Navigation Links
Bionovo Receives Positive Guidance from FDA on Menerba®
Date:8/30/2010

EMERYVILLE, Calif., Aug. 30 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq: BNVI, BNVID) announced today that it has received positive guidance from the U.S. Food and Drug Administration (FDA) regarding the Company's Chemistry, Manufacturing and Controls (CMC) plan for its lead drug candidate Menerba®. The FDA indicated its agreement with Bionovo's plan. This agreement provides the necessary groundwork for the Company to progress to pivotal phase 3 clinical testing.

Menerba is a botanically derived drug candidate designed for the safe and effective treatment of vasomotor symptoms (hot flashes) associated with menopause.  It is estimated that there are 40 million women in the U.S. and 37 million in Europe suffering from symptoms associated with menopause. The only FDA approved drugs for this indication are hormone replacement therapies with known serious side effects, including breast cancer. Menerba's Phase 2 clinical trial indicated it is well tolerated with no serious side effects and statistically superior to placebo in reducing the number of hot flashes in menopausal women.

With the FDA's agreement regarding the Company's CMC plan, Bionovo is now in final discussions with the FDA to complete the design of the Phase 3 pivotal trial in the U.S. Upon finalization, the Company expects to quickly commence enrollment.

"We are extremely pleased with the outcome of these meetings. We recognize the care and prudence that the FDA must take in considering our drug which may be used by millions of women," said Dr. Isaac Cohen, Bionovo's Chairman and Chief Executive Officer. "The outcome of these discussions with the FDA constitutes a breakthrough in the history of botanical drug development."

Dr. Cohen continued, "The FDA accepted our combined innovative analytical approaches to the drug's characterization and consistency as well as the process change from the Phase 2 material. As with all drugs proposing manufacturing process chang
'/>"/>

SOURCE Bionovo, Inc.
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related medicine technology :

