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MS Drug Gilenya Positive Benefit-Risk Profile Following CHMP Review, Europe

Posted: Published on April 24th, 2012

Editor's Choice Main Category: Multiple Sclerosis Also Included In: Regulatory Affairs / Drug Approvals Article Date: 23 Apr 2012 - 11:00 PDT email to a friend printer friendly opinions Current Article Ratings: 1 (1 votes) In agreement with the CHMP, the company has updated their E.U. product information after the Article 20 review the EMA announced in January 2012, in order to offer further guidance to healthcare providers who want to initiate using Gilenya in MS patients. In the E.U., Gilenya is approved for the treatment of individuals with highly active relapsing-remitting MS, regardless of treatment with beta interferon, or in patients with rapidly evolving severe relapsing-remitting MS. Gilenya is the first in a new class of sphingosine 1-phosphate receptor (S1PR) modulating compounds and has demonstrated superior efficacy over Avonex (interferon-beta-1a IM), a commonly prescribed treatment. In a pivotal head-to-head trial in patients with relapsing- remitting multiple sclerosis at one year, Gilenya achieved both its primary and secondary endpoints, i.e. a 52% relative reduction of the yearly relapse rate and a 40% relative reduction in the rate of brain atrophy. A recent sub-analysis at one year revealed that in comparison to interferon-beta-1a (IM), Gilenya achieved a 61% relative reduction in … Continue reading →

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StudioPMG's "Challenge Walk MS Documentary" Lands Spot in Prestigious Newport Beach Film Festival

Posted: Published on April 24th, 2012

IRVINE, CA--(Marketwire -04/23/12)- A documentary film produced by digital marketing agency StudioPMG has been named an "Offical Selection" at the 2012 Newport Beach Film Festival (NBFF). The award-winning film, titled "Challenge Walk MS Documentary," will be screened at Islands Cinema 3 in Newport Beach, California on April 29, 2012 at 4:30 p.m. StudioPMG, a provider of digital marketing, mobile applications and marketing analytics solutions, developed the documentary to help its client, Acorda Therapeutics, increase awareness and research for Multiple Sclerosis (MS). "Challenge Walk MS Documentary" is a 43-minute film about Team OptiMiStic, a group of seven women, five of whom have MS, who walk 50 miles in three days during the 2009 MS Challenge Walk. The documentary follows their progress from Carlsbad to San Diego, California, as they share their personal stories along the way. It was developed by StudioPMG as part of Acorda's "I Walk Because" campaign. Erica Wishner (Director, Consumer Communication and Outreach) and Maria Verastegui (Director, Creative Services) at Acorda developed the "I Walk Because" campaign to increase awareness for the Walk MS fundraising events and provide people with a place to share their Walk MS experience with others. "We are very proud of this film," said … Continue reading →

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New Warnings for MS Drug Gilenya After FDA Review

Posted: Published on April 24th, 2012

Heart Risk Safety Concerns Added to Multiple Sclerosis Drug's Label By Cari Nierenberg WebMD Health News Reviewed by Laura J. Martin, MD April 20, 2012 -- Novartis, the maker of the drug Gilenya (fingolimod), a once-daily oral capsule taken for multiple sclerosis, has added stronger warnings to labels and prescription information about the drug's possible heart risks, according to a company statement. Labels will now recommend that all patients have an electrocardiogram (ECG) before taking their first dose of the MS drug. In addition, those starting treatment with Gilenya are also advised to get a second ECG six hours after their first dose of the medication. New patients are advised to take the drug for the first time in their doctor's office with hourly blood pressure and heart rate checks during a six-hour monitoring period. The revised label information will not affect people currently taking the drug. But it may apply to them if they stop taking Gilenya for more than two weeks and need to restart the treatment. They would need to repeat the ECGs as well as the six-hour monitoring period. These changes follow an FDA report in December 2011 of an MS patient who died within 24 … Continue reading →

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Bestellen Sie den kostenlosen Newsletter von 4investors:

