Apr 26, 2006
By:Patrick Clinton, Natasha T. Metzler
A federal district court ruled that FDA cannot fail to rule on a
Sandoz's application for approval of omnitrope, a human growth
hormone, just because it has no policy for generic biologics. Court
watchers say the decision may help other generic biologics move
forward in the approvals process.
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Apr 26, 2006
By:Natasha T. Metzler
A new study details the physiological reasons why COX-2
inhibitorsincrease the risk of heart disease. Suppressing the
production of one key fact does reduce pain, but it also deprives
the body of a mechanism to curb blood clots, resist artery
hardening, and regulate blood pressure.
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Apr 12, 2006
By:Natasha T. Metzler
Psychiatrists offer insight on the second phase of results from a National Institutes of Health study comparing different anti-psychotic drugs.
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Apr 12, 2006
By:Natasha T. Metzler
Industry experts weigh in on what could be the resolution of a long saga.
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Apr 12, 2006
By:Natasha T. Metzler
New research shows that travel to and from work is important in spreading influenza from city to city and state to state.
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Mar 29, 2006
By:Natasha T. Metzler
A new study indicates that a protein produced by HIV invades uninfected B cells and inhibits a mechanism that makes certain antibodies very good at targeting invading agents.
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Mar 29, 2006
By:Natasha T. Metzler
Experts say proposed label changes or black box warnings would not significantly decrease ADHD drug prescriptions. But they see potential market opportunities for new products and generics.
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Mar 29, 2006
By:Natasha T. Metzler
The high court could fine-tune the definition of what is patentable in deciding LabCorp v. Metabolite. Legal experts weigh-in on the nuances of the case.
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Mar 15, 2006
By:Natasha T. Metzler
The recommendation shows traditional risk-benefit analysis is still working, experts say. But they also believe the Tysabri saga illustrates a trend towards increased use of advisory committees and requirements for drug mechanism data.
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