The Food and Drug Administration needs three more months to review an application to a neuropathic pain drug being developed by XenoPort Inc. and GlaxoSmithKline PLC, the companies said.

{tiny;XNPT;3}XenoPort, Inc.(NASDAQ:XNPT) and GlaxoSmithKline said the FDA should complete its review of the drug, called gabapentin enacarbil, by Feb. 9, 2010. The review period was originally scheduled to end Monday.

The FDA determined that a Risk Evaluation and Mitigation Strategy (REMS) was necessary for GSK1838262. In response to FDA’s request, GSK submitted a proposed REMS. The FDA accepted this submission as a solicited major amendment to the GSK1838262 NDA. The FDA has the option to extend the PDUFA goal date when a sponsor submits a major amendment that provides a substantial amount of new data not previously reviewed by the FDA.

XenoPort, Inc. is a biopharmaceutical company. The Company is focused on developing a portfolio of internally discovered product candidates that utilize the body’s natural nutrient transport mechanisms to improve the therapeutic benefits of existing drugs.

The Company focuses on development and commercialization efforts on potential treatments of central nervous system (CNS), disorders. Its product candidate, XP13512, known in the United States by the trade name Solzira (gabapentin enacarbil) Extended Release Tablets, is being developed for the treatment of a number of CNS disorders. During the year ended December 31, 2008, XP13512 completed a Phase IIa clinical trial for the management of post-herpetic neuralgia (PHN), in the United States.

Eli Lilly (NYSE:LLY) expects to report results from a third Phase 3 Clinical Trial are expected in late 2009 for arzoxifene to increase bone mineral density in post-menopausal women. Arzoxifene has been shown to reduce bone turnover/breakdown and is also being studied to reduce the risk of breast cancer. The drug significantly increased lumbar spine and total hip bone mineral density (BMD) in postmenopausal women with normal or low bone mass, versus placebo. The third Phase 3 trial, GENERATIONS, is a five-year, randomized, double-blind, placebo-controlled study assessing the effects of arzoxifene on vertebral fracture incidence and on invasive breast cancer incidence in postmenopausal women with osteoporosis or with low bone density, with results expected in late 2009.

On 4/21/09, Alkermes (NASDAQ:ALKS) announced the completion of patient enrollment for the registration study of Vivitrol (naltrexone for extended-release injectable suspension) for the treatment of opiate dependence. ALKS expects topline results for the study during 4Q09 and plans to file a sNDA with the FDA during 2010 to expand the label of Vivitrol from its current indication in the treatment of alcohol dependence.

On 4/29/09, Rockwell Medical (NASDAQ:RMTI) announced the completion of patient enrollment in the Phase 2b study of SFP, which is a six-month, dose-ranging study in about 130 hemodialysis patients to determine the safety parameters and optimal SFP concentration to maintain normal levels of iron and hemoglobin. The Phase 2b trial should be completed by the end of September and data should be released about 60 days later, which should occur in late November or early December. The Phase 3 clinical trial for SFP should begin sometime during 4Q09-1Q10 and RMTI has guided for adequate cash flow and liquidity to reach this point without the need for raising cash. Click here to view or download my PDF stock profile report for RMTI from late April 2009.

On 5/7/09, Avanir Pharma (NASDAQ:AVNR) provided an update on its lead, Phase 3 compound called Zenvia (dextromethorphan + quinidine) AVNR completed target enrollment on 3/16/09 of patients into the STAR trial, which is a confirmatory Phase 3 clinical trial of Zenvia in patients exhibiting signs and symptoms of pseudobulbar affect. The randomized, multi-center, international STAR trial is designed to compare the effects of Zenvia 30/10 mg, Zenvia 20/10 mg and placebo on the rates of involuntary crying and laughing episodes. The final number of patients exceeded the original target by approximately 20% allowing a larger safety database and increased statistical power for the study. AVNR affirmed guidance that top-line data from the confirmatory Phase 3 STAR trial is expected no later than September 2009.