Posted: Published on April 24th, 2012

PRESS RELEASE: Santhera Shareholders Approve all Board Proposals at Annual Shareholders' Meeting Santhera Pharmaceuticals Holding AG / Santhera Shareholders Approve all Board Proposals at Annual Shareholders' Meeting . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement. Liestal, Switzerland, April 23, 2012 - Santhera Pharmaceuticals (SIX: SANN) announced that all proposals at today's annual shareholders' meeting passed with a vast majority. Santhera's shareholders approved the annual report, the annual financial statements and the consolidated financial statements for 2011. Santhera's shareholders voted in favor of the proposed appropriation of the results, the renewal of authorized and the increase of conditional share capital. The annual shareholders' meeting also granted discharge to the members of the Board of Directors and management. Klaus Schollmeier and Timothy Rink were re-elected as Board members for a period of one and three years, respectively. The shareholders also re-elected Ernst & Young as auditors. A total of 1,691,639 shares or 46.05 % of the share capital was represented at the Annual Shareholders' Meeting. In his presentation to shareholders, Thomas Meier, Chief Executive Officer, reported on significant progress with the Company's key projects and the impact of last year's restructuring: … Continue reading →

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PRESS RELEASE: Santhera Shareholders Approve all Board Proposals at Annual Shareholders' Meeting

Posted: Published on April 24th, 2012

Santhera Pharmaceuticals Holding AG / Santhera Shareholders Approve all Board Proposals at Annual Shareholders' Meeting . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement. Liestal, Switzerland, April 23, 2012 - Santhera Pharmaceuticals (SIX: SANN) announced that all proposals at today's annual shareholders' meeting passed with a vast majority. Santhera's shareholders approved the annual report, the annual financial statements and the consolidated financial statements for 2011. Santhera's shareholders voted in favor of the proposed appropriation of the results, the renewal of authorized and the increase of conditional share capital. The annual shareholders' meeting also granted discharge to the members of the Board of Directors and management. Klaus Schollmeier and Timothy Rink were re-elected as Board members for a period of one and three years, respectively. The shareholders also re-elected Ernst & Young as auditors. A total of 1,691,639 shares or 46.05 % of the share capital was represented at the Annual Shareholders' Meeting. In his presentation to shareholders, Thomas Meier, Chief Executive Officer, reported on significant progress with the Company's key projects and the impact of last year's restructuring: "In Europe, we submitted the application for marketing authorization of idebenone (Catena()) … Continue reading →

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Protein prevents DNA damage in the developing brain and might serve as a tumor suppressor

Posted: Published on April 24th, 2012

ScienceDaily (Apr. 23, 2012) St. Jude Children's Research Hospital scientists have rewritten the job description of the protein TopBP1 after demonstrating that it guards early brain cells from DNA damage. Such damage might foreshadow later problems, including cancer. Researchers showed that cells in the developing brain require TopBP1 to prevent DNA strands from breaking as the molecule is copied prior to cell division. Investigators also reported that stem cells and immature cells known as progenitor cells involved at the beginning of brain development are more sensitive to unrepaired DNA damage than progenitor cells later in the process. Although more developmentally advanced than stem cells, progenitor cells retain the ability to become one of a variety of more specialized neurons. "Such DNA strand breaks have great potential for creating mutations that push a normal cell toward malignancy," said Peter McKinnon, Ph.D., a St. Jude Department of Genetics member and the paper's senior author. "When we selectively knocked out TopBP1 in mice, the amount of DNA damage we saw suggests that TopBP1 is likely to be a tumor suppressor. We are exploring that question now." The work appeared in the April 22 online edition of the scientific journal Nature Neuroscience. The research … Continue reading →

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Santhera Shareholders Approve all Board Proposals at Annual Shareholders' Meeting

Posted: Published on April 24th, 2012

Liestal, Switzerland, April23, 2012 - Santhera Pharmaceuticals (SIX:SANN) announced that all proposals at today`s annual shareholders` meeting passed with a vast majority. Santhera`s shareholders approved the annual report, the annual financial statements and the consolidated financial statements for 2011. Santhera`s shareholders voted in favor of the proposed appropriation of the results, the renewal of authorized and the increase of conditional share capital. The annual shareholders` meeting also granted discharge to the members of the Board of Directors and management. Klaus Schollmeier and Timothy Rink were re-elected as Board members for a period of one and three years, respectively. The shareholders also re-elected Ernst&Young as auditors. A total of 1,691,639 shares or 46.05% of the share capital was represented at the Annual Shareholders` Meeting. In his presentation to shareholders, Thomas Meier, Chief Executive Officer, reported on significant progress with the Company`s key projects and the impact of last year`s restructuring: "In Europe, we submitted the application for marketing authorization of idebenone (Catena) in Leber`s Hereditary Optic Neuropathy (LHON). The revenues from product sales combined with strict cost control measures safeguarded Santhera`s cash reserves." Looking into 2012 he continued: "We expect a decision from the European Medicines Agency on the LHON filing … Continue reading →