1. Bionovo Announces Reverse Stock Split
2. Bionovo Announces Publication Describing Menerbas Effect on Neural Pathways Related to Temperature Regulation
3. Bionovo to Advance Menerba to Phase 3 Clinical Testing in Europe
4. Bionovo, Inc. to Announce Second Quarter Fiscal Year 2010 Financial Results on Wednesday, August 4, 2010
5. Bionovo Announces a $15 Million At-The-Market Firm Commitment Financing Agreement
6. Bionovo Announces 2009 Highlights and Year-End Financial Results
7. Bionovo, Inc. to Announce Fourth Quarter and Fiscal Year 2009 Financial Results on Monday, March 15, 2010
8. Bionovo Announces Publication of Positive Results From the Phase 1B Clinical Trial of Bezielle (BZL101) for Metastatic Breast Cancer
9. Bionovo Announces Third Quarter 2009 Highlights and Financial Results
10. Bionovo, Inc. to Announce Third Quarter Fiscal Year 2009 Financial Results on Thursday, November 5, 2009
11. Bionovo Announces Publication of Data on Potential Increase in Breast Cancer Risk Due to the Inhibitory Effect of Tamoxifen Treatment on Estrogen Receptor Beta
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/19/2013)... June 19, 2013   BioCision , a ... and handling in many areas of medical and ... patents by the U.S. Patent Office that apply ... to standardize sample handling to ensure the consistency ... common laboratory procedures. Patent number ...
(Date:6/19/2013)... MUMBAI, India , June 19, ... Book Bureau has recently added DrugPatentWatch ... Databases. ( http://www.bharatbook.com/drugpatentwatch-tour.pdf ) ... DrugPatentWatch provides comprehensive information on pharmaceutical, ... value-added information supports the critical business ...
(Date:6/19/2013)... Amerivet Solutions, LLC ( AMERIVET ), ... government from Federal to Municipal, is pleased to ... include complex metal design and fabrication manufacturing. "We ... aluminum parts for the Defense Logistics Agency (DLA) ... service government contracts," states Richard Bergen , ...
Breaking Medicine Technology:BioCision Announces Two New U.S. Patents for Thermo-Conductive Products that Standardize Sample Handling in Laboratory Research 2Drug Patent Watch 2Drug Patent Watch 3Amerivet Solutions Expands to Manufacture Complex Metal Designs 2
(Date:6/20/2013)... Dr. Ramtin Kassir is one of ... and NYC and a top cosmetic surgeon in ... is to provide individualized care for a broad spectrum of ... surgeon is partnering with the new and emerging business consultancy ... its specialized needs. , "We are partnering with Tom and ...
(Date:6/20/2013)... June 20, 2013 Volume based manufacturing ... dramatically reduce the retail pricing of both it's WHEY ... replacement products. , Premier Natural Health’s whey protein ... food sources and are formulated to help maintain healthy ... intake and slow the aging process. , Ideal ...
(Date:6/20/2013)... Sydney, Australia (PRWEB) June 20, 2013 ... , research was presented recently, that can show similarities ... food. This could explain the current global obesity ... be addicted to food just as one can be ... Neuroscience and Applied Cognitive Science at the University of ...
(Date:6/19/2013)... (PRWEB) June 20, 2013 With the ... has put together their winter season Santiago day ... adventure day trips in and around Santiago this season, ... into Chile's Central Andes for backcountry skiing, challenging rock ... those who have always dreamed of skiing in ...
(Date:6/19/2013)... York, NY (PRWEB) June 19, 2013 The ... American bands in the country and folk music genre. This ... Brown (who is the lead vocals and guitarist), Jimmy De ... Hopkins (the bass guitarist and in vocals), Coy Bowles (guitarist ... de los Reyes (percussionist). The band was formed in ...
Breaking Medicine News(10 mins):Health News:Celebrity Plastic Surgeon Dr. Kassir Teams Up With X Factor Selling Systems to Enhance Patient Experience 2Health News:Premier Natural Health, a Leading Provider of Natural Food Products and Herbal Solutions, Reduces Prices On Its Popular Whey Protein Product 2Health News:Premier Natural Health, a Leading Provider of Natural Food Products and Herbal Solutions, Reduces Prices On Its Popular Whey Protein Product 3Health News:Research Suggests That Unhealthy Food Addiction Could Explain Global Obesity Epidemic 2Health News:Chile Montaña Announces Winter Season Santiago Day Trips 2Health News:Chile Montaña Announces Winter Season Santiago Day Trips 3Health News:Zac Brown Band Tickets for Raleigh, Columbia, Darien Center, Gilford, Minneapolis, Holmdel, Pittsburgh, Camden, Atlanta, Boston, Bethel, Toronto & Hartford Now Available 2
... ISTA,Pharmaceuticals, Inc. (Nasdaq: ISTA ), today announced ... 30, 2008, after the U.S. markets,close. ISTA will host ... results at 4:30 p.m. Eastern Time on April 30., ... Canadian participants may,dial 866-362-5158; international participants may dial 617-597-5397. ...
... Camp-based therapy proved more beneficial than individual grief counseling, ... Children who experience the unexpected death of a parent ... (PTSD), a finding that has major implications for helping ... researchers. , "Often children who have lost a parent ...
... melanomas die at nearly twice the rate of people with ... researchers at the University of North Carolina at Chapel Hill ... the U.S. confirms that survival rates differ depending on where ... die at a rate 1.84 times higher than those with ...
... millimeters in diameter appear more likely to be melanomas ... April issue of Archives of Dermatology, one of the ... currently used by dermatologists to screen for melanoma are ... screen for melanoma, according to background information in the ...
... Howard G. Smith,announces a May 12, 2008, deadline to ... action lawsuit filed on behalf of all persons who,purchased ... the "Company") (Nasdaq: VRTX ) between June 12, ... shareholder lawsuit,is pending in the United States District Court ...
... Decisions on Bottom Line Return at 3rd Annual ... Pharmaceutical Market Research Summit, NEW ... the pharmaceutical analytics company Eularis, will be,delivering a presentation on ... Research and Decisions on Bottom Line Return., ...
Cached Medicine News:Health News:Treating PTSD Helps Kids Deal With Loss 2Health News:Most lethal melanomas are on scalp and neck 2Health News:Larger skin lesions appear more likely to be melanomas 2Health News:Eularis to Address Making the Right Research Decision for ROI 2
... The Air-Stirrup Plus combines the ... an ankle wrap. In addition, a ... each Air-Stirrup Plus and provides information ... components of ankle sprain management.,Each Air-Stirrup ...
Classic black cast boot with unisex styling...
Ideal for use with thinner casting materials such as polyester or fiberglass. Conforms to any casting material....
... Inc. Rheumatoid Factor (RF) IgM ELISA ... qualitative and semi-quantitative detection of RF ... test system is intended to be ... diagnosis of rheumatoid arthritis. This test ...
Medicine Products: