Pfizer (PFE) announced that the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products advisory committee voted in favor (10 to 1) of data presented to support the safety and effectiveness of Prevnar 13, its 13-valent pneumococcal conjugate candidate vaccine. The favorable recommendation of the vaccine was based on data from 13 phase III studies carried out on more than 7,000 children.  Pfizer is seeking FDA approval for the vaccine to prevent diseases (including sepsis, meningitis, bacteremia, bacteremic pneumonia, and empyema caused by 13 Streptococcus pneumoniae (S. pneumoniae) in infants and young children. Although the FDA is not required to follow the advisory panel’s recommendation, it generally does so. The FDA is reviewing the Biologic License Application (BLA) for Prevnar 13, which has an action date of December 30, 2009. Though the FDA was initially expected to respond by September 30, 2009, the agency had ...

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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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GlaxoSmithKline (GSK) and Denmark-based Genmab received some good news with the US Food and Drug Administration’s (FDA) approval for Arzerra (ofatumumab), a monoclonal antibody for patients with chronic lymphocytic leukemia (CLL), a slowly progressing cancer of the blood and bone marrow.  Arzerra is approved for cancer patients who are no longer responding to the current available treatment options using fludarabine and alemtuzumab. Following the approval, Genmab has become eligible to receive a milestone payment of DKK 116 million (approximately $23 million) from Glaxo.  Earlier, in May 2009, Arzerra had received a positive recommendation from the FDA's Oncologic Drugs Advisory Committee (ODAC) in which the panel had voted 10-3 in favor of the drug. They had found that Arzerra provided some clinical benefit to patients with CLL whose disease was refractory to fludarabine and alemtuzumab.  Arzerra has been approved by the FDA under the accelerated approval process ...

Theravance (THRX) announced its third quarter results after the closing bell yesterday. The company’s loss per share came in at 35 cents, a penny wider than the Zacks Consensus Estimate. It had earned 34 cents per share in the year-ago period. Revenues were $5.5 million during the quarter, compared with $6 million in prior-year quarter. Theravance receives revenues in the form of milestone payments from its collaborating partners including GlaxoSmithKline (GSK) and Astellas Pharma.   Operating expenses remained unchanged at $26.6 million. While R&D expenses declined 2.6% due to lower costs related to the regulatory process for telavancin (Vibativ), G&A expenses increased 8.7% due to higher employee related costs.

The reported quarter had been quite significant for Theravance with the company receiving US Food and Drug Administration (FDA) approval for its long awaited product Vibativ for the treatment of complicated skin and skin structure infections (cSSSI) caused by

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Tuesday October 27, 2009

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TAXS, SCHW, PSFT, DISH, PWRM, MMM, CSRH, WFC, CVAT, JPM, AQNM

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TAXS, TaxMasters Inc., TAXS.OB

TAXS‘ commitment to helping taxpayers in the United States regain compliance with The Internal Revenue Service IRS.

TAXS finalized plans this week to take advantage of the expected surge in sales that begins for the IRS tax relief industry in October and builds through April of the following year. TAXS reported sales for the first six months in 2009 of $18,758,000, an increase of $12,348,000 or 193 percent, over 2008 sales for the same period of $6,410,000. TAXS used this growth

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Recently, Theravance (THRX) received a milestone payment of $20 million from its partner Astellas Pharma. The payment follows the U.S. Food and Drug Administration (FDA) approval of Vibativ (telavancin) and for supplying Astellas Pharma with the launch inventory for the first commercial sale of the drug in the U.S. Vibativ is expected to hit the U.S. market by year-end.

Earlier, in September, Theravance received FDA approval to market Vibativ for the treatment of complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria. While the drug will be marketed and sold by Astellas, Theravance will receive royalties on global sales. In the U.S. , the company will help Astellas in marketing the drug for the first three years post approval.

Apart from cSSSI, Vibativ is also being studied for hospital-acquired pneumonia (HAP). The company has already submitted a New Drug Application (NDA) for this indication and has been assigned a

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On Friday, Wyeth Pharmaceuticals, a division of Wyeth (WYE), announced that the company's 13-valent pneumococcal conjugate vaccine for infants and toddlers received a positive opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP).  The CHMP recommended the approval in children between 6 weeks to 5 years to protect them against 13 serotypes (forms), of a bacterium called streptococcus pneumoniae (pneumococcus) that can cause a series of diseases, ranging from ear infections to pneumonia and meningitis. The EMEA is expected to pass a final verdict on the matter in the coming months.  Prevenar 13 is a new form of Wyeth’s blockbuster pneumococcal 7-valent conjugate vaccine Prevnar which reported revenues of $2.7 billion in 2008. The 13-valent vaccine includes six new serotypes in addition to the seven included in Prevnar. It is estimated that Prevenar 13 would cover 92% of invasive pneumococcal ...

From Fat to Fit: Six Stocks Set to Profit From a Slimmer America

by Marc Lichtenfeld, Advisory Panelist Thursday, September 24, 2009: Issue #1101

Did you know that 59 million American adults are obese? That’s 25% of the adults in this country.

Not overweight. Not “soft around the middle.” Not, “Yeah, I could probably lose a few pounds.”

Obese.

I highlighted that alarming statistic in a report I published last week for my small-cap healthcare service, Access.

Of course, it’s no surprise that America loves to eat. It’s also no surprise that many Americans eat too much – and often, indulge in food that’s bad for us…

It’s obvious that we’ve vaulted from plus size, to king size, to super size. There are even television shows like “The Biggest Loser” focused on the growing problem.

And with the healthcare debate still swirling around Washington,

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In a quantum achievement, Theravance (THRX) received approval from the US Food and Drug Administration (FDA) to market its Vibativ (telavancin) for complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria.

Vibativ, jointly developed with Japan’s Astellas Pharma, is expected to hit the US market by end of this year. While the drug will be marketed and sold by Astellas, Theravance will receive royalties on global sales. In the U.S., the company will help Astellas in marketing the drug for the first three years post approval.

Apart from cSSSI, Vibativ is also being studied for hospital-acquired pneumonia (HAP). The company has already submitted a New Drug Application (NDA) for this indication and has been assigned a Prescription Drug User Fee Act (PDUFA) date of Nov. 26.

The approval for the cSSSI indication comes after a series of delays and a long waiting period since Theravance submitted

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We are pleased to hear that Forest Laboratories (FRX) presented encouraging data from its phase III trial of ceftaroline for the treatment of community-acquired pneumonia (CAP) in hospitalized patients. The company presented new data from two multicenter studies – FOCUS 1 and FOCUS 2 – at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco. In addition to CAP, ceftaroline is also being studied for complicated skin and skin structure infections (cSSSI) caused by gram-positive bacteria.

The randomized, double-blind trial compared ceftaroline with ceftriaxone in hospitalized adult patients with moderate to severe CAP. Following both the trials, it was found that patients treated with ceftaroline demonstrated a better cure rate (84.3%) compared to those treated with ceftriaxone (77.7%). In addition, the overall microbiological response rate in the microbiologically evaluable (ME) population was 87% for ceftaroline and 81% for ceftriaxone, while in the microbiological modified intent-to-treat (MITT)

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