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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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Gene Therapy Cure for ADA-SCID
A recent article published on the New England Journal of medicine by Aiuti and colleagues reports on the progress of 10 patients that have been treated for ADA-SCID by gene therapy. This is a form of severe co...
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By:
administrator
On Friday, 06 February 2009
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