Tag Archives: CONFIRM

THE Million Dollar Question Concerning Obama’s Place Of Birth

By Breaking News

Barack Obama speech 14 SC THE million dollar question concerning Obamas place of birth

Carl Gallups has asked it before. He has asked it on his radio program heard on 1330 WEBY Northwest Florida’s Talk Radio – Freedom Friday With Carl Gallups.

To date – Carl has never received an answer to the question…not from an Obamabot, not from a staunch Obama birth supporter – not from the people in Carl’s question who are the subject of the question. No one can answer the question.

The QUESTION?   Simple – If Obama is really America’s first black president and if he really is the  historical and iconic figure that so many claim that he is – then why can we find not a single hospital in the world that claims this Noble Prize winning, first black president of the United States was born in their facility?  Not a single hospital in a single state ANYWHERE in the United States of America has even erected a plaque in his honor. Why is there not a monument to his birth? Why is there not a single magazine or news article outlining the details of his famous birth at what should be the world’s most famous hospital?

Additionally, we know that two different hospitalshave been claimed as Obama’s birth place. The most recent place claimed by Obama and his fraudulent long form birth certificate is Kapi’olani Medical Center in Honolulu.  Yet, Kapi’olani refuses, WILL NOT, verify the birth or erect a single monument to signify the fact of the first black president’s birth there.  Strange? Odd? You bet!  We know the birth place, birth home, birth town of every other president – going back to George Washington. Most are signified by monuments, plaques, etc. – but not Obama.

Since the Obamabots INSIST that those of us who question Obama’s birth are “nuts,” we submit that Kapi’olani Medical Center must be nuts as well. They won’t put their reputation on the line and CONFIRM that Obama was indeed born there. Not only that – but consider that Obama’s BC proclaims that Kapi’olani is the hospital of his birth. The name is in the birth certificate for all the world to behold. Yet Kapi’olani will NOT verify it or indicate it with a plaque or monument. Apparently even they do not take the word of the fake birth certificate. One can only assume that their own records do not match the information on the fraudulent birth certificate.

Read More at PPSimmons  .

Photo Credit: marcn Creative Commons

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Source: FULL ARTICLE at Western Journalism

Biogen Idec's TECFIDERA™ (Dimethyl Fumarate) Approved in US as a First-Line Oral Treatment for Multi

By Business Wirevia The Motley Fool

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Biogen Idec’s TECFIDERA™ (Dimethyl Fumarate) Approved in US as a First-Line Oral Treatment for Multiple Sclerosis

– Offers a Broad Spectrum of Patients with Relapsing Forms of MS an Effective and Convenient Treatment Option –

– Reduces Relapses and Disability Progression –

– Strengthens Biogen Idec’s Portfolio of Innovative Treatments for People Living with MS –

WESTON, Mass.–(BUSINESS WIRE)– Today Biogen Idec (NAS: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved TECFIDERA™ (dimethyl fumarate), a new first-line oral treatment for people with relapsing forms of multiple sclerosis (MS). Biogen Idec will make this oral capsule available to people living with MS in the United States in the coming days.

Image of Biogen Idec‘s TECFIDERA(TM) (dimethyl fumarate) which was approved by the U.S. FDA on March 27, 2013 for relapsing multiple sclerosis. (Photo: Business Wire)

TECFIDERA has been clinically proven to significantly reduce important measures of disease activity, including relapses and development of brain lesions, as well as to slow disability progression over time, while demonstrating a favorable safety and tolerability profile.

“With the FDA approval of TECFIDERA, we will offer the MS community a treatment with strong efficacy and a favorable safety profile in the convenience of a pill – a combination we believe will have a significant positive impact on the way people live with this chronic disease,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “Biogen Idec is committed to delivering innovative treatments and setting new standards for the next generation of medicines. We believe TECFIDERA will raise expectations for what people living with MS can achieve with their therapy.”

The FDA approval of TECFIDERA is based on data from a robust clinical development program that included DEFINE and CONFIRM, two global Phase 3 studies that enrolled more than 2,600 patients. In the ongoing extension study, ENDORSE, some patients receiving TECFIDERA have been followed for more than four years.