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$4 Million Awarded to Prempro Breast Cancer Survivor

Posted: Published on April 24th, 2012

FAIRFIELD Conn., April 23, 2012 /PRNewswire/ -- Ury & Moskow and Bubalo Rotman secured a $4 million verdict plus punitive damages against Wyeth Inc., on behalf of their client who developed breast cancer after taking Prempro. A Connecticut jury found that Wyeth's hormone-replacement drug Prempro was responsible for the Plaintiff's invasive breast cancer and that Prempro is an unreasonably dangerous product. Wyeth must also pay punitive damages based on its handling of the drug, the jury concluded. Prempro is a hormone therapy medication containing a combination of estrogens and progesterone that is prescribed to treat the symptoms of menopause, including hot flashes and mood swings.More than 6 million women took Prempro and similar drugs until a 2002 study by the National Institutes of Health revealed their link to cancer.Wyeth's Prempro sales reached $2 billion before the release of the study. Attorney Gregory Bubalo led the Prempro case in collaboration with Steven Rotman and Paula Bliss, all of the Bubalo Rotman firm of Louisville, Boston and Lexington, and with Neal Moskow of Ury & Moskow, LLC. Moskow, who has represented plaintiffs Margaret and Joseph Fraser since 2004, said that he was pleased with the verdict, which came after three weeks of … Continue reading →

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Regenerative Medicine Institute, Mexico Presents Summary of Clinical Data at the International Society of Stem Cell …

Posted: Published on April 24th, 2012

TIJUANA, Mexico, April 23, 2012 (GLOBE NEWSWIRE) -- Regenerative Medicine Institute, Mexico (RMI) will be among top scientists and physicians presenting cutting edge data at the International Society of Stem Cell Research (ISSCR). The ISSCR's annual meeting has become the world's premier stem cell research event. The meeting serves as the largest forum for stem cell and regenerative medicine professionals from around the world. The ISSCR 10th Annual Meeting will be held June 13 - 16, 2012 at the Pacifico Yokohama in Yokohama, Japan. A summary of data on the use of adult stem cells from adipose tissue to treat heart failure and COPD will be presented by Kristin Comella, Chief Scientific Officer of Bioheart Inc. Bioheart is focused on the discovery, development, and commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. RMI is currently running Phase I/II trials at the Hospital Angeles in collaboration with Bioheart and the Ageless Regenerative Institute. Dr. Javier Lopez, President and CEO of RMI and a member of ISSCR said that "We are proud to share our initial results with the scientific community at such a prestigious event." For more information on RMI, visit … Continue reading →

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Sherley continues arguing against stem cell research in court

Posted: Published on April 24th, 2012

Sherley continues arguing against stem cell research in court April 24, 2012 Sherley continues arguing against stem cell research in court James L. Sherley, the former Course 20 MIT professor trying to stop government funding of embryonic stem cell research, had his day in court yesterday again. This was his third time before the appeals court. Sherley is now appealing on the merits of his case, after a complex sequence of court events. The D.C. district court found preliminarily in his favor, but the government appealed and the appeals court found against him on the preliminary injunction. Then the district court, respecting the appeals courts decision, ultimately found against Sherley. Both sides argued yesterday before a three-judge panel, which included Chief Judge David B. Sentelle. According to coverage by Science and Nature, Sentelle asked most of the questions in the oral argument. Sentelle, joined by Judge Janice R. Brown, strongly focused on the question of whether the appeals court was bound by its earlier decision on the preliminary injunction (against Sherley). Yesterdays three-judge panel was a different panel from the one that decided the earlier question, although it had one member in common, Karen L. Henderson. Henderson did not speak … Continue reading →

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