Recently, AstraZeneca plc (AZN) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its blood clot preventer Brilinta (ticagrelor). Brilinta is an oral reversible P2Y12 adenosine diphosphate receptor antagonist for arterial thrombosis aimed to compete with the blockbuster drug Plavix which is co-developed by Bristol-Myers Squibb (BMY) and Sanofi-Aventis (SNY). On Oct 26, 2009, AstraZeneca filed for approval of the drug with the European Medicines Agency (EMEA) and is awaiting validation of the application.   AstraZeneca is seeking an FDA approval of Brilinta primarily on the basis of data from PLATO (a study of Platelet Inhibition and Patient Outcomes), a late-stage 18,624 patient trial, that showed that Brilinta was more effective than Plavix in treating patients with acute coronary syndrome (ACS) in 43 countries. Brilinta treatment resulted in a reduction of cardiovascular events (CV death, MI or ...

Genzyme Corporation’s (GENZ) problems continue with the company recently announcing the discontinuation of the development of its kidney disease drug. Genzyme reported results on its advanced phosphate binder (APB) from a phase II/III study.  Although the candidate met its primary endpoint, results showed that it was not more effective than Renvela, a product that is marketed by Genzyme. Based on these results, the company has decided to discontinue further clinical development of the APB.  Genzyme was looking to develop a product with higher potency that would more effectively bind phosphate, while maintaining all the benefits of Renvela. Renvela is a follow-on product of the company’s kidney disease drug, Renagel. Sales of Renagel/Renvela totaled $677.7 million or 15% of total revenue in 2008.  Renagel and Renvela are phosphate binders for the treatment of hyperphosphatemia. The company was looking to gain approval for the APB before Renagel/Renvela ...

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Thursday Nov 19, 2009

DrStockPick.com Stock Report!

PWRM, PFE

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PWRM, Power 3 Medical Products Inc, PWRM.OB

PWRM is a leading bio-medical company engaged in the commercialization of neurodegenerative disease and cancer biomarkers, pathways, and mechanisms of diseases through the development of diagnostic tests and drug targets. PWRM’s patent-pending technologies are being used to develop screening and diagnostic tests for the early detection and prognosis of disease, identify protein biomarkers, and drug targets. Diagnostic tests are targeted toward markets with critical unmet needs in areas including neurodegenerative disease (NuroPro) and breast cancer (BC-SeraPro). PWRM expects to complete phase II clinical validation trials of

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  Recently, Alkermes Inc. (ALKS) announced that its drug Vivitrol, which is indicated for the treatment of alcohol dependence, also helped opioid addicts stay away from drugs. Data from the six-month late-stage trial (n=250) demonstrated that subjects injected with Vivitrol (naltrexone for extended-release injectable suspension) once a month were more likely to pass a urine test compared to recipients of a placebo injection. Furthermore, subjects reported a lower craving for drugs, and half the subjects came clean in at least 90% of their drug tests.   The subjects were addicted to opioid drugs including heroin. Before enrolling for the trial, they had to stay away from drugs for at least a week. The most common adverse event affecting patients during the study were inflammation of the nose and throat in addition to insomnia.   The positive results have formed the basis of Alkermes’ decision to file a supplemental new ...

Genzyme Corporation’s (GENZ) Lumizyme failed to receive approval from the US Food and Drug Administration (FDA) for the treatment of Pompe disease. The FDA issued a complete response letter (CRL) stating that the agency will not grant approval unless the company addresses the manufacturing issues at its Allston Landing plant in Boston. Genzyme said that it believes that other elements like the Risk Evaluation and Mitigation Strategy (REMS), product label and post-marketing requirements, have been satisfactorily addressed. The FDA’s response on Lumizyme does not come as a surprise. The news regarding the delay in Lumizyme’s approval follows a recent announcement regarding the detection of contamination in vials of five drugs marketed by the company. The agency completed its inspection of the company’s plant last week and has provided Genzyme with a list related to the manufacturing deficiencies found at the plant. The company stated that ...

