Wer rennt schneller ? VICL XOMA DVAX HEB ?
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Wertpapier: Dynavax Technologies |
http://www.cnn.com/2009/HEALTH/06/11/swine.flu.who/index.html
On June 9, 2009, Biken issued the following press release in Japan (translated as follows): "Biken decided to expand its manufacturing facilities in Kanonji City. Biken will invest a total of 35 billion Yen (US $350 million) expecting to complete in 2013. Manufacturing capacities will be scaled up by 5 times, so as to be ready to manufacture Swine/Avian Flu vaccine for 60 million people within 6 months. New facilities will focus on the cell culture technology instead of the current poultry egg culture."
According to Japanese research teams, directed by Dr. Hasegawa of the Japanese National Institute of Infectious Diseases (JNIID) and as published in a various peer-reviewed publications and presented at scientific conferences, Ampligen(r), an experimental therapeutic, is an essential co-ingredient to provide experimental efficacy with the Biken vaccine. An updated peer reviewed list of the JNIID publications on this topic is being made available by accessing the Hemispherx web site: www.hemispherx.net.
Hemispherx has a broad global portfolio of pending intellectual property on the subject which includes both field of therapeutic use and composition of elemental matter on Ampligen(r), an experimental therapeutic, as well as its congeners (closely related compounds).
Yesterday, the World Health Organization (WHO) raised the threat level of swine flu to its highest level, level 6.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is a specialty pharma company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection(r) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics, Ampligen(r) and Oragens. Ampligen(r) and Oragens represent experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has in excess of 50 issued patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(r)). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.
Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen(r), Alferon LDO and Oragens) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection(r) do not imply that the product will ever be specifically approved commercially for these other treatment indications; similarly, the completion of the NDA filing process with Ampligen(r) does not imply that the product will ever be approved commercially.
CONTACT: Hemispherx Biopharma, Inc.
Investor Contact:
Dianne Will
518-398-6222
ir@hemispherx.net
at Reuters(Thu 7:35am)
Vical Advances RapidResponse(tm) DNA Vaccine Platform Under $6 Million Grant From NIH
GlobeNewswire(Thu 6:30am)
http://finance.yahoo.com/q?s=vicl
Mon Jun 22, 2009 7:26am EDT
June 22 (Reuters) - Vical Inc (VICL.O) said it received a milestone payment of $1.5 million from Merck & Co (MRK.N) related to an ongoing early-stage trial of a cancer vaccine based on Vical's technology.
"The candidate vaccine is based on Vical's DNA gene delivery technology and encodes human telomerase reverse transcriptase, which was licensed by Merck from a third party," Vical said.
Last week, Vical said it was taking the development of its DNA vaccine manufacturing process -- RapidResponse -- into the third year, under a $6-million grant from the National Institutes of Health. [ID:nBNG250972]
Shares of Vical closed at $2.44 Friday on Nasdaq. (Reporting by Anand Basu in Bangalore; Editing by Himani Sarkar)
Recent News: FDA Approves Ampligen As Treatment For Chronic Fatigue Syndrome. Check Back Later Today For Related Press Releases
http://hemispherx.net/content/investor/...ter%20Today%20For%20Related
http://seekingalpha.com/article/...rix-before-ampligen-s-fda-approval
http://seekingalpha.com/instablog/...smmx-insm-adls-heb-acur-and-halo
Xoma ist draussen...imo grosser fehler..lets see..
DVAX kommt auch wieder...
market pulse
Jun 30, 2009, 6:42 a.m. EST
Vical says swine flu vaccine works in mice
http://www.marketwatch.com/story/...ccine-works-in-mice?siteid=yhoof2
Influenza A(H1N1) - update 55
Laboratory-confirmed cases of new influenza A(H1N1) as officially reported to WHO by States Parties to the International Health Regulations (2005)
http://www.who.int/csr/don/2009_06_29/en/index.html
June 30, 2009
Vical Inc. (NASDAQ: VICL) showed promising swine flu test data in its animal model today and was one of the top rising stocks. A pact from Novavax, Inc. (NASDAQ: NVAX) with the government of Spain and ROVI Pharmaceuticals sent its shares even higher on a percentage basis.
Vical Incorporated (NASDAQ: VICL) said tests in its vaccine against A/H1N1 pandemic influenza, the swine flu, produced robust immune responses that were “well above the accepted protection threshold in 100% of vaccinated mice and rabbits” after a standard two-dose vaccine regimen. The company said that at least 75% of vaccinated animals achieved or exceeded the protection threshold after a single dose of vaccine. Vical went so far as saying that it is ready to advance directly to large-scale cGMP manufacturing of the vaccine for human clinical trials, subject to securing external funding for this program.
