The re-ranking will result in the following eight securities being added to the Index:

{tiny;SPPI;3}Spectrum Pharmaceuticals, Inc. (Nasdaq:SPPI). Prior to this news, this company had no index memberships. SPPI is a commercial-stage biotechnology company with a focus on oncology, develops and commercializes a portfolio of drug products. Its marketed products include ZEVALIN, a form of cancer therapy called radioimmunotherapy for the treatment of non-Hodgkin's Lymphoma (NHL); and FUSILEV, which is indicated after high-dose methotrexate therapy in patients with osteosarcoma. The company is also developing apaziquone for the treatment of non-muscle invasive bladder cancer. Its phase II products include Ozarelix, a drug being investigated for benign prostatic hypertrophy (BPH), a non-cancerous enlargement of the prostate, and hormone dependent prostate cancer; and Ortataxel, a third-generation taxane. In addition, it has exclusive worldwide rights to Renazorb and Renalan and related compounds.

{tiny;PARD;3}Poniard Pharmaceuticals, Inc. (Nasdaq:PARD), together with its subsidiary, NeoRx Manufacturing Group, Inc., focuses on the development and commercialization of oncology products for people with cancer. Its lead platform product candidate, Picoplatin, is a platinum-based cancer therapy that is designed to overcome platinum resistance associated with chemotherapy in solid tumors. Picoplatin is being studied in various cancer indications, combinations, and formulations. Poniard Pharmaceuticals is conducting a phase III clinical trial of intravenous picoplatin in small cell lung cancer; two phase II clinical trials in metastatic colorectal and castration-resistant (hormone refractory) prostate cancers; and a clinical trial of oral picoplatin in solid tumors.

{tiny;CSKI;3}China Sky One Medical, Inc. (Nasdaq:CSKI). Through its subsidiaries, the company engages in the development, manufacture, marketing, and sale of over-the-counter, branded nutritional supplements, and over-the-counter plant and herb based pharmaceutical and medicinal products primarily in China. The company?s products include sumei slim patch to foster weight loss and prevent weight gain; pain killer patch used for the treatment of various ailments, including fever, headache, dysentery, diarrhea, and stiffness and pain in the neck caused by hypertension; anti-hypertension patch that improves circulation and reduces blood pressure; and dysmenorrheal patch for pain relief from dysmenorrheal in a woman?s critical days, and for regulating pain and catamenia.

{tiny;HITK;3}Hi-Tech Pharmacal Co., Inc. (Nasdaq:HITK), develops, manufactures, markets, and sells generic, prescription, over-the-counter (OTC), and nutritional products in liquid and semisolid dosage forms in the United States. It produces a range of products for various disease states, including asthma, bronchial disorders, dermatological disorders, allergies, pain, stomach, oral care, neurological disorders, glaucoma, and other conditions. The company?s generic pharmaceutical products include oral solutions and suspensions, topical creams and ointments, and nasal sprays. Hi-Tech Pharmacal Co. also manufactures and sells liquid ophthalmic, otic, and inhalation products, as well as cough and cold products and prescription vitamins. It markets a line of branded products that include OTC, nutritional lines, and prescription products primarily for people with diabetes.

{tiny;SIGA;3}SIGA Technologies, Inc. (Nasdaq:SIGA) is a biotechnology company, engages in the discovery, development, and commercialization of anti-infectives, antibiotics, and vaccines for the prevention and treatment of serious infectious diseases. The company focus on products for use in defense against biological warfare agents, such as smallpox, arenaviruses (hemorrhagic fevers), and other category A viral agents. Its lead product, ST-246, is an orally administered anti-viral drug that targets orthopox viruses. The company?s product candidates also include ST-294 and ST-193, which demonstrates antiviral activity in cell culture assays against arenavirus pathogens; and ST-669, a broad spectrum antiviral candidate, for various viruses in the Poxviridae, Filoviridae, Bunyaviridae, Arenaviridae, Flaviviridae, Togaviridae, Retroviridae, and Picornaviridae families. In addition, it also has four drug series in the pre-clinical development stage, including ST-610 and ST-148 for dengue virus of the genus Flavivirus.

{tiny;TRGT;3}Targacept, Inc. (Nasdaq:TRGT), is a biopharmaceutical company, engages in the design, discovery, and development of neuronal nicotinic receptor (NNR) Therapeutics for the treatment of diseases and disorders of the central nervous system. It markets Inversine, which is for the management of moderately severe to severe hypertension and uncomplicated cases of malignant hypertension. The company?s clinical stage product candidates include TC-5214 in Phase 2b clinical trial that modulates the activity of various NNR subtypes, including multiple forms of the a4ß2 NNR; AZD3480 (TC-1734), a small molecule, which modulates the activity of the a4ß2 NNR and completed two Phase 2b clinical trials; and TC-5619, a small molecule for cognitive dysfunction in schizophrenia or conditions characterized by cognitive impairment that completed a Phase 1 single and multiple rising dose clinical trial. It also has clinical stage product candidates, such as TC-2216, a product candidate for depression and anxiety disorders that completed a Phase 1 single rising dose clinical trial; and AZD1446 (TC-6683), a small molecule in Phase 1 clinical development that modulates the activity of the a4ß2 NNR.