On 5/11/09, Acadia Pharma (NASDAQ:ACAD) provided the following update along with its quarterly financial results: Enrollment was completed in the Company's first pivotal Phase 3 trial of pimavanserin in patients with Parkinson's disease psychosis (PDP) in early May 2009. Top-line results from this trial are expected to be reported by the end of the third quarter of 2009 (3Q09). ACAD is continuing to enroll patients in the second pivotal Phase 3 trial of pimavanserin in patients with PDP. ACADIA also is continuing to conduct an open-label safety extension study pursuant to which eligible patients who have completed either of the two pivotal Phase 3 trials have the opportunity to enroll if, in the opinion of the physician, a patient may benefit from continued treatment with pimavanserin.

On 5/11/09, GTx Inc. (NASDAQ:GTXI) reported quarterly results and stated that is conducting a pivotal Phase 3 clinical trial evaluating Acapodene (toremifene) 20 mg for the prevention of prostate cancer in men with high-grade pre-cancerous prostate lesions (high-grade PIN). The primary endpoint of the study is a reduction in the incidence of prostate cancer. GTXI anticipates reporting data for this Phase 3 study in late summer 2009 and will file a NDA with the FDA in late 2009 based upon a positive trial outcome. GTXI also has a pending NDA for toremifene 80 mg (standard 10-month review with FDA decision expected in late October) seeking approval for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy.

On 5/28/09, Poniard Pharma (NASDAQ:PARD) announced updated clinical data from its randomized, controlled Phase 2 trial of picoplatin in patients with metastatic colorectal cancer (CRC). The new data demonstrated that picoplatin, given once every four weeks in combination with 5-fluorouracil and leucovorin in the FOLPI regimen, and oxaliplatin, given in combination with 5-fluorouracil and leucovorin in the modified FOLFOX-6 regimen, have similar anti-tumor activity in the treatment of first-line metastatic CRC, as assessed by progression-free survival (PFS) and disease control measured by tumor response rate. New data derived by three independent assessments of neurotoxicity indicated a statistically significant reduction in neurotoxicities with the use of picoplatin. Overall survival data are expected 2H09 for this trial.

On 6/1/09, Raptor Pharma (RPTP.OB) announced that it has dosed the first patient in its Phase 2b clinical trial, conducted in collaboration with the University of California, San Diego ("UCSD"), to evaluate Raptor's proprietary delayed-release cysteamine bitartrate ("DR Cysteamine") capsules in nephropathic cystinosis ("cystinosis"), a rare genetic lysosomal storage disease. Under Raptor's open Investigational New Drug application ("IND"), UCSD is performing the Raptor-sponsored trial at its General Clinical Research Center. The Phase 2b clinical trial will enroll up to six cystinosis patients with a history of good compliance using the currently available immediate-release form of cysteamine bitartrate, the only drug cleared for marketing by the FDA and European Medicines Agency ("EMEA") to treat cystinosis. The clinical trial will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of DR Cysteamine in patients. Data from the study are expected during 3Q09.

On 6/15/09, pSivida Corp. (NASDAQ:PSDV) announced that two newly-published peer reviewed scientific papers showed that Fluocinolone acetonide (FA) both inhibited VEGF (vascular endothelial growth factor) production and protected retinal cells and function (a neuroprotective effect). These findings support expanding the treatment indications for the Company's lead product, Iluvien, a miniaturized, injectable, sustained-release drug delivery system that releases FA directly into the eye. Iluvien is being evaluated in Phase 3 clinical trials for the treatment of Diabetic Macular Edema. Initial data from the 950-patient trials are expected to be reported by the end of 2009, with a NDA filing scheduled for early 2010.

On 6/15/09, Aeterna Zentaris (NASDAQ:AEZS) reported that patient follow-up in the open-label safety study (study 041) of its Phase 3 program in benign prostatic hyperplasia (BPH) with its lead endocrinology compound, cetrorelix pamoate, is scheduled to be completed at the end of the week. Therefore, data analysis and reporting will be brought forward from the scheduled fourth quarter into the third quarter of 2009, and will follow the disclosure of results from the first double-blind placebo controlled efficacy study (study 033). Cetrorelix is currently in three Phase 3 trials involving more than 1,600 patients with symptomatic BPH in Canada, the United States and Europe. First efficacy results are expected during 3Q09 with a NDA filing targeted in 2010.

