FDA panels to review bone drug safety - FiercePharma

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FDA panels to review bone drug safety - FiercePharma

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Should women using bone-building bisphosphonate drugs take a holiday from therapy to help avoid long-term side effects? Or should they limit use of the popular meds--such as Merck's ($MRK) Fosamax, Read more...

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Tags: Bone, Osteoporosis Medication, Drug, FDA, Fosamax, Boniva, Safety

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Most Recently Shared on September 6, 2011 at 4:03 pm By:

FiercePharma FiercePharma

FDA panels gear up for bone-drug safety review. Should Fosamax, Boniva, et al, be limited to 5 years? http://t.co/PglkphC $MRK $ROG

7 months ago...

Weight loss pill Qnexa wins panel vote and awaits approval

news-medical.net — “The drug was rejected in a 10-6 vote the first time it came before a Food and Drug Administration (FDA) advisory panel, in 2010, due to safety concerns. However when the medication returned for another review in February, the advisory committee gave it near-unanimous approval (20-2). Because the FDA often follows the advisory panel's advice, Qnexa is likely to get FDA approval, probably by mid-April.View full resource at news-medical.net

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Most Recently Shared on April 5, 2012 at 11:08 pm By:

Diet_News News-Medical.Net Health News

Diet News: Weight loss pill Qnexa wins panel vote and awaits approval: The drug was rejected in a 10-6 vote the ... http://t.co/rGbONdEq

1 week ago...

FDA says Merck's ridaforolimus meets study goal - Yahoo! News Canada

ca.news.yahoo.com — “From Yahoo! News Canada: WASHINGTON (Reuters) - Merck & Co Inc's ridaforolimus tablets met their primary research end-point of reducing by 25 percent the risk of progression or death in patients with metastatic soft tissue or bone sarcoma, U.S. health regulators said on Friday. A staff review document released by the Food and Drug Administration also said the treatment known by the brand name Taltorvic showed no new or unexpected safety signals in clinical research. The drug will come before an View full resource at ca.news.yahoo.com

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Most Recently Shared on March 16, 2012 at 6:23 pm By:

FDA says Merck's ridaforolimus meets study goal - Yahoo! News

news.yahoo.com — “From Yahoo! News: WASHINGTON (Reuters) - Merck & Co Inc's ridaforolimus tablets met their primary research end-point of reducing by 25 percent the risk of progression or death in patients with metastatic soft tissue or bone sarcoma, U.S. health regulators said on Friday. A staff review document released by the Food and Drug Administration also said the treatment known by the brand name Taltorvic showed no new or unexpected safety signals in clinical research. The drug will come before an advisorView full resource at news.yahoo.com

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Most Recently Shared on March 16, 2012 at 2:46 pm By:

HealthTrendster HealthTrendster Health Executive

FDA says Merck's ridaforolimus meets study goal - WASHINGTON (Reuters) - Merck & Co Inc's ridaforolimus tablets met ... http://t.co/olPZGSSo

4 weeks ago...

FDA says Merck's ridaforolimus meets study goal - Yahoo! News

news.yahoo.com — “From Yahoo! News: WASHINGTON (Reuters) - Merck & Co Inc's ridaforolimus tablets met their primary research end-point of reducing by 25 percent the risk of progression or death in patients with metastatic soft tissue or bone sarcoma, U.S. health regulators said on Friday. A staff review document released by the Food and Drug Administration also said the treatment known by the brand name Taltorvic showed no new or unexpected safety signals in clinical research. The drug will come before an advisorView full resource at news.yahoo.com

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Most Recently Shared on March 16, 2012 at 2:45 pm By:

Doctorwisdom2 OrganizedWisdom OW Health

FDA says Merck's ridaforolimus meets study goal: WASHINGTON (Reuters) - Merck & Co Inc's ridaforolimus tablets m... http://t.co/y7DvS2Cd

4 weeks ago...