{tiny;VNDA;3}Vanda Pharmaceuticals Inc. (Nasdaq:VNDA), is the Rockville, Maryland based biopharmaceutical company, engages in the development and commercialization of clinical-stage drug candidates for central nervous system disorders. Its product portfolio includes Iloperidone (oral), a compound for the treatment of schizophrenia completed Phase III clinical trial; and Tasimelteon, which completed Phase III clinical trials for transient insomnia and chronic primary insomnia. The company?s products also comprise Iloperidone (Injectible) for the treatment of schizophrenia and Tasimelteon for the treatment of depression, which are in the Phase II initiation status. The company was founded in 2002.

All of the companies are either classified as biotechnology or pharmaceutical companies and they all meet other Index eligibility criteria including minimum requirements for market value, average daily share volume and seasoning as a public company.

What does this mean? Well, investors should expect that this will end up being a net positive for the stocks involved. It may even affect the stock prices in a positive, albeit small way, relatively speaking.

At the end of the day, would you rather your favorite company be making the exclusive list or being taken off of it?

Well, just know that Matrixx Initiatives, Inc (Nasdaq:MTXX) is being removed from the Index.

According to NASDAQ OMX Group, the Biotechnology Index is the basis for the iShares Nasdaq Biotechnology Index(SM) Fund (IBB), which seeks investment results that correspond generally to the price and yield performance, before fees and expenses, of the NASDAQ Biotechnology Index. In addition, options based on the NASDAQ Biotechnology Index and the iShares Nasdaq Biotechnology Index Fund trade on various exchanges.

Isis (ISIS), Ligand (LGND) and Vical (VICL) have been my core biotech holdings since the mid 1990s and I have been steadily adding to these positions each time the market has lost faith. They share common themes and some differences. Isis and Vical have maintained consistent management throughout the years, whereas Ligand radically changed direction a few years ago when Daniel Loeb’s Third Point hedge fund took a stake. Now all three are focused on drug discovery; leaving the marketing to others.

All three have many pharmaceutical partnerships and many shots on goal, so one failure would not be devastating. In order of platform strength and a protective moat around their technology; Isis is the strongest, followed by Vical, with Ligand pulling up the rear.

"Progress in public health depends on innovation. Some of the greatest strides forward for health have followed the development and introduction of new medicines and vaccines," said WHO Director-General Margaret Chan said. Veronica Garcia, New Mexico's Secretary of Education, talks about a seminar she and other officials attended on H1N1, the swine flu.

Companies with Certified Existing Treatments for Swine Flu

Companies with Potential Vaccines and Treatments for Swine Flu

CEL-SCI Corporation (Amex: CVM) Product: proprietary L.E.A.P.S. technology (Ligand Epitope Antigen Presentation System)Biota Holdings Ltd.(ASX:BTA) / Daiichi Sankyo Product: CS-8958BioCryst Pharmaceuticals,Inc. (NASDAQ:BCRX) Product: Peramivir IntravenousNovavax, Inc. (NASDAQ:NVAX)Product: Swine Flu Vaccines using Virus-like particle (VLP) technologyInovio Biomedical Corporation (NYSE Amex:INO)Product: SynCon™ H1N1 influenza DNA vaccinesVical Incorporated(Public, NASDAQ:VICL)Product: Patented DNA delivery technologySinovac Biotech Ltd. (Amex: SVA)Product: Panflu(TM)Wyeth (NYSE: WYE) Product: PCV13 or Prevnar 13

MedImmune / AstraZeneca PLC (NYSE:AZN) Product: needle-free, nasal spray swine flu vaccine by using Live Attenuated Influenza Vaccine (LAIV) technology

Sanofi-Aventis SA (NYSE:SNY) Product: Swine Flu Vaccine

Chan, who last month declared a full pandemic underway from the H1N1 virus, said that patents can help ensure that companies develop medicines to "stay ahead of the development of drug resistance" in diseases like malaria and tuberculosis.

"Innovation is needed to keep pace with the emergence of new diseases, including pandemic influenza caused by the new H1N1 virus," she told a meeting on intellectual property and health, a contentious issue that has divided rich and poor nations.

In the speech, Chan said most drug access problems faced by developing countries could be remedied by tinkering with the existing patent system, which "operates as a stimulus for research and development for new products."

In May, at the WHO's annual assembly, rich and poor nations failed to reach consensus on how they should share virus samples of H1N1 and other flu strains with companies that use the biological material to make vaccines.

Indonesia has been especially vocal against this, arguing that developing countries would not be able to afford patented jabs made from their specimens.

PROBLEMS WITH PATENTS

Chan said those talks on "one of the most difficult, and divisive, issues ever negotiated by WHO" had identified problems with patents but said that the existing intellectual property regime did not need to be fully dismantled in pursuit of equity.

"R&D can indeed be needs-driven as well as profit driven," the former Hong Kong health director said. "International agreements that govern the global trading system can indeed be shaped in ways that favor health needs of the poor."

Chan described the global vaccine making capacity as "finite and woefully inadequate for a world of 6.8 billion people, nearly all of whom are susceptible to infection by this entirely new and highly contagious virus."

While acknowledging that "the lion's share of these limited vaccines will go to wealthy countries," she said the shortfall was "the result of limited global manufacturing capacity. It is not, in essence, a result of intellectual property issues."

