FDA GREEN LIGHTS VISIOMED’S FUNHALER
December 3rd 2007 10:30
Link: www.biotechdaily.com.au
Biotech Daily
Friday November 30, 2007
Daily news on ASX-listed biotechnology companies
Friday November 30, 2007
Daily news on ASX-listed biotechnology companies
* ASX UP, BIOTECHS DOWN: CIRCADIAN UP 8%, GENETIC DOWN 9%
* AVEXA’S ATC ‘ACTIVE’ ON INTEGRASE INHIBITOR RESISTANT HIV
* FDA GREEN LIGHTS VISIOMED’S FUNHALER
* SELECT VACCINES GRANTED AUSTRALIAN PATENT
* PROTEOME WITHDRAWS 43% DIRECTORS’ FEE RISE RESOLUTION,
APPOINTS ROGER AMOS CHAIRMAN
* LIVING CELL RECEIVES $6m FROM TAYLOR COLLISON PLACEMENT
* PRIMA’S PHILLIP HAINS RESIGNS
* ABN AMRO BANK, ASSOCIATES TAKES 5.2% OF RESMED
THE MARKET
Thirteen of the Biotech Daily Top 40 stocks were up, 16 stocks fell, eight traded unchanged and three were untraded. Ten of the Top 20 rose with six down while three of the Second 20 were up with 10 stocks falling.
Circadian was best, up 8.5 cents or 7.62 percent to $1.20 on small volumes, followed by Chemgenex up seven cents or seven percent to $1.07.
Genetic Technologies led the falls, down 1.5 cents or 8.82 percent to 15.5 cents on modest volumes, followed by Polartechnics down three cents or 6.52 percent to 43 cents on small volumes.
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VISIOMED
The US Food and Drug Administration has cleared Visiomed’s improved Funhaler paediatric asthma incentive spacer for sale.
Visiomed chief executive officer Dr William Dolphin was jubilant at the news.
“It gives us the green light for sales and marketing in the US,” Dr Dolphin said.
“There are approximately 10 million kids in the US with asthma aged eight years and younger and 50 to 75 percent of them are non-compliant,” Dr Dolphin said.
The Funhaler uses a moving image and whistle sounds as an incentive for children.
Visiomed said the improvements to the Funhaler design evaluated by the FDA included a redesigned incentive module, a redesigned and patent-pending low-flow valve controlling delivery of medication and a number of improved manufacturing processes.
In a media release, Dr Dolphin said the design changes “significantly improve performance and the FDA determined that the implemented changes modify the existing device sufficiently to warrant 510(k) submission”.
“FDA clearance of the improved device was extremely rapid,” Dr Dolphin said.
“We received notification of 510(k) clearance from the FDA less than 60 days following submission.”
Dr Dolphin said Alliance Tech Medical with regional headquarters in California, Texas, Delaware and Illinois would distribute the Funhaler.
Visiomed climbed 0.3 cents or 17.65 percent to two cents with 50.9 million shares traded.
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