FDA Approves Bristol-Myers Squibb For The Production of Biologic Drugs

This article is a bummer!

The need for more companies to endorse the production of the bullshit biologic drugs.  Every time I pass Bristol-Myers Squibb now, I'll think about that toxic drug that I do not support due to the large list of potentially dangerous/deadly side-effects.  

How funny....the word "green" and "biologics" used in the same article. You're talking about a clean, environmentally sound building in contrast to a toxic (possibly dangerous to some people) chemical. 

PRESS RELEASE

May 15, 2012, 11:00 a.m. EDT

U.S. FDA Approves Bristol-Myers Squibb Devens Biologics Manufacturing Facility for Production of ORENCIA(R) (abatacept)

State-of the art Manufacturing Facility Supports Company's Growing Focus on Biologics

NEW YORK, May 15, 2012 (BUSINESS WIRE) -- Bristol-Myers Squibb Company BMY +0.12% announced today that the U.S. Food and Drug Administration (FDA) has approved the company's biologics manufacturing facility in Devens, Massachusetts for commercial production of ORENCIA(R) (abatacept).

The Devens facility, a state-of-the-art bulk biologics manufacturing facility, employs roughly 300 scientists, engineers, bioprocess operators, quality specialists and other skilled workers.

"The approval of our Devens site is an important milestone for Bristol-Myers Squibb as part of our strategic focus on delivering innovative biologic medicines for patients with serious disease," said Lou Schmukler, president, Global Manufacturing & Supply, Bristol-Myers Squibb. "The increased manufacturing capacity from the Devens site will support market demand for ORENCIA and positions us well for future production of additional biologic medicines."

Bristol-Myers Squibb currently manufactures its biologic medicines in a company-owned facility in Syracuse, NY and through third party suppliers, and finishes and packages them in Manati, Puerto Rico. The Syracuse site will remain a key component of the company's biologics strategy and will serve as a center of excellence in process development and early product launch for the company's biologic medicines.

"Bristol-Myers Squibb is committed to building a strong manufacturing capability to support our growing biologics portfolio, and Devens is a key component of this strategy," said Peter Moesta, senior vice president, Biologics Manufacturing and Process Development.

In 2010, the company announced the Devens facility received Leadership in Energy and Environmental Design (LEED(R)) Silver certification while the laboratory and office building at the same facility received LEED Gold certification in December 2009. LEED certification, established by U.S. Green Building Council and verified by the Green Building Certification Institute, is the nation's preeminent program for the design, construction and operation of high performance green buildings.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews .

SOURCE: Bristol-Myers Squibb Company

Just Launched - YouTube Channel Dedicated to IBD Patients ~ Read for more info...

Sweet!  Spread the word and open up people's minds to invincible diseases like crohn's and ulcerative colitis. I've noticed in the past few months that there is more awareness out there in the world regarding digestive diseases and opportunities for people to learn more about ibd to get a better understanding 

Read the article below about the just launched YouTube channel and what it entails. 

the new youtube channel called "you and ibd", dedicated to educate and provide expert advice, patient stories, medication information and important information that patients should be aware about.

PRESS RELEASE

May 17, 2012, 5:47 p.m. EDT

New YouTube Channel Helps People Living with Inflammatory Bowel Disease

LOS ANGELES, May 17, 2012 (BUSINESS WIRE) -- Cornerstones Health Inc., a nonprofit organization working to improve communication between patients with inflammatory bowel disease (IBD) and physicians who treat IBD, in collaboration with Imedex, LLC and Mechanisms in Medicine Inc., announced the launch of the new YouTube "You and IBD" - Animated IBD Patient Channel. The channel gives patients with Crohn's disease or ulcerative colitis quick access to a wide range of videos and animations featuring the latest IBD information, discussions of important topics, patient stories, expert advice.

"We have addressed what we believe to be a major limitation in other IBD Web resources," said Dr. David Rubin, co-founder of Cornerstones Health Inc. "The type of education we're offering empowers patients with the knowledge needed to take charge of their disease and to have important discussions with their health care team about what is the right course of action for them."

The YouTube "You and IBD" - Animated IBD Patient Channel is a companion to the You and IBD website, and part of an overall initiative dedicated to providing IBD patients with educational content, expert advice and tools to help them effectively manage their IBD and achieve the best quality of life.

"IBD patients who visit our site will walk away with a greater understanding of topics that range from how IBD medications work to alternative medicines because of the impact visual reinforcement will have on their existing knowledge," said Dr. Marla Dubinsky, co-founder of Cornerstones Health Inc.