The WHO has recommended that health workers, pregnant women and children should get priority access to H1N1 vaccines, and noted that every country worldwide will need them.

Chan said the ideal H1N1 shot would protect against seasonal strains as well as a range of candidate pandemic viruses.

"This innovation has not come about yet," she said. "This would be the best and most rational insurance policy for increasing supplies and encouraging more equitable access."

Top flu vaccine makers include Sanofi-Aventis, Novartis, Baxter, Schering Plough's Nobilon, GlaxoSmithKline, Solvay and AstraZeneca's MedImmune.

(Editing by Dominic Evans)

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. Another approach is to buy a basket of stocks well ahead of their expected binary events before the trading crowd arrives and causes an increase in the share price and trading volume. As with previous installments, this article is neither an endorsement of the companies profiled nor a complete list of extreme trades included in the FDA Calendar at BioMedReports.

With shares of Human Genome Sciences (NASDAQ:HGSI) more than tripling today on positive Phase 3 results for its experimental lupus drug since being featured as an Extreme FDA Calendar trade in early July, the list below includes an updated selection of companies with stock prices below $5/share. Keep in mind that the FDA does not issue PDUFA decision date deadlines for medical device applications, which consist of the 510(k) and pre-market notification application (PMA) routes. Click here for more info at the FDA website regarding the regulatory approval process for medical devices.

On 7/20/09, Trinity Biotech (NASDAQ:TRIB) ($4.88) announced the submission of a CLIA application for its TRI-stat point-of-care HbA1c product to the FDA.TRI-stat is designed to measure HbA1c, also known as glycated hemoglobin, a measure of a patient's average blood sugar control over the trailing two to three month period. Utilizing a patented boronate affinity and two-phase optical system, together with a simple, fully automated, plug-and-play instrument design, TRI-stat offers highly accurate results in minutes while eliminating the need for refrigeration found with the other three competing products.

On 5/29/09, Theratechnologies (TSE:TH) (PINK:THTCF) ($2.00) filed a New Drug Application (NDA) with the FDA for tesamorelin, an analogue of the growth hormone releasing factor, proposed for the treatment of excess abdominal fat in HIV patients with lipodystrophy. Several factors including the antiretroviral drug regimen and the virus itself are thought to contribute to HIV-associated lipodystrophy, which is characterized by body composition changes, dyslipidemia and glucose intolerance. The changes in body composition include excess abdominal fat accumulation. There is currently no approved treatment available for the excess abdominal fat related to HIV-associated lipodystrophy, a condition that can stigmatize patients and discourage HIV treatment adherence. The estimated PDUFA decision date for a standard, 10-month review by the FDA is expected to occur in late 1Q10.

On 7/20/09, A.P. Pharma (NASDAQ:APPA) ($0.88) announced that the FDA accepted for review the Company's New Drug Application (NDA) for APF530 for the potential treatment of chemotherapy-induced nausea and vomiting (CINV) with a PDUFA action date set for late 1Q10 for a possible FDA decision. APF530 is a long-acting formulation of granisetron that utilizes the Company's proprietary Biochronomer drug delivery system. The NDA was submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, whereby the Company can rely upon the FDA's prior safety and efficacy findings for APF530's active ingredient, granisetron, which is already approved by the Agency.

On 7/14/09, Genta (OTC:GETA) ($0.34) announced the publication of a paper that independently confirms the link of a key biomarker to overall survival in patients with advanced melanoma. The biomarker, a tumor-derived enzyme known as lactate dehydrogenase (LDH), is measured by a widely available blood test. Genta's recently completed Phase 3 trial of Genasense in advanced melanoma, known as AGENDA, specified low-normal LDH as an enrollment criterion. Results for progression-free survival (PFS), a co-primary endpoint of AGENDA along with overall survival (OS), are anticipated during 4Q09 and, if positive, are expected to support global regulatory applications for Genasense in this indication.

On 5/19/09, Genta announced that the independent Data Monitoring Board (DMB) for AGENDA notified the Company that the study passed its final futility analysis for progression-free survival (PFS). Accordingly, the Board has recommended that the study should continue to completion. Coincident with this recommendation, Genta submitted an "intent-to-file" notice via the centralized procedure to the European Medicines Agency (EMEA), which is required prior to submission of a Marketing Authorization Application (MAA) for marketing approval in Europe.

On 7/13/09, Genta began trading under a new ticker (GETA.OB) after implementing a previously announced one-for-fifty reverse stock split of its common stock which reduced the number of outstanding shares from about 5.4 billion to around 108 million shares.

On 6/30/09, AspenBio Pharma (NASDAQ:APPY) ($2.20) announced a 510(k) submission to the FDA for its AppyScore Test, which represents the first blood-based test designed as an aid in the diagnosis of human appendicitis with the proposed indication of use: AppyScore is an ELISA test system that is used to quantitatively measure S100A8/A9 heterodimer complex in blood. It is an in vitro diagnostic device that is intended to be used as an adjunctive tool for the diagnosis of acute appendicitis in conjunction with additional diagnostic modalities (such as clinical exam, basic lab testing, imaging) in patients with abdominal pain that is suspicious for acute appendicitis.