In DEFINE, TECFIDERA, administered twice daily, significantly reduced the proportion of patients who relapsed by 49 percent (p<0.0001), the annualized relapse rate (ARR) by 53 percent (p<0.0001), …read more
Source: FULL ARTICLE at DailyFinance

CHMP Issues Positive Opinion for TECFIDERA™ (Dimethyl Fumarate) as a First-Line Treatment for Multip

By Business Wirevia The Motley Fool

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CHMP Issues Positive Opinion for TECFIDERA (Dimethyl Fumarate) as a First-Line Treatment for Multiple Sclerosis in the European Union

-European Commission Decision Anticipated In Second Quarter of 2013-

WESTON, Mass.–(BUSINESS WIRE)– Today Biogen Idec (NAS: BIIB) announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU) recommending a marketing authorization be granted for TECFIDERA (dimethyl fumarate) as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS). The CHMP, on the basis of quality, safety and efficacy data submitted by Biogen Idec, considers there to be a favorable benefit-to-risk balance for TECFIDERA.

The CHMP‘s recommendation is now referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union. The U.S. Food and Drug Administration is expected to make a decision on the marketing application for TECFIDERA in the United States in the coming days.

“With the CHMP‘s positive opinion for TECFIDERA, we are one step closer to offering the European MS community a treatment with compelling efficacy and a favorable safety profile in the convenience of a pill – a combination we believe will have a significant positive impact on the way people live with this chronic disease,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “Biogen Idec is committed to delivering innovative treatments and setting new standards for the next generation of medicines. We believe TECFIDERA will raise expectations for what people living with MS can achieve with their therapy.”

The CHMP opinion for TECFIDERA is based on data from a large clinical development program that included two global Phase 3 studies, DEFINE and CONFIRM, involving more than 2,600 RRMS patients, as well as an ongoing extension study in which some patients have been followed for more than four years. In DEFINE, TECFIDERA, administered twice-daily, significantly reduced the proportion of patients who relapsed by 49 percent (p<0.0001), the annualized relapse rate (ARR) by 53 percent (p<0.0001), and 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 38 percent (p=0.0050) compared to placebo at two years. In CONFIRM, twice-daily TECFIDERA significantly reduced ARR by 44 percent (p<0.0001) and the proportion of patients who relapsed by 34 percent (p<0.0001) compared to placebo at two years. While not statistically significant, TECFIDERA showed a 21 percent reduction in 12-week confirmed disability progression in CONFIRM. In addition, both studies showed TECFIDERA significantly reduced lesions in the brain …read more
Source: FULL ARTICLE at DailyFinance

US Patent Office Grants Patent Claiming Dosing Regimen for TECFIDERA™ (Dimethyl Fumarate)

By Business Wirevia The Motley Fool

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US Patent Office Grants Patent Claiming Dosing Regimen for TECFIDERA™ (Dimethyl Fumarate)

– Patent Offers Protection Until 2028 and Strengthens Growing Product Patent Portfolio –

– European Patent Office Also Determines Patent Application Covering the Same Dosing Regimen Allowable –

WESTON, Mass.–(BUSINESS WIRE)– Biogen Idec (NAS: BIIB) today announced that the U.S. Patent and Trademark Office (USPTO) has granted U.S. Patent No. 8,399,514, which offers additional protection for TECFIDERA™ (dimethyl fumarate), the company’s oral therapeutic candidate for the treatment of multiple sclerosis (MS). The patent, which will expire in 2028, covers the dosing regimen of daily administration of 480 mg of TECFIDERA. This regimen is included in the proposed marketing application for TECFIDERA, which is currently under review by the U.S. Food and Drug Administration (FDA).

“The patent for this dosing regimen is recognition of the remarkable innovation TECFIDERA represents for the MS community,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “The tremendous research investment required to study and validate the patented dosing regimen is an example of innovation that leads to meaningful benefits to patients.”

The European Patent Office also recently determined that Biogen Idec‘s application for a patent covering the same dosing regimen of TECFIDERA is allowable. Once granted, this patent would also expire in 2028.

The TECFIDERA dose regimen patents add to the growing portfolio of granted patents covering TECFIDERA.

About TECFIDERA

TECFIDERA is the only currently known investigational compound for the treatment of relapsing-remitting multiple sclerosis (RRMS) that has experimentally demonstrated activation of the Nrf-2 pathway. This pathway provides a way for cells in the body to defend themselves against inflammation and oxidative stress caused by conditions like MS.

In 2011 and 2012, Biogen Idec announced positive data from DEFINE and CONFIRM, two global, placebo-controlled Phase 3 clinical trials that evaluated 240 mg of TECFIDERA, administered either twice a day (BID) or three times a day (TID), for two years. TECFIDERA is currently under review by regulatory authorities in the United States, European Union, Australia, Canada and Switzerland.

About Biogen Idec

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Source: FULL ARTICLE at DailyFinance