Neurocrine Biosciences Inc. said Tuesday a potential treatment for major depressive disorder conferred no benefit on patients in a midstage study.
The study on GSK561679 involved 150 patients and was conducted by partner GlaxoSmithKline. It compared the drug candidate with placebo.
Neurocrine said it plans to meet with GlaxoSmithKline in the coming months after full clinical data are available to discuss next steps for the program.
Other ongoing clinical trials on the drug are testing it against post-traumatic stress disorder, anxiety and alcoholism.
Shares of Neurocrine Biosciences fell 79 cents, or 12.6 percent, to $5.46 in after-hours trading after rising 18 cents to close at $6.26 during the regular trading session.
15 September 2010
GlaxoSmithKline gets $21.3M defense contract
GlaxoSmithKline PLC has won a $21.3 million contract to provide medical supplies to the U.S. Army, Navy and Air Force, the Defense Department said Tuesday.
The British company is expected to complete the contract work by Dec. 30, 2011.
The contract was awarded by the Defense Logistics Agency Troop Support in Philadelphia.
Shares of GlaxoSmithKline added 10 cents to $39.87 in aftermarket trading after rising 29 cents to $39.77 during the regular session.
**Published by "AP"
The British company is expected to complete the contract work by Dec. 30, 2011.
The contract was awarded by the Defense Logistics Agency Troop Support in Philadelphia.
Shares of GlaxoSmithKline added 10 cents to $39.87 in aftermarket trading after rising 29 cents to $39.77 during the regular session.
**Published by "AP"
FDA staff question effectiveness of Arena, Eisai's obesity drug lorcaserin
FDA staff said Tuesday that Arena Pharmaceuticals and Eisai's experimental weight loss drug, lorcaserin, met one of the agency's effectiveness standards "by a slim margin," but concerns remain about the drug's safety. Arena shares fell as much as 37 percent on the news.
In documents released ahead of an advisory panel meeting Thursday, Eric Colman, deputy director of the FDA’s Division of Metabolism and Endocrinology Products, noted that lorcaserin did "satisfy the categorical efficacy criterion" of helping at least 35 percent of patients lose at least 5 percent of their weight.
However, the study results "did not satisfy the guidance’s mean efficacy criterion," where the difference in weight loss between patients treated with the drug compared to patients in the placebo group be different by at least 5 percent. In the BLOOM trial, patients treated with the drug lost an average of 5.8 percent of their body weight compared with 2.2 percent body weight loss in the placebo group. The agency noted that a product is considered effective if it meets at least one of the criteria after one year of treatment.
FDA staff also noted that studies of the lorcaserin in rodents demonstrated there was an excess of breast tumours among those dosed at 7 times higher than the proposed clinical dose for humans, but said that no such imbalance in reports of cancer was observed among the more than 7000 patients treated with lorcaserin in late-stage clinical trials. The panel will be asked to vote on whether it thinks the benefits of lorcaserin outweigh the potential risks "when used long-term in a population of overweight and obese individuals."
Commenting on the documents, Hapoalim Securities analyst, Jon Lecroy, said that "knowing the drug doesn’t work that well, I knew the safety concerns would be looked at extremely closely," but said that "the big surprise to us here is the cancer" risk.
Reference Articles
Arena’s diet pill works by a ‘slim margin,’ FDA says - (Bloomberg)
FDA questions safety, effectiveness with diet pill - (MSN Money)
FDA: Arena's weight-loss drug lorcaserin meets one standard (free preview) - (The Wall Street Journal)
Arena tanks on drug safety concerns - (TheStreet.com)
Arena obesity drug was effective by ‘slim margin,’ FDA staff raises rat concern; shares tumble - (Xconomy)
**Published by "First Word"
In documents released ahead of an advisory panel meeting Thursday, Eric Colman, deputy director of the FDA’s Division of Metabolism and Endocrinology Products, noted that lorcaserin did "satisfy the categorical efficacy criterion" of helping at least 35 percent of patients lose at least 5 percent of their weight.
