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Encouraging Data on J&J Drug – Analyst Blog

Zacks Market Commentaries (November 23rd, 2009) Writes:

Johnson and Johnson (JNJ) recently presented long-term data from two phase III clinical trials of Simponi (golimumab), carried out on rheumatoid arthritis (RA) patients. It was observed that patients taking Simponi every four weeks achieved sustained improvements through one year. The data were presented at the 2009 American College of Rheumatology (ACR) Annual Scientific Meeting held last month.

Data from the first trial – GOlimumab After Former anti-TNF (tumor necrosis factor) Therapy Evaluated in RA (GO-AFTER) revealed that patients previously treated with TNF inhibitors (adalimumab, etanercept or infliximab) responded as well as showed continued response to the drug for an entire year. At week 52, data measured by American College of Rheumatology (ACR 20) response found a 20% improvement in arthritis symptoms in 63% of patients receiving the drug while 41% of the patients achieved a 50% improvement in arthritis symptoms measured by ACR 50 response.

Results from the second trial

...

EU Nod for J&J/Schering Drug – Analyst Blog

Zacks Market Commentaries (October 7th, 2009) Writes:
Yesterday, Schering-Plough Corp. (SGP) and Johnson & Johnson (JNJ) announced the approval of their drug Simponi (golimumab) in the European Union for the treatment of rheumatoid arthritis and other immune system disorders. The drug was approved by the U.S. Food and Drug Administration (FDA) in April 2009.   As a reminder, Schering acquired co-development rights to Simponi in the third quarter of 2005 from Johnson & Johnson’s biotech arm, Centocor Inc., which had developed and discovered the drug. Johnson & Johnson enjoys exclusive marketing rights of Simponi in the U.S., while Schering-Plough holds marketing rights outside the U.S.  excluding Japan, Indonesia and Taiwan where the drug will be co-marketed with other vendors subsequent to regulatory approvals.   Simponi, a next-generation, fully human, anti-tumor necrosis factor (TNF), received European approval as a once-a-month treatment for rheumatoid arthritis (RA), psoriatic arthritis (PA) and ankylosing spondylitis (AS), which is a ...

Provectus Pharmaceuticals Inc. (PVCT.OB) Initiates Phase 1 Trial of Liver Cancer Drug

QualityStocks (October 1st, 2009) Writes:

Provectus Pharmaceuticals Inc., a development-stage oncology and dermatology biopharmaceutical company, has initiated a Phase 1 study of their drug – PV-10 – for liver cancer. The study will enroll up to six subjects with cancer metastatic to the liver or with recurrent liver cancer. The same drug is currently undergoing Phase 2 study for metastatic melanoma.

The primary objective of the open-label study is to determine the safety and tolerability of a single intralesional injection of PV-10 in patients with liver cancer. Additional objectives are to assess the distribution and retention of PV-10 in the injected lesion, tumor response and viability, and plasma pharmacokinetics of the drug following intralesional injection.

The CEO of Provectus, Dr. Craig Dees, PhD, spoke about the Phase 1 trial, “We hope to demonstrate that PV-10, which has shown excellent selectivity for melanoma, will be a viable therapeutic for liver cancer and cancers metastatic to the liver.”

The

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Zacks Bull and Bear of the Day Highlights: ON Semiconductor, Developers Diversified, Alcon Inc., AstraZeneca and Allergan, Inc. – Press Releases

Zacks Market Commentaries (September 18th, 2009) Writes:

For Immediate Release

Chicago, IL – September 18, 2009 – Zacks Equity Research highlights ON Semiconductor (ONNN) as the Bull of the Day and Developers Diversified (DDR) the Bear of the Day. In addition, Zacks Equity Research provides analysis on Alcon Inc.(ACL), AstraZeneca (AZN) and Allergan, Inc.(AGN).

Full analysis of all these stocks is available at http://at.zacks.com/?id=2676

Here is a synopsis of all five stocks:

Bull of the Day:

ON Semiconductor (ONNN) is an OEM of primarily analog semiconductors used within a diverse set of end markets. June quarter results beat consensus expectations, with management guiding for stronger results in the September quarter.

Recent acquisitions, a broad product portfolio, a well diversified business across end markets and geographies, restructuring actions and debt reduction initiatives are other positive factors.

While competition is strong as ever and restrictive covenants and some residual integration

...

GenVec’s TNFerade Nears NDA Status (NASDAQ:GNVC)

Michael Vlaicu (September 9th, 2009) Writes:

GenVec, Inc.

(Public, NASDAQ:GNVC)

StocksHaven Investments profiles a clinical stage biopharmaceutical company developing gene-based therapeutic drugs and vaccines. Its lead product candidate, TNFerade biologic (TNFerade), is being developed for use in the treatment of cancer, and is currently undergoing Phase III trials which are expected to be completed by Q1 2010. In addition to its therapeutic product development programs, GenVec is working with collaborators to develop new applications for its technology through its vaccine development programs. The Company is developing a vaccine in animal health against foot-and-mouth disease and preventative vaccines for malaria, human immunodeficiency virus (HIV), respiratory syncytial virus, and Herpes Simplex Virus Type 2 (HSV-2). Surrounded by cash infusions through grants, mutual and institutional investors, multi-purpose products with billion dollar market potential, and an already flowing revenue stream – GenVec is one company you shouldn’t pass by.

About

Genvec

...
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Wider Label for Bristol Drug – Analyst Blog

Zacks Market Commentaries (August 27th, 2009) Writes:
Bristol Myers Squibb Co. (BMY) yesterday announced the approval of a broader label for its rheumatoid arthritis drug Orencia by the U.S. Food and Drug Administration (FDA).   The agency approved an addition to the label that supports the use of Orencia (abatacept) in patients suffering from moderate to severe rheumatoid arthritis, duration of which is less than or equal to two years. The drug that recorded global sales of $129 million in 2008 is designed to reduce symptoms of rheumatoid arthritis. However, it should not be administered along with tumor necrosis factor (TNF) antagonists and is not recommended for use in tandem with other biologic rheumatoid arthritis therapies.   As a reminder, the drug was initially approved by the FDA in late 2005 and made commercially available in the U.S. in February 2006. At that time its label indicated the usage of the drug for patients with ...

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