FDA panel supports continued testing of pain drugs - seattlepi.com

seattlepi.com — “WASHINGTON (AP) — A panel of arthritis experts recommended Monday that the federal government allow continued testing of an experimental class of pain drugs for arthritis, despite links to bone decay and joint failure The Food and Drug Administration's 21-member panel of arthritis experts voted unanimously that research on the nerve-blocking drugs should continue, with certain safety precautions. Drugmakers have touted the drugs, known as nerve growth factor inhibitors, as a potential breakthrouView full resource at seattlepi.com

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Most Recently Shared on March 15, 2012 at 9:22 pm By:

Drugs_Devices Drugs and Devices OW OW Health

FDA panel supports continued testing of pain drugs: FDA panel supports continued testing of pain drugs Associate... http://t.co/hdzk5XlI

1 month ago...

Arthritis Drugs Linked To Bone Decay Should Continue To Be Tested: FDA Panel

huffingtonpost.com — “WASHINGTON — A panel of arthritis experts recommended Monday that the federal government allow continued testing of an experimental class of pain drugs for arthritis, despite links to bone decay and joint failure The Food and Drug Administration's 21-member panel of arthritis experts voted unanimously that research on the nerve-blocking drugs should continue, with certain safety precautions.View full resource at huffingtonpost.com

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Most Recently Shared on March 13, 2012 at 8:37 am By:

DerekDowell Derek Dowell Patient Expert

Arthritis Drugs Linked To Bone Decay Should Continue To Be ... http://t.co/mS64xHvF

1 month ago...

Arthritis Drugs Linked To Bone Decay Should Continue To Be Tested: FDA Panel

huffingtonpost.com — “WASHINGTON — A panel of arthritis experts recommended Monday that the federal government allow continued testing of an experimental class of pain drugs for arthritis, despite links to bone decay and joint failure The Food and Drug Administration's 21-member panel of arthritis experts voted unanimously that research on the nerve-blocking drugs should continue, with certain safety precautions.View full resource at huffingtonpost.com

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Most Recently Shared on March 13, 2012 at 4:55 am By:

Arthritis_OW Arthritis OW OW Health and Active Health Library

Arthritis Drugs Linked To Bone Decay Should Continue To Be Tested: FDA Panel: The Food and Drug Administration's... http://t.co/DebKIEN5

1 month ago...

FDA Panel Supports Continued Testing Of Pain Drugs | ThirdAge

thirdage.com — “  A panel of arthritis experts recommended Monday that the federal government allow continued testing of an experimental class of pain drugs for arthritis, despite links to bone decay and joint failure. The Food and Drug Administration's 21-member panel of arthritis experts voted unanimously that research on the nerve-blocking drugs should continue, with certain safety precautions. Reports of joint failure led the agency to halt studies of the drugs in 2010 before any of the medicationsView full resource at thirdage.com

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Most Recently Shared on March 13, 2012 at 2:04 am By:

thirdagetimes ThirdAge.com Health Site

FDA Panel Supports Continued Testing Of Pain Drugs http://t.co/4Bg00Va6

1 month ago...

Arthritis Drugs Linked To Bone Decay Should Continue To Be Tested: FDA Panel

huffingtonpost.com — “WASHINGTON — A panel of arthritis experts recommended Monday that the federal government allow continued testing of an experimental class of pain drugs for arthritis, despite links to bone decay and joint failure The Food and Drug Administration's 21-member panel of arthritis experts voted unanimously that research on the nerve-blocking drugs should continue, with certain safety precautions.View full resource at huffingtonpost.com

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Most Recently Shared on March 12, 2012 at 10:46 pm By:

DerekDowell Derek Dowell Patient Expert

Arthritis Drugs Linked To Bone Decay Should Continue To Be Tested: FDA Panel http://t.co/vgMzynVE

1 month ago...

