Higher-than-expected product sales pushed Gilead Sciences Inc.'s fourth-quarter earnings beyond the Street's expectations, according to the company's earnings report released Monday. Read More
Hemispherx Biopharma Inc.'s complete response letter from the FDA in the wake of a negative advisory panel review of Ampligen for chronic fatigue syndrome (CFS) left the company weighing its chances of success in appealing the decision, and left patients without options. Read More
Successful treatment of cancer depends not on killing tumor cells, but in beating them into submission using the immune system, a team of German researchers reported. They have identified a type of immune cell that can "re-educate" cancer cells, so that they enter prolonged periods of growth arrest. Read More
The up-front payment was just $5 million, but a potential $225 million option and licensing deal between Opexa Therapeutics Inc. and Merck Serono SA to develop and commercialize Tcelna (imilecleucel-T), a personalized T-cell immunotherapy in multiple sclerosis (MS), could offer a win-win for the small biotech and for the biopharmaceutical division of Merck KGaA, of Darmstadt, Germany – provided the product crosses the finish line. Read More
• Kineta Inc., of Seattle, and RLB Holdings formed a partnership to develop Kineta's drug candidates ShK-186 and rOAS. ShK-186 is in development or autoimmune disease, and rOAS is a candidate for viral illnesses. Read More
• Isotechnika Pharma Inc., of Edmonton, Alberta, and privately held Aurinia Pharmaceuticals Inc., of Victoria, British Columbia, said they signed a binding term sheet for a merger to create a clinical-stage firm focused on the global nephrology market. Under the terms, Isotechnika will acquire 100 percent of the outstanding securities of Aurinia, a spinout of Swiss company Galenica Group's Vifor Pharma unit, and the deal will result in a 60-40 postmerger ownership, with Isotechnika retaining the larger portion. Read More
• Synageva BioPharma Corp., of Lexington, Mass., said a 12-week Phase I/II extension study data published in Hepatology showed that for seven patients with lysosomal acid lipase deficiency who completed dosing with sebelipase alfa, mean percent decreases for ALT and AST from both the initial baseline to week 12 were 52 percent and 36 percent, respectively (p < 0.05 for both). Read More
• Janssen Research & Development LLC, of Titusville, N.J., a unit of Johnson & Johnson, said its San Diego-based Janssen Labs added a Concept Lab, a shared laboratory to offer entrepreneurs access to bench spaces for early stage research, and an Open Collaboration Space, an open-plan office setting designed to provide companies and individuals with desk space. Read More
• Teva Pharmaceutical Industries Ltd., of Jerusalem, said it enrolled the first patient in the Phase IV MODERATO study to test Azilect (rasagiline tablets) on cognitive function in adults with mild cognitive impairment in Parkinson's disease. Read More