This filing advances the Company's commercialization plan for AppyScore, which involves initially filing the 510(k) based on the ELISA test format. Upon receiving market clearance for this device, the company plans to use the ELISA device as a predicate for a rapid assay device that includes a reader instrument. AspenBio plans to begin initial hospital testing of the rapid assay device in late 2009. Assuming the company receives FDA clearance of the AppyScore ELISA test and development work is completed, clinical trials of the rapid assay are planned to begin in early 2010.

Javelin Pharma (AMEX:JAV) ($1.60): Ereska is a non-opiate pain drug being developed by JAV for the acute treatment of moderate to severe pain in military, trauma, post-operative, and emergency room settings with the potential for treating breakthrough pain from cancer as well. The drug is delivered by a disposable manual pump with a rapid onset and duration of pain relief of about two hours without opiate side effects such as respiratory depression. JAV expects to release the primary endpoint data from the Ereska (intranasal ketamine) Phase 3 pivotal trial in mid-2009, which consists of 220 adult patients to evaluate the safety and effectiveness of the drug in the treatment of acute pain (arising from surgery, trauma, or injury). The stock price for JAV has increased by about 24% in the last five trading days and the volume was over 2X its average on 7/20/09.

In late March, Arena Pharma (NASDAQ:ARNA) ($4.25) announced top-line results from its BLOOM clinical trial of experimental weight loss drug lorcaserin, and the Company expects to report results from the second pivotal trial, BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), by the end of September 2009 and expects to submit a NDA for FDA approval by year-end. Vivus (NASDAQ:VVUS) ($6.85) expects to report pivotal Phase 3 clinical trial results during 3Q09 for its experimental weight loss drug Qnexa.

On 7/20/09, Orexigen Therapeutics (NASDAQ:OREX) ($7.20) announced that all three remaining Phase 3 trials evaluating Contrave (bupropion SR/naltrexone SR) met their co-primary endpoints. The results from the successfully completed Contrave Obesity Research, or COR, program of more than 4,500 patients exceed the FDA categorical efficacy benchmark for clinically significant weight loss, supporting the Company's plan to file a New Drug Application (NDA) with the FDA during 1H10. Contrave was generally well tolerated by patients across the COR Phase 3 program, and the data continue to be analyzed and compiled for submission to relevant scientific conferences, peer-reviewed journals and regulatory agencies.

Hemispherx Biopharma (AMEX:HEB) ($2.49): 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 FDA-approved treatments) and the drug has an Orphan Drug Status with a PDUFA decision date of 5/25/09. On 5/26/09, HEB announced that the FDA advised the Company that it may require up to 1-2 additional weeks to take action beyond the original PDUFA action date of 5/25/09. Click here for an exclusive interview of HEB's CEO, Dr. William A. Carter, which was posted at BioMedReports.com on 6/12/09.

On 7/20/09, Labopharm (NASDAQ:DDSS) ($2.00) announced it has received a complete response letter (CRL) from the FDA for its new drug application (NDA) for a novel formulation (rapid onset) of the antidepressant trazodone (DDS-04A). The CRL indicates the Company's application cannot be approved in its present form due to deficiencies following an FDA inspection of the active pharmaceutical ingredient (API) manufacturing facility, which was completed 7/3/09. The FDA letter states that, "Satisfactory resolution of these deficiencies is required before this application may be approved." No efficacy or safety issues were raised by the Agency for the NDA. The API manufacturer, Angelini, has informed DDSS that it can confirm that the observations raised by the FDA are not critical and that it has not been questioned about the continued supply of trazodone to the U.S. market. Angelini intends to address the observations raised by the FDA in an action plan to be submitted to the Agency by 7/24/09.

On 6/8/09, Dyax Corp. (NASDAQ:DYAX) ($3.26) announced today that the FDA accepted the Company's submission in response to the FDA's March 2009 Complete Response Letter (CRL), which outlined requirements for approval of DX-88 for the treatment of acute attacks of hereditary angioedema (HAE). In connection with the acceptance, the FDA assigned Dyax's BLA a new PDUFA action date of 12/1/09, which represents a six-month, Class 2 Review. In the CRL received 3/25/09, the FDA requested submission of a Risk Evaluation and Mitigation Strategy (REMS) and additional information with respect to the chemistry, manufacturing and controls (CMC) section of the BLA. Dyax believes these issues are fully addressed in its reply, which was submitted 6/1/09, and the Company's share price has increased by about 58% in the past month.

On 6/11/09, Transcept Pharma (NASDAQ:TSPT) ($4.65) announced that the FDA has informed the Company that it should expect to receive formal notice of a three month extension of the review period for the new drug application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet). The Intermezzo NDA had been assigned a PDUFA action date of 7/30/09. Under this revised timeline, TSPT now anticipates action from the FDA on the NDA on or before 10/31/09. In the normal course of the Intermezzo NDA review, the FDA previously requested additional information regarding middle of the night dosing instructions. As both the request and the TSPT response occurred late in the review cycle, the FDA has informed the company that it will extend the NDA review cycle by three months to consider the new information.

