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 ...

A panel of experts of the US Food and Drug Administration (FDA) has recently asked for additional data to judge the efficacy of Human Genome Sciences Inc.’s (HGSI) anthrax infection treatment ABthrax (raxibacumab) compared to existing anti-bacterial drugs.  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.  Data from studies had revealed that antibiotic medicines used alone were highly effective against anthrax, thereby raising questions about the added benefit of ABthrax. Furthermore, the drug appeared to be effective when used with antibiotics in rabbits and monkeys. The same panel also voted in favor of using data from the animal studies to predict how the drug will work in humans. However, more data is required for the purpose. Last week, the FDA expressed concerns regarding some ...

Recently, Human Genome Sciences Inc. (HGSI) suffered a setback when the US Food and Drug Administration (FDA) questioned the efficacy of its drug ABthrax (raxibacumab), meant for treating anthrax infection.  The FDA accepted that the medication was more effective than a placebo in treating anthrax exposure in animals. However, it was unsure as to how effective the treatment would be for humans since the reliability of human data is doubtful. Though the drug appeared to be effective when used with antibiotics in rabbits and monkeys, animal studies do not always predict success in humans.  Later today, an advisory panel from the FDA is scheduled to meet to decide whether the benefits of the drug outweigh the risks for treating deadly infections caused by anthrax inhalation.  As a reminder, Human Genome had filed a Biologics License Application with the FDA in May 2009. The company is ...

DOR BioPharma Inc. is a late-stage biotechnology company that has been gaining national attention for its state-of-the-art technology. DOR reached a major milestone in the advancement of its company with the announcement that it has been awarded a $9.4 million grant from the National Institute of Allergy and Infectious Diseases, which is a division of the National Institute of Health (NIH).

This grant will assist the company’s future over the next five years with the development of formulation and manufacturing processes for vaccines, including RiVax(TM), that are stable at elevated temperatures. The grant will also fund the development of improved thermostable adjuvants expected to result in rapidly acting vaccines that can be given with fewer injections over shorter intervals.

The development of heat-stable vaccines will take advantage of combining several novel formulation processes with well-characterized adjuvants that have been evaluated in numerous vaccine field trials. The formulation and process technology funded

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TEN, Tenneco Inc.

ADLS, Advanced Life Sciences Holdings Inc, ADLS.OB

PennyOmega.com Watch List!

PennyOmega.com Watch List ! for Tuesday September 1st, 2009

Our Picks at PennyOmega.com for Tuesday September 1st, 2009 are:

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TEN, Tenneco Inc.

TEN has grown to become one of the world’s leading designers, manufacturers and distributors of emission control and ride control products and systems for the automotive original equipment market and the aftermarket. The company is well-balanced across product lines, markets served and geographic regions.

Using a combination of leading-edge technology, manufacturing expertise and dedication to customer service, TEN has increased revenues to $5.9 billion annually and penetrated new markets to solidify its leadership in the global automotive supply industry. TEN is well positioned to

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ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc., announced this morning that it has executed a Material Transfer Agreement (MTA) with Archimedes Development Limited. This collaboration enables the companies to identify possible synergies between their technology platforms.

“Multiple studies in different model systems have shown that Homspera can protect experimental animals and enhance their immune responses to vaccine-delivered antigens, DNA-encoded viral proteins or tumor antigens, as well as provide protection in our anthrax and influenza therapeutic studies,” stated Hal Siegel, Ph.D., ImmuneRegen’s Vice President and Chief Scientific Officer.

He continued, “In addition to these findings in animals where Homspera has been administered intranasally as a liquid, inhaled or injected under the skin, we have shown in laboratory studies that Homspera can stimulate blood-forming stem cells to produce more white blood cell precursors, particularly those for granulocytes and macrophages, mature blood cells which play a significant role in

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Universal Detection Technology, a developer of early-warning monitoring technologies and bioterrorism detection devices, recently announced that the company, through its agreement with U.S. Department of Commerce’s Commercial Service, is promoting its handheld assays, which can be used to effectively detect up to five bioterrorism agents.

Under the terms of the agreement, Universal Detection Technology will be listed as a featured U.S. exporter on Commercial Service’s United Kingdom website in preparation for the 2012 Summer Olympics, which will be held in London. Universal Detection Technology’s five-agent bioterrorism detection kits have been used by first responders and private industry throughout the United States to test for anthrax, botulinum toxin, Ricin, plague (Y. Pestis) and SEB’s in three minutes or less.

Jacques Tizabi, Universal Detection Technology’s chief executive officer, stated, “The listing with the department of commerce gives us the opportunity to market our anti-terrorism products in the United Kingdom.” He continued, “The

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Human Genome Sciences Inc. (HGSI) announced that it plans to raise approximately $310 million as net proceeds by selling 23.2 million common shares at $14 per share. This reflects an expansion of the initial public offering where the company had planned to sell 18 million shares in public.   The Rockville, Maryland-based company further stated that the underwriters would be given a month to buy up to an additional 3.48 million common shares to cover any over-allotments. The offering, expected to close on August 3, will lead to considerable dilution in the shareholder base.   Human Genome intends to use the proceeds for general corporate and acquisition or investment purposes. Additionally, this funding arrangement is also expected to provide cash for further development of the pipeline.   As a reminder, Human Genome has a robust and diversified pipeline which includes drugs to treat hepatitis C, lupus, anthrax, cancer, ...

The awareness of defending our country after the Anthrax scare and 9/11 pushed companies into action to develop better early warning control systems. With the advantage of technology constantly improving, this gave researchers the edge to cover a wide range of threats. From biological and chemical attacks, to tracking the movements of bomb making equipment and their ingredients, the US government and private industries are constantly searching for the best that companies have to offer. The development of early warning detection systems for our country is now in high demand and will be far into the future.

Society within the U.S. before all of this felt somewhat invincible. As we watched other parts of the world go through death and destruction brought on by anything from I.E.D.’s (Improvised Explosive Devises), to human bombs, we felt secure. The first act of aggression was felt on the US Cole but it was so

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This week, biopharmaceutical company Human Genome Sciences Inc. (HGSI) announced the commencement of an underwritten public offering of up to 18 million shares of its common stock. The Maryland-based company stated that the underwriters would be given a month’s period to buy up to an additional 2.7 million common shares. While the company should be able to raise funds sufficient to finance operations through this operation, the issuance of shares will lead to considerable dilution in the shareholder base. The company intends to use the proceeds for general corporate and acquisition or investment purposes. Additionally, this funding arrangement is also expected to provide cash for further development of the pipeline.

As a reminder, Human Genome has a robust and diversified pipeline, which includes drugs to treat hepatitis C, lupus, anthrax disease, cancer, rheumatoid arthritis and HIV/AIDS. The company has recently filed a Biologics License Application (BLA) for ABthrax for

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