Scientists at Isis Pharmaceuticals Inc., with both industrial colleagues from Genzyme Corp. and academic colleagues from Cold Spring Harbor Laboratory and Harvard Medical School, have managed to improve the symptoms of spinal muscular atrophy (SMA) in a mouse model of the disorder by treating the animals with an antisense oligonucleotide. The work, Frank Bennett, Isis senior vice president of research, told BioWorld Today, "sets the stage for going forward into the clinic" with the compound, which the company hopes to do later in 2011. Read More
Threshold Pharmaceuticals Inc. expects to raise about $30 million in a registered direct offering to advance clinical trials for its lead hypoxia-activated prodrug TH-302 including a Phase III trial for soft tissue sarcoma expected to start in mid-2011. Read More
Anti-angiogenic drug aflibercept (VEGF-Trap) failed to improve overall survival in a Phase III trial in non-small-cell lung cancer, news that came as no surprise to analysts who have criticized Regeneron Pharmaceuticals Inc.'s and partner Paris-based Sanofi-Aventis SA's aggressive move into late-stage trials. Read More
Senesco Technologies Inc., of New Brunswick, N.J., said the FDA put the firm's planned study of SNS01-T in multiple myeloma on hold until the drug master file of one of its suppliers is updated. No other issues were raised with the firm's investigational new drug application, and Senesco plans to start the studies in the first half of this year. SNS01-T is designed to regulate a growth control switch that induces apoptosis. Read More
Shares in Cell Therapeutics Inc., of Seattle, (NASDAQ:CTIC) gained 40.2 percent Friday on news a day earlier that the company had a final pivotal trial design for pixantrone in diffuse large B-cell lymphoma, following discussions with the FDA. The stock gained 9 cents to close at 30 cents. The study, designated PIX 306, will compare a combination of pixantrone plus Rituxan (rituximab, Genentech Inc./Roche AG and Biogen Idec Inc.) to a combination of gemcitabine plus rituximab in patients with relapsed or refractory disease who have received one to three prior lines of therapy. Read More
The future of a $760 million partnership between Tolerx Inc. and GlaxoSmithKline plc has been cast into doubt as their investigational humanized anti-CD3 antibody missed its primary endpoint in a Phase III trial. Read More
WASHINGTON – One company's gain could be another's loss if the FDA raises the financial resources threshold for user fee waivers for drugs and biologics. Read More
