While the reauthorization of PDUFA was the focal point of a House subcommittee hearing Wednesday, lawmakers also began consideration of two acts that require and incentivize pediatric drug trials. Read More
LONDON – AstraZeneca plc said it will spend more of its annual $5 billion R&D budget with external partners as it announced it is once again taking the ax to the in-house R&D operations, in a third phase of restructuring that will see a further 2,200 job cuts added to the 5,300 R&D posts the company has cut since 2007. Read More
Shares in AB Science SA surged 71.5 percent Thursday on news that its tyrosine kinase inhibitor masitinib strongly outperformed Sutent (sunitinib malate) in a Phase II head-to-head trial in 44 patients with Gleevec-resistant gastrointestinal stromal tumors (GIST). Read More
• Compugen Ltd., of Tel Aviv, Israel, reported findings on the potential of CGEN-15001T, a membrane protein, as a therapeutic target for multiple cancers using monoclonal antibody (mAb) therapy. The results indicated that CGEN-15001T is expressed on numerous types of cancer, including carcinomas, sarcomas, melanoma and hematological cancers, as well as on immune cells. Read More
• Tranzyme Pharma Inc., of Research Triangle Park, N.C., said it received an additional $9.3 million in term loan proceeds through an amendment and restatement of its existing debt financing facility with Oxford Finance LLC and Horizon Technology Finance Corp. The firm will use a portion of the new proceeds to pay off part of its existing debt, and the financing is expected to extend its cash runway into the fourth quarter of 2013. Read More
• OncoGenex Pharmaceuticals Inc., of Bothell, Wash., reported preliminary results from a Phase II trial that showed 71 percent of chemotherapy-naive patients with metastatic castrate-resistant prostate cancer (mCRPC) treated with OGX-427 plus prednisone had no disease progression at 12 weeks compared with 33 percent of those treated with prednisone alone. The OGX-427 group also had greater declines in prostate-specific antigen and circulating tumor cells. Read More