On 6/4/09, Somaxon Pharma (NASDAQ:SOMX) ($1.22) announced that it has resubmitted its New Drug Application (NDA) to the FDA for Silenor (doxepin) for the treatment of insomnia in response to a 2/25/09 Complete Response Letter (CRL) and following a 4/6/09 meeting with the FDA. The resubmission includes additional statistical analyses of the Company's clinical data relating to the durability of subjective sleep maintenance efficacy. It also includes the results of the Company's completed clinical trial of doxepin that evaluated the potential for electrocardiogram (ECG) effects. The results of that clinical trial demonstrated that Silenor had no effect on QT interval prolongation when administered at 6 mg or under exaggerated exposure conditions of 50 mg. The FDA has indicated that the review cycle for the resubmission will be six months (a Class 2 Review designation) for an estimated decision date of 12/4/09 on the Silenor NDA resubmission. Shares of SOMX have increased by about 239% over the past three months and the Company raised $6 million in a private placement in early July - providing adequate liquidity through 2Q10.

On 7/8/09, Noveko (TSE:EKO) (PINK:NKOFF) ($1.39) announced that its management recently held constructive discussions with the FDA regarding its pending 510(k) submission for the Noveko 3xEZ Antibacterial Surgical Mask to obtain clarifications on and narrow FDA's remaining data requests so that the Company can timely respond to them. As such, the Company received confirmation that it has now until 10/23/09 to submit the requested remaining data. The Company believes that when the 510(k) is cleared for the Noveko 3xEZ Antibacterial Surgical Mask, it will likely be the first mover in the U.S. market, further protected by its underlying product patent portfolio.

On 6/24/09, Cell Therapeutics (NASDAQ:CTIC) ($1.46) announced that it has completed the submission of the New Drug Application (NDA) to the FDA for pixantrone to treat relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). CTIC requested a six-month priority review, which if granted by the Agency would result in a possible FDA decision during 4Q09. On 5/5/09, CTIC announced that pixantrone is available on a named-patient basis for use in Europe to treat patients with aggressive NHL that has either relapsed or is refractory to standard treatment options. CTIC is now awaiting a likely mid to late August response from the FDA to accept the NDA filing, rule on the status of the priority review request, and issue a PDUFA action date for pixantrone.

Nuvo Research (PINK:NRIFF) (TSE:NRI) ($0.36) has a pending NDA re-submission for Pennsaid with a PDUFA action date of 8/5/09 for a possible FDA decision. On 6/16/09, Nuvo announced a deal with Covidien (NYSE:COV) granting it exclusive rights to market and sell Pennsaid, and its follow-on product, Pennsaid Plus, in the U.S. Pennsaid and Pennsaid Plus are Nuvo's topical non-steroidal anti-inflammatory drug (NSAID) candidates that deliver diclofenac through the skin directly to the site of pain. Nuvo receives an up-front, non-refundable payment of US$10 million and is also eligible to receive a US$15 million milestone payment on Pennsaid's approval by the FDA, which will increase to US$20 million if certain labeling criteria are agreed to by the FDA.

Advanced Life Sciences (OTC:ADLS) ($0.46): Cethromycin NDA (a once-daily antibiotic for the treatment of community acquired pneumonia - CAP) with an expected PDUFA decision date of 7/31/09. On 6/2/09, ADLS announced that the FDA's Anti-Infective Drugs Advisory Committee voted in the majority that Restanza (cethromycin) demonstrated safety for the outpatient treatment of adults with mild-to-moderate CAP (11 positive, 3 negative, 1 abstaining). However, the committee voted that Restanza did not demonstrate efficacy in the treatment of CAP (3 positive, 11 negative, 1 abstaining).

On 7/1/09, CombinatoRx (NASDAQ:CRXX) ($0.75) and privately-held Neuromed Pharma announced they have entered into a definitive merger agreement under which CRXX and Neuromed will merge in an all-stock transaction. Under the terms of the merger agreement, CRXX is expected to issue approximately 36 million new shares of its common stock to Neuromed stockholders with each party owning approximately 50% of the voting power of the merged organization upon closing. Relative ownership of CRXX will then be adjusted based upon the outcome of a FDA review for Neuromed's New Drug Application (NDA) product candidate, Exalgo (a once-daily, extended-release oral formulation of the opiate pain drug hydromorphone).

The rights to Exalgo have been acquired by Mallinckrodt Inc., a subsidiary of Covidien (NYSE:COV), for $15 million in upfront payments, additional development funding of up to $16 million to cover internal and external costs associated with Exalgo, an approval milestone of $30 million, which could potentially increase up to $40 million, and tiered royalties on net sales after approval. Neuromed has a pending NDA for Exalgo with the FDA, which has a PDUFA action date during 4Q09 for a possible FDA decision.

On 7/8/09, Transdel Pharma (OTC:TDLP) ($1.40) announced the successful completion of patient enrollment in a pivotal Phase 3 clinical study for Ketotransdel, which is a topical cream based non-steroidal anti-inflammatory drug (NSAID) for the treatment of acute pain. As previously announced, TDLP.OB expects to report the top-line results from this Phase 3 trial later in 3Q09. The multi-center trial is being conducted at about 30 sites in the U.S. and has enrolled over 350 patients. The primary efficacy endpoint is the change from baseline in pain intensity as measured by a Visual Analog Scale (VAS) during daily activities over the past 24 hours at Day 3. The Company also stated that it is either engaged in or pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures to support Ketotransdel in the event that the product is approved and commercialized.

