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Antwort auf Beitrag Nr.: 43.437.805 von binda am 30.07.12 15:52:00http://psdv.client.shareholder.com/releasedetail.cfm?Release…
"This is our first commercial agreement for Tethadur, based on BioSilicon, our second key technology platform, following our three approved products utilizing our Durasert ™ technology platform. We are very pleased to be entering into this evaluation agreement with a global leader in the field," said Dr. Paul Ashton, President and CEO of pSivida Corp. "A sustained delivery system for these types of molecules would offer a significant clinical advance in the ophthalmic area where injections of protein based drugs into the eye every one or two months are sometimes required."
pSivida has developed three of the four sustained release devices for retinal diseases that have been approved in either the US or Europe, the most recent being ILUVIEN®, partnered with Alimera and approved in multiple EU countries. Independently, pSivida is developing an injectable, sustained release product to treat uveitis affecting the back of the eye (posterior uveitis) and an injectable, bioerodible product to treat glaucoma and ocular hypertension in collaboration with Pfizer.
"This is our first commercial agreement for Tethadur, based on BioSilicon, our second key technology platform, following our three approved products utilizing our Durasert ™ technology platform. We are very pleased to be entering into this evaluation agreement with a global leader in the field," said Dr. Paul Ashton, President and CEO of pSivida Corp. "A sustained delivery system for these types of molecules would offer a significant clinical advance in the ophthalmic area where injections of protein based drugs into the eye every one or two months are sometimes required."
pSivida has developed three of the four sustained release devices for retinal diseases that have been approved in either the US or Europe, the most recent being ILUVIEN®, partnered with Alimera and approved in multiple EU countries. Independently, pSivida is developing an injectable, sustained release product to treat uveitis affecting the back of the eye (posterior uveitis) and an injectable, bioerodible product to treat glaucoma and ocular hypertension in collaboration with Pfizer.
Zitat von gogo26: http://www.benzinga.com/news/12/07/2786352/psivida-corp-anno…
pSivida Corp. Announces Tech Evaluation Agreement for Tethadur™ Protein/Antibody Delivery System with Leading Biopharmaceutical Company
Allie Wickman, Benzinga Staff Writer July 30, 2012 9:16 AM
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pSivida Corp. (NASDAQ: PSDV) today announced that it has signed a funded technology evaluation agreement with a leading global biopharmaceutical company to evaluate pSivida's Tethadur™ protein/antibody delivery technology in the field of ophthalmology.
Tethadur™ is an application of pSivida's BioSilicon™ technology platform designed to provide sustained delivery of large biologic molecules, including proteins, antibodies and peptides. Tethadur utilizes an injectable, bioerodible, nanostructured, porous BioSilicon material for drug delivery. The sizes of the pores in the BioSilicon material are manufactured using nanotechnology to accommodate specific protein, peptide or antibody molecules that are then released on a sustained basis over time as the material bioerodes.
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(c) 2012 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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Antwort auf Beitrag Nr.: 43.427.316 von gogo26 am 26.07.12 16:10:45Dies ist keine Angelegenheit von Psivida sondern von Alimera. Meines Wissens ist das ganze nicht aus der Welt. Wenn ich nicht falsch liege soll Alimera bezügl. der Nebenwirkungen noch einige Daten beschaffen. Alimera ist mit der FDA noch im Gespräch.
Die direkte Angelegenheit für Psivida sind die 25 Mio. Meilensteinzahlung bei Zulassung FDA.
Die direkte Angelegenheit für Psivida sind die 25 Mio. Meilensteinzahlung bei Zulassung FDA.
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Wie ist denn eigentlich der Stand? Hat psivida die Klamotte nochmal eingereicht oder passiert da nichts mehr?
Antwort auf Beitrag Nr.: 43.427.003 von gogo26 am 26.07.12 15:10:45Weil es korrupte Schweine sind, siehe meine Arena, Dendreon......
Warum hat nur die FDA Mafia nicht genehmigt. Ich ärger mich immer noch!
Our product now has marketing authorization in five of the seven targeted EU countries," said Dr. Paul Ashton
Die restl. 2 kriegen wir auch noch.
Die restl. 2 kriegen wir auch noch.
26.07.2012 | 14:26
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Business Wire · Mehr Nachrichten von Business Wire
pSivida Corp. Announces Germany Grants ILUVIEN® Marketing Authorization for the Treatment of Chronic Diabetic Macular Edema
pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced the Federal Ministry of Health of Germany (Bundesministerium fur Gesundheit, BfArM) has granted marketing authorization to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
This marketing authorization follows the completion of the Decentralized Regulatory Procedure (DCP) in the European Union (EU), in which the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, serving as the Reference Member State (RMS), delivered a positive outcome for ILUVIEN along with six Concerned Members States (CMS), specifically Austria, France, Germany, Italy, Portugal and Spain. The German authorization is the fifth national approval in the EU, preceded by Austria, Portugal, the U.K. and France.
"We are very pleased ILUVIEN has received marketing authorization in Germany. Our product now has marketing authorization in five of the seven targeted EU countries," said Dr. Paul Ashton, president and chief executive officer of pSivida. "We look forward to ILUVIEN's commercial launch in these countries and to it receiving approval in the two remaining CMS countries, Italy and Spain, in the coming months."
The International Diabetes Federation estimates that more than five million people are currently living with diabetes in Germany, and according to estimates of Alimera Sciences, pSivida's licensee of ILUVIEN for the treatment of DME, more than 215,000 people suffer from vision loss associated with DME.
ILUVIEN is an injectable, sustained-release intravitreal insert that releases sub-microgram levels of fluocinolone acetonide (FAc) for up to 36 months for the treatment of chronic DME. pSivida is developing an insert of the same design for the treatment of uveitis affecting the posterior of the eye.
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