Archive for the ‘pharma industry’ Category
Septiembre 24, 2009
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The Dallas Morning News reports on the lure of the medical imaging business, which is many say is a “growth industry,” including the idea that a “second or thirdhand MRI machine” can be purchased by a physician practice or freestanding imaging center for a few hundred thousand dollars but yield millions in new revenue. A report by Americas Health Insurance Plans says as many as half the scans are unnecessary, and a McKinsey Global Institute study found the extra machines produce around $26.4 billion in additional costs each year. In addition, they expose patients to avoidable radiation (McNeill, 9/22). Separately, drug maker Eli Lilly recently disclosed payments to 3,400 doctors around the country who promoted the companys products to other doctors in their communities, the Orlando Sentinel reports. The payments to the socalled “Lilly faculty” totaled more than $22 million in the first quarter of this year, and were disclosed as part of a settlement with the federal government. An Institute of Medicine panel said the speaking payments lead to increased drug sales and should be halted. A Harvard medical school professor and panelist said the speeches also drive up health costs by encouraging doctors to choose more expensive, brandname drugs (LaMendola and Quintero, 9/23). This information was reprinted from kaiserhealthnews.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at kaiserhealthnews.org. © Henry J. Kaiser Family Foundation. All rights reserved.
Septiembre 16, 2009
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Academic Press, a division of Elsevier, would like to announce the new book, Pharmacology Principles and Practice, authored by Miles Hacker, William S. Messer, II and Kenneth A. Bachmann This unique and much needed textbook meets the rapidly emerging needs of programs training pharmacologic scientists seeking careers in basic research and drug discovery rather than such applied fields as pharmacy and medicine. While the market is crowded with many clinical and therapeutic pharmacology textbooks, the field of pharmacology is booming with the prospects of discovering new drugs, and virtually no extant textbook meets this need at the student level. The industry is so bereft of such approaches that many pharmaceutical companies will look towards this book to help train new drug researchers. The explosion in pharmacology research is driven by the recent decryption of the human genome and enormous progress in controlling genes and synthesizing proteins, making new and even custom drug design possible. Hacker, Messer, and Bachman make use of these discoveries by moving logically from drug receptors to the target molecules drug researchers seek, and covering such modern topics along the way as side effects, drug resistance, Pharmacogenomics, and even nutriceuticals, one in a string of culminating chapters on the drug discovery process. Pharmacology Principles and Practice Source
Septiembre 11, 2009
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By forging partnerships with developing countries, biotechnology companies from developed countries may be able to stay afloat during the current economic crisis and bolster innovation, according to a study published Thursday in the journal Nature Biotechnology, Livemint.com reports. Of the 181 Canadian biotech firms included in the study by the McLaughlinRotman Centre for Global Health, researchers found one in four had partnerships in the developing world. The findings also revealed that 47 percent of the firms have “manufacturing collaboration” with China and 43 percent have “contract research activities” in India (Singh, 9/9). Firms also had collaborations in Latin America, subSaharan and North Africa, East Asia and the Pacific and the Middle East, according to a McLaughlinRotman Centre for Global Health/EurekAlert! release (9/9). The firms with developing country collaborations also pulled in more average revenue than those without partnerships, $16.3 million compared to $4.4 million, Livemint.com reports. According to the release, study coauthor Peter Singer said, “The emerging economies used to be dismissively labelled Rest of World in pharmaceutical circles and virtually ignored. But the socalled Rest of the World has most of the people, most of the health problems, and most of the economic growth” (9/9). The article includes information on how collaboration is changing the way biotech companies in developing countries look to “acquire intellectual property in the North” to develop into products locally and the resulting joint products in the pipeline (9/9). This information was reprinted from globalhealth.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the archives and sign up for email delivery at globalhealth.kff.org. © Henry J. Kaiser Family Foundation. All rights reserved.