On 7/8/09, Vical (NASDAQ:VICL) ($2.68) announced that its TransVax therapeutic DNA cytomegalovirus (CMV) vaccine provided promising results compared with placebo across a broad range of clinical efficacy endpoints at the four-month interim analysis in an ongoing Phase 2 trial. The trial is evaluating the potential for TransVax to prevent CMV reactivation in immunosuppressed CMV-seropositive hematopoietic stem cell transplant (HCT) recipients, which could reduce antiviral usage and CMV-associated disease. The interim efficacy data for evaluable subjects, unblinded by treatment groups, also reinforced encouraging immunogenicity data from an initial group of HCT recipients in the trial reported previously in 4Q08. Vical expects the trial to be completed during 4Q09 with final data available during 1H10.

On 11/14/08, Nephros (OTC:NEPH) ($1.25) submitted a 510(k) application to the FDA for approval of its HDF products for ESRD in the U.S. market. Following its review of the application, the FDA requested additional information, and Nephros replied to the Agency on 3/13/09. Per FDA guidelines, the FDA has 90 days to review the additional information provided by the Company, but a response from the Agency is still pending for the OLpur H2H Hemodiafiltration (HDF) Module and OLpur MD 220 Hemodiafilter.

Disclosure: No positions.

Companies with Certified Existing Treatments for Swine Flu

Companies with Potential Vaccines and Treatments for Swine Flu

CEL-SCI Corporation (Amex: CVM) Product: proprietary L.E.A.P.S. technology (Ligand Epitope Antigen Presentation System)Biota Holdings Ltd.(ASX:BTA) / Daiichi Sankyo Product: CS-8958BioCryst Pharmaceuticals,Inc. (NASDAQ:BCRX) Product: Peramivir IntravenousNovavax, Inc. (NASDAQ:NVAX)Product: Swine Flu Vaccines using Virus-like particle (VLP) technologyInovio Biomedical Corporation (NYSE Amex:INO)Product: SynCon™ H1N1 influenza DNA vaccinesVical Incorporated(Public, NASDAQ:VICL)Product: Patented DNA delivery technologySinovac Biotech Ltd. (Amex: SVA)Product: Panflu(TM)Wyeth (NYSE: WYE) Product: PCV13 or Prevnar 13

MedImmune / AstraZeneca PLC (NYSE:AZN) Product: needle-free, nasal spray swine flu vaccine by using Live Attenuated Influenza Vaccine (LAIV) technology

Sanofi-Aventis SA (NYSE:SNY) Product: Swine Flu Vaccine

The launch of clinical trials is a key part of a widening programme of work being undertaken by big pharmaceutical companies as they prepare for mass vaccination from next month.

GlaxoSmithKline , the other "big three" flu vaccine supplier, said it would initiate clinical studies later this month.

H1N1 swine flu, which first surfaced in Mexico in April and was declared a pandemic by the World Health Organisation (WHO) in June, has infected millions and killed an unknown number.

The WHO stopped counting at 800 confirmed deaths, since not every patient can possibly be tested.

Healthcare officials are relying on a vaccine to contain the spread of disease, providing a potential sales windfall for those companies that are able to deliver quickly and in large volume.

Australia's CSL has so far been the fastest commercial operator, after starting its first clinical trials in Australia two weeks ago. Now others are catching up.

"We started a little over a week ago," Novartis spokesman Eric Althoff said by telephone from Basel.

Benoit Rungeard, product communications director for Sanofi Pasteur, the vaccines division of the French drugmaker, told Reuters his company would start "in the coming days or next week".

Althoff said Swiss-based Novartis was conducting its clinical trials in a number of countries, including the United States, Britain and Germany, and was testing both single and booster, or repeat, doses of vaccines.

Novartis, in common with other manufacturers, will also compare vaccines with and without adjuvants -- ingredients that boost the immune system response.

AstraZeneca, whose MedImmune unit makes smaller amounts of a flu vaccine that is sprayed into the nose rather than injected, said it would start clinical trials in the United States around Aug. 17.

As well as racing against the clock, vaccine companies are also working flat out to maximise their production capacity.

Initially, all the manufacturers except MedImmune -- which uses a different process -- struggled with low yields when making swine flu vaccine, with most companies only getting about 30 percent of the usual yield of seasonal flu strains.

But that is starting to improve.

"We are higher than that (30 percent)," Sanofi's Rungeard said.

"During the production campaign the yield increases because we learn how to better use it -- at the beginning it is not same as at the end," he added. Regulators in Europe and the United States plan to fast-track approval of swine flu vaccines to ensure they are available for the start of the northern hemisphere winter.