Recently, Human Genome Sciences Inc. (HGSI) announced that the U.S. Food and Drug Administration (FDA) delayed the approval of ABthrax (raxibacumab), the company’s candidate for anthrax treatment, asking for additional information pertaining to the drug.   The agency issued a complete response letter wherein it asked for additional information in response to the Biologics License Application (BLA) filed in May 2009. The company intends to provide the agency with the requested information shortly.   The agency’s decision comes weeks after an FDA advisory panel questioned the drug’s effectiveness when compared to existing anti-bacterial drugs since ABthrax was primarily tested in animals, not humans. Late last month, the panel of experts voted 17 to 6, with one abstention, that the company should submit more evidence on whether adding ABthrax to older drugs is beneficial for anthrax treatment. Consequently, the decision to delay approval does not surprise us.   As ...

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Tuesday November 17, 2009

DrStockPick.com Stock Report!

PWRM, NGSX

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PWRM, Power 3 Medical Products Inc, PWRM.OB

PWRM is a leading bio-medical company engaged in the commercialization of neurodegenerative disease and cancer biomarkers, pathways, and mechanisms of diseases through the development of diagnostic tests and drug targets. PWRM’s patent-pending technologies are being used to develop screening and diagnostic tests for the early detection and prognosis of disease, identify protein biomarkers, and drug targets. Diagnostic tests are targeted toward markets with critical unmet needs in areas including neurodegenerative disease (NuroPro) and breast cancer (BC-SeraPro). PWRM expects to complete phase II clinical validation trials of

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For Immediate Release

Chicago, IL – November 17, 2009 – Zacks Equity Research highlights Sealed Air Corporation (SEE) as the Bull of the Day and Hologic, Inc. (HOLX) the Bear of the Day. In addition, Zacks Equity Research provides analysis on Genzyme Corp.(GENZ), Shire plc (SHPGY) and Protalix BioTherapeutics Inc. (PLX).

Full analysis of all these stocks is available at http://at.zacks.com/?id=5506

Here is a synopsis of all five stocks:

Bull of the Day:

Sealed Air Corporation (SEE) reported third quarter 2009 EPS of 38 cents, above the Zacks Consensus Estimate of 33 cents and the prior-year EPS of 28 cents. The company raised its full-year 2009 EPS guidance to a range between $1.37-$1.45.

The company expects to continue to realize benefits from its cost reduction and productivity programs in the fourth quarter. Also, the company is witnessing improved market conditions in

...

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DrStockPick.com Watch List!

My Picks for Tuesday November 17, 2009 are:

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NGSX, NeurogesX, Inc.

NGSX is a biopharmaceutical company focused on developing and commercializing novel pain management therapies.

** The U.S. Food and Drug Administration (FDA) has approved NGSX’s Qutenza(TM) (capsaicin) 8% patch, the first and only product containing prescription strength capsaicin, for the management of neuropathic pain due to postherpetic neuralgia, the nerve pain which can follow an attack of shingles.

NGSX’s Qutenza delivers a synthetic form of capsaicin, the substance in chili peppers that gives them their heat sensation, through a dermal delivery system, providing up to 12 weeks of reduced

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Biotech company Genzyme Corp. (GENZ), faced yet another setback recently when the U.S. Food and Drug Administration (FDA) announced that vials of five drugs marketed by the company were found to be contaminated.   The affected drugs include Cerezyme, Myozyme, Fabrazyme, Aldurazyme and Thyrogen. All these drugs, excluding Thyrogen, are indicated for the treatment of rare disorders. The vials were found to be contaminated with stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process which could potentially harm patients.   As adverse events are yet to be reported and given the lack of alternative treatments for these drugs which treat rare disorders, the FDA did not issue a product recall. Instead, Genzyme has issued letters to U.S. healthcare providers reminding them to conduct a visual inspection of the vials and to filter them before using the products.   Genzyme has been ...