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.454 Life Sciences, a Roche Company (SWX:RO) (SWX:ROG) (Pink Sheets: RHHBY), announced today at the Association of Molecular Pathology Annual Meeting in Kissimmee, Florida a series of revolutionary developments which significantly expand the company’s high-throughput sequencing portfolio.Advanced Cell Technology, Inc. (OTCBB:ACTC) announced today that it filed an Investigational New Drug (IND) Application with the US Food and Drug Administration (FDA) to initiate a Phase I/II multicenter study using embryonic stem cell derived retinal cells to treat patients with Stargardt’s Macular Dystrophy (SMD).Advanced Cell Technology, Inc. (OTCBB:ACTC) announced today that it filed an Investigational New Drug (IND) Application with the US Food and Drug Administration (FDA) to initiate a Phase I/II multicenter study using embryonic stem cell derived retinal cells to treat patients with Stargardt’s Macular Dystrophy (SMD).Bioanalytical Systems, Inc. (NASDAQ:BASI) announced today that its application to transfer from the NASDAQ Stock Market to the NASDAQ Capital Market has been accepted. The transfer will occur on November 20, 2009.Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) presented data from its pipeline programs at the 2009 EORTC-NCI-AACR (European Organization for Research and Treatment of Cancer-National Cancer Institute-American Association for Cancer Research) annual meeting in Boston, Massachusetts.Geron Corporation (Nasdaq:GERN) today announced the presentation of interim data from its ongoing trial of imetelstat (GRN163L), a telomerase inhibitor drug, in patients with refractory, advanced solid cancers at the 2009 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.NeoStem, Inc. (NYSE Amex: NBS), announced today that it has sent the following letter to its shareholders, discussing the Company's acquisition, on October 30, 2009, of China Biopharmaceuticals Holdings, Inc. (CHBP), an integrated bio-pharmaceutical company based in the People's Republic of China.Non-Invasive Monitoring Systems, Inc. [NIMS] (OTCBB:NIMU) announced that the Nogawa Patent Office in Japan issued Patent number 4391595 to NIMS on October 16, 2009. This patent, entitled “Reciprocating Movement Platform for Shifting Subject To and Fro In Headwards-Footwards Direction,” relates to the comprehensively researched technology underlying NIMS’ Exer-Rest acceleration therapeutic platform.OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that it will host a live webcast of its R&D Analyst Day on Thursday, December 3, 2009 at 12:30 p.m. Eastern Time.Perrigo Company (Nasdaq: PRGO; TASE) today announced that Perrigo Chairman and CEO Joseph C. Papa will present at the Sidoti Emerging Growth Conference on Friday, November 20, at 3:15 p.m. (EST) at the Grand Hyatt Hotel in New York City.Sensient Technologies Corporation (NYSE: SXT) announced today that it has entered into an agreement with a group of financial institutions for the issuance of $110 million in fixed-rate, senior notes.SeraCare Life Sciences, Inc. (NASDAQ: SRLS), a global life sciences company providing vital products and services to facilitate the discovery, development and production of human diagnostics and therapeutics, today reported operational and financial results for its fourth quarter and fiscal year ended September 30, 2009.Unilife Medical Solutions Limited ("Unilife" or "the Company") (ASX: UNI)(PINKSHEETS: UNIFF) today announced the appointment of Mikron Group ("Mikron") as its contracted supply partner for the development and supply of automated assembly systems to support the commercial production of the Unifill™ ready-to-fill syringe (Unifill™ syringe).