At the moment swine flu is rated only a "moderate" pandemic by WHO standards but it could worsen as temperatures cool, making conditions better for the virus. (Editing by Greg Mahlich)

Companies with Certified Existing Treatments for Swine Flu

Companies with Potential Vaccines and Treatments for Swine Flu

CEL-SCI Corporation (Amex: CVM) Product: proprietary L.E.A.P.S. technology (Ligand Epitope Antigen Presentation System)Biota Holdings Ltd.(ASX:BTA) / Daiichi Sankyo Product: CS-8958BioCryst Pharmaceuticals,Inc. (NASDAQ:BCRX) Product: Peramivir IntravenousNovavax, Inc. (NASDAQ:NVAX)Product: Swine Flu Vaccines using Virus-like particle (VLP) technologyInovio Biomedical Corporation (NYSE Amex:INO)Product: SynCon™ H1N1 influenza DNA vaccinesVical Incorporated(Public, NASDAQ:VICL)Product: Patented DNA delivery technologySinovac Biotech Ltd. (Amex: SVA)Product: Panflu(TM)Wyeth (NYSE: WYE) Product: PCV13 or Prevnar 13

MedImmune / AstraZeneca PLC (NYSE:AZN) Product: needle-free, nasal spray swine flu vaccine by using Live Attenuated Influenza Vaccine (LAIV) technology

Sanofi-Aventis SA (NYSE:SNY) Product: Swine Flu Vaccine

Companies with Certified Existing Treatments for Swine Flu

Companies with Potential Treatments for Swine Flu

CEL-SCI Corporation (Amex: CVM) Product: proprietary L.E.A.P.S. technology (Ligand Epitope Antigen Presentation System)

Companies with Potential Vaccines for Swine FluBiota Holdings Ltd.(ASX:BTA) / Daiichi Sankyo Product: CS-8958BioCryst Pharmaceuticals,Inc. (NASDAQ:BCRX) Product: Peramivir IntravenousNovavax, Inc. (NASDAQ:NVAX)Product: Swine Flu Vaccines using Virus-like particle (VLP) technologyInovio Biomedical Corporation (NYSE Amex:INO)Product: SynCon™ H1N1 influenza DNA vaccinesVical Incorporated(Public, NASDAQ:VICL)Product: Patented DNA delivery technologySinovac Biotech Ltd. (Amex: SVA)Product: Panflu(TM)Wyeth (NYSE: WYE) Product: PCV13 or Prevnar 13

MedImmune / AstraZeneca PLC (NYSE:AZN) Product: needle-free, nasal spray swine flu vaccine by using Live Attenuated Influenza Vaccine (LAIV) technology

Sanofi-Aventis SA (NYSE:SNY) Product: Swine Flu Vaccine

The company which develops and commercializes products to stimulate the body’s natural tissue regenerative process and whose protein therapeutic-device combination products are used for the treatment of musculoskeletal injuries and conditions affecting bones, tendons, ligaments, and cartilage saw it's stock close at $13.08 +1.37 (11.70%) as the small-cap prepares for a presentation next week at the Orthopedic Trauma Association's Annual meeting (Oct. 8-10) and at the American Orthopaedic Foot & Ankle Society conference on Nov. 6-7.

Also among the winners was Elron Electronic Industries Ltd. (NASDAQ:ELRN) which closed up +0.56 (10.89%) to $5.70. This is a multi-faceted play that covers various sectors including healthcare beacuse it's technically a technology operational holding company that operates through its group companies. The company is engaged primarily in the fields of medical devices, information communications, technology, semiconductors and clean technology. Clean tech is being touted by many as the next big opportunity sector for investors.

NovaMed, Inc.(NASDAQ:NOVA) closed at $4.58+0.36 (8.53%) and saw nearly half it's gains for the day come in the closing minutes of the regular session. After hour trades were not unusual and didn't show any added volatility or price increase, however. NovaMed, Inc. is a health care services company and an owner and operator of ambulatory surgery centers (ASCs).

Leading the losers was MannKind Corporation (NASDAQ:MNKD). Shares of  this biopharmaceutical company focused on the discovery, development and commercialization of therapeutic products for diseases, such as diabetes and cancer have plummeted over 31% on Tuesday to $6.31, after the company said it would be unable to conclude a partnership deal for its inhaled insulin product, AFRESA, by the end of the year.

DepoMed, Inc.(NASDAQ:DEPO) pulled back just a bit after Monday's big jump for the stock. The company announced top-line results from a Phase 3 clinical trial demonstrating DM-1796 (also referred to as gabapentin ER) achieved a statistically significant reduction in pain associated with postherpetic neuralgia (PHN) versus placebo using the baseline observation carried forward (BOCF) method required by FDA. The primary endpoint measured pain scores from baseline to the end of a ten-week treatment period using the numerical Likert pain scale. Some analysts are reiterating a positive rating for the stock and believe the market has yet to factor in the potential that this drug has in terms of delivering milestones and royalties to the company from partner Abbott Labs. As subscribers to our FDA and Clinical Trials Calendar know, up next for Depomed is the phase III Breeze data testing Serada in menopausal hot flashes. That data is expected to be out later this month and should help continue pushing shares upward.

For Wednesday, watch Vical Incorporated (Nasdaq:VICL) the company announced early this morning that the company's TransVax(TM) cytomegalovirus (CMV) vaccine continued to demonstrate an overall increase in cellular immune responses compared with placebo at the seven-month immunogenicity data point in an ongoing Phase 2 trial. Alain P. Rolland, Pharm.D., Ph.D., Vical's Executive Vice President of Product Development, presented the data today at the World Vaccine Congress (Lyon, France).

Here are the rest of Tuesday's Top Winners and Losers in healthcare:

BioCryst's investigational H1N1 drug granted Emergency Use OK CEO Says H1N1 Flu Drug Candidate Could Propel Company Onto World Stage Who's Afraid of the Big Bad Flu?