Septiembre 11, 2009
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American Medical News examines the ethical considerations of outsourcing pharmaceutical clinical trials to developing countries. The article highlights how it is less expensive for a drug company to conduct a trial in India, where it runs about $2,000 to track a patient through a trial, compared to the cost in the U.S., which is “10 times more.” The disparities between participants in the two countries in terms of income, education and access to care are “stark” and the playing field “uneven,” writes American Medical News. While twenty years ago, most U.S. companies conducted clinical trials on their home soil, now “[t]he 20 largest U.S.based drugmakers conduct about a third of their phase III clinical trials outside the country, and a majority of their study sites also are elsewhere, says a Feb. 19 article in The New England Journal of Medicine,” according to American Medical News. “There are just going to be more people in other parts of the world who are having health issues that need to be addressed and are ready to consent to clinical trials, because really it is the only mechanism for receiving care,” said Jill Fisher of Vanderbilt Universitys Center for Biomedical Ethics and Society. She added that “clinical trials are a problematic kind of care, because it comes in the context of a study intervention. But people are ready to enroll, because they see it as such an incredible advantage over basically nothing.” The article outlines additional concerns about outsourcing clinical trials, such as limited ethical oversight of trials, language barriers, cultural norms and government corruption, as well as comments by other experts on the pros and cons of clinicaltrial outsourcing (OReilly, 9/7). This information was reprinted from globalhealth.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the archives and sign up for email delivery at globalhealth.kff.org. © Henry J. Kaiser Family Foundation. All rights reserved.
Septiembre 04, 2009
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A new type of experimental anticancer drug developed by Genentech, which inhibits the hedgehog signalling pathway, was effective in treating patients with advanced skin cancer. It was also very effective at first in treating a patient with an advanced type of brain cancer, and initial results were dramatic, but after a few months the cancer became resistant to the drug. Nevertheless, experts suggest the findings open a route to new types of drugs for fighting cancer that shut down the gene signalling pathways that spur tumor growth. Three papers about the effectiveness of the new drug have been published in the last few days, two in the New England Journal of Medicine and one in Science. One of the NEJM papers describes a promising trial where the safety and antitumor activity of the experimental hedgehog inhibitor drug was tested on patients with advanced and inoperable basalcell carcinomas, and the other NEJM paper reports using the drug to treat a patient with a very advanced metastatic medulloblastoma (a type of brain cancer) where the effect was dramatic but did not last. The Science report decribes a genetic investigation into what happened with the brain cancer patient, and found that certain acquired mutations in a key receptor can lead to drug resistance in human cancer. The drug referred to in all three studies, which were supported by funds from the company, is Genentechs experimental drug code named GDC0449 that blocks the hedgehog signalling pathway, a new and exciting field of development for cancer treament. The hedgehog molecule, which exists in organisms ranging from flies to humans, controls the signals that cells need to grow properly, and is active from embryo through to childhood. It is supposed to switch off in adulthood, but if it doesnt, it can promote cancer. In the first NEJM paper, Dr Daniel D Von Hoff, from the Translational Genomics Research Institute and Scottsdale Healthcare in Scottsdale, Arizona, and colleagues described how basalcell carcinoma is often characterized by mutations in two hedgehog pathway genes PTCH1 (patched homologue 1) and SMO (smoothened homologue). Basalcell carcinoma is the most common type of skin cancer and affects about 1 million Americans a year. It is rarely fatal but it can cause severe disfigurement and should be treated straight away. For their study, which was a phase 1 clinical trial, Von Hoff and colleagues assessed the safety and workings of GDC0449, which they described as a smallmolecule inhibitor of SMO, as a treatment for metastatic (already spreading to other sites) and locally advanced basalcell carcinoma in 33 patients. Each patient received one of three oral doses of GDC0449. 