The US Justice Department and the Securities and Exchange Commission are investigating whether pharmaceutical companies paid bribes in foreign countries to boost sales and accelerate approvals of their drugs, The Wall Street Journal reported Tuesday, citing sources familiar with the matter. To date, no drugmakers have been accused of wrongdoing and the investigation may not result in charges.
The Journal noted that investigators have sent letters to drugmakers identifying four types of possible violations of the Foreign Corrupt Practices Act, including bribing government-employed physicians to purchase drugs; paying company sales agents commissions that are passed along to government physicians; paying hospital committees to approve drug purchases; and paying regulators to obtain drug approvals.
Justice department officials also noted that the probe, which focuses on business conducted in Brazil, China, Germany, Italy, Poland, Russia and Saudi Arabia, could also include bribes made to government officials in the form of payment for travel, meals, entertainment or speaking fees.
In recent months, pharmaceutical companies, including AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline and Merck & Co., have disclosed that they are part of the probe. In addition, Eli Lilly and SciClone Pharmaceuticals confirmed that they have been subpoenaed in relation to marketing practices in Poland and China, respectively, and Baxter also confirmed that it is being investigated.
The Journal noted that the companies involved are cooperating with the government. However, a lawyer for one drugmaker noted that the industry has been somewhat confused because the recent requests were so broad. "If you don't have any specifics, a lot of this is just guesswork," the lawyer noted, adding that "everyone was running around to get in the door to meet with the government so they can better understand what the issues are."
Reference Articles
Drugmakers probed on global bribery allegations, WSJ reports - (Bloomberg)
Pharmas probed over foreign bribery allegations - (Daily Finance)
Drug firms face bribery probe (free preview) - (The Wall Street Journal)
**Published in "First Word"
05 October 2010
Mylan gets FDA approval for generic Reyataz
Mylan Inc. said Tuesday that it received tentative Food and Drug Administration approval for a generic version of Bristol-Myers Squibb Co.'s HIV drug Reyataz.
Mylan received approval under the President's Emergency Plan for AIDS Relief. The generic drug will be eligible for sales outside the U.S.
Reyataz, or atazanavir sulfate capsules, are used in combination with other medications to control HIV infection.
**Published by "AP"
Mylan received approval under the President's Emergency Plan for AIDS Relief. The generic drug will be eligible for sales outside the U.S.
Reyataz, or atazanavir sulfate capsules, are used in combination with other medications to control HIV infection.
**Published by "AP"
Accera appoints Dr. Thomas Werner president & CEO and announces FDA acceptance of IND application for AC-1204 for mild-to-moderate Alzheimer's disease
Accera, Inc., a medical research and development company delivering breakthrough therapies for serious diseases such as Alzheimer's disease (AD), announced today that Thomas Werner, Ph.D., has been appointed President and CEO. Concurrently with Dr. Werner's appointment, the U.S. Food and Drug Administration (FDA) has accepted Accera's Investigational New Drug (IND) application to conduct a phase 2-3 clinical study in patients with mild-to-moderate AD with its product AC-1204.
Dr. Werner was elected to Accera's board of directors in March 2009. Prior to his election, he was the managing director and senior vice president of GlaxoSmithKline (GSK) in Germany and had served as CEO of the GSK Foundation until early 2009. Dr. Werner was instrumental in the development of successful growth strategies for the German subsidiaries of GSK and Bristol-Myers Squibb. Under his leadership, the ACE inhibitor Captopril became the largest selling pharmaceutical product in Germany, and the asthma drug Viani™ grew to become one of the leading pharmaceutical products in Germany.
Dr. Werner cofounded the Genetic Research Center, a joint venture with the Max Planck Institute for Psychiatry and the Ludwig-Maximilians-University, both in Munich. Dr. Werner earned his Ph.D. in chemistry at the University of Gottingen in Germany.
"We are delighted to appoint Dr. Werner as Accera's president and CEO," said Claude H. Nash, Ph.D., Chairman of Accera's Board of Directors. "As Accera continues expanding its commercialization efforts for Axona® and initiates clinical trials with AC-1204, Dr. Werner's leadership will maximize Accera's development of therapeutic alternatives for Alzheimer's disease."
