NOTE TO EDITORS: The Following Is an Investment Opinion Being Issued by WallStSense.com

The market for initial public offerings is thawing, but retail investors shouldn't expect to find access to this notoriously exclusive market any easier -- though a few back doors are open for those who know where to look.

See the rest of the story here.

Theflyonthewall.com is Wall Street's specialist in breaking equity news. Veteran traders build a proprietary feed of news that's faster and more relevant than any other source. Try us for free and discover for yourself.

See the rest of the story here.

Theflyonthewall.com is Wall Street's specialist in breaking equity news. Veteran traders build a proprietary feed of news that's faster and more relevant than any other source. Try us for free and discover for yourself.

Visit StreetInsider.com at http://www.streetinsider.com/news.php?st=p&id=5129077 for the full story.

See the rest of the story here.

Theflyonthewall.com is Wall Street's specialist in breaking equity news. Veteran traders build a proprietary feed of news that's faster and more relevant than any other source. Try us for free and discover for yourself.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has set a new action date under the Prescription Drug User Fee Act for the review of the New Drug Application (NDA) for Exalgo™ (hydromorphone HCl extended-release) Tablets (CII), (Exalgo) of February 22, 2010.Antigenics Inc. (NASDAQ: AGEN) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has formally adopted a negative opinion on the marketing authorization application (MAA) for Oncophage (vitespen) as a treatment in earlier-stage, localized renal cell carcinoma (kidney cancer).Inovio Biomedical Corporation (NYSE Amex:INO), a leader in DNA vaccine design, development and delivery, announced today that a combination of its synthetic consensus H1N1, H2N2, H3N2, and H5N1 influenza vaccine candidates achieved protective antibody responses against several different influenza sub-types and strains in ferrets.Genta Incorporated (OTCBB: GETA.OB) announced preliminary results that show a high objective response rate in a pilot study of patients with advanced melanoma that incorporates the Company’s lead oncology product, Genasense® (oblimersen sodium) Injection, administered for the first time as a 1-hour high-dose intravenous (IV) infusion.POZEN Inc. (NASDAQ: POZN) announced today the start of enrollment for the phase 3 studies for PA32540. PA32540 is a fixed-dose combination of 325 mg of enteric coated aspirin and 40 mg of immediate release omeprazole, under investigation for use in the secondary prevention of heart attacks and strokes in patients at risk for associated gastric ulcers.Novavax, Inc. (Nasdaq: NVAX) today announced that it has priced an underwritten public offering of 6,800,000 shares of its common stock at a price to the public of $3.30 per share.GLG Life Tech Corporation (TSX:GLG)(NASDA:GLGL), the vertically integrated leader in the agricultural and industrial development of high quality stevia extracts, announced today that it has commenced trading on the NASDAQ Global Market under the symbol "GLGL".PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy and hospital pharmacy management services, announced that it has appointed Geoffrey G. Meyers to the Company’s Board of Directors.Cyberonics, Inc. (Nasdaq: CYBX) today announced that Dan Moore, President and Chief Executive Officer, and Greg Browne, Chief Financial Officer, will present at the 21st Annual Piper Jaffray Health Care Conference in New York on Wednesday, December 2, 2009 at 12:00 PM EST.Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ABILIFY® (aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.Lannett Company, Inc. (NYSE AMEX: LCI) today announced that its Board of Directors has approved a reauthorization of the stock repurchase program. Under the program the company is authorized to repurchase up to $5 million of Lannett’s outstanding common stock from time to time in open market and privately negotiated transactions.Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced that it will webcast its presentations at the Piper Jaffray 21st Annual Health Care Conference on Wednesday, December 2, 2009 at 2:00 p.m. EST and at the 2009 Deutsche Bank Biotech Boston Confab on Tuesday, December 15, 2009 at 9:00 a.m. EST.OPTIMIZERx Corporation (OTCBB:OPRX) has engaged Beringea LLC, an investment banking and private equity firm, to assist in financial planning and strategic positioning for the company's continued growth.Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food and Drug Administration (FDA) provided written acknowledgement that the Company's amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T) is a complete response.Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that data from a preclinical study on its selective androgen receptor modulator (SARM) LGD-4033 was featured in a poster presentation at the 62nd Annual Meeting of the Gerontology Society of America in Atlanta. LGD-4033 exhibited desirable in vivo efficacy on skeletal muscle and bone measurements in animal models of male hypogonadism and postmenopausal osteoporosis.BD (Becton, Dickinson and Company) (NYSE:BDX) today announced the completion of its acquisition of HandyLab, Inc., an Ann Arbor, Michigan-based company that develops and manufactures molecular diagnostic assays and automation platforms.Soligenix, Inc. (OTC Bulletin Board: SNGX), formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today that it has formed a consortium to develop thermostable technology to advance RiVax(TM) and other rapidly acting vaccines.