However, the study results "did not satisfy the guidance’s mean efficacy criterion," where the difference in weight loss between patients treated with the drug compared to patients in the placebo group be different by at least 5 percent. In the BLOOM trial, patients treated with the drug lost an average of 5.8 percent of their body weight compared with 2.2 percent body weight loss in the placebo group. The agency noted that a product is considered effective if it meets at least one of the criteria after one year of treatment.
FDA staff also noted that studies of the lorcaserin in rodents demonstrated there was an excess of breast tumours among those dosed at 7 times higher than the proposed clinical dose for humans, but said that no such imbalance in reports of cancer was observed among the more than 7000 patients treated with lorcaserin in late-stage clinical trials. The panel will be asked to vote on whether it thinks the benefits of lorcaserin outweigh the potential risks "when used long-term in a population of overweight and obese individuals."
Commenting on the documents, Hapoalim Securities analyst, Jon Lecroy, said that "knowing the drug doesn’t work that well, I knew the safety concerns would be looked at extremely closely," but said that "the big surprise to us here is the cancer" risk.
Reference Articles
Arena’s diet pill works by a ‘slim margin,’ FDA says - (Bloomberg)
FDA questions safety, effectiveness with diet pill - (MSN Money)
FDA: Arena's weight-loss drug lorcaserin meets one standard (free preview) - (The Wall Street Journal)
Arena tanks on drug safety concerns - (TheStreet.com)
Arena obesity drug was effective by ‘slim margin,’ FDA staff raises rat concern; shares tumble - (Xconomy)
**Published by "First Word"
Genzyme confirms 1,000 job cuts over 15 months
Genzyme Corp (NasdaqGS:GENZ - News) said it expects a broad cost-cutting program that includes laying off 1,000 employees over 15 months will boost profitability and allow it to invest in areas crucial to its business, such as manufacturing.
The Cambridge, Massachusetts-based biotechnology company, which recently rejected an $18.5 billion takeover offer from French drugmaker Sanofi-Aventis (Paris:SASY.PA - News), confirmed the job cuts on Wednesday. They had previously been reported by The Boston Globe.
"Reducing our operating costs will allow us to operate in a more cost-effective way and become more profitable, and it creates capacity for us to invest in critical areas," said Bo Piela, a spokesman for Genzyme.
Piela declined to immediately say how much the company expects to save, or the likely impact on earnings, but he said the job cuts will account for about half of the savings identified by the company as part of a plan announced in May to enhance shareholder value.
The remainder of the cost savings will come through a combination of more efficient procurement of goods and services, as well as reduced expenditures on high-cost items such as travel, Piela said.
Genzyme is working its way through a manufacturing crisis that forced it last year to temporarily close its Boston manufacturing plant. The closure led to a shortage of two key drugs, hurting sales and sending its stock price plummeting.
Genzyme's shares fell from a high of nearly $84 in 2008, before the manufacturing crisis, to a low of $45.39 in May, their lowest since July, 2004. The offer from Sanofi-Aventis of $69 a share has lifted them again. They were trading at $70.27 in early trading on Wednesday.
Piela said the cost savings will allow the company to put more resources into ensuring it maintains top-notch manufacturing facilities and will allow it to focus more on its drugs for rare genetic disorders and its experimental drug to treat multiple sclerosis.
"We have spent the past few months evaluating the company and the plan we are executing on what we said we would deliver," Piela said.
**Published by "Reuters"
The Cambridge, Massachusetts-based biotechnology company, which recently rejected an $18.5 billion takeover offer from French drugmaker Sanofi-Aventis (Paris:SASY.PA - News), confirmed the job cuts on Wednesday. They had previously been reported by The Boston Globe.
"Reducing our operating costs will allow us to operate in a more cost-effective way and become more profitable, and it creates capacity for us to invest in critical areas," said Bo Piela, a spokesman for Genzyme.
