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Discovery
Labs to meet FDA to review lung drug options 4:45 PM 9/10/2009
Reuters
Discovery Laboratories Inc will meet with the US FDA to review the options
available to gain marketing approval for its lung drug surfaxin as a treatment for respiratory distress syndrome
(RDS) in premature infants.
...
Americans
Urged To Get Seasonal Influenza Vaccine Early 2:11 PM 9/10/2009
Reuters
US public health officials and medical
experts urged Americans to be vigilant and get immunized early for
protection against seasonal influenza.
...
MedImmune
says swine flu vaccine ready end-Sept 2:09 PM 9/10/2009
Reuters
MedImmune has submitted safety data for their inhaled vaccine against the pandemic H1N1
virus to the US FDA.
...
Biogen
downplays virus threat with MS drug Tysabri 1:51 PM 9/10/2009
Reuters
Biogen Idec Inc has not found any correlation between the level of JC
virus in the blood or urine and the likelihood of a patient developing the rare brain infection progressive
multifocal
leukoencephalopathy (PML).
...
Merck
abandons one migraine drug, pursues another 1:49 PM 9/10/2009
Reuters
Merck & Co is abandoning experimental drug MK-3207 to treat acute
migraines because the drug caused elevated liver enzyme levels. Merck continues development of its drug
telcagepant (MK-0974) for the treatment of acute migraines.
...
Zeltia
says FDA seeks more data on cancer drug 12:04 PM 9/10/2009
Reuters
A panel of cancer experts recommended the US FDA not approve the use of
Yondelis for ovarian cancer due to risks of heart and liver toxicity. The US FDA now asks Zeltia for more data.
...
USDA
gives livestock vaccine makers flu seed virus 11:48 AM 9/10/2009
Reuters
The US Agriculture Department is trying to speed the development of a H1N1
flu vaccine for hogs. Master seed viruses are sent to five veterinary vaccine makers.
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Acorda's
MS drug improves walking speed over 2 yrs 10:14 AM 9/10/2009
Reuters
Acorda Therapeutics said a late-stage trial of its experimental multiple
sclerosis treatment Fampridine-SR showed improved walking speed in patients over a two-year period.
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MAP
Pharma: migraine drug helps hard-to-treat groups 9:24 AM 9/10/2009
Reuters
MAP Pharmaceuticals Inc said Levadex combats headache pain in a range of
hard-to-treat patient groups.
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FDA
gives Dynavax OK to resume hepatitis B trials 5:23 AM 9/10/2009
Reuters
Dynavax Technologies Corp presented additional data to the US FDA which gives
the go-ahead to immunize patients with chronic kidney disease who do not respond well to approved medication.
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Privately
owned Evolva takes over biotech Arpida 4:51 AM 9/10/2009
Reuters
Evolva is taking over troubled Arpida which failed to gain regulatory approval for its
lead drug candidate intravenous antibiotic iclaprim.
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FDA
panel backs Glaxo cervical cancer vaccine 1:08 PM 9/9/2009
Reuters
GlaxoSmithKline PLC's proposed cervical cancer Cervarix vaccine is safe
and effective for females ages 10 to 25.
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Affymax
Provides Phase 3 Program Update for Investigational Drug
... 8:59 AM 9/9/2009
Reuters
Affymax Inc
expects to submit an NDA for Hematide in chronic renal failure in 2010. Additional patient follow-up will extend
the time to study completion.
...
ChemGenex
Submits New Drug Application for OMAPRO
... 8:33 AM 9/9/2009
Reuters
ChemGenex
Pharmaceuticals Limited announced completion of its marketing submission to the US FDA for OMAPRO (omacetaxine
mepesuccinate) developed for the treatment of chronic myeloid leukemia (CML) and Bcr-Abl T315I mutation failing
treatment with imatinib.
...
Drug
improves sleep of women with hot flashes 8:23 AM 9/9/2009
Los Angeles Times
A study finds that the drug gabapentin improved sleep quality in women
experiencing hot flashes.
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