Dr Stock Pick HOT News & Alerts!

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Tuesday Nov 24, 2009

DrStockPick.com Stock Report!

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Consorteum Holdings Inc. (OTCBB: CSRH) launched its consumer stored value rebate card. The consumer rebate card program will offer manufacturers and retailers a new way to process mail-in rebates that ensures increased customer loyalty and decreased overhead costs. Consorteum will work directly with manufactures and retailers to reduce the administration costs associated with mail-in rebate programs while providing a new way to increase consumer awareness. Additional revenue and cost-saving opportunities will be available to all parties through unspent funds

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Merck (MRK) announced that the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Elonva (corifollitropin alfa injection). Merck is seeking the drug’s approval as a treatment in controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women who have participated in an assisted reproductive technology (ART) program. On European Commission’s approval, Merck would be able to market Elonva with unified labeling valid in all European Union Member States.

Elonva is the first in a class of sustained follicle stimulants (SFS). It scores better than the current available treatment option − a single subcutaneous injection of Elonva is likely to replace the first seven injections of any daily recombinant follicle stimulating hormone (rFSH) preparation in a COS treatment cycle.

The positive opinion of the committee is based on data from Elonva’s phase III development program,

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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 ...

Recently, Novartis AG (NVS) announced that it has received a Complete Response Letter (CRL) for QAB149 (indacaterol) − a bronchodilator for the treatment of adults suffering from chronic obstructive pulmonary disease (COPD) − from the US Food and Drug Administration (FDA). The US agency has asked for additional information on the proposed dosing of the drug. Novartis had filed for the US approval of the drug in December last year.  Last month, the Committee for Medicinal Products for Human Use (CHMP) recommended the approval of QAB149 in the European Union to treat COPD patients as a once-daily therapy with two doses (150 micrograms and 300 micrograms). The positive opinion from the CHMP is a boost to Novartis as it aims to be a strong player in the field of respiratory medicine. Currently, the market is dominated by big players such as GlaxoSmithKline (GSK), AstraZeneca (AZN) ...

Sanofi-Aventis (SNY) received good news earlier this week with the company receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) for Multaq. The CHMP recommended that Multaq should receive marketing authorization in the European Union.  The CHMP has recommended the approval of Multaq for use in adult clinically stable patients with history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate. The CHMP’s positive opinion is based on clinical data including results from seven international, multi-center, randomized clinical trials involving more than 7000 patients and including the landmark ATHENA trial.  Phase III results on Multaq showed that it, along with standard therapy, significantly reduced the risk of cardiovascular hospitalizations or death from any cause by 24% compared to placebo. This data should help Multaq gain share. We ...

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 ...

Dr Stock Pick HOT News & Alerts!

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Friday September 25, 2009

DrStockPick.com Stock Report!

PWRM, PFE, NVS

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PWRM, Power 3 Medical Products Inc, PWRM.OB

Power3 Medical Products, Inc. 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. Power3’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). Power3 expects to complete phase II

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On July 24, New York-based biopharmaceutical company Regeneron Pharmaceuticals Inc. (REGN) announced that its once-weekly injection Arcalyst (Rilonacept) received a positive response from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). The drug is used for treating Cryopyrin-Associated Periodic Syndromes (CAPS), a group of rare, inherited, auto-inflammatory conditions characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue.

CHMP has recommended that rilonacept, an interleukin-1 blocker, be granted marketing authorization under exceptional circumstances. Such authorizations are granted to products on which comprehensive data cannot be provided by the company, which may happen due to the the rarity of the condition. The agency also asked Regeneron to  provide new information, if available, pertaining to the drug every year for review.

The company submitted a Marketing Authorization Application (MAA) with the EMEA for Arcalyst for the treatment of CAPS in the European

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Opaxio awaits EMEA approval by the end of 2009 There is some good news for Cell Therapeutics (CTIC) as the European Medicines Agency (EMEA) today agreed to an oral explanation in support of the Opaxio Marketing Authorization Application (MAA) in September, 2009. The agency has extended the timeframe for review by the Committee for Medicinal Products for Human Use (CHMP) regarding the approval until the fourth quarter of 2009. Earlier, in April, 2008 the EMEA accepted for review the MAA of Opaxio for the treatment of patients with advanced non-small cell lung cancer (NSCLC). The meeting with the EMEA was scheduled to take place on June 2009, but did not occur as the company was busy submitting the pixantrone (for the treatment of NHL) New Drug Application (NDA). Although Opaxio was undergoing clinical trials since 2005, all of them failed to meet the primary end-point ...

Below are 12 extreme FDA trades for 11 companies with market caps below $200M which have pending new drug product decisions or other meetings/milestones scheduled with the FDA that are expected to have a major impact on each of the underlying stock prices as the PDUFA decision dates approach and the decision is ultimately announced. A high risk/reward trading approach to consider for speculative traders is investing a small amount of money that you can afford to lose in a basket of stocks included in extreme FDA and Clinical Trial Calendar trades, which are highlighted in periodic articles at BioMedReports.com.

Hemispherx Biopharma [HEB: 1.36, -0.10 (-6.85%)]: Ampligen (Poly I: Poly C12U) NDA (three month PDUFA decision date delay was announced on 2/18/09 as additional data was submitted by HEB within three months of original decision date). Ampligen is an experimental treatment for chronic fatigue syndrome (which has no

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