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... Read more...

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... Read more...

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... Read more...

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: ... Read more...

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... Read more...

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... Read more...