Targovax er enste Biotec selskap i Norge som har fått Spesial status fra FDA, dette dreier seg om behandling av
Mesothelioma kreft med ONCOS-102. Nye data skal presenteres i februar 2017.

Hva er en Spesial status fra FDA:

Incentives Orphan drugs are desperately needed by patients with rare diseases. The
ODA provides for granting special status, orphan drug designation, to a product to treat a
rare disease or condition upon request of a sponsor. The product to treat the rare disease
or condition must meet certain criteria. Orphan designation qualifies the sponsor of the
product for:
- Seven-year marketing exclusivity to the first sponsor obtaining FDA approval of a
designated drug
- Tax credit equal to 50% of clinical investigation expenses
- Exemption/Waiver of PDUFA application (filing) fees
- Assistance in the drug development process
- Orphan Products Grant funding


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Targovax Drug Gets Special Status as Mesothelioma Treatment
Scientists at the meeting learned that ONCOS-102 has been granted a special status by the U.S. Food and Drug Administration (FDA) and the European Medical Agency (EMA).

This special status recognizes ONCOS-102 as a drug that can be tested for the treatment of mesothelioma.

“[W]e believe [ONCOS-102] has the potential to address a high unmet medical need in a very difficult to treat cancer,” representatives of the company said.

Plans are shaping up to try ONCOS-102 with a group of patients larger than that in the first phase of testing, the company said.

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The company said that ONCOS-102 worked so well for one of the patients taking part in the Phase I study that his mesothelioma tumors shrunk by 47 percent.

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Alt kan leses her:
http://www.mesotheliomaclinic.org/targovax-keeps-working-on-mesothelioma-drug-oncos-102/