17 patients received 150 mg a day, 15 received 270 mg a day and 1 patient received 540 mg a day. After a median treatment period of 9.8 months, the results showed that18 of the 33 patients had an objective response to the drug 2 had a complete response and 16 had a partial. “GDC0449, an orally active small molecule that targets the hedgehog pathway, appears to have antitumor activity in locally advanced or metastatic basalcell carcinoma.” In the second NEJM paper, Dr Charles M Rudin of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University in Baltimore, Maryland, and colleagues, wrote that abnormal activation of the hedgehog signalling pathway is thought to play a key role in the development of some cases of medulloblastoma, the most common malignant brain tumor in children. They reported the case of a 26year old man with medulloblastoma that had spread to other sites in his body and was resistant to several types of therapy, including radiation and chemotherapy. He had also had extensive surgery. When the researchers analysed specimens of his tumor tissue they found evidence that the hedgehog pathway was active. After treatment with GDC0449, scans showed that the man had surprisingly fewer tumors and he also experienced fewer symptoms and gained a little weight. However, within a few months of starting the new drug, the cancer became resistant to it and the man died. The authors wrote that “Identifying the mechanisms of acquired resistance to selective hedgehog pathway inhibitors in patients with medulloblastoma will be of particular interest in future studies.” They commented that using an inhibitor that targets a pathway that is clearly involved in developing malignant tumors in medulloblastoma may be a better treatment option than those currently available, and it may avoid some of their side effects. However, they caution that the hedgehog pathway regulates several growth processes, and although initial tests with adults show “acceptable” sideeffects, this may not be the case with children, who may experience skeletal growth complications on both cartilage and bone. “Cautious application of these initial observations through carefully monitored clinical trials involving a broad spectrum of patients with medulloblastoma is warranted,” wrote Rudin and colleagues. In the Science paper, Robert L. Yauch, from Genentech, South San Francisco, California, and colleagues, some of whom also worked on both the NEJM studies, investigated what happened in the case of the single medulloblastoma patient whose cancer became resistant to GDC0449 after showing such a dramatic initial response. They looked at the state of the hedgehog signalling genes in the tumors after they had been treated and the disease had started progressing again. The found an amino acid in the SMO gene that had no effect on the hedgehog signalling but disrupted the ability of the drug to bind to SMO and suppress the signalling. To double check their finding, they found the same amino acid occurred in mice bred with medulloblastoma that also showed resistance to GDC0449. Yauch and colleagues concluded that certain acquired receptor mutations can “serve as a mechanism of drug resistance in human cancer”. In an editorial accompanying the NEJM papers, Drs Andrzej A. Dlugosz and Moshe Talpaz, wrote “These studies require that we learn much more about the safety and efficacy of GDC0449. Nonetheless, the remarkable responses that are reported in the initial cases suggest that the hedgehog pathway can be the basis of an important new class of therapeutic agents with farreaching implications in oncology.” “Inhibition of the Hedgehog Pathway in Advanced BasalCell Carcinoma.” “Treatment of Medulloblastoma with Hedgehog Pathway Inhibitor GDC0449.” “Smoothened Mutation Confers Resistance to a Hedgehog Pathway Inhibitor in Medulloblastoma.” Written by Catharine Paddock, PhD
Septiembre 04, 2009
Filed Under (pharma industry) by admin
A new type of experimental anticancer drug developed by Genentech, which inhibits the hedgehog signalling pathway, was effective in treating patients with advanced skin cancer. It was also very effective at first in treating a patient with an advanced type of brain cancer, and initial results were dramatic, but after a few months the cancer became resistant to the drug. Nevertheless, experts suggest the findings open a route to new types of drugs for fighting cancer that shut down the gene signalling pathways that spur tumor growth. Three papers about the effectiveness of the new drug have been published in the last few days, two in the New England Journal of Medicine and one in Science. One of the NEJM papers describes a promising trial where the safety and antitumor activity of the experimental hedgehog inhibitor drug was tested on patients with advanced and inoperable basalcell carcinomas, and the other NEJM paper reports using the drug to treat a patient with a very advanced metastatic medulloblastoma (a type of brain cancer) where the effect was dramatic but did not last. The Science report decribes a genetic investigation into what happened with the brain cancer patient, and found that certain acquired mutations in a key receptor can lead to drug resistance in human cancer. The drug referred to in all three studies, which were supported by funds from the company, is Genentechs experimental drug code named GDC0449 that blocks the hedgehog signalling pathway, a new and exciting field of development for cancer treament. The hedgehog molecule, which exists in organisms ranging from flies to humans, controls the signals that cells need to grow properly, and is active from embryo through to childhood. It is supposed to switch off in adulthood, but if it doesnt, it can promote cancer. In the first NEJM paper, Dr Daniel D Von Hoff, from the Translational Genomics Research Institute and Scottsdale Healthcare in Scottsdale, Arizona, and colleagues described how basalcell carcinoma is often characterized by mutations in two hedgehog pathway genes PTCH1 (patched homologue 1) and SMO (smoothened homologue). Basalcell carcinoma is the most common type of skin cancer and affects about 1 million Americans a year. It is rarely fatal but it can cause severe disfigurement and should be treated straight away. For their study, which was a phase 1 clinical trial, Von Hoff and colleagues assessed the safety and workings of GDC0449, which they described as a smallmolecule inhibitor of SMO, as a treatment for metastatic (already spreading to other sites) and locally advanced basalcell carcinoma in 33 patients. Each patient received one of three oral doses of GDC0449. 