Based in part on available clinical data associated with Axona/AC-1202, Accera will forego conducting the traditional phase 1 dose-escalation trial of AC-1204 and proceed directly to a phase 2-3 study. Referred to as the ALERT Protocol (AC-1204 Long-Term Efficacy Response Trial), the planned trial will be a six month, double-blind, randomized, placebo-controlled, parallel-group study to investigate the effects of daily administration of AC-1204 in subjects with mild to moderate AD. Approximately 400 study subjects are anticipated to enroll in as many as 30 clinical sites within the U.S. The efficacy of AC-1204 versus placebo will be measured by two primary outcomes: changes from baseline test scores in the Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog) and the Clinician's Interview-Based Impression of Change Plus (CIBIC-plus). These tests have been established as validated measurements of efficacy accepted by FDA for approval of other medications for AD.
Accera has completed four clinical trials with similar compounds in elderly normal volunteers and in patients with memory impairment or mild-to-moderate AD. In these trials, patients with mild-to-moderate AD receiving Axona (AC-1202) for up to 90 days experienced cognitive improvement compared with placebo. These treatment effects were notably significant among patients who were not carriers of the apolipoprotein E4 allele (APOE4), a genetic risk factor associated with a higher probability of developing AD. Approximately 50% of individuals diagnosed with probable AD are estimated to be APOE4 positive. Peer-reviewed results were published in Nutrition & Metabolism in August 2009 in the article entitled "Study of the ketogenic agent AC-1202 in mild to moderate Alzheimer's disease: a randomized, double-blind, placebo-controlled, multicenter trial." Axona (AC-1202) is currently commercially available in the U.S. as a prescription medical food product.
Like Axona, AC-1204 increases production of ketone bodies, which can serve as an alternative fuel for the brain in AD patients suffering from glucose hypometabolism. Numerous studies have shown that an early feature of AD is region-specific declines in cerebral glucose metabolism. One strategy to treat this condition has been to supplement the brain's normal glucose supply with ketone bodies.
"Accera is in a period of significant growth in both the commercialization of Axona and development of clinical trials with AC-1204. I look forward to leading the Company in both efforts," said Dr. Werner. "The IND acceptance for AC-1204 represents a further validation of Accera's methods, research and commitment to advancing novel therapeutic alternatives for Alzheimer's disease. We expect the ALERT study will further demonstrate the long-term benefits of Accera's
Dr. Werner was elected to Accera's board of directors in March 2009. Prior to his election, he was the managing director and senior vice president of GlaxoSmithKline (GSK) in Germany and had served as CEO of the GSK Foundation until early 2009. Dr. Werner was instrumental in the development of successful growth strategies for the German subsidiaries of GSK and Bristol-Myers Squibb. Under his leadership, the ACE inhibitor Captopril became the largest selling pharmaceutical product in Germany, and the asthma drug Viani™ grew to become one of the leading pharmaceutical products in Germany.
Dr. Werner cofounded the Genetic Research Center, a joint venture with the Max Planck Institute for Psychiatry and the Ludwig-Maximilians-University, both in Munich. Dr. Werner earned his Ph.D. in chemistry at the University of Gottingen in Germany.
"We are delighted to appoint Dr. Werner as Accera's president and CEO," said Claude H. Nash, Ph.D., Chairman of Accera's Board of Directors. "As Accera continues expanding its commercialization efforts for Axona® and initiates clinical trials with AC-1204, Dr. Werner's leadership will maximize Accera's development of therapeutic alternatives for Alzheimer's disease."