 

The amended BLA includes data from the IMPACT trial, which was conducted under a Special Protocol Assessment agreement with the FDA. The IMPACT study met its pre-specified primary endpoint demonstrating a statistically significant improvement in overall survival in men with metastatic CRPC.

PROVENGE is currently available through several ongoing clinical trials, including OpenACT, an open label trial enrolling men with metastatic CRPC, ProACT, and NeoACT. On 4/28/09, DNDN announced that its experimental cancer vaccine Provenge extended the life of patients with advanced prostate cancer by a median of 4.1 months, which is one month longer than the only other treatment option, Taxotere. The Company will have the manufacturing capacity to generate possible sales of $60-125 million during 2H10 until full capacity is achieved in late 2011.

On 11/20/09, the FDA accepted Dendreon's amended BLA as a complete response and set a PDUFA action date of 5/1/10 for an expected FDA decision, seeking approval for PROVENGE in men with metastatic castrate-resistant prostate cancer (CRPC). The FDA considers the amended BLA to be a complete, Class 2 Resubmission following the action letter the company received in 2007.

On 11/16/09, CombinatoRx (NASDAQ: CRXX) announced that on 11/13/09, representatives of Neuromed discussed the pending Exalgo NDA with staff from the FDA. In these discussions, the FDA staff indicated that the NDA in its current form would not be sufficient to form the basis for approval of Exalgo. Based on these discussions with the FDA, Neuromed is working with Mallinckrodt, who owns the commercial rights to Exalgo, to determine the appropriate actions to be taken based on the discussions with the staff of the FDA, which actions may include amending the existing NDA, or potentially resubmitting the NDA under Section 505(b)(2), which utilizes different criteria to determine the basis for approval of a new drug candidate.

On 7/1/09, CRXX and Neuromed Pharma (privately held) announced a definitive merger agreement under which CRXX and Neuromed will merge in an all-stock transaction. Final merger terms will be adjusted based upon the outcome of a pending FDA decision for Exalgo (a once-daily, extended-release oral formulation of the opiate pain drug hydromorphone) seeking approval for the treatment of moderate to severe pain in opioid tolerant patients. The rights to Exalgo have been acquired by a subsidiary (Mallinckrodt) of Covidien (NYSE: COV). A FDA Advisory Panel was conducted on 9/23/09 for Exalgo, which had an original PDUFA action date of 11/22/09 that was extended today by three months until 2/22/10.

On 11/20/09, Pozen (NASDAQ: POZN) announced the start of enrollment for the Phase 3 studies evaluating PA32540, which is a fixed-dose combination of 325 mg of enteric coated aspirin and 40 mg of immediate release omeprazole that is being studied for the potential use in the secondary prevention of heart attacks and strokes in patients at risk for associated gastric ulcers. POZN is conducting two pivotal Phase 3 studies and one long-term safety study.

The two Phase 3 pivotal trials will be conducted under a Special Protocol Assessment (SPA) agreed upon with the FDA. These studies will involve over 100 sites, enrolling approximately 500 patients per study. The primary endpoint of the pivotal studies is the cumulative incidence of gastric ulcers over the six-month treatment period for PA32540 versus 325 mg of enteric-coated aspirin. The long-term safety study will be enrolling approximately 400 subjects and will assess the safety of PA32540 over one year.

Key elements of this Phase 3 development program include: (1) bio-equivalency proven to enteric coated aspirin (ECASA); (2) SPA agreement with FDA for 2 replicate 6-month Phase 3 studies to demonstrate that PA32540 is associated with a significant reduction in gastric ulcers compared to ECASA 325 mg in patients requiring aspirin therapy for secondary CV prevention who are at risk for ASA-associated gastric ulcers; and (3) safety of PA32540 based on at least 100 patients with 12 months exposure.

On 6/30/09, Photocure (OSL: PHO) (OTC: PHCUF.PK) announced that a New Drug Application (NDA) was submitted to the FDA seeking approval for Hexvix for use in the detection of papillary bladder cancer using fluorescence cystoscopy. The NDA includes clinical data from 1838 patients, comprising two recently completed clinical studies, one Phase 3 pivotal study in 789 patients from EU/US and a Phase 3 study performed in Denmark in 233 patients. All studies in the documentation demonstrate that fluorescence cystoscopy using Hexvix significantly improves detection of papillary bladder cancer compared to standard white light cystoscopy.

Photocure, in collaboration with GE Healthcare (NYSE: GE) has had several meetings with the FDA, leading up to this submission and the results of the pivotal Phase 3 study have been presented to the FDA. On 8/31/09, Photocure announced the FDA granted a priority (6-month) review for the NDA with an expected PDUFA decision date of 12/30/09. On 12/17/09, this NDA will be discussed at a meeting of the FDA Oncologic Drugs Advisory Committee.

The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results.

Coming soon is a premium service offered in collaboration with Investars YOU for full access to a global database of over 1,000 stocks which are organized and managed within my 23 ProActive HavRx stock indexes. This service will allow investors to create custom portfolios, personalized exchange-traded funds (ETFs), and generate investment ideas based on their personal preferences, beliefs, and opinions through specialized stock indexes that are organized and targeted toward a wide variety of themes.

