Johnson & Johnson recently launched Stelara for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis. Although Stelara is entering a crowded treatment room for psoriasis, this first-in-class interleukin IL inhibitor could still put the "no more tears" back in J&J's future -- if...
Johnson & Johnson recently launched Stelara for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis. Although Stelara is entering a crowded treatment room for psoriasis, this first-in-class interleukin IL inhibitor could still put the "no more tears" back in J&J's future -- if...
Belgian drugmaker Movetis said today that it will seek up to �112.4 ($167 million) in an upcoming IPO. The gastroenterology company--which was founded in 2006 as a spin-off Johnson & Johnson units Janssen and Ortho-McNeil--recently won European approval of its chronic constipation treatment Resolor. It's also marketed in Iceland, Liechtenstein, Norway and...
As of today the top ten most traded option contracts were:
Johnson & Johnson (JNJ) January 55 Call OptionsJohnson & Johnson January 50 Call OptionsJohnson & Johnson November 60 Call OptionsS&P 500 SPDR (SPY) November 110 Call OptionsS&P 500 SPDR November 109 Put OptionsPowerShares QQQ (QQQQ) November 43 Put OptionsS&P 500 SPDR November 110 Put OptionsS&P 500 SPDR November 111 Call[More...]
Epinex Diagnostics Inc. (click on preceding link for the Company's News Room page) is a private company that 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.[More...]
On 11/19/09, the Company announced positive results in a pilot clinical study which included Prelude skin preparation and the placement of 10 Symphony tCGM biosensors on subjects with Type 1 or Type 2 Diabetes. Venous reference blood samples were taken from intravenous lines at 15-minute intervals for 24 hours and measured on a YSI 2300STAT PLUS laboratory analyzer to establish the gold standard / reference in this study, resulting in 97% accuracy for the Symphony tCGM System that was derived from approximately 900 glucose measurements with no adverse events related to the Prelude skin prep / permeation process.
The Prelude SkinPrep System removes the top level of dead skin (stratum corneum), which is painless and a similar process to exfoliation, resulting in the opportunity for enhanced delivery of reformulated, topical drugs that are already approved (e.g. lidocaine) and a needle-free means of measuring blood glucose levels in conjuction with the Symphony tCGM System by using an electrochemical sensor in combination with a short-range RF transmitter that is affixed to the skin area prepared with Prelude.
In mid-November, Echo Therapeutics announced a deal to raise about $3 million in capital that included the sale of 2.37 million shares of common stock @$1.25 per share and 2.2 million common stock warrants with an exercise price of $2 per share and a five-year term. The Company expects the additional capital will be sufficient to finance additional development activities and commercialization of its Prelude SkinPrep and Symphony tCGM Systems.
The Prelude SkinPrep has been licensed to Ferndale Pharma in North America + UK for the enhanced delivery of its topical lidocaine skin-numbing agent (LMX4), with a FDA 510(k) submission expected during 1Q10 for potential marketing clearance and royalty revenue starting in 2Q10. The deal with Ferndale included $750,000 upfront, another $750,000 upon FDA approval, double digit royalties on net product sales, and $12.5 million in milestone / guaranteed minimum royalties.
The Symphony tCGM has been licensed in South Korea to Handok Pharma and a pivotal trial is expected to begin by late February 2010 with a FDA PMA submission expected to follow. This deal included approximately $600,000 upfront, FDA approval / first South Korean sales milestone payments, royalties on net product sales, and Handok covers product development expenses in their local market.
The BioMedReports.com research download section includes the Company's most recent corporate presentation, which is available to view or download. 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.
The market for all diabetes monitoring products is the largest medical diagnostics market in the world at $12.4 billion in 2000 and estimated to grow to a level of $27 billion by 2010, representing a 12% CAGR (compound annual growth rate). The diabetes testing market includes diversified, global healthcare giants and smaller niche players, including those outlined below.
Johnson & Johnson (NYSE: JNJ) (LifeScan - One Touch), Abbott Labs (NYSE: ABT) (FreeStyle), Becton Dickinson (NYSE: BDX) (BD Diagnostics), Roche (OTC: RHHBY.PK) (Accu-Chek), Bayer (OTC: BAYRY.PK) (Ascenscia), Bio-Rad Labs (NYSE: BIO), Home Diagnostics (NASDAQ: HDIX), Insulet Corp. (NASDAQ: PODD), and DexCom (NASDAQ: DXCM).