Based in part on available clinical data associated with Axona/AC-1202, Accera will forego conducting the traditional phase 1 dose-escalation trial of AC-1204 and proceed directly to a phase 2-3 study. Referred to as the ALERT Protocol (AC-1204 Long-Term Efficacy Response Trial), the planned trial will be a six month, double-blind, randomized, placebo-controlled, parallel-group study to investigate the effects of daily administration of AC-1204 in subjects with mild to moderate AD. Approximately 400 study subjects are anticipated to enroll in as many as 30 clinical sites within the U.S. The efficacy of AC-1204 versus placebo will be measured by two primary outcomes: changes from baseline test scores in the Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog) and the Clinician's Interview-Based Impression of Change Plus (CIBIC-plus). These tests have been established as validated measurements of efficacy accepted by FDA for approval of other medications for AD.
Accera has completed four clinical trials with similar compounds in elderly normal volunteers and in patients with memory impairment or mild-to-moderate AD. In these trials, patients with mild-to-moderate AD receiving Axona (AC-1202) for up to 90 days experienced cognitive improvement compared with placebo. These treatment effects were notably significant among patients who were not carriers of the apolipoprotein E4 allele (APOE4), a genetic risk factor associated with a higher probability of developing AD. Approximately 50% of individuals diagnosed with probable AD are estimated to be APOE4 positive. Peer-reviewed results were published in Nutrition & Metabolism in August 2009 in the article entitled "Study of the ketogenic agent AC-1202 in mild to moderate Alzheimer's disease: a randomized, double-blind, placebo-controlled, multicenter trial." Axona (AC-1202) is currently commercially available in the U.S. as a prescription medical food product.
Like Axona, AC-1204 increases production of ketone bodies, which can serve as an alternative fuel for the brain in AD patients suffering from glucose hypometabolism. Numerous studies have shown that an early feature of AD is region-specific declines in cerebral glucose metabolism. One strategy to treat this condition has been to supplement the brain's normal glucose supply with ketone bodies.
"Accera is in a period of significant growth in both the commercialization of Axona and development of clinical trials with AC-1204. I look forward to leading the Company in both efforts," said Dr. Werner. "The IND acceptance for AC-1204 represents a further validation of Accera's methods, research and commitment to advancing novel therapeutic alternatives for Alzheimer's disease. We expect the ALERT study will further demonstrate the long-term benefits of Accera's
Sleep Loss Hampers Weight Loss Efforts
If your diet isn't going as well as you had hoped, the problem may not be your food choices or exercise habits. It may be your sleeping habits. Sleep loss may hamper even your best attempts to lose weight, according to new research in the Oct. 5 issue of the Annals of Internal Medicine.
Overweight adults lost 55% less fat when they got 5.5 hours of sleep per night, compared with when they slept for 8.5 hours a night, the new study showed.
"Sleep loss can prevent the loss of fat and make the body stingier when it comes to using fat as a fuel," explains Plamen Penev, MD, PhD, an assistant professor of medicine at the University of Chicago. Instead, the body burns off lean body mass, he says. The weight loss may be the same at the end of the day, but people who get adequate sleep lose more fat than their counterparts who are sleep-deprived.
"The sleep loss slows the loss of fat and speeds the undesirable loss of lean body mass, which doesn't help the body burn energy or calories," he says. "Sleep loss is accompanied by an increase in hunger that makes it less likely that you could adhere to diet."
In general, "losing weight becomes a more difficult fight when you don't get adequate sleep," he tells WebMD.
-Sleep Loss Impedes Dieting Efforts
The new study of 10 overweight adults was conducted in two, two-week intervals. Participants ate a low-calorie diet and were scheduled to sleep for 8.5 hours per night for two weeks and for 5.5 hours per night for two weeks. Researchers measured their weight loss, loss of fat, and fat-free body mass.
During the longer sleep intervention, participants on average got about 7 hours and 25 minutes of sleep per night, while they slept for 5 hours and 14 minutes during the shortened sleep intervention.
Men and women lost 55% less body fat and were hungrier at night during the 5.5-hour-sleep weeks, the study showed.
Participants lost about 6.6 pounds during each two-week intervention. The main difference was in terms of fat loss. During the two weeks where they got adequate sleep, men and women lost 3.1 pounds of fat and 3.3 pounds of fat-free body mass (which was mostly made up of protein). By contrast, men and women lost 1.3 pounds of fat and 5.3 pounds of fat-free mass when they slept for shorter amounts of time, the researchers report.
