Read more: Biogen, Glaxo pour millions into S.F. firm iPerian - Triangle Business Journal
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Saturday, September 11, 2010
Read more: Biogen, Glaxo pour millions into S.F. firm iPerian - Triangle Business Journal
Friday, September 10, 2010
Genmab A/S - 10.09.2010 Dissemination of a Adhoc News, transmitted by DGAP - a company of EquityStory AG. The issuer is solely responsible for the content of this announcement.
Summary: Genmab announces 48 week results from a Phase II study of ofatumumab in RRMS.
Copenhagen, Denmark; September 10, 2010 - Genmab A/S (OMX: GEN) announced today encouraging results from an ofatumumab Phase II safety and pharmacokinetics study in patients with relapsing-remitting multiple sclerosis (RRMS). A total of 38 patients were included in this double-blind, dose escalation trial.
Patients were randomized to receive two infusions of 100 mg, 300 mg or 700 mg of ofatumumab or placebo. After 24 weeks, the patients randomized to placebo were treated with ofatumumab and patients who were treated with ofatumumab received placebo. All patients were then followed for an additional 24 weeks.
In the study, there were no dose limiting toxicities, no unexpected safety findings, and no patients tested positive for human anti-human antibodies. Efficacy was assessed by MRI (magnetic resonance imaging) as a secondary endpoint. Repeated MRI scans showed a sustained reduction in the number of brain lesions up to week 48 in patients (n=26) who were treated with ofatumumab followed by placebo. Patients who received placebo followed by ofatumumab (n=12) showed similar 24 week results to those who were treated with ofatumumab followed by placebo.
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The National MS Society
and MS Learn Online present...
A new Feature Presentation:
Part one of a two-part video webcast series that explores...
Novartis International AG: Novartis announces Russian regulatory approval for Gilenya®, a once-daily oral multiple sclerosis therapy
Novartis International AG / Novartis announces Russian regulatory approval for Gilenya, a once-daily oral multiple sclerosis therapy and first in a new class processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
* Russia is first country to approve Gilenya for the treatment of relapsing remitting MS, the most common form of the disease
* Gilenya is the first disease-modifying treatment in a new drug class and offers significant efficacy with a well-characterized safety tolerability profile
* Action from the US Food and Drug Administration (FDA) on Gilenya is expected in September 2010; other submissions under review worldwide Basel, September 10, 2010- The Russian health authority, the Federal Service on Surveillance in Healthcare and Social Development, has granted approval for Gilenya (fingolimod) 0.5 mg once-daily oral therapy for the treatment of relapsing remitting multiple sclerosis (MS).
Approximately 85% of patients with MS are estimated to have the relapsing remitting form at the onset of disease.
Russia is the first country to approve Gilenya, providing a new treatment option offering significant efficacy for patients in the convenience of an oral capsule. Novartis expects to launch Gilenya in Russia in early 2011.
In June, an advisory committee of the US Food and Drug Administration (FDA) unanimously recommended approval of Gilenya and action from the FDA is expected in September 2010. Gilenya is also under review by the European Medicines Agency (EMA) as well as other health authorities worldwide.
Continue reading this Reuter's article by clicking here
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Thursday, September 9, 2010
Two weeks ago, a federal judge issued a preliminary injunction halting all federal funding for human embryonic stem cell research (ESCR). This was a huge setback on the achievements that MS Activists have fought hard to attain in our efforts to move us closer to a world free of multiple sclerosis. Fortunately, just today, the DC Court of Appeals sided with the Department of Justice and stopped the preliminary injunction from halting federal funding for human embryonic stem cell research. This ruling is temporary and only in place while the full arguments are heard in the Court of Appeals. These full arguments could occur later this month. The Director of the National Institutes of Health (NIH), Dr. Francis Collins, indicated emphatically that he views the attempts to block federal funding as a major crisis in science and that delays will cause irreparable damage to critical research being conducted utilizing stem cells.
With the help of MS Activists, Congress twice comfortably passed bi-partisan legislation permitting federal funding of ESCR, but both bills received presidential vetoes. However, in 2009 an Executive Order lifted previous restrictions on federal funding of ESCR and brought new hope to the millions of people living with chronic and debilitating diseases or disabilities. Click here to see the Society’s historical work with ESCR.
The current judicial proceedings threaten the progress we have made in stem cell research. Once again, MS Activists must mobilize to ensure that scientists and researchers have the funding and authority they need to explore this promising field of ESCR.
While legal battles in the court system are underway, the only way to guarantee a permanent solution is to pass bi-partisan legislation. Congress must make it a priority to secure a legislative fix to this situation immediately. There are already bi-partisan efforts underway, but we need broad support to fuel momentum.
Congress will soon be back from its summer recess but will only have a few weeks before it recesses again for the November election. That time between Congressional recesses may be the last opportunity to secure needed action from the 111th Congress.
The National MS Society has made a commitment to pursue promising avenues that will lead to solutions that stop disease progression, restore function, and ultimately prevent future generations from ever receiving an MS diagnosis. This commitment is reflected in our decision to support the conduct of scientifically meritorious medical research, including research using human cells, in accordance with federal, state and local laws, and with adherence to the strictest ethical and procedural guidelines. This decision was not reached without intense scrutiny and discussion among volunteers, people living with MS, ethicists, researchers and scientists, and MS neurologists.
Ultimately, more research is needed to better understand which stem cells, and from what sources, could hold significant promise for repairing damage and restoring function, as well as provide a better understanding of the underlying disease cause.
Click here to email your Members of Congress today and ask them to make stem cell research legislation a priority this session.
Wednesday, September 8, 2010
The Pros and Cons of Gilenya (Gilenia) (FTY720) - the first Oral medication for MS that will soon be FDA approved
Sure for many it may be easier to pop a pill rather than doing an injection, but just know there are adverse effects from the orals that can make it more dangerous than the injectable therapies or even the once a month infusion.
I obtained the information found below for you to learn more on how Gilenia works and the known side effects. ( I say known because until thousands begin using this, outside of research study, we really do not know what other side effects the medication might have)
To prove the effectiveness of the drug in dealing with MS, the Basel, Switzerland based pharmaceutical giant undertook a study on 1,200 patients suffering from the disease.
In MS, white blood cells attack the myelin sheathes that protect nerve cells. Gilenia keeps white blood cells penned up in lymph nodes by taking away the chemical key they need to unlock the lymph-node door.
However Gilenia has some side effects like heart attack along with the lung, liver, and eye toxicity and increased risk of infection.
Read more from the source for this information by clicking here
Then, please share this blog posting with others who may need to learn too.