This channel was developed in conjunction with Imedex, LLC, an accredited medical education company based in Alpharetta, Georgia and Mechanisms in Medicine, a medical animation and e-learning company based in Toronto, Canada. "This project is part of an ongoing collaboration between our organizations aimed at enabling patients to be more informed with regard to their disease and treatment options so that they are able to have more active dialogue with their physicians about how to best manage their disease," said Christopher Bolwell, VP and Compliance Officer of Imedex, LLC. "We are pleased to have been part of producing this valuable patient education resource."

About Cornerstones

Cornerstones Health Inc. is a nonprofit organization founded by physicians Marla Dubinsky and David Rubin in 2008. It was established to provide a new paradigm in patient care by utilizing novel approaches to improve the communication between physicians and patients. Offering state-of-the-art educational content, expert-based instruction, and creative communication techniques, Cornerstones enhances and transforms the relationships among health care providers, industry partners and patients. Contact Cornerstones at info@cornerstoneshealth.org, or visit them on the Web at www.cornerstoneshealth.org .

About Imedex

Imedex, LLC is an ACCME accredited medical education company based in Alpharetta, GA, which has been producing physician education programs for over 25 years. Imedex contributes to the quality and cost efficacy of medical care by increasing the knowledge of healthcare professionals. Our team of dedicated and knowledgeable professionals work in specialized therapeutic areas to develop and implement high quality, effective medical education programming that translates the latest research into clinical practice. All activities are delivered in healthcare professionals' preferred formats (live meetings and enduring activities) all the while upholding the high standards set forth by the ACCME and related governing bodies. Contact Imedex, LLC at officeofcme.com, or visit them on the web at www.imedex.com

About Mechanisms in Medicine Inc.

Mechanisms in Medicine Inc. is a medical animation and e-learning company based in Toronto, Canada. We provide a unique approach to online health education through visually compelling animation and video resources that are designed to ease the understanding of complex medical concepts. We work to facilitate improved health outcomes by increasing the knowledge and awareness levels of patients and healthcare professionals, for multiple diseases and health issues. Contact Mechanisms in Medicine at mail@mechanismsinmedicine.com, or visit them on the Web at www.MechanismsInMedicine.com .

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Tweet this

Check out new @IBDpatient YouTube Channel at http://bit.ly/Hj0trf ! #Crohns #colitis (82 characters; bit.ly URL)

News Facts

-- Cornerstones, in collaboration with Imedex, LLC and Mechanisms in Medicine Inc., announces launch of new YouTube "You and IBD" - Animated IBD Patient Channel, giving IBD patients quick access to patient and expert videos, and IBD animations.

-- The YouTube channel is a companion to the You and IBD site, and part of an overall initiative dedicated to helping IBD patients achieve the best quality of life.

Images

-- Cornerstones logo

-- Imedex logo

-- Mechanisms in Medicine logo

-- Screen capture of YouTube channel

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50282672&lang=en

SOURCE: Cornerstones Health Inc.

Cancer Patients Are Encouraged To Research Low Dose Naltrexone (LDN) As a Treatment Option!

Another positive article regarding the treatment of LDN (low dose naltrexone) for off label conditions.  Click the link below to read the details.

** People that have been able to obtain this medication and take it in low doses (1-4.5mg) have displayed great improvement.  It's a promising treatment for an array of diseases from MS, Crohn's Disease, different forms of cancers, autoimmune diseases, & the list goes on.

For people that would like to read up on what LDN is, how the drug works, how it could be obtained and the science behind the use of LDN for conditions other than what the drug was originally targeted to treat (opiate addiction), please see my sidebar links.  I also have several blog posts that give general information about the drug and blogs that have clinical trials that have been conducted and their findings.  

• PS:  If you need to find a doctor in your area that prescribes LDN, I can help you.  Send me a message and I'd be happy to assist you with this.  

Bonnie and Ken Shockey encourage cancer patients to research Low Dose Naltrexone

FDA Concerns Pertaining to The Risks, The Benefits & The Appropriateness of Tofacitinib to Treat Rheumatoid Arthritis

Hmmmm!! They ask questions???  I wonder who died.

"The FDA said tofacitinib might be associated with an increased risk of cancer such as lymphoma, and that it increased the risk of serious infections, some of which were fatal. The agency also said it couldn't make "definitive conclusions" regarding the drug's effectiveness on a measure that looked at disease progression."