Participants saw close to a 10-point increase their levels of the appetite hormone ghrelin during the two weeks when their sleep was restricted to 5.5 hours per night. Ghrelin levels rose from 75 nanograms per liter of blood (ng/L) to 84 ng/L, the study showed.
**Published in "Web Med"
Overweight adults lost 55% less fat when they got 5.5 hours of sleep per night, compared with when they slept for 8.5 hours a night, the new study showed.
"Sleep loss can prevent the loss of fat and make the body stingier when it comes to using fat as a fuel," explains Plamen Penev, MD, PhD, an assistant professor of medicine at the University of Chicago. Instead, the body burns off lean body mass, he says. The weight loss may be the same at the end of the day, but people who get adequate sleep lose more fat than their counterparts who are sleep-deprived.
"The sleep loss slows the loss of fat and speeds the undesirable loss of lean body mass, which doesn't help the body burn energy or calories," he says. "Sleep loss is accompanied by an increase in hunger that makes it less likely that you could adhere to diet."
In general, "losing weight becomes a more difficult fight when you don't get adequate sleep," he tells WebMD.
-Sleep Loss Impedes Dieting Efforts
The new study of 10 overweight adults was conducted in two, two-week intervals. Participants ate a low-calorie diet and were scheduled to sleep for 8.5 hours per night for two weeks and for 5.5 hours per night for two weeks. Researchers measured their weight loss, loss of fat, and fat-free body mass.
During the longer sleep intervention, participants on average got about 7 hours and 25 minutes of sleep per night, while they slept for 5 hours and 14 minutes during the shortened sleep intervention.
Men and women lost 55% less body fat and were hungrier at night during the 5.5-hour-sleep weeks, the study showed.
Participants lost about 6.6 pounds during each two-week intervention. The main difference was in terms of fat loss. During the two weeks where they got adequate sleep, men and women lost 3.1 pounds of fat and 3.3 pounds of fat-free body mass (which was mostly made up of protein). By contrast, men and women lost 1.3 pounds of fat and 5.3 pounds of fat-free mass when they slept for shorter amounts of time, the researchers report.
Participants saw close to a 10-point increase their levels of the appetite hormone ghrelin during the two weeks when their sleep was restricted to 5.5 hours per night. Ghrelin levels rose from 75 nanograms per liter of blood (ng/L) to 84 ng/L, the study showed.
**Published in "Web Med"
Shares in Celldex surge following release of positive trial data on CDX-110
Shares of Celldex Therapeutics surged as much as 20 percent Tuesday after the Journal of Clinical Oncology published positive data from clinical trials of the company's experimental cancer vaccine, CDX-110.
Reference Articles
Celldex reports strong clinical results for cancer vaccine - (FOX Business)
Celldex Therapeutics rises on positive data (VIDEO) - (Forbes)
Celldex rallies on cancer drug data - (MarketWatch)
Celldex Therapeutics soars on data - (TheStreet.com)
Celldex surges on brain cancer drug study data - (Yahoo!Finance)
**Published in "First Word"
Reference Articles
Celldex reports strong clinical results for cancer vaccine - (FOX Business)
Celldex Therapeutics rises on positive data (VIDEO) - (Forbes)
Celldex rallies on cancer drug data - (MarketWatch)
Celldex Therapeutics soars on data - (TheStreet.com)
Celldex surges on brain cancer drug study data - (Yahoo!Finance)
**Published in "First Word"
2 granadinas entre los ganadores de los premios de “Inspirados por la Diabetes” 2010
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Lilly da a conocer los ganadores españoles del III Certamen Internacional de Expresión Creativa "Inspirados por la diabetes". Entre las más de 100 obras presentadas a concurso, el jurado, compuesto por reconocidas personalidades del mundo del arte y la salud, ha seleccionado las 18 obras finalistas de 2010.
