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Alnylam Pharmaceuticals, Inc. Message Board

robert.vince 31 posts  |  Last Activity: Sep 12, 2014 10:36 AM Member since: Aug 30, 2012
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  • robert.vince by robert.vince Aug 5, 2014 11:48 AM Flag

    "Seperately, AstraZeneca was among the companies speculated to be interested in Durata Therapeutics, a US-listed superbug antibiotic developer. Takeover gossip led Durata shares to jump on Monday, giving the group a market value of about $385m." From The Financial Times article entitled:
    High cost to AstraZeneca independence

    Key Word : Among

  • robert.vince by robert.vince Aug 1, 2014 12:06 PM Flag

    Dear Stellar Biotechnologies’ Supporter:
    Below are links (sorry, yahoo won't let me post links, google it) to stories released last week regarding two of our collaboration partners.
    Stellar long-time customer Neovacs (Paris: ALNEV) discusses the company's immunotherapy programs and pipeline for autoimmune disease

    Neovacs is developing the next generation of immunotherapies using Stellar KLH™ as the carrier molecule in three of its products now in clinical development for Rheumatoid Arthritis, Crohn’s Disease, and Lupus.
    News regarding OBI-822 Immunotherapy: Clinical trial for breast cancer drug completes patient collection

    Stellar is working in collaboration with Amaran Biotechnology, Inc., a privately-held Taiwan biopharmaceuticals manufacturer, to develop and evaluate methods for the manufacture of OBI-822 active immunotherapy using Stellar's GMP grade KLH.

  • Co announced that its Dutch subsidiary, Durata Therapeutics International B.V., has entered into a license and supply agreement with Angelini, an international group leader in the pharmaceutical and mass-market sectors, to commercialize dalbavancin in 36 countries, which include Italy, Spain, Poland, Portugal, many Eastern European countries, Russia, Turkey, and Commonwealth of Independent States.
    Durata will receive an upfront payment from Angelini of $15 million and another $10 million upon European Medicines Agency approval. The Co will also receive payments upon the achievement of certain countries' pricing approvals and sales milestones, as well as royalties on sales.
    Durata's Marketing Authorization Application for dalbavancin is under review with the European Medicines Agency and anticipates a decision in 1H 2015.

  • In consequence of recent public notices about the rapid expansion of its national affiliate marketing network and agreements with major trading partners, and pursuant to its public assurances that Green PolkaDot Box Incorporated (GPDB) "GPDB" or "Company" will become fully reporting in 2014, the Company announces that it has retained Salt Lake City-based Tanner & Company, an independent, regional accounting firm.

    In a related move, GPDB has also hired Christopher Foley to act as its full-time CFO and assist Tanner & Company with completion of the audit work and meeting public reporting requirements. Mr. Foley brings over 28 years of diverse business and financial management experience to GPDB after working for several renowned Fortune 100 companies, including General Electric, Johnson & Johnson and American Express Financial Advisors, as well as several large financial institutions including PNC Bank and Zions Bank.

    The hiring of Mr. Foley and retention of Tanner & Company is calculated to position the Company to increase shareholder value and liquidity.

    GPDB CEO, Rod Smith, commented on the timing of this strategic move: "As we contemplate the positive impact and potential of our new sales and marketing opportunities; diversity of operations into private label, 3PL services; and the production and expansion of Living Produce(R) it has become imperative that we serve the best interests' of our shareholders by preparing to uplist to a major exchange."

  • Starpharma (SPL.AX) (SPHRY) today announced achievement of a major milestone with the receipt of Conformity Assessment Certification for the VivaGel® condom by the Australian Therapeutic Goods Administration (TGA). This TGA certification is similar to CE certification of devices (CE Mark) in Europe.

    Starpharma’s marketing partner, Ansell (ANN.AX) plans to launch the VivaGel® condom under their brand, LifeStyles Dual Protect™, in the coming months, following listing on the Australian Register of Therapeutic Goods (ARTG). TGA certification will also support certain regulatory processes in other markets.

    The VivaGel® condom is a world-first product based on innovative Australian technology. It is the only condom of its type, providing barrier protection and incorporating a proprietary antiviral compound (VivaGel®) in the lubricant.

    LifeStyles Dual Protect™ condoms to be marketed by Ansell will carry the VivaGel® brand and Starpharma will receive royalties based on sales.

    Ansell President & General Manager, Sexual Wellness Global Business Unit, Peter Carroll, said:

    “Ansell looks forward to rolling out its marketing and sales campaign to support the launch of LifeStyles Dual Protect™ over the coming months with the first product expected to be available on shelves soon.

    “Our partnership with Starpharma is a great example of two highly innovative Australian businesses working together to bring to market a ground-breaking new sexual health product. New product development is central to Ansell’s business strategy and this highly innovative product is exciting for both companies.”

    Ansell is a global leader in protection solutions, manufacturing and marketing condoms across the world and ranked number two globally. In Australia, Ansell’s share of the condom market is around 70%. The global branded condom market is estimated to be worth approximately $1.1 billion.

