Researchers reported this week that in mice, they have been able to induce adult heart stem cells to proliferate and repair damage by "priming" them with the peptide Tbeta-4. Read More
WASHINGTON – The FDA is putting the cart before the horse, Talecris Biotherapeutics Inc. said in a comment on the agency's proposed biosimilar fee structure. Read More
Vertex Pharmaceuticals Inc. reported positive interim results from a Phase II trial of a combination of two investigational drugs for cystic fibrosis (CF). Although the trial documented solid, statistically significant chances in the outcome marker, sweat chloride, the results were not perceived as a home run. Read More
Neoprobe Corp., of Dublin, Ohio, said full results from its NEO3-05 study demonstrated that Lymphoseek (99mTc-tilmanocept) met all primary and secondary endpoints in intraoperative lymphatic mapping procedures. Study subjects yielded a total of 215 lymph nodes stained with vital blue dye and, of those, Lymphoseek detected 210, for a concordance rate of 97.67 percent, hitting statistical significance (p < 0.0001). Read More
Ambit Biosciences Corp., of San Diego, withdrew its proposed initial public offering, stating that the current market was not "sufficiently attractive." Ambit filed its S-1 last year, hoping to raise $86 million to fund its portion of pivotal trials for quizartinib, being developed with partner Astellas Pharma Inc., of Tokyo, for acute myeloid leukemia. Read More
Emergent BioSolutions Inc., of Rockville, Md., said investigational anthrax vaccine NuThrax (anthrax vaccine adsorbed with CPG 7909 adjuvant) was granted fast-track status by the FDA. The candidate, also known as aV7909, consists of BioThrax (anthrax vaccine adsorbed) in combination with an immunostimulatory oligodeoxynucleotide compound, CPG 7909, and is being evaluated in a Phase Ib trial. Read More
It's a generalization – but by all accounts true – that the biotechnology industry in China today is big on low-cost services, yet lacking in innovation. Read More
NEW YORK – Some of the most investment-ready emerging markets (EM) are in Latin America, particularly in Mexico and Brazil; not all the way around the world from the U.S., according to the consensus perspective of a panel at the inaugural Jefferies 2011 Global Healthcare Conference in New York this week. Read More
