tivozanib

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Name: tivozanib
First reported 6 hours ago - Updated 6 hours ago - 1 reports

Astellas cans MAA plans for tivozanib

Home » Syndicated Content » Aveo Pharmaceuticals Inc. (NASDAQ:AVEO) disclosed in an SEC filing late Thursday that partner Astellas Pharma Inc. (Tokyo:4503) said it no longer plans to submit an MAA to EMA for tivozanib (AV-951, ASP4130) to treat advanced ... [Published BioPortfolio - 6 hours ago]
First reported 8 hours ago - Updated 8 hours ago - 1 reports

This Week in Biotech

Filed under: Investing With the  SPDR S&P Biotech Index  up 35% over the trailing-12-month period, it's evident that investment dollars are willingly flowing into the biotech sector. Keeping that in mind, let's have a look at some of the rulings, ... [Published EquityJungle - v0.1 - 8 hours ago]
First reported May 24 2013 - Updated May 24 2013 - 4 reports

Company co-founded by M.D. Anderson prez dealt new blow

, the biotech firm co-founded by University of Texas M.D. Anderson Cancer Center President Dr. Ronald DePinho has been informed its financial partner won’t fund future studies of the company?s struggling kidney cancer drug.Aveo Pharmaceuticals, DePinho’s ... [Published Houston Chronicle - May 24 2013]
First reported May 24 2013 - Updated May 24 2013 - 1 reports

Streetinsider.com After-Hours Movers 05/23: (BLOX) (P) (MRVL) Higher; (SHLD) (AVEO) (CRM)

Infoblox (NYSE: BLOX) 16% HIGHER; reported Q3 EPS of $0.11, $0.05 better than the analyst estimate of $0.06. Revenue for the quarter came in at $58 million versus the consensus estimate of $56.06 million. Infoblox sees Q4 2013 EPS of $0.08-0.09, versus ... [Published Street Insider - May 24 2013]
First reported May 24 2013 - Updated May 24 2013 - 1 reports

U.S. Stock Futures Slide, Signaling Third Day of S&P 500 Losses

May 24 (Bloomberg) -- U.S. stock futures fell, indicating the Standard & Poor’s 500 Index will retreat for a third day, as investors awaited a report on durable-goods orders.S&P 500 futures expiring in June dropped 0.3 percent to 1,644.8 at 10:36 a.m. ... [Published La Repubblica - May 24 2013]
First reported May 22 2013 - Updated May 22 2013 - 1 reports

AVEO and Astellas to Present Tivozanib Clinical Data

AVEO Oncology and Astellas Pharma Inc. announced that additional data from the Phase 3 TIVO-1 trial (TIvozanib Versus sOrafenib in 1st line advanced RCC) of investigational agent tivozanib in patients with advanced renal cell carcinoma (RCC) will be ... [Published News from Kidney Cancer Association - May 22 2013]
First reported May 21 2013 - Updated May 21 2013 - 1 reports

Todd M. Garber Announces Investigation of AVEO Pharmaceuticals

Specifically, the investigation concerns whether the Company misrepresented or failed to disclose that: (1) the FDA had recommended that the Company conduct an additional Phase III trial due to adverse trends in the Company's first Phase III trial; (2) ... [Published News from Kidney Cancer Association - May 21 2013]
First reported May 21 2013 - Updated May 21 2013 - 1 reports

AVEO and Astellas to Present Tivozanib Clinical Data at 2013 American Society of Clinical Oncology Annual Meeting

AVEO Oncology and Astellas Pharma Inc. announced that additional data from the Phase 3 TIVO-1 trial (TIvozanib Versus sOrafenib in 1st line advanced RCC) of investigational agent tivozanib in patients with advanced renal cell carcinoma (RCC) will be presented ... [Published Individual.com - May 21 2013]
First reported May 02 2013 - Updated May 03 2013 - 20 reports

FDA Panel Votes 'No' on Tivozanib for Renal Cancer

The US Food and Drug Administrations Oncologic Drugs Advisory Committee (ODAC) has voted 13 to 1 against tivozanib after reviewing AVEO's new drug application (NDA) for the treatment of metastatic renal cell carcinoma (RCC). The committee voted that the ... [Published Cancernetwork.com - May 03 2013]
First reported May 02 2013 - Updated May 03 2013 - 9 reports

Delcath Confirms FDA Panel Voted 16-0 Against Melblez Kit; A. . .