On 6/17/09, BioMimetic Therapeutics (NASDAQ:BMTI) announced that it has submitted both the pre-clinical pharmacology/toxicology and quality/manufacturing modules of its Premarket Approval (PMA) application for marketing of Augment Bone Graft in the U.S. These are two of the three parts, or modules, required for a complete PMA application to the FDA. The Company intends to file the third and final module, containing the clinical data during 4Q09. On 5/7/09, BMTI announced that the Company completed enrollment in its Augment Bone Graft 436-patient North American pivotal clinical trial in foot and ankle fusions in December 2008 and is on track with patient follow-up. The Company expects to release top line data from the trial during 2H09.

On 7/3/09, Novo Nordisk (NYSE:NVO) announced European Commission marketing authorization for Victoza (liraglutide) in the treatment of type 2 diabetes in adults. NVO will launch Victoza in Britain, Germany, and Denmark this summer and in other European markets during the remainder of 2009 and in 2010. Victoza is regarded as the most important compound in Novo's pipeline and a key FDA decision is still pending. The original PDUFA action date for the Company's pending Victoza NDA for type 2 diabetes was 3/23/09, but a FDA decision is still pending.

Victoza is used once-daily via subcutaneous injection, and the drug is a synthetic glucagon-like peptide-1 (GLP-1) that works by stimulating insulin release when glucose levels become high. On 4/2/09, an FDA Advisory Panel stated liraglutide does not appear to carry heart risks, though serious questions remain about its possible links to tumors. Panelists were split, voting 6 to 6, on whether the drug should be approved in the face of evidence it caused cancerous thyroid tumors in rats and mice. The panel voted 8 to 5 in favor of the drug's cardiovascular safety profile.

On 7/6/09, Protalix BioTherapeutics (AMEX:PLX) announced that it was approached by the FDA and asked to consider submitting a treatment protocol for the use of prGCD in patients with Gaucher disease in order to address an expected shortage of the drug Cerezyme, a mammalian cell expressed version of glucocerebrosidase (GCD) and the only enzyme replacement therapy currently approved for Gaucher disease. Gaucher disease is a rare and serious lysosomal storage disorder in humans with severe and debilitating symptoms. prGCD, the Company's lead product candidate, is a proprietary plant-cell expressed recombinant form of glucocerebrosidase and is currently the subject of a Phase 3 clinical trial for the treatment of Gaucher disease.

The FDA indicated to the Company that it believes the Company's development program for prGCD satisfies the regulatory criteria required to supply prGCD for expanded access to patients under a treatment protocol. PLX expects to submit a treatment protocol to the FDA for its review as a supplement to its current Investigational New Drug (IND) application for prGCD. PLX expects to report results of the Phase 3 trial during 2H09 and expects to submit a NDA for prGCD to the FDA and other global regulatory agencies during 4Q09.

On 7/7/09, Cell Therapeutics (NASDAQ:CTIC) announced that the EMEA has agreed to an oral explanation in support of the OPAXIO (paclitaxel poliglumex, CT-2103) Marketing Authorization Application (MAA) in September 2009 extending the review for the Committee for Medicinal Products for Human Use (CHMP) opinion on European marketing approval until 4Q09. In April, 2008 the EMEA accepted for review the MAA for OPAXIO for first-line treatment of patients with advanced non-small cell lung cancer who are performance status 2, based on a non-inferior survival and improved side effect profile.

On 6/24/09, CTIC 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. The Company 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.

On 7/22/09, Hemispherx Biopharma (AMEX:HEB) provided guidance that it does not expect a FDA decision on its Ampligen New Drug Application (NDA) until fall 2009. President/CEO Dr. William Carter said staffing problems at the FDA this year have resulted in the agency missing deadlines for final decisions on nearly two-thirds of NDAs under review. During a 7/22 conference call, Dr. Carter said HEB has been in contact with the FDA since May, has been regularly providing reports to different reviewers, and does not believe any additional documentation will be required by the Agency. Ampligen (Poly I: Poly C12U) is an experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) with Orphan Drug Status.

