Dendreon’s Reached Orbit… Now Who’s Next?

by Robert Williams, Publisher

When the opening bell rang on Tuesday morning, as the broader market sagged, shares of Dendreon Corp. (Nasdaq: DNDN) sprinted out of the gates, rising by 5.7%.

Unless you live in a cave, you should know about this biotech stock.

Back in April, shares went “parabolic,” blasting 454% higher during the month.

(That’s not a typo. The stock increased almost five-fold over the course of a single month, rendering the S&P 500’s 10% gain over the same period completely insignificant.)

With an impressive move like that, you might think the run is over. But shares will likely head higher still…

You see, Dendreon is blazing a brand new path in biotech. Its prostate cancer drug, Provenge, which it just submitted to the FDA for approval, is the first

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MannKind Pharma’s (MNKD) third quarter loss per share came in at 42 cents, better than the Zacks Consensus Estimate of 49 cents and loss of 67 cents reported in the year-ago period. The company does not have any revenue stream at present -- its lead product, Afresa (inhaled insulin for the treatment of type I and type II diabetes) is currently under US Food and Drug Administration (FDA) review. MannKind filed a New Drug Application (NDA) for Afresa with the FDA in March 2009, which was subsequently accepted in May 2009. The company has been assigned a Prescription Drug User Fee Act (PDUFA) date of January 16, 2010. Operating expenses for the third quarter declined 38% to $42.8 million, primarily due to a huge reduction in R&D expenses. Reduced costs associated with the clinical development of Afresa along with a decline in manufacturing costs brought down ...

In one of the most surprising news today, Dynavax Technologies Corporation (NASDAQ:DVAX) has announced that the first clinical data of their HEPLISAV has shown increase in the protection rate for chronic kidney disease patients. The data will be presented publicly in a poster session on Saturday, October 31, 2009 at the Annual Meeting of the Infectious Disease Society of America (IDSA) in Philadelphia, Pennsylvania.

Dynavax Technologies Corporation is a biopharmaceutical company that discovers and develops product candidates like Toll-like Receptor also known as TLR. HEPLISAV is a Phase 3 adult hepatitis B vaccine that provides increased and rapid protection to the patients with fewer doses compare to the current licensed vaccines available in the market. During the Phase 3 trial of HEPLISAV around 2500 individuals were vaccinated with

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On Monday morning, the Food and Drug Administration panel approved Arzerra, a leukemia treatment that will be marketed and commercialized by GlaxoSmithKline Plc (ADR) (NYSE:GSK). As per the announcement made by the GSK executives, Arzerra is for those patients who have failed to respond to other therapies that cure leukemia. This new drug marketed by GSK was originally developed by GlaxoSmithKline and Genmab A/S, a Danish company. The drug is designed to treat patients with chronic lymphocytic leukemia also known as CLL and for those whose disease has progressed despite previous treatments with other cancer drugs.

GSK is a global healthcare company that is more into the creation and development, manufacturing and marketing of various pharmaceutical products including vaccines and over the counter medicines and other health related

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Encorium Group Inc. is a full-service multinational contract research organization (CRO). They provide design, development, and management capabilities for clinical trials and patient registries. They do this for many of the world’s leading pharmaceutical companies. Trading on the NASDAQ Capital Market, Encorium Group Inc. has offices in 10 countries, managing clinical trials with their own employees. The Company’s corporate headquarters are in Wayne, Pennsylvania.

Encorium Group, Inc. provides their services to the pharmaceutical, biotechnology, and medical device industries. Their corporate mission is to provide their clients with high quality, full-service support for their biopharmaceutical and medical device development programs. They offer therapeutic expertise, experienced team management, and advanced technologies.

