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Anti-Smoking Vaccine from Glaxo – Analyst Blog

Zacks Market Commentaries (November 17th, 2009) Writes:

GlaxoSmithKline (GSK) and Nabi Biopharmaceuticals (NABI) signed a licensing agreement for a nicotine conjugate vaccine (NicVAX) as well as for the development of a second generation nicotine vaccine. NicVAX is an investigational vaccine for the treatment of nicotine addiction and the prevention of smoking relapse. Earlier in October, the vaccine received a $10 million grant from the National Institute on Drug Abuse.

As per the agreement, Nabi will get an upfront payment of $40 million and is eligible to receive more than $500 million (together with upfront payment) as option fees and milestones for the vaccine, NicVAX, and follow-on nicotine vaccines. Nabi has the potential to receive double-digit royalties from sales if the product is commercialized. GlaxoSmithKline will have an option to exclusively in-license NicVAX on a worldwide basis and a license to develop follow-on next-generation nicotine vaccines using Nabi's intellectual property together with GSK's own technology.

NicVAX is currently

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Zacks Analyst Blog Highlights: GlaxoSmithKline plc, Sanofi-Aventis, Novartis, Baxter International and AstraZeneca – Press Releases

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

For Immediate Release

Chicago, IL – November 16, 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), Sanofi-Aventis (SNY), Novartis (NVS), Baxter International (BAX) and AstraZeneca (AZN).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=5513

Here are highlights from Friday’s Analyst Blog:

Glaxo H1N1 Vaccine Approved

GlaxoSmithKline plc (GSK) recently received approval from the U.S. Food and Drug Administration (FDA) for its unadjuvanted influenza A (H1N1) pandemic vaccine. The FDA approved the supplemental biologics license application (sBLA), which was filed as a strain change supplement to Glaxo’s FluLaval seasonal flu vaccine. This

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Glaxo H1N1 Vaccine Approved – Analyst Blog

Zacks Market Commentaries (November 13th, 2009) Writes:
GlaxoSmithKline plc (GSK) recently received approval from the U.S. Food and Drug Administration (FDA) for its unadjuvanted influenza A (H1N1) pandemic vaccine.  The FDA approved the supplemental biologics license application (sBLA), which was filed as a strain change supplement to Glaxo’s FluLaval seasonal flu vaccine. This means that Glaxo can now market its swine flu vaccine for use in adults to prevent influenza.     The company has already received an order for 7.6 million doses of its swine flu vaccine from the United States Department of Health and Human Services. This order is a part of the US Government’s intention to secure about 250 million doses to help fight the swine flu pandemic.   The current outbreak of swine flu pandemic can prove to be a big opportunity for vaccine manufacturers. In addition to Glaxo, other major players in this field include Sanofi-Aventis (SNY), Novartis ...

Gilead Awaits Committee Outcome – Analyst Blog

Zacks Market Commentaries (November 13th, 2009) Writes:
Gilead Sciences, Inc (GILD) is awaiting the outcome of the Anti-Infective Drugs Advisory Committee of the US Food and Drug Administration (FDA) scheduled on December 10, 2009. The committee will review Gilead ’s aztreonam for inhalation solution, an investigational product for the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa (P. aeruginosa) in patients with cystic fibrosis (CF). Earlier, in September 2008, the drug was denied approval by the FDA, which then asked Gilead to resubmit the application with more data.  In September 2009, the drug received conditional marketing approval in Canada and Europe under the trade name Cayston (aztreonam lysine 75 mg powder and solvent for nebuliser solution). Gilead plans to make the product available in Germany and the UK in early 2010. Aztreonam formulated with lysine is a proprietary formulation of aztreonam developed specifically for inhalation, which has orphan drug status in the US ...

Wider Loss for Alnylam – Analyst Blog

Zacks Market Commentaries (November 12th, 2009) Writes:

Alnylam Pharmaceuticals Inc. (ALNY) reported a third-quarter loss of 22 cents per share, below the Zacks Consensus Estimate of 24 cents but wider than the year-ago loss of 7 cents. The higher loss in the quarter is attributable to higher stock based compensation and legal expenses.

