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Home  /  Forum  /  BioPharma  /  Mooi instap moment Dendreon

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Mooi instap moment Dendreon

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1.743 Posts
Pagina: «« 1 ... 67 68 69 70 71 ... 88 »» | Laatste | Omlaag ↓
  3. [verwijderd] 21 mei 2007 23:00
    quote:

    geldmaker72 schreef:

    us.rd.yahoo.com/finance/external/reut...
    Dendreon's shares are up and its options are very active today on what seems to be the idea that pressure could force the FDA to hasten its approval process for Provenge," William Lefkowitz, an options strategist at brokerage firm vFinance Investments in New York, said.

    Lefkowitz said cancer patients, who were looking forward for Provenge to be approved, were working together to pressure the U.S. Food and Drug Administration to hasten the approval process.

    P.
    "The saga continues"
  5. [verwijderd] 22 mei 2007 08:56
    FYI Nu krijgt de FDA hevige kritiek (oa van de WSJ) vanwege nalatigheid bij Avandia drug (diabetes) van Glaxo GSK.
    Een meta-study (analyse van vele andere studies) heeft aangetoond dat bij gebruik Avandia kans op hartproblemen met 45 % toeneemt.
    FDA was bekend met deze studie maar nam geen aktie.... GSK is 1 van de grote pharma's ... zou dat een rol spelen.

    Sequel for Vioxx Critic: Attack on Diabetes Pill
    online.wsj.com/article/SB117976261302...

    Zie voor volledige tekst mijn posting in Amylin draadje.
  6. [verwijderd] 22 mei 2007 10:44
    quote:

    xzorro123 schreef:

    FYI Nu krijgt de FDA hevige kritiek (oa van de WSJ) vanwege nalatigheid bij Avandia drug (diabetes) van Glaxo GSK.
    Een meta-study (analyse van vele andere studies) heeft aangetoond dat bij gebruik Avandia kans op hartproblemen met 45 % toeneemt.
    FDA was bekend met deze studie maar nam geen aktie.... GSK is 1 van de grote pharma's ... zou dat een rol spelen.

    Sequel for Vioxx Critic: Attack on Diabetes Pill
    online.wsj.com/article/SB117976261302...

    Zie voor volledige tekst mijn posting in Amylin draadje.
    Hi X, ik volg dit sinds gisteravond op CNBC en Bloomberg, maar in wezen zegt het mij niet zo veel.
    Wellicht komen de andere diabetes middelen er met een 52% kans uit na meta analyse.
    Wel zou dit moeten betekenen, dat elk middel een fase IV zou moeten hebben om de lange termijn effecten (via onderzoek) en de breedte effecten (via bv. panelgroups) te kunnen bekijken. Waarna eventueel een terugtrekking van de medicatie. (waarbij uniciteit, levensbedreigendheid van de ziekte etc. versoepelende factoren moeten zijn).
    Maar dat vind ik.

    Psycho
  7. [verwijderd] 22 mei 2007 13:05
    www.provengenow.org/actions.html

    We are not fighting this battle alone. Below are some of the actions taken by others to speak up about the delaying in bringing provenge to patients now.

    Raise A Voice Writes to FDA Advisory Committee

    Raise a Voice, an advocacy group for advanced prostate cancer patients calling for patient access to drugs that have passed through Phase I trials, has written a thank you letter to the FDA Advisory Committee on Dendreon's sipuleucel-T (Provenge®). The letter is signed by 19 prostate cancer advocacy groups including US Too International and National Prostate Cancer Coalition. The writers say:

    The advocates of "Raise a Voice", a grass roots initiative for advanced prostate cancer, would like to express our appreciation for the opportunity to present comments at the Cellular, Tissue and Gene Therapies Advisory Committee meeting on March 29, 2007.

    We respect and appreciate the importance and difficulty of the FDA's current process towards decision on approval of Provenge (sipuleucel-T).

    Given the following points, we would like to reaffirm our position on the need for additional effective treatments with fewer side effects for advanced prostate cancer.