Bristol-Myers (NYSE:BMY) and AstraZeneca (NYSE:AZN) have a pending NDA for Onglyza (saxagliptin oral tablets), which is a dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor for Type 2 Diabetes. On 4/1/09, the FDA panel voted 10 to 2 that the clinical data for the drug rule out the risk that the drug hastens heart attack, stroke and other problems. On 4/23/09, the FDA extended the PDUFA decision date by three months to 7/30/09.

United Therapeutics (NASDAQ:UTHR) announced on 4/28/09 that the FDA has extended the PDUFA action date for the Company's pending Tyvaso (inhaled treprostinil) NDA. The new PDUFA date is 7/30/09 and UTHR expected the delay (which was announced in a PR in mid-March) due to the submission of additional clinical trial data to the FDA, which was considered a major amendment by the agency. The additional data was related to human factors testing to validate the instructions for using the Optineb nebulizer device which delivers the medication.

On 6/16/09, a FDA Advisory Panel ruled that Savient Pharma's (NASDAQ:SVNT) experimental gout drug is safe and effective for certain patients with the disorder. SVNT is seeking FDA approval for the infused drug (Krystexxa) for those who have the painful type of arthritis, but fail to improve with first-line treatments or cannot tolerate other treatments. The FDA's panel of outside experts (in a 14-1 vote) ruled that the dramatic results in nearly half of the patients studied were encouraging, despite risks that could include serious heart problems and allergic reactions. In December, the FDA accepted the Company's BLA and granted priority review status, but SVNT submitted several key amendments for the BLA earlier this year in January. The FDA accepted the amendments and determined that the additional information constituted a major amendment and extended the original PDUFA decision date by three months to 8/1/09.

On 3/12/09, Endo Pharma's (NASDAQ:ENDP) majority-owned subsidiary Indevus Pharma announced that the FDA accepted for review the complete response submission to the NDA for Nebido (testosterone undecanoate) intramuscular injection, an investigational testosterone preparation for the treatment of male hypogonadism. The FDA is targeting 9/2/09 as the PDUFA action date for a possible decision on the NDA. Nebido is a long-lasting injection designed to treat hypogonadism, a hormonal condition that interferes with the functioning of the testes. The drug is already approved in Europe, where it is marketed by BayerSchering.

On 7/8/09, Spectrum Pharma (NASDAQ:SPPI) submitted a formal response to the Complete Response Letter (CRL) it received from the FDA 7/2/09 regarding its supplemental Biologics License Application (sBLA) for Zevalin (ibritumomab tiuxetan) in the first-line consolidation setting for non-Hodgkin's Lymphoma (NHL) patients. Zevalin is currently FDA approved and marketed by SPPI for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients who have rituximab-refractory follicular NHL. The FDA requested the Company to submit data files from the FIT study to support and verify a subset of the data that are currently under review to support the proposed labeling. On 7/20/09, SPPI announced that the FDA accepted the Company's CRL resubmission for filing as a Class 1 (60-day) review with a new PDUFA action date of 9/7/09 (which falls on Labor Day, so a decision is more likely to be announced on Tuesday 9/8).

The FDA accepted Spectrum Pharma's supplemental New Drug Application (sNDA) for FUSILEV (levoleucovorin) for Injection on 3/26/09 in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. The user fee goal (PDUFA) date for the sNDA is October 8, 2009. The FDA approved FUSILEV on March 7, 2008 for rescue after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.

On 4/24/09, the FDA accepted as complete for review Theravance's (NASDAQ:THRX) response to the Agency's February 2009 Complete Response Letter (CRL), which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections (cSSSI). Telavancin is a novel, bactericidal, once-daily injectable investigational antibiotic studied in the treatment of cSSSI and hospital-acquired pneumonia (HAP) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). The FDA assigned a PDUFA action date of 9/16/09 for approval of telavancin in the treatment of cSSSI.

On 4/6/09, the FDA Accepted Theravance's NDA for Telavancin as a once-daily injectable antibiotic for the treatment of hospital-acquired pneumonia (HAP), including MRSA strains of antibiotic-resistant and other Gram-positive bacteria. The FDA has established a goal of a standard 10-month review of the telavancin NDA, resulting in PDUFA decision date deadline of 11/26/09 and triggering a milestone payment of $10M from THRX partner, Astellas Pharma (ALPMF.PK).

