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Tarceva’s PDUFA date extended (NASDAQ:OSIP)

Jay Garcilazo (January 20th, 2010) Writes:

Tarceva – which is the brand name for the generic drug erlotinib – is co-marketed by OSI Pharmaceuticals, Inc. (NASDAQ:OSIP) and Roche Holding AG (NASDAQ:RHHBY). Both companies have already submitted a special type of application – known as the Supplemental new drug application (sNDA) – regarding Tarceva to the United States of America’s Food & Drug Administration. Upon receiving the application, the FDA has given OSI Pharma and Roche Holdings AG a Prescription Drug User Fee Act date (also called Action date or just PDUFA date). This was the date on which the Food & Drug Administration must respond to the companies’ application. According to OSI Pharma, the initial PDUFA date for Tarceva was January 18, 2010. However, on January 15, 2010, the corporation disclosed that the United States of America’s one of the toughest regulators, the Food and Drug Administration, has delayed the PDUFA date by 90 days.

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Why are Gilead Sciences (NASDAQ:GILD) shares falling?

Eric Cheshier (October 21st, 2009) Writes:
Gilead Sciences, Inc. (Public, NASDAQ:GILD) reported earnings yesterday, but the blow-http://www.cvilledevelopment.com/blog/wp-content/uploads/2008/12/gravy_train.jpgout-quarter doesn't seem to be impressing investors today, as shares are down 3%. Here is a summary of the call: * Net profit 72 cents/share beats 67 cents/share estimate * Revenue increases 31 pct to $1.8 billion Gilead Sciences Inc said on Tuesday its quarterly profit rose 36 percent, due in part to royalties on sales of the flu drug, Tamiflu, but sales of its core HIV drugs failed to impress investors ...

Amgen Joins GSK for Denosumab – Analyst Blog

Zacks Market Commentaries (July 29th, 2009) Writes:

Amgen (AMGN) has joined with GlaxoSmithKline (GSK) for the commercialization of one of the most anticipated drugs, denosumab, meant for the treatment of osteoporosis. Osteoporosis is a bone disease leading to increased fracture risk. Glaxo will make an initial payment of $120 million along with royalties for marketing the medicine in Europe. Glaxo has the marketing rights for emerging markets such as China, Brazil, India and South Korea, where the company has a strong presence.

This is a major win for Glaxo (beating 10 other companies), which had been eyeing the emerging markets for quite sometime. Sales growth of pharma products in these areas is far greater than the matured markets. This deal is beneficial to both the companies as Amgen has a strong foothold in the US and Europe while Glaxo has a presence all over the world.

Denosumab is the most prized pipeline candidate for Amgen. Currently, the

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Top Non-US Equity Funds – Mutual Fund Commentary

Zacks Market Commentaries (July 2nd, 2009) Writes:
Today we are featuring top-performing "Non-US" equity mutual funds, which primarily invest in equity securities of foreign companies.

Investors can find such funds by checking out the entire list of the Zacks #1 Rank Non-US Equity Funds.

3 Solid Investments

Dreyfus Emerging Asia A (DEAAX) was incepted in December 2007 and seeks long-term capital appreciation.

The fund mainly invests in stocks of companies that are located or principally traded in Asian emerging market countries or are tied economically to those markets. At times, it may invest a substantial portion of its assets in a single developing Asian country.

Unit holders need to make a minimum initial investment of $1,000 to enter the Zacks#1 Rank ("Strong Buy") fund. It distributes dividends and capital gains, if any, annually.

Matthews Asia Pacific (MPACX) seeks long-term capital appreciation by investing in common and preferred

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Top Non-US Equity Funds – Mutual Fund Commentary

Zacks Market Commentaries (June 3rd, 2009) Writes:

Today we are featuring top-performing "Non-US" equity mutual funds, which primarily invest in equity securities of foreign companies.

Investors can find such funds by checking out the entire list of the Zacks #1 Rank Non-US Equity Funds.3 Solid Plays

Dreyfus Emerging Asia A (DEAAX) was incepted in December 2007 and seeks long-term capital appreciation.

The fund mainly invests in stocks of companies that are located or principally traded in Asian emerging market countries or are tied economically to those markets. At times, it may invest a substantial portion of its assets in a single developing Asian country.

Unit holders need to make a minimum initial investment of $1,000 to enter the Zacks#1 Rank ("Strong Buy") fund. It distributes dividends and capital gains, if any, annually.

Matthews Asia Pacific (MPACX) seeks long-term capital appreciation by investing in

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Anadys: Too Early for HCV Drug – Analyst Blog

Zacks Market Commentaries (April 27th, 2009) Writes:
Highlights include Anadys Pharmaceuticals Inc. (ANDS), Roche Holding AG (RHHBY), Schering-Plough (SGP), Gilead Sciences (GILD), Vertex Pharmaceuticals (VTRX) and Valeant Pharmaceuticals International (VRX).Strong efficacy data observed in early phase Ib studies for ANA598, but a severe rash raises safety concernsANA598 is Anadys' (ANDS) lead anti-HCV (hepatitis C Virus) drug candidate currently under phase I studies. The company's share price got a boost recently on its strong efficacy data from a phase Ib study.Anadys presented the final antiviral and safety data from all three dose levels (200, 400 and 800 mg bid) at the 44th annual meeting of the European Association for the Study of the Liver (EASL) on April 23, 2009. The trial enrolled total 35 subjects. ANA598 treatment resulted in rapid and sustained reductions in HCV RNA with median reductions at end of treatment (day 4) ...

Top European Mutual Funds – Mutual Fund Commentary

Zacks Market Commentaries (April 3rd, 2009) Writes:

Today we are featuring top-performing "European equity" mutual funds, which invest at least 50% of net assets in equity securities of European companies.

Investors can find such funds by checking out the entire list of the Zacks #1 Rank European Funds list..

3 Choice Funds

Threadneedle European Equity A (AXEAX) seeks capital appreciation. This non-diversified mutual fund primarily invests in equity securities of European companies with growth potential.

Although the fund emphasizes investments in developed countries, it may also invest in equity securities of companies located in developing or emerging markets. AXEAX normally has exposure to foreign currencies. It has allocated 87.75% of its total assets in foreign stock and 9.95% in large-growth equities.

AXEAX was incepted in June 2000 and Rob Jones has been the lead manager at the fund since January 2003. Nestle, Roche Holding AG and Vodafone Group Plc are

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