Piela declined to immediately say how much the company expects to save, or the likely impact on earnings, but he said the job cuts will account for about half of the savings identified by the company as part of a plan announced in May to enhance shareholder value.
The remainder of the cost savings will come through a combination of more efficient procurement of goods and services, as well as reduced expenditures on high-cost items such as travel, Piela said.
Genzyme is working its way through a manufacturing crisis that forced it last year to temporarily close its Boston manufacturing plant. The closure led to a shortage of two key drugs, hurting sales and sending its stock price plummeting.
Genzyme's shares fell from a high of nearly $84 in 2008, before the manufacturing crisis, to a low of $45.39 in May, their lowest since July, 2004. The offer from Sanofi-Aventis of $69 a share has lifted them again. They were trading at $70.27 in early trading on Wednesday.
Piela said the cost savings will allow the company to put more resources into ensuring it maintains top-notch manufacturing facilities and will allow it to focus more on its drugs for rare genetic disorders and its experimental drug to treat multiple sclerosis.
"We have spent the past few months evaluating the company and the plan we are executing on what we said we would deliver," Piela said.
**Published by "Reuters"
Savient reiterates sale plans following approval of Krystexxa
Savient on Wednesday reiterated its plans to sell the company, just one day after the drugmaker received approval for its Krystexxa gout treatment. Shares in the company rose as much as 26 percent on the approval news.
Reference Articles
Savient’s shares surge after US approves new gout treatment - (Bloomberg)
Savient shares rally as FDA approves gout drug - (FinanzNachrichten)
Savient shares zoom 27% premarket on gout-drug OK - (MarketWatch)
Savient investors expect a sale - (TheStreet.com)
**Published in "First Word"
Reference Articles
Savient’s shares surge after US approves new gout treatment - (Bloomberg)
Savient shares rally as FDA approves gout drug - (FinanzNachrichten)
Savient shares zoom 27% premarket on gout-drug OK - (MarketWatch)
Savient investors expect a sale - (TheStreet.com)
**Published in "First Word"
Nuevas técnicas e implantes, temas estelares del 86 Congreso de la Sociedad Española de Oftalmología
Más de 2.000 oftalmólogos participarán del 22 al 25 de septiembre en el Palacio Municipal de Congresos de Madrid en el 86 Congreso de la Sociedad Española de Oftalmología. En él se tratarán temas como las posibilidades de las córneas artificiales en pacientes con baja visión, las lentes intraoculares, las nuevas técnicas quirúrgicas no invasivas y los fármacos en investigación para lesiones maculares.
Al congreso asisten expertos procedentes de Estados Unidos, Sudamérica, Europa, Norte de África y Oriente Medio, entre otros. Entre los ponentes destacan algunos de los expertos más prestigiosos del mundo en su campo, como los doctores Brian B. Berger, director médico del Retina Research Center, en Austin (Texas); Eduardo Alfonso, catedrático de Oftalmología de la Universidad de Miami, o Norbet Pfeiffer, de la Universidad de Mainz (en Alemania).
Los organizadores del evento, los doctores Carlos Cortés y Juan Murube del Castillo, subrayan, entre los contenidos, “la ponencia oficial sobre patología y cirugía macular, la mesa redonda sobre protocolos en neuro-oftalmología, la comunicación sobre trasplantes del endotelio corneal, y las conferencias de invitados especiales de Argentina, Estados Unidos y Alemania, cuya excepcional capacidad creativa y didáctica nos informará de la vanguardia en queratoplastias y queratoprótesis, glaucoma, retinopatías, y tumores uveales”.
Durante el congreso también tendrán lugar las reuniones de la Sociedad Española de Glaucoma, la Sociedad Española de Estrabología, la Sociedad Ergoftalmológica, del Club de Neuroftalmología y del Grupo de Historia y Humanidades de Oftalmología; así como las Jornadas Nacionales de Oftalmología Pediátrica.