  • MONMOUTH JUNCTION, NJ--(July 17, 2014) - CytoSorbents Corporation (OTCQB: CTSO), a critical care immunotherapy company commercializing its CytoSorb® cytokine adsorber in multiple countries worldwide, announced the PDF availability of the first publication describing the use of CytoSorb® intra-operatively during cardiac surgery at the Ludwig Maximilian University of Munich Hospital - Grosshadern Campus, in Germany.

    The retrospective study, authored by Frank Born, et al., was recently published in the scientific journal "Kardiotechnik" and entitled, "Systemic Inflammatory Response Syndrome in Heart Surgery: New possibilities for treatment through the use of a cytokine adsorber during ECC?" The study compared the post-operative inflammatory response in 40 patients (20 control vs 20 CytoSorb® treated) undergoing high risk cardiac surgery involving hypothermic arrest and antegrade cerebral perfusion. In the treatment group, CytoSorb® was placed into a bypass blood circuit in the heart-lung machine and used intra-operatively (during surgery) to remove inflammatory mediators from the patients' blood. The control group did not utilize CytoSorb®.
    The authors demonstrate that CytoSorb® usage results in a statistically significant decline in inflammatory mediators such as interleukin-6 (IL-6) and procalcitonin in the treatment group, compared to the control group, during the three days after the operation.

  • Starpharma Holdings Ltd (SPL.AX) (SPHRY) today announced that the US Food and Drug Administration (FDA) has granted Special Protocol Assessment (SPA) agreement on the design and planned analyses of the phase 3 clinical studies of the VivaGel® bacterial vaginosis (BV) product for the prevention of recurrent BV.

    The favourable SPA outcome provides a binding agreement from the FDA that the phase 3 clinical study design, endpoints, statistical analyses and other aspects of the planned studies adequately address objectives in support of a US regulatory submission for approval of the product.

    The granting of SPA agreement by the FDA follows the earlier agreement of the European Medicines Agency (EMA) on the design of the phase 3 studies.

    Starpharma will now commence its two pivotal phase 3 clinical trials of VivaGel® for the prevention of recurrent BV at sites in North America, Europe and Asia.

    The two phase 3, double-blind, randomised, placebo-controlled trials will be identical in design and will compare the rate of BV recurrence in women using VivaGel® to the rate of recurrence in women using a placebo gel during a 16 week treatment period. Approximately 600 women will be recruited into each study.

    Starpharma Chief Executive Officer, Dr Jackie Fairley, said: “Receiving agreement on the SPA is an important and very positive development as it effectively eliminates the US regulatory risk associated with clinical development, by specifying upfront the FDA’s agreed trial design. This significantly reduces overall development risk for VivaGel®. SPA agreement from the FDA is protected by US law and gives Starpharma certainty and confidence that the studies will support a regulatory submission for the approval of VivaGel® for the prevention of recurrent BV in the US.”

  • robert.vince robert.vince Jul 9, 2014 3:51 PM Flag

    He can't say... just swallowed his tongue.

  • Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, is pleased to announce that a research collaboration with Fox Chase Chemical Diversity Center has led to the award of a Phase 2B Small Business Innovation Research (SBIR) grant to FCCDC from the National Institute of Allergy and Infectious Disease (NIAID) of the National Institute of Health (NIH).

    The SBIR grant is for up to $1.5 million over two years and research will be directed at developing the Cellceutix technology platform on host defense protein (HDP) mimics for treatment of disseminated fungal infections, particularly those caused by Candida species.

    "This grant to research our novel compounds dovetails with our strategy to partner with leading organizations and universities in the development of new therapeutic agents for some of the most difficult to treat fungal and bacterial infections," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "Candida infections were recently named in the final rule of the U.S. Food and Drug Administration's list of qualifying pathogens under the Generating Antibiotic Incentives Now Act. We clearly see the potential and value of new drugs for Candida infections and are very pleased that the funding is now in place for FCCDC to conduct studies on our compounds in this area."

  • Regado Biosciences, Inc. (RGDO), a biopharmaceutical company focused on the discovery and development of actively controllable aptamer therapeutics for the acute care setting, today announced the publication in the Journal of Thrombosis and Thrombolysis of data from a single escalating-dose Phase 1 clinical trial of the REG2 anticoagulation system. The published data demonstrates the dose and concentration-dependent attenuation of thrombin generation and subsequent restoration of thrombin following reversal associated with REG2.

    REG2 is a two-component system consisting of a subcutaneous depot formulation of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation Factor IXa, and its complementary intravenous injectable oligonucleotide active control agent, anivamersen. REG2 is being developed to be the preferred therapeutic option in high value sub-acute venous thrombosis indications such as DVT and VTE prophylaxis. REG2 will be an important part of the life cycle franchise strategy associated with Revolixys™ Kit which ultimately entails broad use throughout the hospital.

    Christopher Rusconi, Ph.D., Regado's Chief Scientific Officer and co-discoverer of the Regado controllable aptamer technology, commented, "These results support the choice of FIXa as an excellent target for anticoagulant therapy. In addition, the concentration-dependent inhibition of thrombin generation observed in this study further supports the pegnivacogin dose selected for the REGULATE-PCI Phase 3 study of the companion product candidate, Revolixys™ Kit."

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