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Allen ein friedvolles und fröhliches Weihnachtsfest. Hoffen wir auf gute News im 1. Quartal, damit wir evt. endlich das letzte Tal der Tränen hinter uns lassen.
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Aber immer daran denken: Es gibt im Leben viel wichtigere Dinge wie Geld.
In diesem Sinne
Grüße
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Informationen zu Quintiles
Quintiles Transnational Corp. führt die nächste Generation des
Gesundheitswesens an und bietet eine breite Palette professioneller
Dienstleistungen für die Arzneimittelentwicklung, sowie Finanz- und
Kommerzialisierungspartnerschaften für die Biotechnologie- und
Gesundheitsbranchen. Mit 17.000 Mitarbeitern und Niederlassungen in mehr als
50 Ländern konzentriert sich das Unternehmen auf die Bereitstellung von
kundenorientierten Lösungen, die als Goldstandard der Branche gelten.
Weiterführende Informationen erhalten Sie auf der Webseite des Unternehmens
unter www.quintiles.com.
Quintiles Transnational Corp. führt die nächste Generation des
Gesundheitswesens an und bietet eine breite Palette professioneller
Dienstleistungen für die Arzneimittelentwicklung, sowie Finanz- und
Kommerzialisierungspartnerschaften für die Biotechnologie- und
Gesundheitsbranchen. Mit 17.000 Mitarbeitern und Niederlassungen in mehr als
50 Ländern konzentriert sich das Unternehmen auf die Bereitstellung von
kundenorientierten Lösungen, die als Goldstandard der Branche gelten.
Weiterführende Informationen erhalten Sie auf der Webseite des Unternehmens
unter www.quintiles.com.
04.12.2012 | 22:50
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PR Newswire · Mehr Nachrichten von PR Newswire
Alimera Sciences Signs Agreement With Quintiles for European Commercial Launch of ILUVIEN®
ATLANTA, Dec. 4, 2012 /PRNewswire/ --Alimera Sciences, Inc., (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced it has signed a Master Services Agreement with Quintiles Commercial Europe Ltd. (Quintiles) for the commercial launch of ILUVIEN® in certain European countries. ILUVIEN is Alimera's product for the treatment of chronic diabetic macular edema considered insufficiently responsive to available therapies.
"We believe this strategic collaboration with Quintiles will be pivotal in achieving a successful launch of ILUVIEN in Europe, and at the outset, our initial launch market of Germany," said Dan Myers, president and chief executive officer, Alimera. "Quintiles' broad track-record in the implementation and execution of multi-country, European commercialization projects made the organization an ideal services provider for Alimera in support of the commercial launch of ILUVIEN in Europe."
Services provided by Quintiles under the Master Services Agreement may include marketing, brand management, sales promotion and detailing, market access, regulatory, medical science liaison and communications and advisory services in certain European countries. Under this agreement, Alimera and Quintiles will enter into individual project orders that will specify the services to be provided.
The German Project Order, the first under the Master Services Agreement, was signed November 28, 2012. Under this project order, Quintiles Commercial Germany GmbH will provide services related to recruitment, employment, deployment and administration of the ILUVIEN commercialization team in Germany through December 31, 2015. Alimera and Quintiles expect to sign additional project orders for similar services in the United Kingdom and France. Quintiles began interviewing and hiring personnel in Germany, the United Kingdom and France in September in anticipation of the execution of project orders in all three countries.
"This relationship leverages Quintiles' core commercial talent and strengths. In addition, as the healthcare landscape has become more complex, it is increasingly important to engage with multiple stakeholders across the patient pathway. We have the broad expertise and experience to make this happen," said Chris Pepler, senior vice president, Commercial Solutions at Quintiles. "As Alimera Sciences enters these critical markets, we are excited to partner with them to help drive the success of ILUVIEN in the European ophthalmic market."