Revenues for the quarter came in at $24.2 million as against $25.7 million in the year-ago quarter, down 5.8%. Research and development costs increased 5% to $23.2 million primarily because of increased costs for clinical and pre-clinical programs coupled with increased R&D headcount to support Alnylam’s alliances and development programs.    General and administrative expenses increased 56% to $10.7 million. The increase in general and administrative spend was primarily driven by higher professional service fees in association with business activities, primarily legal activities, coupled with increased stock based compensation expenses.   Alnylam exited the quarter with $453.5 million in cash, cash equivalents and marketable securities

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Small Cap Voice Featured Company: Biomagnetics Diagnostics Corp. (BMGP.PK)

QualityStocks (November 12th, 2009) Writes:

Biomagnetics Diagnostics Corp. is an advanced medical device and biotechnology company with a revolutionary diagnostics system and test kit testing technology for HIV, Hepatitis, H-Pylori, HPV, Tuberculosis and many other viruses, bacterium’s, toxins and diseases. The company focuses on real-time testing for the actual presence of the virus/ toxin/ disease itself, instead of the antibodies produced by the body’s immune system which may take anywhere from weeks to months to appear.

The company intends to follow the lead of established Western drugmakers and biotechs Merck & Co. (MRK), Wyeth (WYE), Eli Lilly & Co. (LLY), Schering-Plough (SGP), Novartis (NVS), Sanofi-Aventis (SNY), Genentech (DNA), Bristol Meyers Squibb (BMYS) and many others that are ramping up investments in China, India and Singapore. The company is currently working to establish a separate Chinese operating company that it intends to apply for listing on the Shenzhen or Hong Kong stock exchange.

Biomagnetics is also currently

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Zacks Industry Outlook Highlights: Alcon, Novartis, Gilead Sciences, Biogen Idec and Acorda Therapeutics – Press Releases

Zacks Market Commentaries (November 10th, 2009) Writes:
For Immediate Release

Chicago, IL – November 10, 2009 – Zacks.com announces the latest Industry Outlook. Today, Zacks Equity Research discusses the Big Pharma & Biotech sector, including Alcon (ACL), Novartis (NVS), Gilead Sciences (GILD), Biogen Idec (BIIB) and Acorda Therapeutics (ACOR).

A synopsis of today’s Industry Outlook is presented below. The full article can be read at http://www.zacks.com/stock/news/27081/Big+Pharma+and+Biotech.

In the pharma space, we are positive on stocks like Alcon (ACL) and Novartis (NVS). We believe these companies will continue witnessing revenue growth based on continued international penetration, new product launches and market share expansion. Pipeline expansion through in-licensing deals and acquisitions should also add to growth.

Novartis should see strong vaccine sales this flu season. The company has received approval from the U.S. Food and Drug Administration for its swine flu vaccine, which

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Big Pharma and Biotech – Industry Outlook

Zacks Market Commentaries (November 9th, 2009) Writes:
The pharmaceutical industry has witnessed major changes in 2009. Performance has been affected by factors like sluggish prescription trends, intensifying generic competition and limited phase III catalysts. The next five years are expected to reflect a significant imbalance between new product introductions and patent losses. According to IMS Health (RX), this is the main reason why global pharmaceutical market growth will be restricted to the mid-single digits through 2013. Over the next five years, products that currently generate about $137 billion in sales are expected to face generic competition, including Lipitor, Plavix and Seretide. At the same time, new products are not expected to generate the same level of sales as the products losing patent protection have. With most of the big pharma companies already facing patent challenges for their blockbuster products or likely to face them going forward, the companies have been looking toward mergers ...
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Lower Q3 Loss for Human Genome – Analyst Blog

Zacks Market Commentaries (November 5th, 2009) Writes:
Human Genome Sciences, Inc. (HGSI) reported third quarter net loss of $49 million or 32 cents per share, in-line with the Zacks Consensus Estimate. The company reported a net loss of $74.2 million or 50 cents in the year ago quarter. The lower net loss for the quarter was primarily attributable to increased revenues from manufacturing and development services and lower operating expenses. Revenues for the quarter came in at $18.834 million which reflected an increase of 60.6%. Revenues were inclusive of $8.7 million from manufacturing and development services, $8.9 million recognized under the company’s agreement with Novartis (NVS) pertaining to hepatitis C drug Zalbin, and $1.0 million recognized under the agreement with GlaxoSmithKline plc (GSK) pertaining to the potential blockbuster lupus drug Benlysta. Research & development spend declined 36% to $34.8 million in the quarter. Selling general & administrative expenses declined 6.3% to ...

Baxter Eyes Swine Flu Market – Analyst Blog

Zacks Market Commentaries (October 19th, 2009) Writes:
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 ...

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