PHARMACY

FDA panel to review Qnexa in February 2012

BY Allison Cerra

MOUNTAIN VIEW, Calif. — The Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee is set to review an investigational treatment for obesity.

Biopharmaceutical company Vivus said the panel will review its new drug application for Qnexa on Feb. 22, 2012.

Meanwhile, the FDA will complete its review of the NDA for Qnexa on April 17, 2012. The regulatory agency accepted the NDA in November after Vivus’ resubmission of the NDA in October.


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J.GLADSON says:
May-21-2012 05:15 am

This is indeed a great news. This committee has taken valuable steps in reviewing the treatment for obesity. Inorder to overcome this , a new drug is introduced. Basically obesity is a condition which occurs when excess body fat is accumulated in the body. Regards, James Gladson

a.steveni says:
Apr-30-2012 07:45 am

I think that nowadays lot of people are facing the problem of obesity and hence such type of FDA panels will really be helpful for them. Regards, Arnold Steveni

jack1000 says:
Apr-04-2012 10:47 pm

I would love to see this work for obesity. I hope to see more research done on this and get approved. There is so many people dealing with this and need help.

D.Ringold says:
Feb-17-2012 02:01 am

I has been that Qnexa and the other drugs would provide effective weight-loss without the dangerous side effects such as Fen-phen, Meridia and Alli. But FDA recently warned consumers about Alli's link to severe liver damage. I mean that sounds pretty dangerous. So stay away.

Ned Phan says:
Feb-16-2012 04:19 am

The drug should completely and thoroughly be reviewed and checked before it is introduced in the market..Many people will be waiting for this drug to be launched in the market as so many are facing the problem of obesity.

a.steveni says:
Feb-14-2012 06:02 am

I guess that something great and beneficial is going to happen here in this panel.I would like to recommend this to my friends and also to peolpe who are facing the problem of obesity.

drjone says:
Dec-24-2011 01:35 am

It is really anyones guess as to what will happen here. If this is not prescribed to any woman who could become pregnant, I don't see the problem.

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Bristol-Myers Squibb, Gladstone Institutes to collaborate on Alzheimer’s drug discovery

BY Alaric DeArment

SAN FRANCISCO — Drug maker Bristol-Myers Squibb and the Gladstone Institutes will collaborate to find new ways to treat Alzheimer’s disease, the two said Thursday.

Gladstone’s research will focus on dysfunction of the Tau protein. The protein regulates the internal structure of cells and is thought to also regulate brain cell activity, but in Alzheimer’s patients, it forms abnormal deposits called neurofibrillary tangles, a hallmark pathology of the disease. By identifying ways to reverse Tau dysfunction, Bristol and Gladstone hope to develop new drugs to modify the disease’s course.

"Bristol-Myers Squibb is committed to helping patients address the unmet medical need for effective treatments across the Alzheimer’s disease continuum, from predementia to severe disease, by developing and studying a broad and diversified portfolio of compounds directed at multiple pathologies and different mechanisms," Bristol SVP discovery Francis Cuss said.


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Four Congress members add their voice to Express Scripts-Medco merger opposition

BY Michael Johnsen

ALEXANDRIA, Va. — In the wake of a key Senate subcommittee hearing this month, and on the heels of the collapse of the blockbuster AT&T and T-Mobile merger, four more U.S. lawmakers have joined the growing ranks of consumer groups, members of Congress and employers questioning the proposed mega-merger of pharmacy benefit managers Express Scripts and Medco Health Solutions.
 
In a joint letter to Federal Trade Commission chairman Jon Leibowitz, the entire South Dakota congressional delegation — Sens. Tim Johnson (D) and John Thune (R) and Rep. Kristi Noem (R) — urged that “preserving access to care and consumer choice should not be overlooked.” They pointed to the potential dominance that the company, if combined, would have, particularly in the specialty and mail order pharmacy markets and noted that in South Dakota, “community pharmacists provide vital services to patients and support our local economies.”
 
In a separate letter to Leibowitz, Rep. G.K. Butterfield, D-N.C., noted, “I am concerned that this market dominance could force community pharmacies in my district, and across the country, out of business. In addition, because the consolidated PBM will have the largest piece of a market that is already highly concentrated, there is a possibility that prescription prices would increase. Ultimately this market consolidation and price increase will be disproportionally felt by elderly, poor and rural populations.”
 
Regarding the additional support, the National Community Pharmacists Association Douglas Hoey said, “We greatly appreciate these members of Congress, and all members, who have taken a stand for patients by voicing their doubts about this merger. Concern about this merger is bipartisan, bicameral and widespread. If approved, we fear it would reduce patient choice and access to pharmacy services and ultimately result in higher prescription drug costs.
 
“While CEOs for these companies may talk a good game in their congressional testimony, many of their claims simply do not hold up to scrutiny,” Hoey added. “Their actions speak louder than words and raise serious questions about their commitment to containing costs for plan sponsors and beneficiaries.”
 
With these letters, now 33 members of Congress have directly voiced concerns about the merger.
 
In addition, while the FTC continues to scrutinize the merger, at least 28 state attorneys general have formed a working group to conduct their own review.


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