About Quintiles
Quintiles is the world's leading provider of biopharmaceutical services. With a network of more than 27,000 professionals working in more than 80 countries, Quintiles has helped develop or commercialize all of the top 50 best selling drugs on the market. With extensive therapeutic, scientific and analytics expertise, Quintiles helps biopharmaceutical and health sciences customers navigate the increasingly complex landscape with more predictability to enable better outcomes.
About ILUVIEN®
ILUVIEN (190 micrograms fluocinolone acetonide intravitreal implant in applicator) is a sustained release intravitreal implant used to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Each ILUVIEN implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc). ILUVIEN is injected in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound. In the FAME Study, the most frequently reported adverse drug reactions included cataract operation, cataract and increased ocular pressure.
In July 2010, Alimera submitted a Marketing Authorization Application (MAA) to seven European countries via the Decentralized Procedure (DCP) with the Medicines and Healthcare products Regulatory Agency of the U.K. (MHRA) serving as the Reference Member State (RMS). The MAA included data from two Phase 3 pivotal clinical trials (collectively known as the FAME Study) for ILUVIEN conducted by Alimera. The trials involved 956 patients in sites across the United States, Canada, Europe and India to assess the efficacy and safety of ILUVIEN for the treatment of DME. At the end of the DCP, a consensus was reached by the RMS and the other six countries that the MAA for ILUVIEN was approvable. To date, five of the seven countries, Austria, the United Kingdom, Portugal, France and Germany have granted national licenses for ILUVIEN. ILUVIEN has not been approved by the United States Food and Drug Administration.
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PR Newswire · Mehr Nachrichten von PR Newswire
Alimera Sciences Signs Agreement With Quintiles for European Commercial Launch of ILUVIEN®
ATLANTA, Dec. 4, 2012 /PRNewswire/ --Alimera Sciences, Inc., (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced it has signed a Master Services Agreement with Quintiles Commercial Europe Ltd. (Quintiles) for the commercial launch of ILUVIEN® in certain European countries. ILUVIEN is Alimera's product for the treatment of chronic diabetic macular edema considered insufficiently responsive to available therapies.
"We believe this strategic collaboration with Quintiles will be pivotal in achieving a successful launch of ILUVIEN in Europe, and at the outset, our initial launch market of Germany," said Dan Myers, president and chief executive officer, Alimera. "Quintiles' broad track-record in the implementation and execution of multi-country, European commercialization projects made the organization an ideal services provider for Alimera in support of the commercial launch of ILUVIEN in Europe."
Services provided by Quintiles under the Master Services Agreement may include marketing, brand management, sales promotion and detailing, market access, regulatory, medical science liaison and communications and advisory services in certain European countries. Under this agreement, Alimera and Quintiles will enter into individual project orders that will specify the services to be provided.
The German Project Order, the first under the Master Services Agreement, was signed November 28, 2012. Under this project order, Quintiles Commercial Germany GmbH will provide services related to recruitment, employment, deployment and administration of the ILUVIEN commercialization team in Germany through December 31, 2015. Alimera and Quintiles expect to sign additional project orders for similar services in the United Kingdom and France. Quintiles began interviewing and hiring personnel in Germany, the United Kingdom and France in September in anticipation of the execution of project orders in all three countries.
"This relationship leverages Quintiles' core commercial talent and strengths. In addition, as the healthcare landscape has become more complex, it is increasingly important to engage with multiple stakeholders across the patient pathway. We have the broad expertise and experience to make this happen," said Chris Pepler, senior vice president, Commercial Solutions at Quintiles. "As Alimera Sciences enters these critical markets, we are excited to partner with them to help drive the success of ILUVIEN in the European ophthalmic market."
About Quintiles
Quintiles is the world's leading provider of biopharmaceutical services. With a network of more than 27,000 professionals working in more than 80 countries, Quintiles has helped develop or commercialize all of the top 50 best selling drugs on the market. With extensive therapeutic, scientific and analytics expertise, Quintiles helps biopharmaceutical and health sciences customers navigate the increasingly complex landscape with more predictability to enable better outcomes.