Delcath Confirms FDA Panel Voted 16-0 Against Melblez Kit; AVEO, Astellas Confirm Unfavorable Vote by FDA on TivozanibStaff and Wire ReportsBioMed ReportsBelow is a look at some of the headlines for companies that made news in the healthcare sector on ... [Published Equities.com - May 03 2013]
First reported Apr 30 2013 - Updated May 01 2013 - 8 reports

AVEO Drops on Possibility of Second Phase III Trial

Shares of AVEO Oncology Inc. plummeted to historic lows Tuesday with the realization that the company may have to conduct a second Phase III trial before the FDA considers approving tivozanib to treat advanced renal cell carcinoma (RCC).In its heaviest ... [Published Pharmacy Choice - May 01 2013]
First reported Apr 29 2013 - Updated Apr 30 2013 - 7 reports

UPDATE 2-U.S. FDA staff question whether Aveo drug needs new trial

* Question to experts sends Aveo shares down as much as 26.7pct* Analysts provide mixed interpretations of FDA reviewBy Toni ClarkeApril 30 (Reuters) - Staff reviewers for the U.S. Food andDrug Administration have asked a panel of outside medicalexperts ... [Published Reuters - Apr 30 2013]

Quotes

"We believe this signals the end for tivozanib," Klein said. "We forecast a significant cost cutting effort will occur in the near future as management attempts to conserve cash, which will likely include a meaningful headcount reduction."
In the SEC filing, Aveo said that the company "is currently evaluating the effect of Astellas' decision on the clinical and regulatory path forward for tivozanib in RCC." Astellas is also partnered with Aveo on colorectal and breast cancer and Butt told Reuters that that part of the agreement looks like it will survive...
...By tracking the size and price of each montha'a "s short transactions, BUYINS.NET provides institutions, traders, analysts, journalists and individual investors the exact price point where short sellers start losing money."
Moreover, on May 2, 2013, the ODAC voted by an overwhelming majority (13 to 1) not to recommend approval of Tivopath, because "the application ... did not demonstrate a favorable benefit-to-risk evaluation for the treatment of advanced renal cell carcinoma (RCC) in an adequate and well-controlled trial." As a result, Aveo shares declined a further $2.61 per share or nearly 50%, to close at $2.65 on May 2, 2013