ArQule, Inc. (Nasdaq: ARQL) presented data at the AACR-NCI-EORTC meeting in Boston demonstrating the capabilities of the Company’s proprietary drug discovery platform to generate a class of small molecules with significant therapeutic potential.Art's Way Manufacturing, Inc. (Nasdaq: ARTW), announces its wholly owned subsidiary, Art's Way Scientific, Inc. - Buildings For Science - will be providing 6 modular swine facilities for breeding, gestation, farrowing, nursery and finisher operations.BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), a specialty pharmaceutical company developing products for female sexual health, including LibiGel® for th treatment of hypoactive sexual desire disorder (HSDD), applauds the efforts of Boehringer Ingelheim to develop a therapy to treat this unmet medical need. Cannabis Science Inc. (NASD OTCBB: CBIS) an emerging pharmaceutical cannabis company, is hailing the call by the American Medical Association's House of Delegates for “marijuana's status as a federal Schedule I controlled substance be reviewed with the goal of facilitating the conduct of clinical research and development of cannabinoid-based medicines."Cadus Corporation (OTC Bulletin Board: KDUS) announced financial results for the third quarter ended September 30, 2009.Derma Sciences, Inc. (OTC Bulletin Board: DSCI) a specialty medical device/pharmaceutical company focused on advanced wound care, announced it has filed an S-1 Registration Statement to offer 1,500,000 shares of its common stock. Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) announced data from its pipeline programs will be presented at the 2009 EORTC-NCI-AACR (European Organization for Research and Treatment of Cancer-National Cancer Institute-American Association for Cancer Research) annual meeting being held November 16-19, 2009 in Boston, Massachusetts.Exact Sciences Corp. (Nasdaq: EXAS) announced it will present at the Lazard Capital Markets Sixth Annual Healthcare Conference, which is being held Nov. 17-18, at the St. Regis Hotel in New York.Health Grades, Inc. (Nasdaq: HGRD), the leading healthcare ratings company, announced Kerry Hicks, President and Chief Executive Officer of Health Grade, will be presenting at the Sidoti & Company, LLC New York II Emerging Growth Institutional Investor Forum at The Grand Hyatt Hotel in New York on Friday, November 20, 2009, at 8:30 a.m. Eastern time.Inovio Biomedical Corporation (NYSE AMEX: INO) reported financial results for the three and nine months ended September 30, 2009.Mead Johnson Nutrition Company (NYSE: MJN) announced it intends to file a Registration Statement on Form S-4 with the Securities and Exchange Commission (SEC), which includes details of a proposed exchange offer whereby Bristol-Myers Squibb Company (BMS) shareholders can exchange some, none or all of their shares of BMS common stock for shares of Mead Johnson common stock.Metabolix, Inc. (NASDAQ: MBLX), a bioscience company focused on developing sustainable solutions for plastics, chemicals and energy, announced the complete on of its previously announced underwritten public offering of 3,450,000 shares of its common stock at a price of $9.00 per share for gross proceeds of approximately $31 million.  NovaDel Pharma Inc. (NYSE:NVD), a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed treatments, reported financial results for its third quarter and nine months ended September 30, 2009.Neogen Corporation (Nasdaq: NEOG) announced that its Board of Directors has approved a 3-for-2 stock split. OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced the Oncologic Drugs Advisory Committee (ODAC) will review the use of Tarceva® (erlotinib) as a first-line maintenance therapy for patients with advanced non-small cell lung cancer (NSCLC) who have not progressed following first-line treatment with platinum-based chemotherapy at its December 16, 2009 meeting.PPD, Inc. (Nasdaq: PPDI) announced it has entered an agreement with Janssen Pharmaceutica N.V. to develop and commercialize two Phase II-ready therapeutic compounds, one to treat diarrhea-predominant irritable bowel syndrome (IBS-d) and the other to treat complicated skin and skin structure and respiratory infections.Roche`s (SWX:RO) (SWX:ROG) (Pink Sheets: RHHBY) RealTime ready Influenza A/H1N1 Detection Set for the 2009 H1N1 influenza virus has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA). Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI), a commercial-stage biotechnology company with a primary focus in oncology, announced it has been selected for addition to the NASDAQ Biotechnology Index® (Nasdaq: NBI).Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics™, announced it has been selected for addition to the NASDAQ Biotechnology Index (NASDAQ: NBI) effective with the U.S. market open on Monday, November 23, 2009.ZOLL Medical Corporation (Nasdaq GS: ZOLL), a manufacturer of medical devices and related software solutions, announced the R Series® defibrillators with new monitoring capability added as well as its new intravascular temperature management solutions are being exhibited in Booth #1417 at the American Heart Association Scientific Sessions 2009 November 15-17th at the Orange County Convention Center in Orlando.