    * The very favorable risk-benefit ratio of Provenge
    * The survival data discussed at March 29th meeting
    * The necessity for additional effective treatments for advanced and hormone refractory prostate cancer based on the current U.S. death rate of approximately 27,000 men a year

    Signers of this letters:
    1. Us TOO International
    2. Prostate Cancer Research Institute
    3. Prostate Health Education Network
    4. Malecare
    5. National Alliance of State Prostate Cancer Coalitions
    6. Virginia Prostate Cancer Coalition
    7. Georgia Prostate Cancer Coalition
    8. Washington State Prostate Cancer Coalition
    9. Prostate Cancer Coalition of Michigan
    10. National Prostate Cancer Coalition
    11. American Prostate Cancer Initiative
    12. The Prostate Cancer Education Forum of Connecticut
    13. Maine Coalition to Fight Prostate Cancer
    14. Nevada's Prostate Cancer Task Force
    15. Prostate Cancer Support Association of New Mexico
    16. Hawaii Prostate Cancer Coalition
    17. Texas Prostate Cancer Coalition
    18. Prostate Cancer 101 of New York
    19. New York Prostate Cancer Coalition

    The Provenge Now lead organizations include:

    Us TOO
    Prostate Health Education Network (PHEN)
    Prostate Cancer Research Institute
    Malecare
    Survivors Celebration
    Raise A Voice
    Patient Advocates for Advanced Cancer Treatments (PAACT)

    Psycho
    the pressure is rising

  8. [verwijderd] 23 mei 2007 15:21
    De falanxen worden gevuld, nog enkele dagmarsen:

    ***The New Media*** (8 Ratings)(Yahoo, DNDN MB)

    Good Morning,

    The good media coverage monday and sunday was only the begining. I am working directly with these out reach groups. They are planning much more in the short term. Just wait and watch what happens over the next three weeks. With what is planned this will we be a much bigger National story than a 2 min cnbc huckman clip or a short bash by the street.com guy who is out of the loop. He will be insignifigant in the end. Just about every cancer out reach group is now on board. I expect this "raise a voice" movement to be one of the largest ever. Be proud that you are involved with dendreon. You are apart of history in the making. The government will listen becauase they have no choice. Last i saw this was still a democracy. Power in numbers friends. Thats all for now. I will try and give a more comprehensive update later into what will be going on in the coming days. I have a busy day. Will try to return around 8 or 9 est tonight.

    P.
  10. [verwijderd] 28 mei 2007 10:26
    Here come the vultures...

    Federman & Sherwood Announces That a Securities Class Action Lawsuit has Been Filed Against Dendreon Corporation
    Last update: 5/25/2007 1:27:00 PM
    OKLAHOMA CITY, May 25, 2007 /PRNewswire via COMTEX/ -- On May 24, 2007, a class action lawsuit was filed in the United States District Court for the Western District of Washington against Dendreon Corporation (DNDN). The complaint alleges violations of federal securities laws, Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5, including allegations of issuing a series of material misrepresentations to the market which had the effect of artificially inflating the market price. The class period is from March 30, 2007 through May 8, 2007.
    Plaintiff seeks to recover damages on behalf of the Class. If you are a member of the Class as described above, you may move the Court no later than Tuesday, July 24, 2007, to serve as a lead plaintiff for the Class. However, in order to do so, you must meet certain legal requirements pursuant to the Private Securities Litigation Reform Act of 1995.
    If you wish to discuss this action, participate in this or any other lawsuit, or have any questions or concerns regarding this notice, or preservation of your rights, please contact:

    William B. Federman
    FEDERMAN & SHERWOOD
    10205 North Pennsylvania Avenue
    Oklahoma City, OK 73120
    Email to: wfederman@aol.com -

