Becton Dickinson (NYSE: BDX) closed yesterday at $73.46. So far the stock has hit a 52-week low of $58.14 and 52-week high of $77.11. Becton Dickinson stock has been showing support around 72.26 and resistance...(Click the story link or go to http://www.marketintelligencecenter.com for the full story)
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.Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has set a new action date under the Prescription Drug User Fee Act for the review of the New Drug Application (NDA) for Exalgo™ (hydromorphone HCl extended-release) Tablets (CII), (Exalgo) of February 22, 2010.Antigenics Inc. (NASDAQ: AGEN) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has formally adopted a negative opinion on the marketing authorization application (MAA) for Oncophage (vitespen) as a treatment in earlier-stage, localized renal cell carcinoma (kidney cancer).Inovio Biomedical Corporation (NYSE Amex:INO), a leader in DNA vaccine design, development and delivery, announced today that a combination of its synthetic consensus H1N1, H2N2, H3N2, and H5N1 influenza vaccine candidates achieved protective antibody responses against several different influenza sub-types and strains in ferrets.Genta Incorporated (OTCBB: GETA.OB) announced preliminary results that show a high objective response rate in a pilot study of patients with advanced melanoma that incorporates the Company’s lead oncology product, Genasense® (oblimersen sodium) Injection, administered for the first time as a 1-hour high-dose intravenous (IV) infusion.POZEN Inc. (NASDAQ: POZN) announced today the start of enrollment for the phase 3 studies for PA32540. PA32540 is a fixed-dose combination of 325 mg of enteric coated aspirin and 40 mg of immediate release omeprazole, under investigation for use in the secondary prevention of heart attacks and strokes in patients at risk for associated gastric ulcers.Novavax, Inc. (Nasdaq: NVAX) today announced that it has priced an underwritten public offering of 6,800,000 shares of its common stock at a price to the public of $3.30 per share.GLG Life Tech Corporation (TSX:GLG)(NASDA:GLGL), the vertically integrated leader in the agricultural and industrial development of high quality stevia extracts, announced today that it has commenced trading on the NASDAQ Global Market under the symbol "GLGL".PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy and hospital pharmacy management services, announced that it has appointed Geoffrey G. Meyers to the Company’s Board of Directors.Cyberonics, Inc. (Nasdaq: CYBX) today announced that Dan Moore, President and Chief Executive Officer, and Greg Browne, Chief Financial Officer, will present at the 21st Annual Piper Jaffray Health Care Conference in New York on Wednesday, December 2, 2009 at 12:00 PM EST.Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ABILIFY® (aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.Lannett Company, Inc. (NYSE AMEX: LCI) today announced that its Board of Directors has approved a reauthorization of the stock repurchase program. Under the program the company is authorized to repurchase up to $5 million of Lannett’s outstanding common stock from time to time in open market and privately negotiated transactions.Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced that it will webcast its presentations at the Piper Jaffray 21st Annual Health Care Conference on Wednesday, December 2, 2009 at 2:00 p.m. EST and at the 2009 Deutsche Bank Biotech Boston Confab on Tuesday, December 15, 2009 at 9:00 a.m. EST.OPTIMIZERx Corporation (OTCBB:OPRX) has engaged Beringea LLC, an investment banking and private equity firm, to assist in financial planning and strategic positioning for the company's continued growth.Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food and Drug Administration (FDA) provided written acknowledgement that the Company's amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T) is a complete response.Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that data from a preclinical study on its selective androgen receptor modulator (SARM) LGD-4033 was featured in a poster presentation at the 62nd Annual Meeting of the Gerontology Society of America in Atlanta. LGD-4033 exhibited desirable in vivo efficacy on skeletal muscle and bone measurements in animal models of male hypogonadism and postmenopausal osteoporosis.BD (Becton, Dickinson and Company) (NYSE:BDX) today announced the completion of its acquisition of HandyLab, Inc., an Ann Arbor, Michigan-based company that develops and manufactures molecular diagnostic assays and automation platforms.Soligenix, Inc. (OTC Bulletin Board: SNGX), formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today that it has formed a consortium to develop thermostable technology to advance RiVax(TM) and other rapidly acting vaccines.
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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CareFusion Corp. (CFN) entered into a multi-year technology licensing agreement with Masimo Corp. (MASI) regarding the use of Masimo Rainbow SET Pulse CO-Oximetry technology in CareFusion infusion and respiratory products, which are presently under development.
The agreement enables CareFusion’s future infusion and respiratory products to non-invasively and continuously measure multiple blood constituents to more accurately assess [...]
CareFusion Corp. (CFN) entered into a multi-year technology licensing agreement with Masimo Corp. (MASI) regarding the use of Masimo Rainbow SET Pulse CO-Oximetry technology in CareFusion infusion and respiratory products, which are presently under development.
The agreement enables CareFusion’s future infusion and respiratory products to non-invasively and continuously measure multiple blood constituents to more accurately assess dyshemoglobins affecting oxygenation, predict fluid responsiveness, and provide earlier identification of respiratory compromise.
CareFusion’s ventilators and infusion pumps facilitate earlier detection, diagnosis and treatment of potentially life-threatening conditions by accessing total hemoglobin (SpHb), oxygen content (SpOC), carboxyhemoglobin (SpCO), methemoglobin (SpMet), and PVI for fluid responsiveness, in addition to oxyhemoglobin (SpO2), perfusion index (PI), and pulse rate.
CareFusion is a medical technology company formed recently by the spin-off of the Clinical and Medical Products business of Cardinal Health, Inc. (CAH). The spin-off was completed in September 2009 through a pro rata distribution of roughly 81% of CareFusion’s common stock.
Masimo develops, manufactures and markets a family of non-invasive blood monitoring systems that consist of a monitor, circuit board and sensors. The systems are primarily used to monitor blood oxygen saturation levels and protect against hypoxemia and hyperoxemia. Hypoxemia, low blood-oxygen levels, can result in brain damage and death. Hyperoxemia, high-blood oxygen levels, can result in permanent eye-damage and blindness. If infusion and respiratory products are developed successfully, the agreement enables CareFusion to use Masimo’s expertise in pulse oximetry technology. This will boost demand for CareFusion infusion and respiratory products which will expand the company’s top-line.
Companies featured in this segment: General Motors Corporation (NYSE:GM), Chrysler LLC, Ford (NYSE:F), FPL Group Incorporated (NYSE:FPL), Becton Dickinson and Company (NYSE:BDX), Coca Cola Enterprises (NYSE:CCE), Larsen & Toubro Limited (BSE:500510), Westinghouse Electric Company LLC, Total SA (NYSE:TOT), Advatech LLC, URS Corporation (NYSE:URS), Ameren Corporation's (NYSE: AEE), Enterprise Products Partners LP (NYSE:EPD), Wood Group (LON:WG), and EnCana Corporation (NYSE:ECA).
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