17 patients received 150 mg a day, 15 received 270 mg a day and 1 patient received 540 mg a day. After a median treatment period of 9.8 months, the results showed that18 of the 33 patients had an objective response to the drug 2 had a complete response and 16 had a partial. “GDC0449, an orally active small molecule that targets the hedgehog pathway, appears to have antitumor activity in locally advanced or metastatic basalcell carcinoma.” In the second NEJM paper, Dr Charles M Rudin of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University in Baltimore, Maryland, and colleagues, wrote that abnormal activation of the hedgehog signalling pathway is thought to play a key role in the development of some cases of medulloblastoma, the most common malignant brain tumor in children. They reported the case of a 26year old man with medulloblastoma that had spread to other sites in his body and was resistant to several types of therapy, including radiation and chemotherapy. He had also had extensive surgery. When the researchers analysed specimens of his tumor tissue they found evidence that the hedgehog pathway was active. After treatment with GDC0449, scans showed that the man had surprisingly fewer tumors and he also experienced fewer symptoms and gained a little weight. However, within a few months of starting the new drug, the cancer became resistant to it and the man died. The authors wrote that “Identifying the mechanisms of acquired resistance to selective hedgehog pathway inhibitors in patients with medulloblastoma will be of particular interest in future studies.” They commented that using an inhibitor that targets a pathway that is clearly involved in developing malignant tumors in medulloblastoma may be a better treatment option than those currently available, and it may avoid some of their side effects. However, they caution that the hedgehog pathway regulates several growth processes, and although initial tests with adults show “acceptable” sideeffects, this may not be the case with children, who may experience skeletal growth complications on both cartilage and bone. “Cautious application of these initial observations through carefully monitored clinical trials involving a broad spectrum of patients with medulloblastoma is warranted,” wrote Rudin and colleagues. In the Science paper, Robert L. Yauch, from Genentech, South San Francisco, California, and colleagues, some of whom also worked on both the NEJM studies, investigated what happened in the case of the single medulloblastoma patient whose cancer became resistant to GDC0449 after showing such a dramatic initial response. They looked at the state of the hedgehog signalling genes in the tumors after they had been treated and the disease had started progressing again. The found an amino acid in the SMO gene that had no effect on the hedgehog signalling but disrupted the ability of the drug to bind to SMO and suppress the signalling. To double check their finding, they found the same amino acid occurred in mice bred with medulloblastoma that also showed resistance to GDC0449. Yauch and colleagues concluded that certain acquired receptor mutations can “serve as a mechanism of drug resistance in human cancer”. In an editorial accompanying the NEJM papers, Drs Andrzej A. Dlugosz and Moshe Talpaz, wrote “These studies require that we learn much more about the safety and efficacy of GDC0449. Nonetheless, the remarkable responses that are reported in the initial cases suggest that the hedgehog pathway can be the basis of an important new class of therapeutic agents with farreaching implications in oncology.” “Inhibition of the Hedgehog Pathway in Advanced BasalCell Carcinoma.” “Treatment of Medulloblastoma with Hedgehog Pathway Inhibitor GDC0449.” “Smoothened Mutation Confers Resistance to a Hedgehog Pathway Inhibitor in Medulloblastoma.” Written by Catharine Paddock, PhD
Agosto 06, 2009
Filed Under (pharma industry) by admin
WHO American Association of Pharmaceutical Scientists (AAPS) WHAT Scientists from around the world gather to discuss the discovery and development of pharmaceutical products in an effort to enhance global health care. WHEN November 8 12, 2009 WHERE Los Angeles Convention Center, Los Angeles, Calif. BACKGROUND Over 8,500 individuals from the field of pharmaceutical research are expected to attend this years AAPS Annual Meeting and Exposition. During the meeting, scientists from around the world will have the opportunity to present new research, methods and technologies as they relate to the field of pharmaceutical sciences. Not only is the meeting the premiere international event for the industry, it also serves as a forum for presentations and intellectual discussion among representatives from the academia, pharmaceutical, government and scientific worlds. Topics scheduled for the Los Angeles meeting include Alternatives to drug delivery options currently on the market; Advances in therapeutic technology for cancer and HIV, and; Progress in the expedition and accuracy in getting more targeted and efficient medications to patients. Keynote speakers include Andrew von Eschenbach, Former Commissioner, U.S. Food and Drug Administration Trisha Meili, motivational speaker often described as the “Central Park Jogger” Source
