| Amgen's Prolia Considered a Breakthrough - And Blockbuster Prohost Biotech submits:In a surprising move, the FDA approved Amgen’s (AMGN) osteoporosis drug Prolia (denosumab) two months earlier than the scheduled date, after it had caused a several months' delay in the drug’s marketing. The question is, why scientists label Prolia a breakthrough and why most analysts expect it to become a blockbuster, generating billions of dollars in revenues? Assessment of breakthrough drugs entails many intellectual practices that require knowledge of history that would confirm the absence of precedents in the same category and science that enables evaluating the drug’s structure and understanding the physiological and pathological pathways of the body system targeted for treatment. These are usually followed by a hypothetical assumption of efficacy based on the results collected from all the above studies. Confirmation of the degree of both safety and efficacy, however, comes only with the results of well-planned clinical trials. Complete Story » seekingalpha.com |
Geron to Resume Stem-Cell Study Geron can proceed with early testing of an embryonic-stem-cell treatment for spinal-cord injuries after the FDA lifted a nearly yearlong hold on the trial. online.wsj.com |
Cord Blood America CEO Interview Details Company's 2010 Achievements (PR Newswire) Cord Blood America, Inc. said today that its co-founder and CEO, Matthew Schissler, reviewed the Company's progress in 2010, saying it is "on track" to accomplish all of its goals, in an interview with analyst Francis Gaskins. Â us.rd.yahoo.com |
ImmunoCellular Therapeutics CEO Explains Economic Significance of New Vaccine Manufacturing Method M.E. Garza submits: On Wednesday morning, ImmunoCellular Therapeutics (IMUC.OB) announced that it has developed an innovative method for manufacturing the company’s dendritic cell-based vaccine for the treatment of glioblastoma multiforme (GBM). Given all the headlines that Dendreon (Nasdaq:DNDN) has made with its manufacturing problems, IMUC's lead product candidate, ICT-107, may well start making news of its own. DNDN's Provenge won FDA approval last April, but sales have been hindered by the company's limited production capacity, an issue which DNDN management has said it expects to resolve some time next year.Complete Story » seekingalpha.com |
Cord Blood America Says Happy Thanksgiving to the CBAI Family, Investors, Friends [PR Newswire] - On this day before Thanksgiving, a day when our entire nation gives thanks for its blessing, Cord Blood America, Inc. , the umbilical cord blood stem cell preservation company focused on bringing the life saving potential of stem cells to families nationwide and internationally, would like to share with its investors a post from its web site by Dr. us.rd.yahoo.com |