En la categoría de niños, las obras "Diabetes" (Sandra Augusto, Madrid), "Mi hermano tiene diabetes y está feliz" (Inés Puga, Ourense) y "A diabetes tamén ten cousas boas" (Millán Puga, Ourense), han resultado clasificadas en los primeros puestos en los formatos de dibujo y pintura. En la categoría de poema y relato infantil, los ganadores han sido "La luna diabética" (Isabel Arroyo, Granada), "Yo diabético" (Carlos David Hernández, Tenerife) y "Detrás de una desgracia siempre encontramos un regalo" (Ana Isabel Afonso, Tenerife); mientras que en fotografía infantil, Betsabé Marrero (Tenerife) ha resultado la gran galardonada con su composición "El autocontrol es vida".
Por su parte, en la categoría de adultos, los primeros premios en los formatos de dibujo y pintura han recaído sobre las obras "Es posible" (Miguel Flores, Lleida), "Échame una mano" (Aitziber Eraso, Pamplona) y "Contra la diabetes muévete" (Margarita Redondo, Madrid). En los formatos de poema y relato, Mario Zunzarren (Pamplona) recibe el primer galardón con su obra "DIA-B-TT", mientras Victoria Motos (Granada) y María del Espino (Ávila) han resultado finalistas con sus textos "Vuela" y "Gracias", respectivamente. Por último, en fotografía, las obras "Unidos por ti" (Juan Susach, Madrid), "Los inconvenientes de ser tan dulce" (Emma Muñoz, Madrid) y "Excursiones" (Juantxo Remón, Pamplona) han logrado los principales galardones. (Ver tabla adjunta para la relación de premiados)
La sesión de deliberación y fallo del jurado, que tuvo lugar recientemente en Madrid, ha contado con la participación de Eugenio Ramos, pintor e ilustrador autodidacta con varios premios internacionales en su haber y especialista en publicidad médica y general; Ángel Cabrera, presidente de la Federación de Diabéticos Españoles (FEDE); Irene Salgado, representante de la Sociedad Española de Diabetes (SED); Mikel Sierra, vicepresidente de la Asociación Nacional de Informadores de la Salud (ANIS); la Dra. Clotilde Vázquez, Jefa de la Unidad de Nutrición y Dietética del Hospital Ramón y Cajal de Madrid; y la Dra. Elena Gallego, de la Unidad de Endocrinología Pediátrica del Hospital 12 de Octubre de Madrid.
Las obras presentadas a concurso son piezas originales presentadas por particulares de todo el territorio nacional y también las realizadas a través de talleres creativos organizados por las asociaciones de pacientes diabéticos de Ourense, Ferrol, León, Astorga, Tenerife, Navarra, Granada, Galapagar y Alpedrete (éstas últimas en Madrid). Además de las actividades creativas, la mayoría de estos talleres contaron también con la colaboración de educadores en diabetes que han impartido a lo asistentes breves charlas sobre esta patología.
En la categoría de niños, las obras "Diabetes" (Sandra Augusto, Madrid), "Mi hermano tiene diabetes y está feliz" (Inés Puga, Ourense) y "A diabetes tamén ten cousas boas" (Millán Puga, Ourense), han resultado clasificadas en los primeros puestos en los formatos de dibujo y pintura. En la categoría de poema y relato infantil, los ganadores han sido "La luna diabética" (Isabel Arroyo, Granada), "Yo diabético" (Carlos David Hernández, Tenerife) y "Detrás de una desgracia siempre encontramos un regalo" (Ana Isabel Afonso, Tenerife); mientras que en fotografía infantil, Betsabé Marrero (Tenerife) ha resultado la gran galardonada con su composición "El autocontrol es vida".
