For more than 20 years, erythropoiesis-stimulating agents (ESAs) have dominated the anemia field. But this month's advisory committee win by Affymax Inc.'s peginesatide, as well as new data coming out of the American Society of Nephrology's Kidney Week and the American Society of Hematology's annual meeting, indicate big changes are afoot – changes that impact competitors not only in the ESA space but in the iron-replacement space as well. Read More
Despite a better efficacy and safety profile than Rituxan (rituximab, Roche AG and Biogen Idec Inc.), Zevalin ([90Y]-ibritumomab tiuxetan), the radioactive form of Rituxan, has never been a big seller. Read More
Multiple myeloma patients have gone from no options to three approved drugs in the past decade. And that fact is presumably part of what prompted the FDA's decision to refuse to give a priority review to Onyx Pharmaceuticals Inc.'s carfilzomib.
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FinancingsAriad Pharmaceuticals Inc. raised $224 million in a public stock offering.Cell Therapeutics Inc. is raising $20 million in a registered direct offering of stock and warrants.Cerulean Pharma Inc. closed a $15 million Series D financing.Ember Therapeutics raised $34 million in Series A financing for obesity and diabetes drugs.ImmusanT Inc. raised $20 million in a Series A round for celiac disease vaccine Nexvax2. Read More
"This is clinical development so there are going to be some setbacks."– Gil Van Bokkelen, CEO of Athersys Inc. and chairman of the Alliance for Regenerative Medicine"You can see a slight change in subject one's pulse here. But I can tell you, his pulse was substantially lower than my own pulse when this vector was going in."– Amit Nathwani, investigator on a trial testing Factor IX gene therapy for hemophilia B, describing monitoring patients for adverse reaction during infusions"If programs stumble, jobs are at stake." Read More
The House approved H.R. 1540, the National Defense Authorization Act, which includes an amendment that would finally reauthorize the SBIR program and would allow up to 25 percent of SBIR grants to go to companies that are majority owned by multiple venture capitalists.An FDA advisory committee debated how to test smallpox drugs under the animal rule when no animal model of the disease exists. Read More
