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Sanofi drags Hospira and Apotex (NYSE:SNY)

Jyotsna Ramani (October 27th, 2009) Writes:

Sanofi-Aventis SA (ADR) (NYSE:SNY), France’s biggest pharmaceutical group has accused Hospira Inc and Canada’s Apotex Inc of infringing patents for the cancer drug Taxotere. Sanofi-Aventis has said that both the companies have tried to copy their products. Earlier Sanofi-Aventis have filed separate complaints against Hospira Inc and Apotex Inc that they have violated the patent laws and have attempted to duplicate their top ranging product that is developed and marketed for the treatment of cancer patients. Though the market reacted sharply after the news broke into the market, but there was not much of fluctuation in the shares of Sanofi-Aventis at the end of the day.

Sanofi-Aventis is one of the leading pharmaceutical companies in France and globally as well. The company is into the research, development, manufacturing

...

FDA Recommends 2 New Drugs – Analyst Blog

Zacks Market Commentaries (March 20th, 2009) Writes:
Highlights include Sanofi-Aventis SA (SNY) and Johnson & Johnson (JNJ).On March 18th and 19th, the FDA advisory panels recommended approval of 2 important cardiovascular product candidates. The FDA does not have to follow the recommendations of the panels but usually does.On Wednesday, the 18th of March, an FDA advisory panel recommended approval of Sanofi-Aventis' (SNY) heart drug Multaq. Multaq (dronedarone) is a new class III anti-arrhythmic drug developed for atrial fibrillation (AF).On Thursday the 19th, an FDA review panel voted 15 to 2 in favor of approving Johnson & Johnson's (JNJ) anticoagulant rivaroxaban. Rivaroxaban, which will be sold under the brand name Xarelto upon approval, will be marketed in the U.S. by J&J and is already sold partner Bayer AG outside of the U.S. Multaq was initially submitted to the FDA for approval in 2006 but the FDA responded ...

Sanofi Poised for Eventful Year – Analyst Blog

Zacks Market Commentaries (February 12th, 2009) Writes:
Highlighted stocks include Sanofi-Aventis (SNY) and Biogen-Idec (BIIB).On February 11, 2009, Sanofi-Aventis (SNY) announced financial results for the 4th quarter 2008. Revenue of EUR7,456 million increased by 3% from the 4th quarter of 2007, and was ahead of our estimate of EUR7,101 million. Revenue benefitted from strong sales of Lantus, Lovenox, Plavix and Ambien CR.Revenue was also positively impacted by foreign exchange translation. EPS, adjusted for non-recurring charges, was EUR1.25 in the 4th quarter, compared to our estimate of EUR1.24. Relative to our expectations, EPS was negatively impacted by higher R&D and SG&A spend and a slightly tighter-than-expected gross margin, partially offset by a lower tax rate.For the full-year 2008, revenue of EUR28.8 billion was down 1% from 2007, while EPS increased by 2% to EUR5.36. Foreign exchange negatively impacted sales and EPS by 5% and 8%, respectively, for the ...

Cell Genesys, Inc. (CEGE) Receives Expected FDA Halt on Clinical Prostate Cancer

QualityStocks (September 11th, 2008) Writes:

Cell Genesys (Nasdaq:CEGE) focuses on the development and commercialization of novel biological therapies for patients with cancer. The company’s lead product platform, GVAX immunotherapy for cancer, holds the potential to treat multiple types of cancer, including prostate cancer, leukemia, pancreatic cancer and lung cancer.

The company today announced the U.S. Food and Drug Administration has placed an expected partial clinical hold on phase 3 program for GVAX. The halt follows the company’s August 27, 2008 announcement in which it said it will end the VITAL-2 phase 3 trial for GVAX.

Cell Genesys terminated the trial after its Independent Data Monitoring Committee (IDMC) observed an imbalance in deaths between two treatment arms of the VITAL-2 study, which compared GVAX immunotherapy in combination with Taxotere to Taxotere plus prednisone in patients with advanced prostate cancer.

In today’s announcement, Cell Genesys said the FDA confirmed that patients in the VITAL-1 phase 3 trial

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Cell Genesys, Inc. (CEGE) Halts Cancer Treatment Trial to Ensure Patient Safety

QualityStocks (August 27th, 2008) Writes:

Cell Genesys, Inc. (Nasdaq: CEGE) focuses on the development and commercialization of biological therapies to treat multiple types of cancer. The company’s lead product platform, GVAX immunotherapy, holds the potential to treat various types of cancer, including prostate cancer, leukemia, pancreatic cancer and lung cancer. Cell Genesys today announced it has terminated VITAL-2, the second of two phase III clinical trials of GVAX.

The trial was set to compare GVAX immunotherapy in combination with Taxotere to Taxotere combined with prednisone in patients with advanced-stage prostate cancer. However, after reviewing an imbalance in deaths between the two treatment arms of study, the company’s Independent Data Monitoring Committee (IDMC) recommended the trial end to ensure patient safety.

“Patient safety is always our paramount concern and so we have immediately responded to the recommendation of the IDMC. We are currently notifying all participating clinical trial sites and regulatory agencies that enrollment of new patients

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