UCLA Professor Says Qnexa Has The "Highest Efficacy" for Weight Loss

emaxhealth.com — “After a second review of its effectiveness and safety profile, Qnexa, an anti-obesity drug by Vivus Inc, has gained an FDA panel's approval and may so...View full resource at emaxhealth.com

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Most Recently Shared on February 23, 2012 at 5:05 pm By:

healthycarolina Denise Reynolds RD Dietitian and Nutritionist

UCLA Professor on FDA Panel Says Qnexa Has The "Highest Efficacy" for Weight Loss http://t.co/tCgqYnQr

2 months ago...

UPDATE 2-US FDA staff focus on safety of Forest lung drug | Reuters

reuters.com — “* Drug worked to treat chronic lung disease-FDA staff* Uncertain signals about heart safety with drug* FDA advisory panel to review drug on ThursdayBy Anna YukhananovWASHINGTON, Feb 21 (Reuters) -View full resource at reuters.com

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Most Recently Shared on February 21, 2012 at 2:24 pm By:

FiercePharma FiercePharma Health Site

RT @JohnCFierce: FDA regulators like Forest COPD drug's efficacy, but raise questions on cardio risks for the class. http://t.co/qxyBK25k

2 months ago...

FDA notes concerns about Vivus diet pill safety ahead of panel - FierceBiotech

fiercebiotech.com — “U.S. regulators have cited concerns about the safety of Vivus’ ($VVUS) experimental diet pill Qnexa in review documents as the California drug developer pursues the first FDA approval of a Read more...View full resource at fiercebiotech.com

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Most Recently Shared on February 17, 2012 at 3:52 pm By:

FierceBiotech FierceBiotech Health News

FDA notes concerns about Vivus diet pill safety ahead of panel http://t.co/Z8Nc7jXR $VVUS

2 months ago...

Senators propose relaxing FDA conflict rules | Reuters

reuters.com — “WASHINGTON (Reuters) - A bill that would loosen conflict of interest rules for advisers to the Food and Drug Administration has been proposed by three U.S. senators seeking to speed up review times forView full resource at reuters.com

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Most Recently Shared on October 14, 2011 at 4:54 pm By:

CUsafepatient Safe Patient Project

Bill allowing drug company experts to sit on FDA panels will compromise drug and medical device safety http://t.co/cFOgrwq9 @AnnaHealth

6 months ago...

FDA advisory panel suggests warning for bisphosphonates but does not specify wording

news-medical.net — “Two independent advisory panels to the Food and Drug Administration (FDA) on Friday recommended increasing the cautionary language on the product labels of bone-building drugs taken by more than five million women in the United States. They did not however mention the exact words of the safety warnings and did not recommend limiting use of the drugs to a proposed five years. About 11 percent of women 55 and older take the drugs to prevent bone fractures.View full resource at news-medical.net

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Most Recently Shared on September 12, 2011 at 3:09 pm By:

Osteoporosis_nt News-Medical.Net Health News

Osteoporosis News: FDA advisory panel suggests warning for bisphosphonates but does not specify wording: Two ind... http://t.co/pV4RZTU

7 months ago...

Bisphosphonates - New Labeling Data On Long-term Usage Recommended By FDA Advisory Panel - QualityPoint Technologies

qualitypointtech.net — “Bisphosphonates, medications for the treatment and prevention of osteoporosis and other bone conditions, should have additional data on their labels on treatment duration, an FDA Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee (the Panel) recommended. However, the panel did not go as far as advising that specific time limits be included. Approximately 5 million Americans fill bisphosphonates prescriptions annually, and include such branView full resource at qualitypointtech.net

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Most Recently Shared on September 10, 2011 at 8:45 pm By:

MedicalFeed MedicalFeed Health News Feed

Bisphosphonates - New Labeling Data On Long-term Usage Recommended By FDA Advisory Panel: Bisphosphonates, medicat... http://t.co/07wDoRQ

7 months ago...

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