the use of Hycamtin topotecan from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) in combination with cisplatin to treat recurrent or stage IVB cervical cancer only in cisplatin-naïve...
00:52 , Sep 5, 2009 |  BC Extra  |  Company News

NICE backs narrowed Efient use

The U.K.'s NICE issued a final appraisal determination (FAD) that supports use of cardiovascular drug Efient prasugrel from Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568) and Eli Lilly and Co. (NYSE:LLY) in a patient population that...