Por su parte, en la categoría de adultos, los primeros premios en los formatos de dibujo y pintura han recaído sobre las obras "Es posible" (Miguel Flores, Lleida), "Échame una mano" (Aitziber Eraso, Pamplona) y "Contra la diabetes muévete" (Margarita Redondo, Madrid). En los formatos de poema y relato, Mario Zunzarren (Pamplona) recibe el primer galardón con su obra "DIA-B-TT", mientras Victoria Motos (Granada) y María del Espino (Ávila) han resultado finalistas con sus textos "Vuela" y "Gracias", respectivamente. Por último, en fotografía, las obras "Unidos por ti" (Juan Susach, Madrid), "Los inconvenientes de ser tan dulce" (Emma Muñoz, Madrid) y "Excursiones" (Juantxo Remón, Pamplona) han logrado los principales galardones. (Ver tabla adjunta para la relación de premiados)
La sesión de deliberación y fallo del jurado, que tuvo lugar recientemente en Madrid, ha contado con la participación de Eugenio Ramos, pintor e ilustrador autodidacta con varios premios internacionales en su haber y especialista en publicidad médica y general; Ángel Cabrera, presidente de la Federación de Diabéticos Españoles (FEDE); Irene Salgado, representante de la Sociedad Española de Diabetes (SED); Mikel Sierra, vicepresidente de la Asociación Nacional de Informadores de la Salud (ANIS); la Dra. Clotilde Vázquez, Jefa de la Unidad de Nutrición y Dietética del Hospital Ramón y Cajal de Madrid; y la Dra. Elena Gallego, de la Unidad de Endocrinología Pediátrica del Hospital 12 de Octubre de Madrid.
Las obras presentadas a concurso son piezas originales presentadas por particulares de todo el territorio nacional y también las realizadas a través de talleres creativos organizados por las asociaciones de pacientes diabéticos de Ourense, Ferrol, León, Astorga, Tenerife, Navarra, Granada, Galapagar y Alpedrete (éstas últimas en Madrid). Además de las actividades creativas, la mayoría de estos talleres contaron también con la colaboración de educadores en diabetes que han impartido a lo asistentes breves charlas sobre esta patología.
-Entrega de galardones
La Sala de Exposiciones del Museo CosmoCaixa de Alcobendas (Madrid) acogió, desde el día 1 hasta el 3 de octubre, la exposición que recopila las más de 100 obras originales presentadas a la III Edición de "Inspirados por la Diabetes", con el objetivo de concienciar a la sociedad general sobre la influencia de la diabetes. En el marco de esta exposición pública, el día 1 de octubre se llevó a cabo la ceremonia de entrega de galardones a los primeros clasificados.
Este certamen tiene por objeto concienciar a la sociedad sobre una patología cuyas cifras hablan ya de epidemia. En paralelo, al participar en este certamen, los concursantes ayudan a cambiar la vida de más de 1.000 niños y niñas con diabetes en 18 países en vías de desarrollo, ya que, por cada una de las obras presentadas, Lilly dona un dólar al programa de la IDF "Vida para un Niño" (Life for a Child en inglés), encaminado a ofrecer asistencia y medicamentos a niños y jóvenes con diabetes, cuya lucha contra esta enfermedad les supone, a ellos y a sus familiares, un reto de supervivencia.
La Sala de Exposiciones del Museo CosmoCaixa de Alcobendas (Madrid) acogió, desde el día 1 hasta el 3 de octubre, la exposición que recopila las más de 100 obras originales presentadas a la III Edición de "Inspirados por la Diabetes", con el objetivo de concienciar a la sociedad general sobre la influencia de la diabetes. En el marco de esta exposición pública, el día 1 de octubre se llevó a cabo la ceremonia de entrega de galardones a los primeros clasificados.
Este certamen tiene por objeto concienciar a la sociedad sobre una patología cuyas cifras hablan ya de epidemia. En paralelo, al participar en este certamen, los concursantes ayudan a cambiar la vida de más de 1.000 niños y niñas con diabetes en 18 países en vías de desarrollo, ya que, por cada una de las obras presentadas, Lilly dona un dólar al programa de la IDF "Vida para un Niño" (Life for a Child en inglés), encaminado a ofrecer asistencia y medicamentos a niños y jóvenes con diabetes, cuya lucha contra esta enfermedad les supone, a ellos y a sus familiares, un reto de supervivencia.
*Para saber más sobre "Inspirados por la diabetes": www.lillydiabetes.es
*Para saber más sobre "Vida para un niño": www.lifeforachild.org
*Para saber más sobre "Vida para un niño": www.lifeforachild.org
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