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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 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…


June 1, 2010 - Postmenopausal women at increased risk of bone fractures from osteoporosis, and men with prostate cancer who suffer bone loss associated with hormone ablation treatment will finally get Amgen’s (AMGN) drug Prolia (denosumab) in Europe. The good news for these patients and for Amgen (AMGN) has come as the European Medicines Agency’s (EMEA) Commission has granted approval for the use of Prolia in both conditions. Suddenly, Prolia…


Better than expected results are announced from phase 3 randomized, double-blind, placebo-controlled ADVANCE study with Vertex’ hepatitis C drug telaprevir. Around 1,095 patients suffering from the genotype 1 chronic hepatitis C virus took telaprevir, which has tremendously increased the cure rate at record treatment duration. Many liver experts considered this news a historical advancement in the management of progressive disabling, life-threatening and sometimes deadly chronic hepatitis C viral infection. First,…


Things happen for reasons. Curiosity is an advantage and the ability to satisfy it is a luxury restricted to humans. Those who ignore such natural gifts miss causes and outcomes of meaningful activities and events that go around them. They miss chances to opportunities. Satisfying one’s inherent curiosity is the road to wellbeing and in some instances, life-saving. When Sanofi-Avantis made a major endorsement of Regeneron's (REGN) technology in 1997…


A Press release: GILEAD (GILD) announced that the company's Board of Directors has authorized the repurchase of up to $5 billion of the company's common stock through May 2013. "Gilead's Board of Directors and senior management team believe that the stock repurchase program announced today represents an appropriate and strategic use of the company's cash, while allowing sufficient flexibility for other expenditures going forward, including investments in research and development…


We expect to see breakthrough discoveries and treatments being made by Compugen through its far-reaching discovery and validation engines. We discussed many previous discoveries in past Prohost Letters and today news enabled us to witness an important revelation. The membrane protein, CGEN-928, which had no recognized function or potential clinical utility, could now serve as a multiple myeloma drug target thanks to Compugen’s discovery engines. What is the story? Earlier…


Are we lovers of redundancy? No. We are lovers of fairness and the lack of it cannot be visualized unless what goes on wrong gets caught and documented by history. Dendreon’s (DNDN) history, as written in the Prohost news on Prohost website, illustrates how unfair has been Wall Street evaluation to clinical-stage firms during the past decade and how tremendous were the opportunities investors have let escape from hand by…


Despite the emergence of new biological treatments for cancer, Chemotherapy is still essential, and indispensable as a major treatment for malignancies. The adverse events caused by these chemicals were found to be acceptable as a risk versus the great reward of using chemotherapy. The technological evolution that took place in the past decade and the surfacing of state-of-the-art technologies such as nanotechnology, scientists believed possibilities exist now for improving the…


Practicing personalized medicine, or predictive medicine is no more a dream. It is real and it is performed at the genetic level. The breakthrough capability is made possible through the effective use of next-generation sequencing technologies provided by genomic firms that have constantly upgraded their gene analysis techniques and programs. Currently, millions of DNA sequences can be read simultaneously in a single experiment. What we are witnessing here is a…


Those who follow on the advancement of biotechnology achievements walk up every day looking for specific news about breakthrough treatments for cancer and chronic devastating diseases, not for just a modest improvement of drugs, or me-too drugs that do little against the diseases and a lot in devastating the healthcare budget. The more we see breakthroughs, the more we get greedy, asking or at least hoping for more treatments that…
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