Julio 16, 2009
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GenWay Biotech, Inc., a USbased diagnostic company has become CLIA certified and received a California lab license. Their license currently permits the testing of immunological biomarkers. This is a very important step in the direction of commercialization of the novel innovative diagnostic tests currently being developed at GenWay. In upcoming weeks, GenWay will add new cancer biomarker tests to their portfolio as well as several infectious diseases such as sexual transmitted diseases. GenWay is seeking to obtain CAP accreditation by the end of the year. Dr. Joe Voland, CLIA Pathologist and lab director, claims that he has never seen a CLIA lab get set up so efficiently and professionally as GenWay has done. GenWay Biotech Inc. is a GMP compliant facility with capabilities for research, development and manufacturing of proteins, antibodies, immunoassays, and diagnostics. Consequently, most quality control and assurance measures were already in place facilitating the transition into a CLIA certified laboratory. Furthermore, GenWays lab is under construction for the addition of a Class 10,000 clean room which should be complete sometime in August 2009. Dylan Malayter, Project Manager, who has played a predominant role in guiding the lab through the CLIA certification process, feels “This is an immense step forward for GenWay Biotech, Inc. We are excited to begin accepting patient samples and performing revolutionary tests that may save patients lives and enhance their treatment by monitoring their condition with simple noninvasive blood tests.” The GenWay team is looking forward to the future impact of the cancer biomarker tests they will offer. They have secured exclusive rights to the DR70 test from AMDL and have secured several other biomarkers in the field of cancer diagnostics. Source
Julio 09, 2009
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AlphaRx Inc. (OTCBB ALRX) reported positive preclinical results on GAI122 injectable nanoemulsion in multiple models of acute hepatitis, an inflammatory liver disease. GAI122 significantly reduced Aminotransferase (ALT), an enzyme released into the blood that indicates damage to the liver, following IP administration in three different preclinical models of acute liver injury. Very high levels of ALT are usually due to acute hepatitis or a viral infection. In the aFas model of liver injury, GAI122 markedly reduced ALT levels by 90% from baseline, where control ALT values were ~22,000 IU/L. Significant efficacy was also demonstrated in the rat TNFa/Gln model and in the Druginduced liver injury (DILI) model. “DILI accounts for more than 50% of acute liver failure and there are no satisfactory treatment options currently available. The excellent efficacy data demonstrated by these studies suggest that GAI122 may represent a potential first line treatment option for patients with liver disease”, stated Dr. Michael Weisspapir, MD, PhD, Chief Medical Scientist of AlphaRx. In October 2008, AlphaRx licensed GAI122 to Gaia BioPharma. Under the terms of the amended agreement, AlphaRx is eligible to receive milestone payments of up to $50 million for the successful development and commercialization of GAI122, as well as royalties on worldwide sales. In addition, Gaia BioPharma has assumed all development costs. About AlphaRx Inc. AlphaRx is a specialty pharmaceutical company dedicated to developing proven therapies by reformulating FDA approved and marketed drugs which through the application of its proprietary sitespecific nano drug delivery technology, offers improved medical benefits and a potential for significant commercial product development. About Gaia BioPharma Gaia BioPharma Limited, a privately held, early stage biopharmaceutical company focused on hospitalbased injectable therapeutics. Gaia BioPharma seeks to address key unmet therapeutic needs by taking established compounds and changing their administration routes to create patentprotected, valueadded products. FORWARD LOOKING STATEMENTS This release contains forwardlooking statements within the meaning and pursuant to the Safe Harbor provisions of the Securities Litigation Reform Act of 1995 and involve risks and uncertainties that may individually or mutually impact the matters herein described, including but not limited to product development and acceptance, manufacturing, competition, regulatory and/or other factors, which are outside the control of the Company.
Junio 30, 2009
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Centocor Ortho Biotech Inc. announced today that a federal jury has returned a verdict of $1.67 billion against Abbott Laboratories in a patent infringement suit. “We are pleased that the jury has ruled in our favor in the patent litigation case against Abbott,” said Kim Taylor, President, Centocor Ortho Biotech Inc. The patent in question relates to the companys antiTNF class of arthritis treatments, and is coowned by New York University and Centocor, for which Centocor is the exclusive licensee. “We are particularly gratified that the jury recognized our valuable intellectual property, finding our patent both valid and infringed. We will continue to assert intellectual property rights for our immunology therapies, as they offer significant advances in treatment for patients with a number of immune mediated inflammatory diseases,” Taylor added. Source |
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