The poor people that took the risk and didn't benefit?

Well, we will see on Wednesday if they make the logical decision based on the numbers they see showing disease advancement or decline. 

 

FDA:Questions Safety, Effectiveness Of Proposed Pfizer Arthritis Drug
 

Published May 07, 2012
 

Dow Jones Newswires
 

WASHINGTON –  The Food and Drug Administration questioned the safety and effectiveness of a proposed Pfizer Inc. (PFE) drug for rheumatoid arthritis.
The drug, tofacitinib, is designed to treat the disease in a different manner than currently approved therapies. The product will be reviewed on Wednesday by the FDA's arthritis drugs advisory committee.
The FDA said tofacitinib might be associated with an increased risk of cancer such as lymphoma, and that it increased the risk of serious infections, some of which were fatal. The agency also said it couldn't make "definitive conclusions" regarding the drug's effectiveness on a measure that looked at disease progression.
The FDA released a review of the product Monday in preparation for Wednesday's meeting. Tofacitinib works to inhibit a cell-signaling mechanism referred to as JAK and is a key drug in Pfizer's pipeline.
The company studied the drug in about 4,800 patients. Five studies were submitted to the FDA in support of the drug's approval. Most of the patients in the studies hadn't responded to initial therapy with a drug called methotrexate. One study focused on patients who had an inadequate response to newer drugs called TNF-inhibitors such as Remicade or Humira, which work to block a substance in the body called tumor necrosis factor that can cause inflammation and lead to immune-system diseases, such as rheumatoid arthritis, Crohn's disease and ulcerative colitis.
Pfizer has said it believes the side-effect profile of tofacitinib is similar to other treatments on the market. The labels for TNF-blockers warn of serious and sometimes fatal infections and a possible increased risk of getting certain types of cancer.
The FDA's panel, which is made up of non-FDA medical experts, will be asked to vote on whether it thinks the drug should be approved. The FDA isn't required to follow the advice of its panels but usually does.
Rheumatoid arthritis is a chronic inflammatory disorder that usually affects small joints in the hands and feet.
Copyright © 2012 Dow Jones Newswires


Read more: http://www.foxbusiness.com/news/2012/05/07/fdaquestions-safety-effectiveness-proposed-pfizer-arthritis-drug/#ixzz1uBr92NAR

Ali Carter, Professional Pool Player - Visited by The Crohn During The World Championship

It figures.  Crohn's always comes to visit at the most inappropriate times.  I 

compare Crohn's Disease to that rude and obnoxious "friend" that over stays

their welcome and doesn't get the hint that it's time to leave.  
 

Carter takes step closer to second World 

Championship final

Updated: Friday, 04 May 2012 22:42

Ali Carter nearly quit the game because of Crohn's disease

Ali Carter was considering retirement at the turn of the year, but now a second appearance in the World Championship final beckons for the 32-year-old from Tiptree.

He leads Stephen Maguire 14-10 overnight after dominating a large part of their two sessions today.

The final three frames of the day went Maguire's way though as he belatedly found some mental poise, but the Scot still faces a tall order when they play to a finish tomorrow afternoon.

As the effect of Crohn's disease, the condition Carter was diagnosed with nine years ago, began to take a drastic physical toll, he went to the World Professional Billiards and Snooker Association to request a year-long sabbatical.

It did not come to that, and Carter's health has improved markedly thanks to a no-wheat, no-dairy diet, albeit with a setback this week when he complained of feeling badly bloated after eating a steak.

He vowed after beating Jamie Jones in the quarter-finals that illness would not obstruct his Crucible mission, and Carter used all his guile to back Maguire into a corner he will do well to fight his way out of.

In the morning session, which saw Carter move from 5-3 to 10-6 ahead, Maguire twice lost his cool, firstly with a wild attempt to escape from a snooker and then when he thumped the table to draw gasps from spectators. He later appeared to question the judgement of referee Leo Scullion, his fellow Glaswegian, when a foul was called against him.

Maguire fired a 142 break shortly before lunch, while 134 and 73 in the space of three frames tonight nudged Carter to 14-7.

A strategy hinging on safety-first tactics made Carter a frustrating opponent for Maguire, but when the Scot fired breaks of 72 and 70, before pinching the final frame of the day, he at least had a platform to build from tomorrow.

The winner of this match will meet either Ronnie O'Sullivan or Matthew Stevens. O'Sullivan leads 11-5.