About ILUVIEN®
ILUVIEN (190 micrograms fluocinolone acetonide intravitreal implant in applicator) is a sustained release intravitreal implant used to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Each ILUVIEN implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc). ILUVIEN is injected in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound. In the FAME Study, the most frequently reported adverse drug reactions included cataract operation, cataract and increased ocular pressure.
In July 2010, Alimera submitted a Marketing Authorization Application (MAA) to seven European countries via the Decentralized Procedure (DCP) with the Medicines and Healthcare products Regulatory Agency of the U.K. (MHRA) serving as the Reference Member State (RMS). The MAA included data from two Phase 3 pivotal clinical trials (collectively known as the FAME Study) for ILUVIEN conducted by Alimera. The trials involved 956 patients in sites across the United States, Canada, Europe and India to assess the efficacy and safety of ILUVIEN for the treatment of DME. At the end of the DCP, a consensus was reached by the RMS and the other six countries that the MAA for ILUVIEN was approvable. To date, five of the seven countries, Austria, the United Kingdom, Portugal, France and Germany have granted national licenses for ILUVIEN. ILUVIEN has not been approved by the United States Food and Drug Administration.
Antwort auf Beitrag Nr.: 43.879.861 von wuenschmirwas am 30.11.12 14:24:05Korrektur aus Alimera Rapport:
Andrew Lotery, Professor of Ophthalmology, University of Southampton, sagte: "Ich freue mich sehr, dass NICE erkannt hat, dass Iluvien klinisch wirksam bei chronischen diabetischen Makulaödems ist. Ich bin zuversichtlich, dass diese Retard-Therapie zur Verfügung steht, um den Tausenden von Menschen Betroffene mit Diabetes im Vereinigten Königreich zu helfen.
Die Internationale Diabetes Federation schätzt, dass mehr als 3 Millionen Menschen leben derzeit mit Diabetes in Großbritannien, fast 200.000 von ihnen nach Alimera Schätzungen leiden mit Verlust der Sehkraft von DME.
"In Anerkennung des laufenden Prozesses mit NICE, haben wir sofort damit begonnen, ein Patient Zugang Schema zu entwickeln, das, wenn das angenommen wird, Iluvien für alle chronischen DME-Patienten im Großbritannien verbessert ansprechen, um die verfügbaren Therapien erfolgreich abzuschliessen ", sagte Dan Myers, Präsident und Chief Executive Officer, Alimera.
Andrew Lotery, Professor of Ophthalmology, University of Southampton, sagte: "Ich freue mich sehr, dass NICE erkannt hat, dass Iluvien klinisch wirksam bei chronischen diabetischen Makulaödems ist. Ich bin zuversichtlich, dass diese Retard-Therapie zur Verfügung steht, um den Tausenden von Menschen Betroffene mit Diabetes im Vereinigten Königreich zu helfen.
Die Internationale Diabetes Federation schätzt, dass mehr als 3 Millionen Menschen leben derzeit mit Diabetes in Großbritannien, fast 200.000 von ihnen nach Alimera Schätzungen leiden mit Verlust der Sehkraft von DME.
"In Anerkennung des laufenden Prozesses mit NICE, haben wir sofort damit begonnen, ein Patient Zugang Schema zu entwickeln, das, wenn das angenommen wird, Iluvien für alle chronischen DME-Patienten im Großbritannien verbessert ansprechen, um die verfügbaren Therapien erfolgreich abzuschliessen ", sagte Dan Myers, Präsident und Chief Executive Officer, Alimera.
Trading Spotlight
Wenn ich das richtig verstehe bleibt Iluvien in UK genehmigt, aber die Behandlung wird von der Kasse nicht bezahlt, da diese der Meinung ist, dass der Preis von Iluvien nicht im Verhältnis zum Nutzen steht.
