07:00 , Sep 10, 2012 |  BC Week In Review  |  Clinical News

Calsed amrubicin regulatory update

Dainippon submitted a regulatory application to China's State Food and Drug Administration (SFDA) for amrubicin as first-line treatment for small cell lung cancer (SCLC). Celgene has North American and European rights to the third-generation synthetic...
07:00 , Aug 23, 2012 |  BC Innovations  |  Distillery Therapeutics

Indication: Cancer

Indication Target/marker/pathway Summary Licensing status Publication and contact information Cancer Cancer Topoisomerase I (TOP1); TOP2 In vitro and mouse studies suggest a class of dual inhibitors of...
07:00 , Mar 19, 2012 |  BioCentury  |  Strategy

Incentivized success

Boston Biomedical Inc.'s story shows what can happen when researchers are given the imperative and the resources to invent as if their livelihoods depend on it. The company emerged from ArQule Inc. in 2006 and...
07:00 , Jul 4, 2011 |  BioCentury  |  Finance

2Q Stock Wrap-Up: Stand and deliver

Several market cap bands tracked by BioCentury did well last quarter, as investors rewarded late-stage data and transformative deals. The NYSE Arca Biotechnology Index and the BioCentury 100 each gained 7% in 2Q, while the NASDAQ...
07:00 , May 23, 2011 |  BC Week In Review  |  Clinical News

Calsed amrubicin: Phase III data

The open-label, international Phase III ACT-1 trial in 637 patients showed that IV amrubicin as second-line therapy missed the primary endpoint of significantly improving OS vs. topotecan (7.5 vs. 7.8 months, p=0.17). Amrubicin also missed...
07:00 , May 23, 2011 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory milestones Acorda Therapeutics Inc. (NASDAQ:ACOR) gained $3.67 (14%) to $30.38 on Friday, while partner Biogen Idec Inc. (NASDAQ:BIIB) was up $0.39 to $97.11, after EMA's CHMP reversed a prior decision and recommended conditional approval of...
00:41 , May 20, 2011 |  BC Extra  |  Clinical News

Amrubicin misses in lung cancer

Second-line treatment with amrubicin from Celgene Corp. (NASDAQ:CELG) missed the primary endpoint of significantly improving overall survival vs. topotecan in the Phase III ACT-1 trial to treat small cell lung cancer (SCLC), according to an...
07:00 , Oct 4, 2010 |  BioCentury  |  Finance

4Q10 milestones

4Q10 milestones Company Product Indication Event Milestone Adventrx Pharmaceuticals Inc. (NYSE-A:ANX) Exelbine vinorelbine emulsion (ANX-530) Non-small cell lung cancer (NSCLC) Resubmit NDA 4Q10 Alexza Pharmaceuticals...
07:00 , Jul 5, 2010 |  BioCentury  |  Finance

2H10 milestones

2H10 milestones Selected products with Phase III or regulatory milestones expected in 2H10 Company Product Indication Event Milestone Actelion Ltd. (SIX:ATLN) Pivlaz clazosentan Prevent the occurrence...
07:00 , Aug 10, 2009 |  BC Week In Review  |  Clinical News

Calsed amrubicin: Final Phase II data

Final data from 72 evaluable patients sensitive to previous first-line platinum-based therapy in an open-label, U.S. Phase II trial, showed that amrubicin met the primary endpoint of a significantly higher ORR than Hycamtin topotecan...