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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

On 10/14/09, Progenics Pharma (NASDAQ: PGNX) announced a deal with Wyeth to re-acqurie all of the worldwide rights to the RELISTOR franchise after a one-year transition period. RELISTOR (subcutaneous injection) is the only drug approved to treat opioid-induced constipation (OIC) in patients with advanced illness receiving palliative care. PGNX will aggressively continue development to expand the utility of both subcutaneous and oral RELISTOR into a new population for patients with chronic pain who experience OIC.

On 8/4/09, Wyeth and PGNX announced submission of a supplemental New Drug Application (sNDA) to the FDA and an Extension Application to the European Medicines Agency (EMEA) for RELISTOR (methylnaltrexone bromide) subcutaneous injection for a new delivery system, pre-filled syringes. RELISTOR was approved last year in single-use vials. RELISTOR is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has been insufficient. If approved, pre-filled syringes of RELISTOR are expected to be available in the U.S. and Europe as early as the first half of 2010. Single-use vials of RELISTOR will continue to be available. The estimated PDUFA action date is 6/4/10 for a standard, 10-month review and possible FDA decision on this sNDA.

On 10/14/09, Somanetics (NASDAQ: SMTS) announced that it has signed an Exclusive Sublicense Agreement with Raba Equity Partners II and obtained exclusive rights to new cerebral auto-regulation technology developed at The Johns Hopkins University. Integration of this technology into Somanetics' INVOS Cerebral / Somatic Oximeter would yield the first noninvasive monitor providing cerebral auto-regulation data for routine clinical use. SMTS plans to utilize this patent-pending method of combining blood pressure measurements and signals from the INVOS System to continuously monitor and display cerebral auto-regulatory function information.

SMTS plans to file a new 510(k) pre-market notification with the FDA to support marketing the new module in the U.S. by late 2010 and initiate product shipments for sale early in 2011. Cerebral auto-regulation refers to the body's ability to maintain constant blood flow to the brain despite changes in blood pressure. In many critical care situations, the brain's auto-regulation can become impaired, making it vulnerable to changes in blood pressure and to potential brain injury due to loss of this critical protective mechanism.

On 10/14/09, Ziopharm Oncology (NASDAQ: ZIOP) reported positive top-line interim data from the multicenter randomized Phase 2 trial of palifosfamide (ZymafosTM, ZIO-201) treating patients with unresectable or metastatic soft tissue sarcoma. The analysis evaluated 62 patients treated as of the end of September, with 58 being analyzed. As a result of reaching a key efficacy milestone and following safety and efficacy data review by the Data Committee, sarcoma experts, and the Company's Medical Advisory Board, the decision was reached formally to stop enrollment yesterday in the trial. The Company will report the interim data in full at the upcoming Connective Tissue Oncology Society Annual Meeting on November 5th and plans to initiate a registration / pivotal Phase 3 study following regulatory review of the palifosfamide program to date.

The Randomized Phase II trial treats patients with unresectable or metastatic soft tissue sarcoma in the front- and second-line setting. A total of 58 patients have been evaluated for PFS (progression-free survival) with 19 documented PFS events (doxorubicin alone = 13 events; palifosfamide + doxorubicin = 6 events) based on a three month median follow-up time. With this analysis based on all randomized and eligible patients, the hazard ratio is 0.67 favoring palifosfamide + doxorubicin, which is the pre-defined milestone was to reach one-sided p=0.1. The interim safety data indicate that the addition of palifosfamide does not add to the toxicity of single agent doxorubicin.

On 10/14/09, Cardium Therapeutics (AMEX: CXM) reported Phase 2b results for the Excellarate product candidate and its components, demonstrating that Ad5PDGF-B and collagen matrix appear to be both safe and well tolerated by patients. The Phase 2b Matrix clinical study was not powered to nor did it differentiate between the relative contributions of the individual Ad5PDGF-B and collagen components that make up Excellarate - but both the Excellarate and the collagen matrix study arms showed substantial improvements in achieving wound closure as compared to standard of care, which is the FDA-accepted control considered appropriate for product registration studies. Approximately 45% of patients receiving the collagen matrix in the Phase 2b study had complete wound closure by 12 weeks, compared to a 31% wound closure rate for the standard of care group.

Based on the Company's clinical studies to date, Cardium will consider submitting an application for FDA 510(k) clearance of Excellagen for use in wound healing applications since collagen is cleared for marketing as a medical device already. (1) Excellagen (a collagen-based topical gel for use by physicians in conjunction with surgical debridement of wounds in patients with chronic or non-chronic diabetic foot ulcers) is expected to be advanced via the FDA 510(k) medical device route while (2) Excellarate (includes both the collagen matrix and the PDGF-B protein to promote wound healing) (Regranex also contains this protein) is expected to proceed to a Phase 3 clinical study for non-healing diabetic foot ulcers.

On 10/14/09, pSivida Corp. (NASDAQ: PSDV) announced that the last patient in the Phase 3 study being conducted by its collaborative partner, Alimera Sciences, for a new treatment for diabetic macular edema (DME) has completed the two-year follow up visit. The Phase 3 studies compare two doses of Iluvien with placebo. PSDV expects to report top-line 24-month data from the trial in mid-December and if the data are positive expects to file a NDA with the FDA during 2Q10.

On 6/15/09, 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. PSDV stated that the newly-published results support expanding the use of Iluvien beyond DME to include conditions such as wet and dry AMD (age-related macular degeneration) for which Phase 2 trials are currently underway; and other degenerative conditions such as retinitis pigmentosa.

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. 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. On 10/13/09, BMTI announced positive top-line results from its pivotal (Phase3) randomized controlled trial comparing its fully synthetic, off-the-shelf bone growth factor product, Augment Bone Graft ("Augment"), to autograft for use in hindfoot and ankle fusion surgery.

The primary study goal was to establish non-inferiority of Augment compared to autograft. Autograft is the historical standard of care but has the limitation that it must be obtained and transplanted from another bone in the patient's body, often requiring a second surgical procedure. These positive top-line results indicate that, with the use of Augment, patients can expect a comparable treatment outcome while being spared the pain and potential morbidity associated with traditional autograft bone harvesting and transplantation. All p values reported in this release are derived from non-inferiority analyses. Analysis of the complete data set will continue for some time. A substantial amount of data in addition to the top-line data announced today will be included in the Company's PMA submission, which is expected to be filed with the FDA within the next three months.

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Disclosure: No positions.

On 10/14/09, Progenics Pharma (NASDAQ: PGNX) announced a deal with Wyeth to re-acquire all of the worldwide rights to the RELISTOR franchise after a one-year transition period. RELISTOR (subcutaneous injection) is the only drug approved to treat opioid-induced constipation (OIC) in patients with advanced illness receiving palliative care.[More...]

Below are extreme trades among 18 companies with stock prices under $5 from the BioMedReports.com FDA Calendar, which includes 232 entries as of 7/3/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA fili (...)[More...]

Neil George, editor of Personal Finance, says Australian microcap bionanotech company pSivida can move up if it manages to cut debt and hook up with a big-pharma partner to license one of its products.