Allos Therapeutics (NASDAQ:ALTH) filed a NDA on 3/25/09 with the FDA for pralatrexate in the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). ALTH received a priority (six-month) review designation on 5/26/09 with a PDUFA decision date of 9/24/09. PTCL comprises a biologically diverse group of hematologic malignancies that typically has a worse prognosis than other types of lymphoma and is less responsive to traditional chemotherapy regimens. There are currently no agents approved by the FDA for the treatment of patients with PTCL.

Amgen (NASDAQ:AMGN) has a pending BLA for denosumab with a PDUFA action date of 10/19/09 for a possible FDA decision. On 6/22/09, the FDA announced that Amgen's experimental osteoporosis drug denosumab (proposed brand name Prolia) will be revied by an Advisory Panel at a meeting on 8/13/09. The FDA Advisory Panel will discuss the Company's proposed uses of (1) treating and preventing osteoporosis in post-menopausal women and (2) treating and preventing bone loss in patients undergoing hormone ablation therapy for prostate and breast cancer.

On 7/7/09, AMGN announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa (zoledronic acid) in the treatment of bone metastases in 2,049 patients with advanced breast cancer met its primary and secondary endpoints and demonstrated superior efficacy compared to Zometa. Superiority was demonstrated for both delaying the time to the first on-study Skeletal Related Events, and delaying the time to the first-and-subsequent SREs. Both results were statistically significant.

On 7/15/09, Cadence Pharma (NASDAQ:CADX) announced that its New Drug Application (NDA) for Acetavance (intravenous acetaminophen), its investigational product candidate for the treatment of acute pain and fever in adults and children, has been accepted for filing by the FDA and designated for a priority (six-month) review. The FDA has issued a PDUFA action date for the NDA of 11/13/09 for a possible decision by the Agency.

GlaxoSmithKline (NYSE:GSK) and XenoPort (NASDAQ:XNPT) have a pending NDA for Solzira (gabapentin enacarbil) seeking approval for the treatment of moderate to severe restless leg syndrome with an early November PDUFA action date for a possible FDA decision.

On 6/8/09, Dyax Corp. (NASDAQ:DYAX) announced 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.

On 6/19/09, BioElectronics (BIEL.PK) announced a corporate update, including the filing of two applications with the FDA earlier in the week. The first of these was for 510(k) marketing clearance for its Allay Menstrual Pain Relief Patch product seeking OTC marketing clearance and an indication for pain reduction associated with dysmenorrhea (period pain and cramps). The second FDA filing was for a reclassification of the Company's technologies from Class III to Class II.

The Company will conduct a conference call on 7/28/09 to discuss the results of a recently completed clinical study and to discuss the status of current FDA filings and additional FDA filings expected to occur over the coming weeks, including one for general plastic surgery recovery and one for foot/ankle/plantar fasciitis. After the general musculoskeletal disorder study is completed the Company expects to file an additional application covering all musculoskeletal disorders. On 6/15/09, BIEL announced that it is filing an application with the FDA for 510(k) clearance to market its Allay Menstrual Pain Relief Patch product. The Allay Menstrual Pain Relief Patch is drug-free and is based on Pulsed Electromagnetic Field (PEMF) therapy, which applies advanced semiconductor and micro-battery technologies into a very small form factor that has been packaged into a wafer thin patch that can be worn directly on the skin.

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.

Curis, Inc. (NASDAQ:CRIS), a drug development company seeking to develop proprietary targeted medicines for cancer treatment, reported its financial results for the third quarter ended September 30, 2009.

AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG), a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, reported unaudited consolidated financial results for the third quarter and nine months ended September 30, 2009.

King Pharmaceuticals, Inc. (NYSE:KG) announced the Company plans to report financial results for the third quarter ended September 30, 2009 prior to the market open on Thursday, November 5, 2009.

Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP) announced it will sponsor a conference call to discuss its financial results for the quarter ended September 30, 2009.

Genta Incorporated (OTC:GETA) announced top-line results from AGENDA, the Company’s Phase 3 trial of Genasense® (oblimersen sodium) Injection in patients with advanced melanoma.

