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M. E. Garza
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M.E. Garza is one of the founders of the biotech and healthcare sector news portal BioMedReports.com. He believes in getting the news from credible sources on the street and often reaches out to CEOs and newsmakers directly for interviews and discussions about their companies. Since he began... More
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  • RxNews Recap: 01-27-10 Repros Therapeutics rockets on news of FDA meeting 0 comments
    Jan 28, 2010 9:05 AM
    Below is a list of the companies that made news in the healthcare sector on Wednesday, January 27, 2010.
    Shares of Repros Therapeutics Inc. (Nasdaq:RPRX) rocketed today after the company announced that it along with consultants participated in a teleconference with the Division of Reproductive and Urologic Products of the FDA on January 25, 2010. The primary purpose of the meeting was to gain a better understanding of the FDA’s position regarding the use of Repros’ oral Androxal® product in the treatment of men with secondary hypogonadism wishing to preserve their fertility. The Company’s data supports the notion that the negative feedback of exogenous testosterone administered by any route suppresses the hypothalamic–pituitary axis and hence spermatogenesis. Shares at one point nearly doubled on the day and eventually closed up over 33%.
    Meanwhile, GenVec, Inc. (Nasdaq: GNVC) saw its shares sink today after the company announced that it has entered into purchase agreements with certain institutional investors for the sale of 14,000,000 shares of its common stock and warrants to purchase 4,200,000 shares of its common stock.  The shares of common stock and warrants are being offered in units consisting of one share of common stock and 0.30 warrants to purchase one share of common stock at a price of $2.00 per unit. The warrants have a term of five years and an exercise price of $2.75 per share. GenVec intends to use the proceeds from this offering to complete the development of TNFerade through the filing of a Biological License Application (BLA) for TNFerade's use in locally advanced pancreatic cancer, which the Company anticipates will take place in 2012," commented Douglas J. Swirsky, GenVec's Senior Vice President and Chief Financial Officer. Shares traded off more than 26% on the day.
    At least two Bio-defense plays were up on the day ahead of the Presidents speach tonight:
    PharmAthene, Inc. (Amex: PIP) a biodefense company specializing in the development and commercialization of medical countermeasures against chemical and biological threats saw its shares rise more than 18% today. Rumors swirled the internet that President Obama will talk about combating bio-terrorism in his State of the Union address this evening.

    Shares of SIGA Technologies, Inc. (Nasdaq:SIGA), a company specializing in the development of pharmaceutical agents to fight biowarfare pathogens also traded higher today in anticipation of President Obama's State of the Union address this evening in which it is understood that he will talk about bio-terrorism.
    In other news Wednesday:
     
    Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies designed for heart recovery, today announced strategic partnership with Opsens (TSX VENTURE EXCHANGE: OPS) (“Opsens”), a leading developer of fiber optic sensors.

    Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Lm) vaccine company, has received $278,978 from the sale of its Fiscal Year 2009 net operating tax losses (NOL) and research tax credits through the NJ Economic Development Authority (NJEDA) pursuant to the rules, regulations and stipulations set forth by the NJ program.

    Array BioPharma Inc. (NASDAQ: ARRY) today announced that Bengt Bergstrom, M.D., has joined the Company as Vice President of Clinical Development.

    Cytori Therapeutics (NASDAQ:CYTX) announced results from its Phase I, randomized, double-blind, placebo-controlled, multiple-dose clinical trial of oral CK-2017357. In the Phase I clinical trial, two cohorts, each comprised of 12 healthy males, were randomized 2:1 to receive daily morning doses of oral CK-2017357 versus matching placebo for seven days. The CK-2017357 dose was 250 mg in Cohort 1 and 375 mg in Cohort 2. At steady state, which was achieved at both dose levels by the sixth day of treatment, both the maximum CK-2017357 plasma concentration (Cmax) and the area under the CK-2017357 plasma concentration versus time curve from dosing until 24 hours after dosing (AUC24h) were generally dose proportional and exhibited only modest accumulation compared to the values measured after the first dose. In general, systemic exposure to CK-2017357 in this trial was high and inter-subject variability was low. In addition, these multiple dose regimens of CK-2017357 were well tolerated, and there were no serious adverse events.
     
    The company also announced today that it had received an order for a StemSource® Cell Bank from Cosmetic Surgery Seishin in Japan. The Cell Bank includes a StemSource® processing system along with all other equipment, software, database, and protocols required to cryopreserve patients’ own adipose-derived regenerative cells when the cells are younger and more viable.

    Elan Corporation, plc (NYSE: ELN) announced today that it will host a conference call on Wednesday, February 10, at 8:30 a.m. Eastern Time (NYSE:ET), 1:30 p.m. GMT with the investment community to discuss Elan’s fourth quarter and full year 2009 financial results, which will be released before the European and U.S. financial markets open.

    Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) ("Enzon") announced that at a special meeting held this morning, its stockholders approved the sale of Enzon's specialty pharmaceutical business to the sigma-tau Group ("sigma-tau").

    GenSpera, Inc. (OTC.BB: GNSZ) announced that the first patient was treated in the Phase I clinical study of its cancer chemotherapeutic agent, G-202, at the University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.

    Gilead Sciences, Inc. (Nasdaq:GILD) announced today its results of operations for the fourth quarter and full year of 2009.

    Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine design, development and delivery, today unveiled its new clinical-grade, miniaturized electroporation device designed to be an easy-to-use, portable delivery product for DNA vaccines.

    Life Technologies Corporation (NASDAQ:LIFE), a provider of innovative life science solutions, today announced a series of investments and new technologies designed to extend the use of sequencing in the research arena and make it more relevant for physicians.

    Spectrum Pharmaceuticals (NasdaqGM: SPPI), today announced that it has terminated its Ozarelix development program in benign prostate hypertrophy (BPH) in order to focus on its portfolio strategy Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. said: "While ozarelix is a potent GnRH antagonist, low-dose intermittent therapy has been disappointing in the treatment of lower urinary tract symptoms in men with BPH. As a result, we have made the strategic decision to discontinue the ozarelix BPH program. By discontinuing the ozarelix program, the savings of more than $40 Million we had budgeted for the clinical trials and other related costs will help us advance other programs that have the greatest likelihood of commercial success in providing patients with more effective treatment options. This is part of a concerted effort at streamlining and prioritizing our portfolio." Shares of SPPI traded higher on the day.

    SurModics, Inc. (Nasdaq: SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, today reported financial results for the first quarter ended December 31, 2009.

    ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that Jonathan Lewis, MD, PhD, Chief Executive Officer, has been invited to participate at the 2nd International Conference on Drug Discovery and Therapy in Dubai, United Arab Emirates as: Chairman of Translational Biomedical Research Chairman of one of four Plenary Sessions An Invited Lecturer (Tuesday, February 2nd): Translational Research in Cancer; Programs of Multi-Institutional University and Industry Collaboration in Drug Discovery and Development.
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