Showing posts with label Advisers. Show all posts
Showing posts with label Advisers. Show all posts

Sunday, June 23, 2013

BRIEF-FDA advisers find Titan's Probuphine useful, express concerns on REMS plan

March 21 (Reuters) - Titan Pharmaceuticals Inc :

* FDA advisers vote 10-5 to agree clinical study data on Titan'S Probuphine

give substantial proof of its effectiveness to treat opioid dependance

* FDA advisers vote 12 yes, 2 no, 1 abstain on whether Titan adequately

characterized safety profile of Probuphine in the intended patient population

* FDA advisers vote 5 yes, 4 no, 6 abstain on whether rems proposed by Titan

are adequte to address risks of potential complications of Probuphine use

* FDA advisers vote 10 yes, 4 no, 1 abstain on whether efficacy, safety and

risk-benefit profile of Titan'S Probuphine support drug's approval

* Further company coverage ((Bangalore Newsroom; +1 646 223 8780))


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Friday, May 10, 2013

UPDATE 1-FDA advisers vote to reject approval of Depomed's menopause drug

(Updates with details) March 4 (Reuters) - Advisers to the U.S. Food and Drug Administration on Monday recommended the agency reject a drug made by Depomed Inc to reduce the frequency and severity of hot flashes associated with menopause. The panel of advisers voted 13-1 that company failed to prove convincingly that the drug worked. They voted 12-2 that its efficacy, when balanced against risk, did not warrant approval. The drug, Sefelsa, is a long-acting version of the epilepsy drug gabapentin. A short-acting version of gabapentin made by Pfizer Inc and marketed as Neurontin was approved in 1993. Clinical trials of Depomed's drug showed it only partially reduced the frequency and severity of hot flashes while side effects included dizziness, sleepiness, headache and nausea. Gabapentin has also been shown to increase the risk of suicide. The FDA does not have to follow the recommendations of its advisory panels but it generally does. Sefelsa is one of two drugs designed to reduce hot flashes being considered on Monday. The second is a drug from a unit of Hisamitsu Pharmaceutical Co Inc that comprises a low dose version of the antidepressant paroxetine. Depomed's drug was approved in the United States in 2011 to treat shingles-related pain and is marketed under the brand Gralise. Depomed's shares were halted pending the panel's vote at $6.52 on Nasdaq.

(Reporting By Toni Clarke; Editing by Gerald E. McCormick and Sofina Mirza-Reid)


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FDA advisers vote against approval for Depomed's menopause drug

March 4 (Reuters) - Advisers to the U.S. Food and Drug Administration on Monday recommended the agency reject a drug made by Depomed Inc to reduce the frequency and severity of hot flashes associated with menopause.

The panel of advisers voted 12-2 against the drug, Sefelsa, which is a long-acting version of the epilepsy drug gabapentin. The panel concluded that the drug's modest efficacy did not outweigh the side effects.

(Reporting By Toni Clarke; Editing by Gerald E. McCormick)

((toni.clarke@thomsonreuters.com)(617-856-4340)(Reuters

Messaging: toni.clarke.reuters.com@reuters.net))

Keywords: MENOPAUSE DEPOMED/


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Wednesday, December 26, 2012

Bipartisan Group Of Former National Security Advisers Condemn Attacks On Hagel


Four former national security advisers in a letter to the editor in the Washington Post published on Tuesday denounced what New York TImes columnist Tom Friedman described as “disgusting” attacks on former Republican senator Chuck Hagel and praised Hagel’s prior service to the United States.

Responding to a Dec. 21 Post story on Hagel’s potential nomination to be Secretary of Defense, the former national security advisers, James L. Jones (Obama), Brent Scowcroft (Ford, H.W Bush) , Zbigniew Brzezinski (Carter) and Frank Carlucci (Reagan), said they “strongly object…to the attacks on the character of former senator Chuck Hagel,” whom they called “a man of unshakable integrity and wisdom who has served his country in the most distinguished manner in peace and war”:

He is a rare example of a public servant willing to rise above partisan politics to advance the interests of the United States and its friends and allies. Moreover, it is damaging to the quality of our civic discourse for prospective Cabinet nominees to be subjected to such vicious attacks on their character before an official nomination.

This type of behavior will only discourage future prospective nominees from public service when our country badly needs quality leadership in government.

Scowcroft and 10 other retired senior U.S. military officials, including William Fallon and Anthony Zinni, signed a letter last week saying that Hagel would be “a strong leader at the Pentagon” and that he’s “eminently qualified for the job.” That letter came on the heals of one just days prior in which nine former U.S. Ambassadors, including Ryan Crocker, signed a letter praising Hagel’s qualifications for the top Pentagon job.

The high-level support for Hagel comes after the “neocon smear machine” recently began a campaign to tar Hagel as an anti-Semite and anti-Israel and not sufficiently militaristic toward Iran after news reports that he is President Obama’s top choice to succeed Leon Panetta.

Friedman defended Hagel against the backlash in his Times column today. “I think he would make a fine secretary of defense — precisely because some of his views are not ‘mainstream.’”

In its Dec. 21 article on Hagel, the Post quoted Sen. Dick Lugar (R-IN) calling the former Nebraska Republican an “excellent candidate” for Pentagon chief. “Most senators who served with Chuck would be favorable to his nomination,” Lugar said.

The Atlantic’s Robert Wright notes today that Hagel has now drawn wide ranging support from across the ideological spectrum. “[B]y and large this fight is between some neocons (plus a few reliable supporters) and everybody else,” he writes, adding: “So it’s in Obama’s hands. There’s a lot at stake here — not just whether McCarthyite smears will be allowed to succeed, but whether Obama, in the wake of the Susan Rice episode, will now get a reputation as someone who caves whenever he faces resistance.”

(Photo: Brent Scowcroft and Zbigniew Brzezinski – Getty)


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