Companies with Certified Existing Treatments for Swine Flu

Companies with Potential Treatments for Swine Flu

CEL-SCI Corporation (Amex: CVM) Product: LEAPS-H1N1 Currently Under Special Fast Track Trials Authorized by FDA

Companies with Potential Vaccines and Treatments for Swine FluBiota Holdings Ltd.(ASX:BTA) / Daiichi Sankyo Product: CS-8958Novavax, Inc. (NASDAQ:NVAX)Product: Swine Flu Vaccines using Virus-like particle (VLP) technologyInovio Biomedical Corporation (NYSE Amex:INO)Product: SynCon™ H1N1 influenza DNA vaccinesVical Incorporated(Public, NASDAQ:VICL)Product: Patented DNA delivery technologySinovac Biotech Ltd. (Amex: SVA)Product: Panflu(TM)Wyeth (NYSE: WYE) Product: PCV13 or Prevnar 13

MedImmune / AstraZeneca PLC (NYSE:AZN) Product: needle-free, nasal spray swine flu vaccine by using Live Attenuated Influenza Vaccine (LAIV) technology

The declaration that Obama signed allows Health and Human Services chief Kathleen Sebelius to bypass federal rules when opening alternative care sites, such as offsite hospital centers at schools or community centers, if needed.

Hospitals could modify patient rules — for example, requiring them to give less information during a hectic time — to quicken access to treatment, with government approval.

The declaration, which the White House announced Saturday, allows HHS in some cases to let hospitals relocate emergency rooms offsite to reduce flu-related burdens and to protect noninfected patients.

Administration officials said the declaration was a pre-emptive move designed to make decisions easier when they need to be made. Officials said this was not in response to any single development on an outbreak that has lasted months and has killed more than 1,000 people in the United States.

It was the second of two steps needed to give Sebelius extraordinary powers during a crisis. On April 26, the administration declared swine flu a public health emergency, allowing the shipment of roughly 12 million doses of flu-fighting medications from a federal stockpile to states in case they eventually needed them. At the time, there were 20 confirmed cases in the U.S. of people recovering easily. There was no vaccine against swine flu, but the CDC had taken the initial step necessary for producing one.

"As a nation, we have prepared at all levels of government, and as individuals and communities, taking unprecedented steps to counter the emerging pandemic," Obama wrote in the declaration.

Because of vaccine production delays, the government has backed off initial, optimistic estimates that as many as 120 million doses would be available by mid-October. As of Wednesday, only 11 million doses had been shipped to health departments, doctor's offices and other providers, according to the Centers for Disease Control and Prevention officials said.

The government now hopes to have about 50 million doses of swine flu vaccine out by mid-November and 150 million in December.

The flu virus has to be grown in chicken eggs, and the yield hasn't been as high as was initially hoped, officials explained.

In Massachusetts, the Boston Globe is reporting that for the first time this fall, public health authorities described the state’s influenza outbreak as widespread, the highest category on the scale of disease spread. In a weekly surveillance report, officials said they had seen a “dramatic increase in influenza-like illnesses over the past few weeks’’ compared with early fall levels in previous years.

“We had always been predicting this,’’ Dr. Lauren Smith, medical director of the state Department of Public Health, said yesterday. “We knew the H1N1 [swine flu] virus was going to be increasing. We didn’t know when, but now we do. It’s here.’’

It was just six months ago that the U.S. Centers for Disease Control and Prevention reported that two children in California had developed a respiratory illness never before seen in humans, referring to the infection as "swine flu" in its Morbidity and Mortality Weekly Report.

Flu activity is now widespread in 46 states. Nationwide, visits to doctors for influenza-like-illness are increasing steeply and are now higher than what is seen at the peak of many regular flu seasons. In addition, flu-related hospitalizations and deaths continue to go up nation-wide and are above what is expected for this time of year.

Below is a summary of the most recent key indicators:

Last week the CDC reported that influenza activity increased dramatically in the U.S.

H1N1 flu 'pushing hospitals to their limit' H1N1 flu vaccine shortage possible While the director admitted that there are new technologies available to speed up the process for flu vaccine production, changes in the way the U.S. Government handles that time intensive process may not see a change for "at least a couple of years." Still, the director insisted that his group is looking closely at some of these new technologies and that his group needs to encourage more development and testing. Some companies are also doing and developing business with their technologies outside the U.S.Currently, the flu virus has to be grown out in chicken eggs, a 50-year-old technology that is "tried and true" but difficult to speed up, says the CDC's director. Delays in growing the virus are the biggest factor contributing to the problem, but some delays have also occurred because countries where the vaccines are manufactured have insisted that their own needs be met before doses are shipped out of the country. With the exception of intranasal vaccine FluMist, all of the influenza vaccines are manufactured in other countries, "leaving this country at the mercy of other governments," according to the Los Angeles Times.This news may affect the shares of some of the publicly traded companies who are developing some of these new vaccination technologies. They include: Novavax, Inc. (NASDAQ:NVAX)Product: Vaccines using Virus-like particle (VLP) technology Inovio Biomedical Corporation (NYSE Amex:INO)Product: SynCon™ H1N1 influenza DNA vaccinesVical Incorporated(Public, NASDAQ:VICL)Product: Patented DNA delivery technologySinovac Biotech Ltd. (Amex: SVA)Product: Panflu(TM)