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Mike Havrilla is an index developer, pharmacist, writer, and Co-Founder of BioMedReports.com with experience that includes online investing since August 1997 and writing for investors since April 2007 with a focus on the healthcare sector and small / micro-cap stocks. Mike holds Doctor of... More
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BioMedReports.com FDA Calendar
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  • BioMed Research Reports: Clinical Data (NASDAQ: CLDA), Lpath (OTC: LPTN.OB)
    The BioMedReports.com research download section has been updated to include PDFs for two recent research reports written by Griffin Securities for Clinical Data (NASDAQ: CLDA) and Lpath, Inc. (OTC: LPTN.OB). Lpath received a buy rating with a $5 per share 12-month price target while CLDA was rated a buy with a 12-month price target of $38 per share. Below is a summary of both companies from their respective reports.
     
    Lpath, Inc. is a biotechnology company focused on lipidomics-based therapeutics that target bioactive signaling lipids for treating a wide range of human disease and is the only company to have developed monoclonal antibodies against bioactive lipids. The Company is currently advancing three early-stage (poised to enter Phase 2 clinical studies) drug candidates (ASONEP™; iSONEP™; and Lpathomab™) in addition to a drug-discovery platform known as ImmuneY2™ which Lpath is leveraging to further expand its pipeline.
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    Nov 25 09:12 pm | Link | Comment!
  • Under the Radar Healthcare Stocks: Protox, Pressure BioSciences, Unilife
    Below are three under the radar stocks from the healthcare sector that I have been following for the past 3-6 months which have upcoming catalysts in the form of expected strategic deals, clinical trial results, and other corporate developments.  Click here to check out my kaChing.com virtual investing portfolio, strategy, long / short virtual stock picks, and statistics since I started using the site in mid-April.
     
    Protox Therapeutics (TSX: PRX.TO) (OTC: PTXRF.PK) (click on preceding link for the Company’s ProActive News Room landing page) applies genetic engineering techniques to create innovative, targeted protein-based therapeutics which are focused on prostate conditions and cancer. The Company's clinical-stage pipeline is based on the PORxin and INxin technology platforms. Lead drugs in clinical development include PRX302 for the treatment of benign prostatic hyperplasia (BPH or enlarged prostate) and localized prostate cancer as well as PRX321 for primary brain cancer (glioblastoma multiforme / GBM and astrocytoma).
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    Nov 24 05:45 pm | Link | Comment!
  • BioMed News Bytes: Transcept, ProUroCare, SciClone, ABIO

    On 11/23/09, Transcept Pharma (NASDAQ: TSPT) announced that it is scheduled to meet with the FDA on 1/20/10 to discuss the Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet). As previously announced, the CRL, received by TSPT on 10/28/09, indicated that the FDA could not approve the NDA in its present form. The NDA seeks approval to market Intermezzo for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

    The FDA indicated that the intended use of Intermezzo in the middle of the night represents a unique insomnia indication and dosing strategy for which safety has not been previously established and the Agency requested additional data demonstrating that Intermezzo, when taken as directed in the middle of the night, would not present an unacceptable risk of residual effects, with particular reference to next day driving ability. The FDA also expressed two concerns regarding the possibility of patient dosing errors in the middle of the night that could lead to next day residual effects.

    Following the receipt of official FDA minutes of the meeting, TSPT plans to provide an update on its discussions with the FDA and the status of the anticipated Intermezzo NDA resubmission. On 8/2/09, TSPT and privately-held Purdue Pharma announced an exclusive deal to commercialize Intermezzo (zolpidem tartrate sublingual tablet) in the U.S. Purdue will pay TSPT near-term milestones that include an upfront cash payment of $25 million and an additional payment of up to $30 million.

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    Nov 23 05:20 pm | Link | Comment!
  • Diabetes Care: Global Investing Opportunities
    The American Diabetes Association estimates that there are currently 23.6 million diabetics in the U.S. (7.8% of the total population, including 17.9 million diagnosed cases, 5.7 million undiagnosed, and 57 million pre-diabetics. Diabetes results in an estimated $174 billion in costs from diagnosed cases of diabetes in the U.S. (2007). On a global scale, the International Diabetes Federation (IDF) estimates 285 million diabetics worldwide in 2010. I have outlined some investing opportunities in this article, with a focus on emerging small / micro-cap companies from across the world which are developing innovative therapeutics, diagnostics, and monitoring products to improve the treatment outcomes for the growing, global diabetes epidemic.
     
    Epinex Diagnostics, Inc. (privately held) is dedicated to the development of innovative point-of-care technologies using rapid diagnostic tests. Epinex has developed a proprietary platform for rapid tests that apply existing immunoassay strips and biosensors to create unique quantitative diagnostic tests, focused on a significant initial market opportunity for a new type of diabetes monitoring test that measures glycated albumin (G1a), with an expected FDA 510(k) filing in early 2010 seeking marketing clearance as a Class 2 medical device for an expected review period of 90 days. My 13-page profile report and the most recent corporate profile for Epinex are available to view or download at the BioMedReports.com research downloads section or at the ProActive News Room landing page for Epinex.
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    Nov 21 07:17 pm | Link | Comment!
  • BioMed News Bytes: CombinatoRx, Dendreon, Photocure, Pozen
    On 11/2/09, Dendreon (NASDAQ: DNDN) announced that it has completed the submission of its amended Biologics License Application (BLA) for PROVENGE (sipuleucel-T), seeking approval for men with metastatic castrate-resistant prostate cancer (CRPC). 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.
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    Nov 20 11:05 am | Link | Comment!
  • BioMed News Bytes: AstraZeneca, Delcath, Unilife
    On 11/19/09, AstraZeneca (NYSE: AZN) announced the submission of a New Drug Application (NDA) to the FDA for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS). The proposed trade name for ticagrelor is BRILINTA, pending approval from the FDA. This submission is based on the results of a comprehensive program, including data from PLATO (A Study of Platelet Inhibition and Patient Outcomes), the Phase 3 head-to-head trial comparing ticagrelor plus aspirin with clopidogrel (Plavix) plus aspirin. Ticagrelor is the first reversibly binding oral P2Y12 adenosine diphosphate (ADP) receptor antagonist. The mode of action involves inhibiting the action of platelets in the blood to prevent platelets from sticking together, thereby reducing recurrent thrombotic (blood clot) events.
     
    On 5/11/09, AZN announced top line results from the phase III trial, PLATO (A Study of Platelet Inhibition and Patient Outcomes), which demonstrate that BRILINTA (ticagrelor), the investigational oral antiplatelet treatment for acute coronary syndromes (ACS), has achieved a statistically significant primary efficacy endpoint versus Plavix (clopidogrel), in the prevention of cardiovascular (CV) events in patients with ACS. The primary efficacy measure was time to first occurrence of any event from the composite of myocardial infarction, stroke, and CV death. In PLATO, the overall safety profile for BRILINTA was in line with the safety data observed in the Phase 2 studies.
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    Nov 19 10:40 am | Link | Comment!
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