Targacept, Inc. (NASDAQ:TRGT), a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics™, announced it will report financial results for the third quarter ended September 30, 2009 on Thursday, November 5, 2009, after the U.S. financial markets close.

Inhibitex, Inc. (Nasdaq:INHX) reported the completion of its previously announced $23 million private placement of common stock and warrants.

Medidata Solutions (Nasdaq:MDSO), a leading global provider of hosted clinical development solutions, announced it will release its third quarter 2009 financial results following the close of the market on Thursday, November 12, 2009.

NPS Pharmaceuticals, Inc. (Nasdaq:NPSP) announced it plans to report its third quarter 2009 financial results on Wednesday, November 4, 2009 at approximately 4:30 p.m. ET.

NeoPharm, Inc. (Other OTC:NEOL.PK) announced the appointment of Dr. Aquilur Rahman to the position of President and CEO of the Company, succeeding Laurence P. Birch, who is stepping down as President and CEO to pursue other opportunities.

ArQule, Inc. (NASDAQ:ARQL) announced it will report its financial results for the third quarter of 2009 in a press release to be issued on Thursday, November 5, 2009 at 7:00 a.m. eastern time.

Phase Forward (NASDAQ:PFWD), a leading provider of data management solutions for clinical trials and drug safety, announced a multi-year contract with renowned eye health company Bausch & Lomb.

Allergan, Inc. (NYSE:AGN) announced operating results for the quarter ended September 30, 2009. Allergan also announced its Board of Directors has declared a third quarter dividend of $0.05 per share, payable on November 30, 2009 to stockholders of record on November 9, 2009.

Medidata Solutions (Nasdaq: MDSO), a leading global provider of hosted clinical development solutions, announced members of its executive team will deliver the following presentations at key industry events in November:  1st DIA China Annual Meeting November 2-3, 2009, Beijing, China.

XenoPort, Inc. (Nasdaq:XNPT) announced it will release its third quarter financial results on November 3, 2009 at approximately 4:00 p.m. Eastern Time.

Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced positive results from Phase 1 studies of CDX-1307 in patients with advanced epithelial cancers, including breast, colon, bladder and pancreatic cancer.

Students at The Pennington School will have an unprecedented opportunity this year to conduct hands-on, high-tech science projects, thanks to sophisticated science equipment donated by Bristol-Myers Squibb Company (NYSE:BMY).

PerkinElmer, Inc. (NYSE:PKI), a global leader focused on improving the health and safety of people and the environment, reported financial results for the third quarter ended October 4, 2009.

Exelixis, Inc. (Nasdaq:EXEL) reported financial results for the third quarter ended September 30, 2009.

PharMerica Corporation (NYSE:PMC), a national provider of institutional pharmacy and hospital pharmacy management services, reported the results of its third quarter of 2009 and nine months ended September 30, 2009.

Human Genome Sciences, Inc. (Nasdaq:HGSI) announced financial results for the quarter ended September 30, 2009, and provided highlights of recent key developments.

ImmunoGen, Inc. (Nasdaq:IMGN), a biotechnology company develops targeted anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology, announced financial results for the three-month period ended September 30, 2009 – the first quarter of the Company’s 2010 fiscal year (1QFY10).

Dynavax Technologies Corporation (Nasdaq:DVAX) announced the first clinical data for HEPLISAVTM investigational hepatitis B vaccine in chronic kidney disease patients.

Cumberland Pharmaceuticals Inc. (Nasdaq:CPIX) and Phebra Pty Ltd., an Australian-based specialty pharmaceutical company, announced they have entered into an exclusive partnership for the commercialization of Caldolor® (ibuprofen) Injection in Australia and New Zealand.

Synovis Life Technologies, Inc. (Nasdaq:SYNO), a leading biomaterial and surgical products company, will present at the Oppenheimer 20th Annual Healthcare Conference at 3:30 p.m. CT (4:30 p.m. ET) on Tuesday, Nov. 3, 2009, at the Waldorf Astoria Hotel in New York City.

Novavax, Inc. (Nasdaq:NVAX) a clinical-stage vaccine company, announced Dr. Rahul Singhvi, President and Chief Executive Officer, will be presenting at the Oppenheimer 20th Annual Healthcare Conference.