Encorium has drug and biologics development as well as clinical trial experience across a broad spectrum of therapeutic areas. These include infectious diseases, cardiovascular, vaccines, oncology, and diabetes endocrinology/metabolism. These also include gene therapy, immunology, neurology, gastroenterology, dermatology, hepatology, women’s health

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Leading DNA vaccine discovery company, Inovio Biomedical Corporation announced that their Scientific Advisory Board Chairman, Dr. David B. Weiner, highlighted advances in the company’s leading electroporation-delivered SynCon™ DNA vaccines at the AIDS Vaccine 2009 Conference in Paris.

The study, led by Dr. Weiner’s team at the University of Pennsylvania, included collaborators from Inovio and Merck. The team previously reported that DNA vaccines delivered using electroporation induced dramatic increases in T-cell and antibody-based immune responses. This collaborative study was the first to directly compare a DNA plasmid-electroporation platform with a recombinant Ad5 vector in an SIV model in non-human primates.

Dr. Weiner presented pre-clinical data showing higher levels of immune responses induced by Inovio’s DNA vaccines than to those induced by the recombinant adenovirus serotype 5 (Ad5) vector. Historically, recombinant Ad5 vector has been shown to be one of the most potent viral vectors for vaccines.

In his presentation, Dr. Weiner also

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Pfizer Inc. (PFE) reported third quarter net income of 51 cents per share, which beat the Zacks Consensus Estimate of 48 cents. The company’s net income was 62 cents per share in the year-ago quarter. Revenues for the quarter decreased 3% to $11.6 billion. Revenues for the quarter were unfavorably impacted by approximately 5% due to foreign exchange, and were favorably impacted by 2% due to an adjustment in the third quarter of 2008 for product returns. U.S. revenues, which accounted for 41% of total revenues in the quarter, came in at $4.8 billion, a decrease of 2% compared with the year-ago quarter. International revenues decreased 4% to $6.8 billion, reflecting 5% operational growth and a 9% unfavorable foreign exchange impact. Sales of Pfizer’s mega-blockbuster anti-cholesterol medicine Lipitor fell 9% globally to $2.85 billion in the third quarter. US sales of the drug fell 12%. ...

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UnitedHealth Group (NYSE:UNH) reported third quarter results today, including growth in revenues and net earnings and a continued strong financial position. Stephen J. Hemsley, president and chief executive officer of UnitedHealth Group, said, “We combined successful overall cost containment and strong execution in our services businesses to continue to perform during a difficult economic period. This reinforces the value of our diversified business model. We continue to focus on delivering value for customers and stakeholders through responsive, high

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Baxter International Inc. (BAX) announced that it sees multiyear opportunity in H1N1 vaccines, commonly known as Swine Flu vaccines. The company expects to recognize $30 million to $40 million in revenues from swine flu vaccines in the fourth quarter. Baxter has not speculated on H1N1 vaccine sales beyond the fourth quarter. However, increasing demand has raised hopes for a multiyear opportunity. Baxter started shipping the product from August 2009.   Baxter and four other companies Sanofi-Aventis (SNY); MedImmune, a subsidiary of AstraZeneca plc (AZN); GlaxoSmithKline plc (GSK); and Novartis have received authorization to market H1N1 vaccines. Baxter has received approval only for a two-dose vaccine and not a single-dose. Baxter uses its cell culture-based technology instead of the traditional one to produce these vaccines.   Baxter recently announced strong third quarter results. Earnings per share stood at 98 cents, surpassing the Zacks Consensus Estimate of ...

Sanofi Pasteur, the vaccines division of Sanofi-Aventis (SNY), yesterday provided an interim analysis of clinical data on the company’s U.S. licensed Influenza A (H1N1) 2009 Monovalent Vaccine. The study is being conducted in infants and children 6 months through 9 years of age.   Although the analysis showed that the vaccine is immunogenic and a single dose may protect many children, results indicated that two doses of the vaccine will be required for optimal protection of children under the age of 10 years. This is in-line with the recommendations for seasonal influenza immunization in children belonging to this age group.   No serious adverse events were reported. The company will monitor the occurrence of adverse events for six months after the second dose of the vaccine. Information regarding the optimal dosage, number of doses and schedule should be available once final data from the ongoing trials are released....