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Vical Shifts To Infectious Disease After Allovectin Fails In Melanoma

 
• By Emily Hayes

CEO Vijay Samant defends Vical’s DNA-based technology platform after 20 years of development culminates in Phase III failure. But the platform still shows promise in other therapeutic areas, Vical says as the company absorbs a major blow to stock price.

Vical Inc. is refocusing its R&D direction to infectious disease after its flagship DNA-based vaccine, Allovectin, failed in a Phase III trial in melanoma, the disappointing end of 20 years of research.

Vical has a DNA-based technology platform for vaccines that has been targeted at cancer and infectious disease. The lead candidate was Allovectin (velimogene aliplasmid), an intratumoral, or intralesional, therapeutic cancer vaccine partnered in Asia with Japan’s AnGes MG Inc

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• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
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The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.

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More from R&D

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
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How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 
• By Joseph Haas and Nielsen Hobbs

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.