The FDA stated that satisfactory resolution of deficiencies related to the Allston Landing manufacturing plant are required before the Lumizyme application can be approved. Genzyme believes the other elements of the Lumizyme review, such as the Risk Evaluation and Mitigation Strategy (REMS), the product label, and post-marketing requirements, have been satisfactorily addressed. The FDA completed its five-week inspection of the Allston plant on 11/13/09 and provided Genzyme with a Form-483 outlining remaining deficiencies.

Genzyme's plan to address these deficiencies includes establishing additional internal controls and updating fill/finish capabilities in Allston, transferring additional filling activities to existing Genzyme contract manufacturers, and utilizing excess capacity at Genzyme's manufacturing facility in Waterford, Ireland, which is undergoing a major expansion with engineering runs scheduled to begin in early next year. This expansion will increase Genzyme's internal filling capacity by 4X.

Cerezyme (imiglucerase for injection) 400-unit vials, which supply over 80% of patients worldwide, will be filled exclusively in Waterford moving forward. Alglucosidase alfa 2000 L scale (Lumizyme) is no longer produced at the Allston facility and Genzyme is transitioning all patients worldwide to the product produced at a larger scale (4000 L) in the company's facility in Belgium with a request for a FDA meeting pending to discuss US approval for this facility.

On 7/13/09, OSI Pharma (NASDAQ: OSIP) announced that SATURN, a pivotal Phase 3 study of Tarceva (erlotinib), met a key secondary endpoint of extending overall survival in patients with advanced non-small cell lung cancer (NSCLC) who received Tarceva immediately after initial chemotherapy. A statistically significant improvement in overall survival was seen in this pre-planned final analysis of the total patient population. The overall survival data will be submitted to the FDA to support the supplemental New Drug Application (sNDA) for use of Tarceva as a first-line maintenance treatment for patients with advanced NSCLC that was submitted on 3/17/09 with an expected PDUFA action date of 1/18/10.

SATURN met its primary endpoint and showed patients with advanced NSCLC who received Tarceva as a first-line maintenance treatment had a 41% improvement in the time they lived without the disease advancing (progression-free survival or PFS) compared to placebo. On 11/16/09, OSIP announced that the Oncologic Drugs Advisory Committee (ODAC) will review the use of Tarceva as a first-line maintenance therapy for patients with advanced non-small cell lung cancer (NSCLC) who have not progressed following first-line treatment with platinum-based chemotherapy on 12/16/09.

On 8/11/09, Wyeth, since acquired by Pfizer (NYSE: PFE), announced it received notice that the action date for the pending FDA review of its Biologics License Application (BLA) for Prevnar 13, (Pneumococcal 13-valent Conjugate Vaccine) has been extended from 9/30/09 to 12/30/09. In response to an FDA request, Wyeth submitted additional analytical method validation and specification information relating to physical and chemical properties of the product in late July. The Agency considered this to be a major amendment and therefore extended the PDUFA action date by three months. On 5/7/09, WYE announced that the FDA granted a priority (six-month) review for this BLA which was filed at the end of March 2009.

The proposed indication in the U.S. for Prevnar 13 is for the prevention of invasive pneumococcal disease (IPD) and otitis media (ear infections) caused by the 13 serotypes included in the investigational vaccine in children aged two months through five years. Prevnar 13 is also being studied in global Phase 3 clinical trials in adults, with regulatory submissions expected in 2010. On 11/18/09, the Vaccines and Related Biological Products Advisory Committee will review this BLA.

On 11/16/09, Seattle Genetics (NASDAQ: SGEN) announced that it has initiated a Phase I clinical trial of SGN-75 for metastatic renal cell carcinoma and relapsed and refractory non-Hodgkin lymphoma. SGN-75 is an antibody-drug conjugate (ADC) targeting CD70 that utilizes the company's proprietary technology. CD70 is expressed on a variety of solid tumors, including renal cell carcinoma, pancreatic, ovarian and lung cancers and glioblastoma (GBM / brain cancer) as well as multiple myeloma and several types of lymphoma. The single-agent Phase I study is designed to enroll up to 80 patients at multiple centers in the US.