Novavax, Inc. (NASDAQ: NVAX) signed a deal with Spain’s health ministry and ROVI Pharma, a specialty drug maker in Spain, to license its genetically engineered technology to produce pandemic and seasonal flu vaccines and build that country’s first vaccine-making plant.
While exact terms are outstanding, this could easily bring in tens of millions of dollars in future royalty and milestone payments if and after the vaccines are approved and marketed. The target here is to get both pandemic flu vaccines and seasonal flu vaccines by 2012.
ROVI has committed to make a $3 million equity investment in Novavax at $2.74, a 10% premium to yesterday’s close. The Spanish government is forming a foundation and will invest in a 60 million facility and a non-profit foundation will be formed will be formed and initially funded with a 25 million euro credit line from the Spanish government.
This was a huge boom for both companies today. Vical Inc. (NASDAQ: VICL) rose over 22% to $2.70, on over 8 million shares. Novavax, Inc. (NASDAQ: NVAX) shares closed up 31% at $3.28, on over 32 million shares. As far as how high that volume is, that is about 14-times average on Vical and nearly 8-times average volume on Novavax.
Jon C. Ogg
Tags: NVAX, VICL
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=39223977
quote
The FDA has fallen weeks behind schedule in responding to select NDA's and PDUFA's. While people across the globe continue to fall ill, suffer and die from disease and debilitations, American drug research and development companies such as Cell Therapeutics (NASDAQ:CTIC), Hemispherx Biopharma (AMEX:HEB), BioDelivery Sciences International (NASDAQ:BDSI), Discovery Laboratories (NASDAQ:DSCO), Acura Phamaceuticals (NASDAQ:ACUR), King Pharmaceuticals (NYSE:KG) and Genta (OTC:GNTA) sit by anxiously awaiting word from the FDA on their medical discoveries - drugs that have demonstrated themselves to be paramount in effectiveness to combat many of these diseases and debilitations.
Stock investors have become impatient with the constant stalling of the FDA. They have set out to try to find answers, to now understand why it is that an agency of the government of the United States, charged with the approval of new drugs for the American marketplace, is withholding drugs such as Ampligen and Genasense from the people.
In their search for the reasons why, many investors have theorized that the hold-ups by the FDA are due to FDA chief Margaret Hamburg and her husband Peter Fitzhugh Brown. On May 26, 2009 The Wall Street Journal reported that Margaret Hamburg and Peter Fitzhugh Brown were heavily invested, both directly and indirectly, in drug company stocks and that they were being required to divest themselves of their holdings due to underlying conflict of interest issues.
Adequate time has lapsed since that article was published for the FDA chief and her husband to comply with the requirement that they divest themselves of their drug stock holdings and associations. Still, weeks have come and gone and no further word has been reported in the media (that I am aware of) as to the compliance of Margaret Hamburg and her husband.
There are other theories as well. Some of them ludicrous and some worthy of contemplation. One theory argues that the FDA is simply overworked and that the additional duties and responsibilities imposed upon them by the new Family Smoking Prevention and Tobacco Control Act only add to the workload and slow down the wheels of progress even further.
The FDA was already behind schedule with NDA responses prior to the Family Smoking Prevention and Tobacco Control Act. To argue that the FDA has fallen behind in their duties to the people due to this Act adding to their workload is, in itself, a ludicrous argument.
It would be more believable to claim that drugs developed by U.S. companies aren't being approved by the U.S. Food and Drug Administration in a timely manner because the U.S. government is indirectly outsourcing drug development to foreign companies in lieu of American companies through the drug approval process.
According to records returned by the FDA's search engine at accessdata.fda.gov, the FDA approved a total of 123 drugs during the three month period of April to June, 2009. Of those 123 drug approvals -
79 of those drugs (64.2%) were developed by companies either located outside of the United States or which are wholly owned subsidiaries of companies located outside of the United States, and
Nearly half (36, or 45.6%) of those drugs were developed by companies either located in India or which are wholly owned subsidiaries of companies located in India.
With only 44 of the drugs approved during that time period being developed by American companies, it would appear as though the FDA's preference for Indian drug research and development companies have become a viable threat to the success of American drug companies.
And what of those 44 American drug research and development companies? As a sideline, it's interesting to note that 27 (61.4%) of the American drugs approved by the U.S. FDA were developed by companies that are privately held (they do not have stocks that trade on the public markets). How this tidbit of information fits into the grand scheme of things is anybody's guess, but it certainly leaves room for more conspiracy theories.
unquote
GlobeNewswire(Tue 6:30am)
http://finance.yahoo.com/news/...ease-pz-1503357358.html?x=0&.v=1