Disclosure: No positions

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.AVANIR Pharmaceuticals, Inc. (NASDAQ:AVNR) announced the Company will present at the Lazard Capital Markets 6th Annual Healthcare Conference on Wednesday, November 18th at 3:15 p.m. Eastern time (12:15 p.m. Pacific time) at the St. Regis in New York.Adamis Pharmaceuticals Corporation (OTC:ADMP), announced it’s wholly owned subsidiary, Adamis Labs has now secured distribution contracts and initial stocking orders from the three major wholesalers of prescription drugs in the U.S.Alexion Pharmaceuticals, Inc. (Nasdaq:ALXN) announced Dr. Leonard Bell, Chief Executive Officer of Alexion Pharmaceuticals, will present at Lazard Capital Markets 6th Annual Healthcare Conference in New York City at 10:00 a.m. ET on Wednesday, November 18, 2009.

Bruker Corporation (NASDAQ:BRKR) announced it will present at the Lazard Capital Markets 6th Annual Healthcare Conference on Tuesday, November 17, 2009, at 10:55 AM Eastern Standard Time in New York City.

Covidien (NYSE:COV) will present at the Lazard Capital Markets 6th Annual Healthcare Conference in New York on Wednesday, November 18, 2009.

Curis, Inc. (NASDAQ:CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, announced the Company will be presenting at the Lazard Capital Markets 6th Annual Healthcare Conference at 3:45 p.m. EST on November 18, 2009, in New York City.

Enzo Biochem, Inc. (NYSE:ENZ), a leading vertically integrated clinical lab, life sciences and therapeutic biotechnology company, announced Barry Weiner, President, and David Goldberg, Vice President, Corporate Development, will be presenting at the Lazard Capital Markets 6th Annual Healthcare Conference on Tuesday, November 17, 2009 at 3:40 PM at The St. Regis Hotel in New York, N.Y.

IMS Health (NYSE: RX), the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries, announced the upcoming launch of IMS Oncology QuantifierTM, a comprehensive, clinically rich analytical tool that enables the company’s clients to assess treatment opportunities and guide commercial decisions in the $48 billion global oncology market.

ImmunoGen, Inc. (Nasdaq:IMGN), a biotechnology company that develops targeted anticancer products, announced Howard Pien was elected to its Board of Directors at today’s Annual Meeting of Shareholders.

LecTec Corporation (OTC:LECT) announced it has reached a settlement with Endo Pharmaceuticals Inc. on outstanding patent litigation related to LecTec’s U.S. Patent Nos. 5,536,263 and 5,741,510.

MS Health (NYSE:RX), the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries, announced the upcoming launch of IMS Oncology QuantifierTM, a comprehensive, clinically rich analytical tool that enables the company’s clients to assess treatment opportunities and guide commercial decisions in the $48 billion global oncology market.NexMed, Inc. (Nasdaq:NEXM), a developer of innovative transdermal products based on the NexACT® drug delivery technology, announced it raised $750,000 in gross proceeds from the issuance of new convertible notes due December 31, 2011 (the “Notes”), which are secured by a mortgage on NexMed’s facility in East Windsor, New Jersey.

Novavax, Inc. (Nasdaq: NVAX) a clinical-stage vaccine company, announced today that John Trizzino, Senior Vice President, International and Government Alliances, will be presenting at the Influenza Congress USA 2009.

Chief Research Officer Morris S. Whitcup, Ph.D., of ORC Guideline (NASDAQ:IUSA) will present findings of the company’s recent research on the impact of social media on fair balance and pharmaceutical marketing at a Food and Drug Administration (FDA) public hearing later this week.

PPD, Inc. (Nasdaq:PPDI) announced its board of directors declared a cash dividend for the fourth quarter of 2009 under its annual cash dividend policy. The quarterly cash dividend will equal $0.15 per share.

Synta Pharmaceuticals Corp. (NASDAQ:SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, announced the Company will be presenting at the Lazard Capital Markets 6th Annual Healthcare Conference on Wednesday, November 18 at 10:00 a.m. (ET) at the St. Regis New York.Tongjitang Chinese Medicines Company (NYSE: TCM), a leading specialty pharmaceutical company focusing on the development, manufacturing, marketing and selling of modernized traditional Chinese medicine in China, announced it plans to announce its third quarter 2009 financial results before the market opens on Wednesday, November 18, 2009.

Schaeffer's analyst Morgan Searcy takes a look at news on the Street before the market open.

Two Veteran Wall Street Analysts discuss: (Vern:) PCAR, COV, ZOLL; (Val:) JNJ, KCI, SYK

Tom Dorsey and Tammy DeRosier - Regressed to Mean

Tammy DeRosier and Jay Ball - Dow Jones vs. New York Stock Exchange Bullish Percent