Depomed, Inc. (NASDAQ:DEPO) reported financial results for the third quarter ended September 30, 2009.

Perrigo Company (Nasdaq:PRGO) announced its Board of Directors declared a quarterly dividend of $0.0625 per share, payable on December 15, 2009 to shareholders of record on November 27, 2009.

Transgenomic Inc. (OTC:TBIO) announces the following Webcast: What: Transgenomic Inc. Third Quarter 2009 Earnings Release Conferece Call When: Thursday, November 5, 2009 @ 5:00 p.m. Eastern Where: http://www.transgenomic.com/events.asp?id=6 How:Live over the Internet -- Simply log on to the web at the address above. Contact:Investor Relations, 402-452-5400

Hospira, Inc. (NYSE:HSP) celebrates the 25th anniversary of its market-leading patient-controlled analgesia (PCA) infusion system. Introduced in 1984, Hospira's PCA was the first pump of its kind, revolutionizing pain management.

IntriCon Corporation (NASDAQ:IIN), a designer, developer, manufacturer and distributor of body-worn medical and electronics devices, announced it will be presenting at the 2009 TechAmerica AeA Classic Financial Conference on Tuesday, Nov. 3, 2009, at 9:05 a.m. PT.

Pfizer Inc. (NYSE:PFE) announced its Board of Directors has approved giving shareholders an advisory vote on executive compensation.

Merck & Co., Inc. (NYSE:MRK) and Schering-Plough Corporation (NYSE: SGP) announced they have received clearance from the U.S. Federal Trade Commission (FTC), the Swiss Competition Commission and the Canadian Competition Bureau for their proposed merger.

CEO Thomas A. Moore of Advaxis, Inc., (OTC:ADXS), the live, attenuated Listeria monocytogenes (Lm) biotechnology company, will present at the 8th Annual BIO Investors Forum at the Grand Hotel in San Francisco, CA.

CNS Response, Inc. (OTC:CNSO) announced CEO George Carpenter will be conducting a conference call and simultaneous web conference to discuss top-line study results in a 12-week trial for patients with depression treatment failure on Tuesday, November 3, at 8:00 a.m. Pacific (PST), 11:00 a.m. Eastern (EST). Joining Mr. Carpenter will be CNS Response President and CMO Daniel Hoffman, M.D., and Charles DeBattista, M.D., Stanford University School of Medicine.

China Biopharmaceuticals Holdings, Inc. (OTC:CHBP), an integrated bio-pharmaceutical company, based in the People's Republic of China, announced its shareholders have approved the acquisition of CHBP by NeoStem, Inc. (NYSE AMEX: NBS) by an overwhelming vote in favor of approximately 80% of all issued and outstanding shares.

Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. (Nasdaq:ONXX) announced more than 25 studies evaluating the use of Nexavar® (sorafenib) tablets in liver cancer will be presented at The Liver Meeting®, the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).

MinuteClinic, the retail health care division of CVS Caremark (NYSE:CVS), and Allina Hospitals & Clinics of Minnesota and western Wisconsin have formed a partnership to pursue collaborative activities which will focus on enhancing high-quality health care services in the communities they serve.

VeriChip Corporation (NASDAQ:CHIP) announced its Chairman and Chief Executive Officer, Scott R. Silverman, will present at the ID World International Congress in Milan, Italy, which runs from November 3-5, 2009, and is the world's leading symposium on the future directions of identification technology.

ArQule, Inc. (NASDAQ:ARQL) announced it will report its financial results for the third quarter of 2009 in a press release to be issued on Thursday, November 5, 2009 at 7:00 a.m. eastern time.

Most speculators have it all wrong when it comes to biotech trading... They'll buy biotech stocks ahead of FDA decisions, hoping an approval will bring 100% overnight gains. But more often than not, the market is one step ahead. The stock price will creep up as everyone anticipates good news.[More...]

The Dollar is getting wacked but clawed back into the end of the day as Gold continued its strength, hitting new highs. The current market is in rally mode on the eve of earnings, but last week’s round of economic data did add some apprehension that the recovery may be in ...