Nun diese drückebergereien kennen wir ja auch von unseren Kassen.
Wollen nur hoffen, dass die Amis deshalb nicht zu sehr verrückt spielen.
Nun diese drückebergereien kennen wir ja auch von unseren Kassen.
Wollen nur hoffen, dass die Amis deshalb nicht zu sehr verrückt spielen.
U.K. NICE issues final draft guidance on Alimera Sciences’ ILUVIEN
Published on November 30, 2012 at 3:07 AM · No Comments
inShare
Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that the United Kingdom's National Institute for Health and Clinical Excellence (NICE) has issued final draft guidance indicating that ILUVIEN is not recommended for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. While the Appraisal Committee acknowledged the clinical effectiveness of ILUVIEN® in the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies, it noted that cost-effectiveness thresholds for the product have not yet been met.
In response to the final draft guidance, Alimera is now developing a Patient Access Scheme (PAS) to address the Appraisal Committee's cost concerns that pose a barrier to access for people in the United Kingdom with chronic DME who might benefit from ILUVIEN. The goal of the PAS will be to determine the appropriate pricing for ILUVIEN in order to ensure that treatment decisions are based on patient need, rather than cost.
Andrew Lotery, Professor of Ophthalmology, University of Southampton, said, "I am very pleased that NICE has recognized that ILUVIEN is clinically effective for chronic diabetic macular oedema. I am hopeful that this sustained-release therapy will become available to the thousands of people affected with diabetes in the United Kingdom."
http://www.news-medical.net/news/20121130/UK-NICE-issues-fin…
oder hier
http://www.ad-hoc-news.de/alimera-sciences-iluvien-receives-…
Published on November 30, 2012 at 3:07 AM · No Comments
inShare
Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that the United Kingdom's National Institute for Health and Clinical Excellence (NICE) has issued final draft guidance indicating that ILUVIEN is not recommended for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. While the Appraisal Committee acknowledged the clinical effectiveness of ILUVIEN® in the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies, it noted that cost-effectiveness thresholds for the product have not yet been met.
In response to the final draft guidance, Alimera is now developing a Patient Access Scheme (PAS) to address the Appraisal Committee's cost concerns that pose a barrier to access for people in the United Kingdom with chronic DME who might benefit from ILUVIEN. The goal of the PAS will be to determine the appropriate pricing for ILUVIEN in order to ensure that treatment decisions are based on patient need, rather than cost.
Andrew Lotery, Professor of Ophthalmology, University of Southampton, said, "I am very pleased that NICE has recognized that ILUVIEN is clinically effective for chronic diabetic macular oedema. I am hopeful that this sustained-release therapy will become available to the thousands of people affected with diabetes in the United Kingdom."
http://www.news-medical.net/news/20121130/UK-NICE-issues-fin…
oder hier
http://www.ad-hoc-news.de/alimera-sciences-iluvien-receives-…
Alimera muss 20% an pSivida abliefern und Alimera ist eigentlich für den Verkauf in Europa zuständig.
Die wollen ihre Freunde die Amerikaner noch mit dieser Technologie aus nicht erklärbaren Gründen verschonen und verzögerten (akademisch gesagt) die Lizensierung bei sich zu Hause. Natürlich eine Sauerei aus eigenem Interesse. Hätte diese Alimera Herzblut bei der Bewilligungspflicht eingesetzt, so wäre pSivida schon längst im Himmel angelangt.
Die wollen ihre Freunde die Amerikaner noch mit dieser Technologie aus nicht erklärbaren Gründen verschonen und verzögerten (akademisch gesagt) die Lizensierung bei sich zu Hause. Natürlich eine Sauerei aus eigenem Interesse. Hätte diese Alimera Herzblut bei der Bewilligungspflicht eingesetzt, so wäre pSivida schon längst im Himmel angelangt.
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