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Member Since : Saturday, 31 July 2010
Last Login : Saturday, 31 July 2010
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Gene therapy in a revival
A recent article summarized some of the most advanced gene therapy approaches: “Gene therapy has matured,” said Ronald Crystal, a researcher at Weill Cornell Medical College in New York who helped pioneer the field two decades ago. ‘Now the real challenge is to choose the right targets, which diseases and, from a commercial point of view, which markets make sense.” There are now 189 companies developing gene therapies, an increase from 44 in 19...
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By:
Jani K. Raty
On Tuesday, 04 May 2010
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ARK fails to get MAA for Cerepro
Today Ark released the negative opinion of EMEA for it's crucial Cerepro- drug. "The main underlying objection from the regulator which had not been resolved concerns specifically whether or not patients treated with Cerepro® might for some reason, have been left longer by surgeons prior to re-intervention than those who did not receive Cerepro®. As time to re-intervention is the main efficacy measure in the primary endpoint, the assessors determined that they could not recommend ap...
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By:
Jani K. Raty
On Friday, 18 December 2009
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Targeted Genetics buys more time - Genzyme gets IP
Targeted Genetics Corporation (NASDAQ: TGEN) today announced the sale to Genzyme Corporation of certain assets, including manufacturing technologies and other adeno-associated viral (AAV) vector technology, for up to $7 million in cash. The purchased assets consist primarily of patents, know-how and manufacturing-related equipment. Genzyme also received a license to use certain technology and materials necessary for manufacturing AAV ve...
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By:
Jani K. Raty
On Tuesday, 15 September 2009
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Ark turns to CMO
Ark Therapeutics is using its expertise and spare capacity to move into the contract manufacturing sector and is hoping to sign deals to produce the DNA-based medicine. Innovator companies are increasingly offering contract services or manufacturing to provide an additional source of revenue, make potentially important contacts in the industry and help develop in-house knowledge and expertise. Ark h...
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By:
Jani K. Raty
On Tuesday, 01 September 2009
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Ark Therapeutics gets approval for named patients use in Finland
Ark Therapeutics, an Anglo-Finnish company announced that its was granted a permission to supply it's gene therapy drug Cerepro to named patients in Finland. Previously the company had obtained a similar approval for named patients in France after a submission by a local neurosurgeon. Ark is expected to receive MAA decision from EMEA later this year and possibly become a first company to market gene therapy drugs in EU: ...
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By:
Jani K. Raty
On Sunday, 17 May 2009
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Gendicine approval in India delayed?
As contrary to previous expectations, Gendicine's approval in India has not yet happened. "HUBEI PROVINCE, China -- Benda Pharmaceutical, Inc. ("Benda" or the "Company") (OTCBB: BPMA), a China-based pharmaceutical company producing traditional Chinese and conventional medicines, as well as Gendicine([R]), the world's first commercialized gene therapy medicine for the treatment of cancer, announced today that Gendicine([R]) has passed major milestones in its cli...
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By:
Jani K. Raty
On Wednesday, 18 March 2009
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