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发帖数: 1511 | 1 FDA Committee Votes to Reject AstraZeneca RSV Drug: Biotech's Latest Mishaps
The U.S. Food and Drug Administration's Antiviral Drugs Advisory Committee
has recommended that the agency reject MedImmune’s application to begin
marketing motavizumab, a monoclonal antibody for the prevention of serious
respiratory syncytial virus disease in high-risk infants. The committee's
recommendation, which was made with a 14 to 3 vote, calls for additional
clinical trials of motavizumab. The recommendation will be considered by FDA
reviewers in their evaluation of the Biologics License Application for the
antibody. “We continue to believe motavizumab offers a meaningful clinical
benefit to patients at high risk for a very common and serious illness,"
says Genevieve Losonsky, vice president, clinical development, infectious
disease at MedImmune, the worldwide biologic unit for AstraZeneca (AZN).
The U. S. Food and Drug Administration informed AstraZeneca that it would
not approve the company’s new drug application for Axanum (aspirin/
esomeprazole magnesium) tablets. The company said it also received a letter
from the agency informing it that it would not approve its supplemental new
drug application Nexium (esomeprazole magnesium). AstraZeneca is currently
evaluating the letters from the FDA and said it will continue discussions
with the agency to determine next steps with respect to both applications
and respond to the agency’s request for additional information. AstraZeneca
submitted both applications to the FDA on April 30, 2009, seeking approval
for Axanum, for the risk reduction of low dose ASA-associated gastric and/or
duodenal ulcers in patients at risk. The Nexium applications was submitted
for the risk reduction of low-dose aspirin-associated peptic ulcers.
The U.S. Food and Drug Administration warned healthcare professionals not to
use the intravenous medications, metronidazole, ciprofloxacin and
ondansetron manufactured by Claris Lifesciences due to contamination. These
products were all manufactured on the same manufacturing line and sold under
the Claris, Sagent Pharmaceuticals, Pfizer (PFE), and West-Ward
Pharmaceuticals labels, the agency said. The FDA received reports of
floating matter in intravenous bags of metronidazole and ondansetron. The
FDA instructed healthcare professionals not to use the products and to
immediately remove them from their pharmacy inventories. Claris is
initiating a recall of all lots of these products. The FDA said it is
investigating the situation.
Marshall Edwards (MSHL) said that a final analysis of its late-stage trial
of orally administered phenoxodiol in women with recurrent ovarian cancer
determined that the trial failed to show a statistically significant
improvement in its primary endpoint of progression-free survival, or its
secondary endpoint of overall survival. The company previously announced
that the trial was closed for recruitment before completion of enrolment
with only 142 out of a planned 340 patients enrolled. "Owing to the fact
that this trial was significantly underpowered due to the small number of
patients enrolled, we were disappointed, but not entirely surprised by the
final outcome," says Daniel Gold, newly appointed Chief Executive Officer of
Marshall Edwards. "However, we remain confident that our investigational
isoflavone platform, including triphendiol, a potentially more potent,
second-generation analogue of phenoxodiol, may be of benefit to women with
ovarian cancer, particularly when administered intravenously.” The company
said phnoxodiol had a good safety profile and was well tolerated.
Ranbaxy Limited (RBXLF.PK) is recalling all unused stock of its generic
gabapentin epilepsy drug because the patient information leaflet has not
been updated to include safety warnings initiated by the European Medicines
Agency, the United Kingdom’s Medicines and Healthcare products Regulatory
Agency said. The missing text included a warning that some users of anti-
epiletpics such as Gabapentin have had thoughts of harming or killing
themselves. Pharmacists are being told to quarantine all remaining stock of
the above batch and return it to the wholesaler from which it was purchased. | y***q
发帖数: 4147 | | M*****g
发帖数: 3145 | 3 如果要飞刀，希望一开盘就飞刀。。。别磨磨唧唧。。。碎刀片割。。。 | e*n
发帖数: 1511 | 4 一般盘前就飞刀了
【在 M*****g 的大作中提到】
: 如果要飞刀，希望一开盘就飞刀。。。别磨磨唧唧。。。碎刀片割。。。
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