07:00 , Jun 18, 2012 |  BC Week In Review  |  Company News

Basilea, GlaxoSmithKline sales and marketing update

Basilea granted GlaxoSmithKline's Stiefel Laboratories Inc. subsidiary exclusive, worldwide rights to the Swiss company's only marketed drug, eczema therapy Toctino alitretinoin. Basilea will receive L146 million ($226.3 million) up front and is eligible for L30-L50...
08:00 , Jan 16, 2012 |  BC Week In Review  |  Clinical News

Doribax: Phase III halted

Johnson & Johnson said in a Dear Healthcare Professional letter that it terminated a double-blind, international Phase III trial after an interim analysis showed a numerically higher mortality and a numerically poorer clinical cure rate...
08:00 , Nov 14, 2011 |  BioCentury  |  Regulation

Inching toward feasibility

Clinical work on compounds to treat community-acquired bacterial pneumonia and hospital-acquired or ventilator-associated bacterial pneumonia has been in limbo since 2008 when FDA began reassessing its requirements for clinical trial designs, which many companies said...
07:00 , Apr 26, 2010 |  BC Week In Review  |  Clinical News

PTZ601: Development discontinued

Novartis disclosed that last quarter it discontinued development of PTZ601 after a high rate of adverse events was observed in a Phase I trial. Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland   Product: PTZ601   Business:...
08:00 , Dec 14, 2009 |  BioCentury  |  Regulation

No rush, then judgment

An FDA advisory panel brushed off the agency's concerns about results of a Phase III trial of Cayston inhaled aztreonam lysine from Gilead Sciences Inc. that have delayed approval of the antibiotic for more than...
08:00 , Dec 7, 2009 |  BioCentury  |  Analyst Picks & Changes

Analyst Picks & Changes

Analyst Picks & Changes Company Bank Analyst Coverage Opinion Wk chg 12/4 cls Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) Roth Capital Partners Andrew Vaino Downgrade Hold (from buy) 4% $17.45 Vaino also lowered his target to $17...
07:00 , Oct 19, 2009 |  BioCentury  |  Analyst Picks & Changes

Analysts Picks & Changes

Analysts Picks & Changes Wk 10/16 Company Bank Analyst Coverage Opinion chg cls Acorda Therapeutics Inc. (NASDAQ:ACOR) Baird Christopher Raymond Upgrade Market outperform (from neutral) 42% $24.90 Deutsche Bank Mark Schoenebaum Price target Buy Merriman...
07:00 , Sep 7, 2009 |  BC Week In Review  |  Clinical News

Zeftera ceftobiprole regulatory update

Basilea said FDA accepted a response from partner Johnson & Johnson to a November complete response letter for an NDA for ceftobiprole to treat complicated skin and skin structure infections (cSSSIs). The agency designated the...
07:00 , Aug 24, 2009 |  BC Week In Review  |  Clinical News

Zeftera ceftobiprole regulatory update

FDA issued a warning letter to Johnson & Johnson in which the agency concluded the company had not adhered to applicable requirements and regulations related to the conduct of clinical trials of ceftobiprole to treat...
07:00 , Aug 17, 2009 |  BioCentury  |  Emerging Company Profile

Calixa: Bettering cephalosporin

Calixa Therapeutics Inc. is developing an in-licensed cephalosporin it says is more potent against multi-drug resistant strains of Pseudomonas aeruginosa than all other available beta lactams. The lead compound, CXA-101 , and two follow-ons are...