Además del programa oficial, están previstos 28 simposios, 21 comunicaciones de investigación, 37 cursos, 47 comunicaciones libres, 90 casos clínicos comentados y 225 comunicaciones en panel. En ellos se abordarán aspectos tan diversos relacionados con la oftalmología como el deporte, la conducción y la literatura. También habrá una exposición de arte a partir de fotografías del ojo, Oftalmoarte. La industria estará representada en la zona comercial con 47 stands.
"Tu Casa Biotech" llega a Pamplona en el marco de la Feria Internacional de Biotecnología, BioSpain 2010
La Asociación Española de Bioempresas (ASEBIO), con el apoyo de la Fundación Española de Ciencia y Tecnología (FECYT), dependiente del Ministerio de Ciencia e Innovación, y las compañías farmacéuticas Merck S.L. y Merck Sharp & Dohme (MSD), lleva a Pamplona la iniciativa sobre divulgación biotecnológica “Tu Casa Biotech” con ocasión de la celebración de BioSpain 2010.
“Tu Casa Biotech” permitirá al visitante descubrir que la biotecnología ya está presente en nuestra vida cotidiana a través de un entorno doméstico cercano al ciudadano, en el que se mostrarán diferentes aportaciones “invisibles” y otros productos y procesos biotecnológicos visibles, que forman parte de nuestra vida.
Se trata de una exposición en la que el visitante se verá implicado en el descubrimiento de la biotecnología, ya que será espontáneamente transportado a la cocina de su casa y podrá descubrir, mediante un sistema de preguntas y respuestas, dónde está la biotecnología en su vida y qué beneficios aporta a su día a día, en áreas como alimentación, salud, agricultura, medioambiente e industria.
De igual modo, el visitante podrá pasearse por la “Tu Casa Biotech” y descubrir toda una serie de productos y artículos que ilustran la implicación de la Biotecnología en nuestras tareas cotidianas
Simultáneamente, se proyectarán videos divulgativos sobre las aportaciones de la biotecnología a la sociedad actual, se darán charlas informativas por parte de científicos que llevan trabajando años en biotecnología y se realizarán talleres prácticos donde el visitante será el auténtico protagonista, gracias a la colaboración de la compañía VitaAidelos, responsable de la realización de estos talleres con el soporte de la Fundación Genoma España.
“Tu Casa Biotech” tendrá entrada gratuita y permanecerá expuesta en una carpa en la Plaza del Palacio de Baluarte de Pamplona del 24 de septiembre al 3 de octubre.
“Tu Casa Biotech” permitirá al visitante descubrir que la biotecnología ya está presente en nuestra vida cotidiana a través de un entorno doméstico cercano al ciudadano, en el que se mostrarán diferentes aportaciones “invisibles” y otros productos y procesos biotecnológicos visibles, que forman parte de nuestra vida.
Se trata de una exposición en la que el visitante se verá implicado en el descubrimiento de la biotecnología, ya que será espontáneamente transportado a la cocina de su casa y podrá descubrir, mediante un sistema de preguntas y respuestas, dónde está la biotecnología en su vida y qué beneficios aporta a su día a día, en áreas como alimentación, salud, agricultura, medioambiente e industria.
De igual modo, el visitante podrá pasearse por la “Tu Casa Biotech” y descubrir toda una serie de productos y artículos que ilustran la implicación de la Biotecnología en nuestras tareas cotidianas
Simultáneamente, se proyectarán videos divulgativos sobre las aportaciones de la biotecnología a la sociedad actual, se darán charlas informativas por parte de científicos que llevan trabajando años en biotecnología y se realizarán talleres prácticos donde el visitante será el auténtico protagonista, gracias a la colaboración de la compañía VitaAidelos, responsable de la realización de estos talleres con el soporte de la Fundación Genoma España.
“Tu Casa Biotech” tendrá entrada gratuita y permanecerá expuesta en una carpa en la Plaza del Palacio de Baluarte de Pamplona del 24 de septiembre al 3 de octubre.
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