More Content

All (205) | News (143) | Reports (17) | Blogs (23) | Audio/Video (0) | Fact Sheets (0) | Press Releases (22)
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Astellas cans MAA plans for tivozanib [Published BioPortfolio - 6 hours ago]
This Week in Biotech [Published EquityJungle - v0.1 - 8 hours ago]
Healthcare Review: VIVUS, ZIOPHARM Oncology, In... [Published BioMedReports - May 25 2013]
Company co-founded by M.D. Anderson prez dealt ... [Published Houston Chronicle - May 24 2013]
Aveo slumps as Astellas pares cancer drug support [Published CNBC - May 24 2013]
Aveo shares shellacked after Astellas drops EU ... [Published FierceBiotech - May 24 2013]
Astellas Tells Aveo to Go It Alone in Kidney Ca... [Published Xconomy - May 24 2013]
U.S. HOT STOCK FUTURES: HOT STOCKS TO WATCH [Published Nasdaq - May 24 2013]
U.S. Stock Futures Slide, Signaling Third Day o... [Published La Repubblica - May 24 2013]
Streetinsider.com After-Hours Movers 05/23: (BL... [Published Street Insider - May 24 2013]
Aveo says partner Astellas will not seek EU nod... [Published Reuters - May 23 2013]
AVEO and Astellas to Present Tivozanib Clinical... [Published News from Kidney Cancer Association - May 22 2013]
2013 FDA Drug Approval Calendar [Published Oncology Business Review - May 21 2013]
Todd M. Garber Announces Investigation of AVEO ... [Published News from Kidney Cancer Association - May 21 2013]
AVEO and Astellas to Present Tivozanib Clinical... [Published Individual.com - May 21 2013]
Global Pharmaceutical & Biotechnology Outlook 2... [Published TransWorldNews - May 20 2013]
NVGN, AVEO, QQEW, Removed From Naked Short List... [Published Individual.com - May 20 2013]
Law Offices of Todd M. Garber Announces Investi... [Published Business Wire - May 20 2013]
Aveo Pharmaceuticals, Inc. Sued by Investor [Published Zecco - May 17 2013]
Aveo Pharmaceuticals, Inc. Sued by Investor [Published Street Insider - May 17 2013]
AVEO and Astellas Announce Presentations of Tiv... [Published Business Wire - May 15 2013]
AVEO and Astellas Announce Presentations of Tiv... [Published Business Wire Health News - May 15 2013]
Aveo Screwed Up but Its Kidney Cancer Drug Is Real [Published BioPortfolio - May 15 2013]
FDA panel votes against Aveo's kidney cancer drug [Published GlobalPost - May 15 2013]
FDA OKs pinpoint prostate cancer radiation drug... [Published FierceBiotech - May 15 2013]
Aveo Screwed Up But Its Kidney Cancer Drug Is Real [Published TheStreet.com - May 15 2013]
Astellas to close down OSI Pharmaceuticals, Per... [Published Drug Discovery News - May 15 2013]
Glancy Binkow & Goldberg LLP Announces Class Ac... [Published Business Wire - May 15 2013]
Abraham, Fruchter & Twersky, LLP Announces That... [Published Street Insider - May 14 2013]
Abraham, Fruchter & Twersky, LLP Announces That... [Published EON - May 14 2013]
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This Week in Biotech [Published EquityJungle - v0.1 - 8 hours ago]
Filed under: Investing With the  SPDR S&P Biotech Index  up 35% over the trailing-12-month period, it's evident that investment dollars are willingly flowing into the biotech sector. Keeping that in mind, let's have a look at some of the rulings, ...
AVEO and Astellas to Present Tivozanib Clinical... [Published News from Kidney Cancer Association - May 22 2013]
AVEO Oncology and Astellas Pharma Inc. announced that additional data from the Phase 3 TIVO-1 trial (TIvozanib Versus sOrafenib in 1st line advanced RCC) of investigational agent tivozanib in patients with advanced renal cell carcinoma (RCC) will be ...
Todd M. Garber Announces Investigation of AVEO ... [Published News from Kidney Cancer Association - May 21 2013]
Specifically, the investigation concerns whether the Company misrepresented or failed to disclose that: (1) the FDA had recommended that the Company conduct an additional Phase III trial due to adverse trends in the Company's first Phase III trial; (2) ...
5 of Last Week’s Biggest Losers [Published EquityJungle - v0.1 - May 05 2013]
Filed under: Investing There's never a shortage of losers in the stock market. Let's take a closer look at five of this past week's biggest sinkers. Company May 3 Weekly Loss Aveo Pharmaceuticals $2.52 67% ZAGG $5.00 27% Nam ...
Aveo Gets Bad News on Tivozanib [Published In the Pipeline - May 02 2013]
The kinase inhibitor tivozanib (for renal cell carcinoma) was shot down this morning at an FDA committee hearing. There are going to be a lot of arguments about this decision, because feelings have been running high on both sides of the issue. ...
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Press Releases

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Law Offices of Todd M. Garber Announces Investi... [Published Business Wire - May 20 2013]
AVEO and Astellas Announce Presentations of Tiv... [Published Business Wire - May 15 2013]
AVEO and Astellas Announce Presentations of Tiv... [Published Business Wire Health News - May 15 2013]
Glancy Binkow & Goldberg LLP Announces Class Ac... [Published Business Wire - May 15 2013]
Shareholder Rights Law Firm Johnson & Weaver, L... [Published Business Wire - May 02 2013]
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