Viewing stories from January, 2012

Appendix 4C - Quarterly Cashflow Report

Starpharma today released its Appendix 4C - Quarterly Cashflow report for the period ended 31 December 2011.

Australian Financial Review: Starpharma's VivaGel step closer to market

Australian Financial Review Journalist Carrie LaFrenz reports: Emerging biotech Starpharma Holdings has been given the tick of approval from the US Federal and Drug Administration on the design of its Phase 3 clinical studies for its key VivaGel product, taking it one step closer to market.

Starpharma has a number of promising technologies and has caught the attention of some large investors. UK-based M&G Investments took a 6.7 per cent stake following the successful $32 million placement in November.

Australian Life Scientist: Starpharma to advance with phase III studies for VivaGel

Australian Life Scientist Journalist Tim Dean notes the significance of Starpharma's written agreement from the FDA on the design of its Phase 3 clinical studies of VivaGel® under the FDA’s Special Protocol Assessment (SPA) scheme: Starpharma has kicked off the year with a tick from the US Food and Drug Administration for its study design for phase III trials of VivaGel under the FDA’s Special Protocol Assessment scheme.

Finance News Network: Starpharma gets binding agreement for VivaGel

Rebecca Richardson of Finance News Network presents on Starpharma's written agreement from the FDA on the design of its Phase 3 clinical studies of VivaGel® for the treatment of bacterial vaginosis (BV) under the FDA’s Special Protocol Assessment (SPA) scheme.

 

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SPL receives FDA Special Protocol Assessment for BV Phase 3

Starpharma today announced that it has received final written agreement from the FDA on the design of its Phase 3 clinical studies of VivaGel® for the treatment of bacterial vaginosis (BV) under the FDA’s Special Protocol Assessment (SPA) scheme.

The SPA is a binding declaration from the FDA that the Phase 3 clinical study design, endpoints, statistical analyses, and other aspects of the planned studies are acceptable to support regulatory approval of the product.

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