    SOURCE Federman & Sherwood
    William B. Federman of Federman & Sherwood, +1-405-235-1560 wfederman@aol.com
    www.investorvillage.com/smbd.asp?mb=9...
    Lawsuit alleges Dendreon misled investors
    By DAN RICHMAN
    P-I REPORTER
    A shareholder of Dendreon Corp. has filed a federal lawsuit against the Seattle biopharmaceutical company on behalf of himself and other investors, alleging that Dendreon and its chief executive, Mitchell Gold, defrauded them as to the company's value.
    The action, filed Thursday in U.S. District Court, alleges that Dendreon and Gold concealed negative information about nascent anti-cancer drug Provenge and made misleading statements that led the plaintiffs to buy shares at artificially inflated prices.
    It also says that Gold personally benefited from the scheme by exercising stock options when the share prices were at that artificially inflated high.
    The company's stock hit a 52-week high of $25.25 on April 10 after a committee of U.S. government advisers recommended approval of Provenge. Shares plunged more than 60 percent earlier this month when the Food and Drug Administration overrode that recommendation and requested more information.
    Dendreon has been at work for a number of years on Provenge, a treatment for prostate cancer that many cancer advocates believe will be preferable to the alternative treatments: chemotherapy and radiation.
    The 23-page complaint, filed Thursday, tracks statements made by Gold about the success of Provenge in clinical trials.
    seattlepi.nwsource.com/business/31733...
  11. [verwijderd] 28 mei 2007 15:26
    [quote=psycho-pharma]
    www.provengenow.org/actions.html

    We are not fighting this battle alone. Below are some of the actions taken by others to speak up about the delaying in bringing provenge to patients now.

    Raise A Voice Writes to FDA Advisory Committee

    Raise a Voice, an advocacy group for advanced prostate cancer patients calling for patient access to drugs that have passed through Phase I trials, has written a thank you letter to the FDA Advisory Committee on Dendreon's sipuleucel-T (Provenge®). The letter is signed by 19 prostate cancer advocacy groups including US Too International and National Prostate Cancer Coalition. The writers say:

    The advocates of "Raise a Voice", a grass roots initiative for advanced prostate cancer, would like to express our appreciation for the opportunity to present comments at the Cellular, Tissue and Gene Therapies Advisory Committee meeting on March 29, 2007.

    We respect and appreciate the importance and difficulty of the FDA's current process towards decision on approval of Provenge (sipuleucel-T).

    Given the following points, we would like to reaffirm our position on the need for additional effective treatments with fewer side effects for advanced prostate cancer.

    * The very favorable risk-benefit ratio of Provenge
    * The survival data discussed at March 29th meeting
    * The necessity for additional effective treatments for advanced and hormone refractory prostate cancer based on the current U.S. death rate of approximately 27,000 men a year

    Signers of this letters:
    1. Us TOO International
    2. Prostate Cancer Research Institute
    3. Prostate Health Education Network
    4. Malecare
    5. National Alliance of State Prostate Cancer Coalitions
    6. Virginia Prostate Cancer Coalition
    7. Georgia Prostate Cancer Coalition
    8. Washington State Prostate Cancer Coalition
    9. Prostate Cancer Coalition of Michigan
    10. National Prostate Cancer Coalition
    11. American Prostate Cancer Initiative
    12. The Prostate Cancer Education Forum of Connecticut
    13. Maine Coalition to Fight Prostate Cancer
    14. Nevada's Prostate Cancer Task Force
    15. Prostate Cancer Support Association of New Mexico
    16. Hawaii Prostate Cancer Coalition
    17. Texas Prostate Cancer Coalition
    18. Prostate Cancer 101 of New York
    19. New York Prostate Cancer Coalition

    The Provenge Now lead organizations include:

    Us TOO
    Prostate Health Education Network (PHEN)
    Prostate Cancer Research Institute
    Malecare
    Survivors Celebration
    Raise A Voice
    Patient Advocates for Advanced Cancer Treatments (PAACT)

    Psycho
    the pressure is rising

    [/quote

    Battle of niet, je had al kunnen cashen bij 25 dollar......succes met het gevecht!
  12. [verwijderd] 31 mei 2007 15:13
    pomperpompompom

    Source: Dendreon Corporation

    Dendreon Announces FDA Confirms Data Required for Provenge(R) Licensure
    Thursday May 31, 9:00 am ET
    Bank of America Company Presentation Available Via Webcast at 10:00 a.m. PT Today

