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AMAG Pharma’s Feraheme Holds Promise – Analyst Blog

Zacks Market Commentaries (July 30th, 2009) Writes:
Yesterday, AMAG Pharmaceuticals Inc. (AMAG) reported second-quarter net loss of $26.5 million, or $1.55 per share, which was slightly higher than the Zacks Consensus estimate of $1.53. The company had reported a net loss of $17.0 million, or $1.00 per share, in the year-ago period.

The higher quarterly net loss is attributable to a 39% increase in year-over-year operating expenses. Research and development expenses rose 43% as the company is working on expanding its manufacturing capabilities and development infrastructure. Selling, general and administrative expenses also increased 37% for commercialization of anti-anemia drug candidate, Feraheme.

Since Feraheme is a very important product for the company, we expect investor focus to remain on the initial sales ramp of the product.

As a reminder, the US Food and Drug Administration (FDA) granted marketing approval to Feraheme injection on June 30. AMAG officially launched Feraheme in the U.S. on July 13. It

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Good News for Sanofi – Analyst Blog

Zacks Market Commentaries (July 16th, 2009) Writes:

At last, the uncertainty regarding Sanofi-Aventis' (SNY) Lantus (generic name insulin glargine) seems to be over. Today, the company released a statement by a board of experts regarding the potential link of Lantus with increased cancer risk. They have come to the conclusion that all the four cases had significant methodological limitations and shortcomings, thus making the results inconclusive.

As a reminder, in the month of June, a study by the European Association for the Study of Diabetes observed that Lantus (generic name insulin glargine) increases the risk of cancer in diabetics taking the drug. The study, carried out on 127,000 patients in four European countries found that out of every 100 patients using Lantus for about 1 1/2 years, one additional person developed cancer.

But the FDA was not convinced with the study as patients were not studied long enough to substantiate the risk. Accordingly, it planned to review the

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Glaxo’s Fundamentals Sound – Analyst Blog

Zacks Market Commentaries (June 22nd, 2009) Writes:
Avandia Sales StabilizingSales of GlaxoSmithKline's (GSK) Avandia have been significantly negatively impacted due to safety concerns, but it appears sales are close to stabilizing. We believe that sales are now at or very near their bottom. While sales of Avandia have been cut in half from their peak level reached in 2006, it remains a very important product, and stabilizing sales represents very good news.Generics a Predominant IssueOther than the Avandia issue, Glaxo still has to deal with generic erosion of a number of drugs including Coreg IR, Flonase, Wellbutrin XR, Paxil, Lamictal, Requip, Valtrex and Imitrex. On the positive front, we continue to be impressed by the vaccine franchise and look forward to the contribution from Rotarix, Promacta and Synflorix. And although we were disappointed by the recent delay with Cervarix, ...

J&J Mounts Remicade Challenge – Analyst Blog

Zacks Market Commentaries (May 21st, 2009) Writes:
In a Schedule 14A proxy statement filed on May 20, 2009 Merck & Co. (MRK) disclosed that it had received notification from Johnson & Johnson's (JNJ) Centocor subsidiary of its intention to terminate, through arbitration, the distribution agreement with Schering-Plough Corp (SGP) for Remicade and golimumab (Simponi). As we detailed in prior reports and blogs, we had expected some sort of challenge from J&J, so the recent news comes as no surprise.In March 2009 Merck and Co. and Schering-Plough announced a merger agreement whereby the companies would combine in a deal currently valued at approximately $48.8 billion. The deal was structured as a "reverse-merger" with Schering-Plough being the surviving entity. Merck believes that the "reverse-merger" structure will avoid triggering a change-of-control provision in Schering-Plough's agreement with J&J relative to rights to Remicade and golimumab.J&J discovered both compounds and licensed ex-U.S. marketing rights ...

Zacks Analyst Blog Highlights: GlaxoSmithKline plc, General Growth Properties, Agria Corp, Regis Corporation and Ulta Salon, Cosmetics & Fragrance, Inc. – Press Releases

Zacks Market Commentaries (April 9th, 2009) Writes:
For Immediate Release

Chicago, IL - April 9, 2009 - Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: GlaxoSmithKline plc (GSK), General Growth Properties (GGP), Agria Corp (GRO), Regis Corporation (RGS) and Ulta Salon, Cosmetics & Fragrance, Inc. (ULTA).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=4579.

Here are highlights from Wednesday's Analyst Blog:

Glaxo's Avandia Issue Priced-In

Sales of Avandia have been significantly negatively impacted due to safety concerns, but it appears they have recently stabilized. We believe that sales are now at, or very near, their bottom. While sales of Avandia have been

...

ReGen Biologics, Inc. (RGBO.OB) Receives FDA 510(K) Clearance for Collagen Scaffold Device

QualityStocks (December 22nd, 2008) Writes:

Today an hour before the opening bell, ReGen Biologics announced that the U.S. Food and Drug Administration (FDA) has given the company clearance to market its collagen scaffold device, the Menaflex™ collagen meniscus implant. This device was designed to be used in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus (a band that spans the knee joint).

Gerald E. Bisbee, Jr., Ph.D., Chairman and Chief Executive Officer of ReGen Biologics, stated, “We are extremely pleased that the FDA has considered the recommendations of the Orthopaedic and Rehabilitation Devices Advisory Panel in support of our collagen scaffold 510(k) and that the FDA agreed to enable U.S. marketing for this important product. Today’s announcement represents the culmination of many years of effort on the part of the Company and the invaluable contribution of many supportive investors, advisors and surgeons, as we sought to bring the Menaflex

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Dyax Corp. (DYAX) Announces Completion of Biologics License Application with FDA; Moves Forward with Treatment for Life-Threatening Angiodema

QualityStocks (September 24th, 2008) Writes:

Dyax Corp. (Nasdaq: DYAX) focuses on the advancement of novel biotherapeutics, such as those for the treatment of hereditary angiodema (HAE), a rare and potentially life-threatening condition that occurs in about one in every 10,000 to 50,000 people. The condition is associated with swelling in various parts of the body (including hands, feet, face and airway), abdominal pain, and nausea and vomiting.

Dyax today announced the completion of its Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of Dyax’s flagship product, DX-88 (ecallantide), for the treatment of HAE.

“The submission of the DX-88 BLA is a major milestone for Dyax,” Henry E. Blair, chairman, president and CEO of Dyax stated in the press release. “We believe DX-88, a recombinant, subcutaneously administered therapy, has many characteristics that match well with the needs of HAE patients and physicians for a therapeutic option. We look forward to working

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