Epinex Diagnostics Inc. (click on preceding link for the Company's News Room page) is a private company that 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. The Company is developing a test that measures glycated albumin (G1a) as a potential paradigm-shifting measurement of average blood sugar control over the past month, as compared to hemoglobin A1c which provides a measurement of average blood sugar levels over the past 2-3 months and is dependent on red blood cell levels whereas albumin is a more widespread protein that is found in the serum portion of the blood.
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Epinex Diagnostics Inc. (click on preceding link for the Company's News Room page) is a private company that 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.
Advantages of the Epinex Quantitative Immunoassay System for Point-of-Care Testing include the following:
1.) Rapid: Results within minutes.
2.) Quantitative: Yields a precise value, not just "yes" or "no".
3.) Easy to use: No training required.
4.) Cost effective: Point-of-care testing reduces overall cost to the healthcare system.
5.) High Sensitivity: Results comparable to the "gold standard" ELISA test.
The Epinex G1A TM (glycated albumin, which is a measure of average blood sugar control over the previous month) Test is the first of a series of diagnostic monitoring tests based on the Company's proprietary detection platform technology and dual-mode test reader. Future rapid tests under development by Epinex include infectious diseases, other metabolic disorders, coronary artery disease, rheumatoid arthritis, Down Syndrome, and neonatal HIV.
Albumin is a protein found in the blood that can be measured with precision and has a turnover or replacement time of 2-3 weeks. Like many proteins in the body, albumin can become altered or glycated. High levels of glycated albumin have been directly linked to major complications of diabetes such as retinopathy (blindness) and nephropathy (kidney failure) through the damage caused to small blood vessels by the altered protein. It is also a marker for other types of diabetes complications. More than 25 years of clinical research has proven that monthly measurement of glycated albumin is a superior technology to monitor and control glycation.
The Epinex G1A TM Rapid Diabetes Monitoring Index Test is a monthly test for the control of glycation. The test is composed of the G1A TM reader and a proprietary dual-channel test cassette, which is able to simultaneously test for glycated albumin and total albumin. A drop of whole blood is placed on the sample well of the cassette and the cassette is inserted into the reader device. Based on the Company's platform technology, the G1A TM reader automatically quantifies the analyte concentrations on the cassette and gives the G1A TM Index, the ratio of glycated albumin to total albumin in serum.
The G1A TM Index shows how well the patients have controlled their level of glycation over the previous month. Simple to operate, the G1A TM test system can be performed at the point of care without the need for highly trained laboratory technicians. It allows for immediate feedback between healthcare provider and patients, thus facilitating timely therapeutic interventions. The results are stored on the device, providing trend analysis as well as displaying immediate results. The results can be transmitted by means of a computer or wireless connection to a doctor's office or other central data location.
The global diabetes epidemic affects an estimated 300 million people worldwide and this number is expected to double by 2030 with an estimated cost of $232 billion. Diabetes is the fifth leading cause of death in the U.S. and fourth leading cause of death on a global basis. Complications of diabetes may include heart disease, blindness, kidney failure, extremity amputations / circulation problems, and neuropathies.
The market for all diabetes monitoring products is the largest medical diagnostics market in the world at $12.4 billion in 2000 and estimated to grow to a level of $27 billion by 2010, representing a 12% CAGR (compound annual growth rate). The diabetes testing market is dominated by global, diversified healthcare giants such as Johnson & Johnson (NYSE: JNJ) (LifeScan - One Touch), Abbott Labs (NYSE: ABT) (FreeStyle), Roche (OTC: RHHBY.PK) (Accu-Chek), and Bayer (OTC: BAYRY.PK) (Ascenscia).
Glycation (binding of excess sugar to proteins such as albumin and hemoglobin) is a major cause of the long-term complications of diabetes and an indicator of the risk of developing those complications. The goal of diabetes monitoring is to control glycation and to avoid the complications of diabetes. This allows diabetics and their health care providers to determine a treatment regimen, to monitor its effectiveness, and to alter it as needed for better overall glucose control. Current diabetes monitoring methods may include periodic doctor visits (e.g. every six months) in addition to multiple tests for monitoring blood sugar levels.
Blood glucose monitoring is the most common and frequent means of measuring blood sugar levels on a real-time basis and may be conducted up to four times daily or more via finger prick or alternate site (e.g. forearm) testing by patients. While blood glucose machines are often subsidized or given away free, the test strips are expensive and represent an ongoing cost along with poor patient compliance due to the high frequency of testing and finger pricks that are involved with this method. Glycated hemoglobin (HbA1c) is typically conducted 2-3 times per year and provides a measure of average blood sugar control over the previous 90 days.
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