    SEATTLE, May 31 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced the Company has received confirmation that the U.S. Food and Drug Administration (FDA) will accept either a positive interim or final analysis of survival from its ongoing IMPACT study to amend the Biologics License Application (BLA) for PROVENGE (sipuleucel-T). This information was obtained in a recent follow up meeting with the FDA to discuss the additional clinical data required to support the licensure of PROVENGE requested by the FDA in the Complete Response Letter the Company received on May 8, 2007.
    ADVERTISEMENT


    "The FDA indicated that either a positive interim or final analysis of survival, as described in the IMPACT Special Protocol Assessment Agreement, would address their request for the submission of additional clinical data in support of our efficacy claim," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "We anticipate completing enrollment in the IMPACT study this year and anticipate interim survival results in 2008. We are committed to making PROVENGE available as rapidly as possible to help the many men with late-stage prostate cancer who currently have few appealing treatment options."

    Financial Outlook

    Management will present an operational update and financial guidance today at the Bank of America 2007 Health Care Conference at The Four Seasons, Las Vegas at 10:00 a.m. Pacific Time. The presentation will be audio webcast live and available for replay from Dendreon's website, www.dendreon.com. The replay of the presentation will be available for 90 days.

    The Company anticipates net cash utilized for operating and capital expenditures for 2007 of approximately $95 million. The Company anticipates spending levels to decrease substantially in 2008 to approximately $55 million because it has already incurred many of the third-party costs necessary to prepare for the commercialization of PROVENGE. These costs include items such as third party clinical trial costs, inventory purchases, capital expenditures related to New Jersey manufacturing and other outside infrastructure costs.

    PROVENGE Biologics License Application

    Dendreon's BLA was submitted under a Fast Track designation and was accepted for filing by the FDA in January 2007. The BLA was based primarily on a multi-center, randomized, double-blind, placebo-controlled Phase 3 study (D9901) that showed that the group of men with asymptomatic, metastatic, androgen-independent prostate cancer who received PROVENGE had a median survival time 4.5 months longer than the median survival seen in the group that had been assigned to receive placebo. For the men who received PROVENGE, there was a 41 percent overall reduction in the risk of death (p-value = 0.010; HR = 1.7). In addition, 34 percent of patients receiving PROVENGE were alive 36 months after treatment compared to 11 percent of patients randomized to receive placebo.

    Treatment with PROVENGE was generally well tolerated. The majority of side effects were mild, including infusion-related fever and chills that were usually of low grade and typically lasted for one to two days following infusion.

    IMPACT Clinical Study

    IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment), also known as D9902B, is an ongoing Phase 3 clinical trial measuring overall survival in men with hormone-refractory prostate cancer receiving PROVENGE versus those receiving placebo.

    In order to be eligible to participate in the IMPACT study, a person must meet certain criteria, such as having cancer that has spread outside the prostate (metastatic) or cancer that has worsened while on hormone therapy among other additional criteria. Interested patients should contact the Dendreon Prostate Cancer Information line at 1-866-4PROSTATE (1-866-477-6782).

    About Prostate Cancer

    Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 218,890 new cases expected to be diagnosed in 2007, and more than 27,000 men expected to die this year from the disease. Currently there are limited treatment options for men with advanced, metastatic prostate cancer.

    About PROVENGE

    PROVENGE (sipuleucel-T) is an investigational product that may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's own immune system. PROVENGE is in late-stage clinical development for the treatment of patients with advanced prostate cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.

    About Active Cellular Immunotherapy

    Active cellular immunotherapy is an approach that uses live human cells to re-engage the patient's own immune system. The goal of active cellular immunotherapy is to turn the immune system "back on" to elicit a specific long-lasting response against cancer. While ACIs are being studied in various cancers, prostate cancer is the first to be treated with them.

    About Dendreon

    Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity. The Company has its headquarters in Seattle, Washington and is traded on the Nasdaq Global Market under the symbol DNDN. For more information about the Company and its programs, visit www.dendreon.com.

    Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of existing clinical trials or from additional clinical trials for PROVENGE will not support approval for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product may not be indicative of results obtained in a later clinical trial, risks that we may
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