The trial will evaluate the safety, tolerability, pharmacokinetic profile and antitumor activity of SGN-75 in order to identify a dose and schedule for future clinical trials. SGN-75 is an ADC comprising an anti-CD70 antibody attached to a potent, synthetic drug payload, monomethyl auristatin F (MMAF), using SGEN's proprietary technology. The ADC is designed to be stable in the bloodstream, but to release its payload upon internalization into CD70-expressing tumor cells, resulting in targeted cell-killing.

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 22 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

(ENZN) Enzon Beats Expectations – Announces Sell-off

For Immediate Release

Chicago, IL – November 11, 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: Enzon (ENZN), Merck (MRK), OSI Pharmaceuticals (OSIP), Pfizer (PFE) and Bank of America Corporation (BAC).

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Here are highlights from Tuesday’s Analyst Blog:

Enzon Beats, Announces Sell-off

Enzon (ENZN) achieved break-even earnings during the third quarter of 2009, better than the Zacks Consensus Estimate of loss of 7 cents but below the year-ago earnings of 1 cent. The company reported revenues of $44.6 million, a decline of 9% compared to $48.8 million reported in the third quarter of 2008.

Enzon records revenues from three sources -- products, royalties and contract manufacturing. The three segments recorded a decline of 1%, 6% and 56%, respectively, compared to the year-ago period.

Enzon has four marketed products -- Oncaspar for the treatment of acute lymphoblastic leukemia (ALL); DepoCyt for lymphomatous meningitis; Abelcet for antifungal infection related to cancer and Adagen used to treat severe combined immunodeficiency disease (SCID), commonly known as the "bubble boy" disease. Apart from Oncaspar, whose sales remained unchanged from the year-ago period, the other three recorded a decline of 4%, 15% and 10%, respectively.

Enzon earns royalties from several products, which have been manufactured using its proprietary PEGylation technology -- Pegintron, marketed by Merck (MRK); Macugen, marketed by OSI Pharmaceuticals (OSIP) and Pfizer (PFE); Pegasys, marketed by Hoffmann-La Roche; and Cimzia, marketed by UCB Pharma. The company earns a majority of royalty revenue from sales of Pegintron, which is approved for the treatment of hepatitis C. Unfavorable movement of the foreign exchange brought down royalty revenues during the quarter.

Additionally, cancelled shipments and discontinuation of customer schedules were responsible for lower contract manufacturing revenues. We expect contract manufacturing revenues to suffer going forward since many of the current contracts are to expire in the next two years.

R&D expenses during the quarter were $15.8 million, unchanged from the year-ago period. The company has several pipeline candidates: PEG-SN38, the HIF-1 alpha antagonist, Survivin (antagonist) and other LNA- and PEGylation- based programs.

The company’s financial position continues to worry us. At the end of the reported quarter, total cash reserves including investments were $201.3 million, down compared to $206.9 million at the end of December 2008, primarily due to the repurchase of $20.4 million of notes in 2009 offset by the cash provided by operating activities.

Shortly after announcing its third quarter results, Enzon announced that it has decided to sell its specialty pharmaceutical business to the Sigma-Tau group of Italy for $300 million. In addition, the company is eligible to receive another $27 million based on success milestones and royalties of 5% - 10% on incremental net sales above a 2009 baseline amount from its four marketed products through 2014.

BofA Extends $184B in Credit

In its latest quarterly Lending & Investing Initiative report, Bank of America Corporation (BAC) said on Monday that it has extended about $184 billion in credit during the third quarter of 2009 to support households and communities.

The report makes obvious how BofA is utilizing the bailout money to support the U.S. economy. According to the report, since the fourth quarter of 2008 when the Troubled Asset Relief Program (TARP) was initiated, BofA had extended $759 billion in new credit. This represents almost $17 for every dollar of the $45 billion it received under the TARP. BofA also continues to provide a significant return on investment to the U.S. taxpayers. The bank is expected to pay more than $2.5 billion in dividend to the U.S. Treasury through Nov 16, 2009.

The extension of home loans continues to be among BofA’s priorities. The company extended $96 billion alone in first mortgages during the reported quarter. The loans helped nearly 450,000 people purchase a home or refinance an existing mortgage.

BofA is also extending credit to the municipalities and non-profits and has already provided $7 billion to help meet local needs and serve communities across the country.

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