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BG-12 Approval Process Underway
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BG-12 Approval Process Underway

I saw this today. Biogen-Idec has submitted BG-12 for FDA approval. They are requesting a 4 month, rather than 10 month, approval process.

http://www.masshightech.com/stories/2012/02/27/daily10-Biogen-sends-oral-MS-drug-to-FDA.html
Tags: Oral, drugs, BG-12, DMD
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18 Comments Post a Comment
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738075_tn?1330579444
Yay!!  I have high hopes for this one.
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488198_tn?1390241348
From the linked story, I actually see a request for a six-month process:

"The Weston, Mass.-based company is hoping that the regulatory body will grant the drug candidate an accelerated, six-month approval process, rather than the standard, 10-month review."

Oddly enough, Biogen's official release makes no mention of the timeframe. All good news nevertheless.

http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1666509
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198419_tn?1360245956
I cannot wait until it's approved and available!

I asked my doctor yesterday about it and he said probably available next year. But, maybe if the 4 month is approved it will indeed be available by the end of the year!

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667078_tn?1316004535
Anyone have Biogen stock!

Alex
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572651_tn?1333939396
Fast track requests are great to hear - this is the drug that had the neuros so excited at ECTRIMS in the fall.  I think everyone is waiting for this approval.
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"Anyone have Biogen stock!" - Alex

This is a very sad truth isn't it?  I just read on one company's website that ms is a 12 billion dollar industry.  I don't think real treatment for all human beings will come until we stop being an industry and start being human beings.

Corina
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1831849_tn?1383231992
If the potential to reap millions of dollars in profits did not exist, there would be no reason for the drug companies to research and develop new MS treatments. I'm OK with the profit motive :-)
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Avatar_f_tn
I'm not ok with the profit motive.

If greed and big business got out of the way scientific inquiry would fuel better science and more discoveries. Then public companies that fed families instead of ultra rich toys could manufacture and distribute  

And yes it really could work this way.

Just my two cents

Corina
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1831849_tn?1383231992
Big Business = Public Companies

For example, Biogen-Idec is a public company.
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Avatar_f_tn
Traded on the stock market is not the same as a public company.  A public company is run by the government for the benefit of all not a chosen few.
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1831849_tn?1383231992
Actually traded on the stock market is the same as a public company. Public companies are not part of the public sector. The public sector is the government.
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488198_tn?1390241348
Neither Biogen nor any other company owes me anything. They make medications I think will help preserve my health, and so I will compensate them for their research and materials. I am thankful to have these medications that were not available a generation ago. I am especially thankful that BG-12 could mean the end to shots (although my enthusiasm is reserved, because I thought the same of Gilenya and it wasn’t good for me.)

Biogen is a public company in the sense that anyone can own stock. If you think the company makes too much money, buy stock and share in those profits. If you think only the executives make too much money, join forces with other stockholders and vote them out. Not as easy as it sounds, but your one vote as one of a few thousand stockholders can be more powerful than your one vote of millions in a federal election. If the medicine they produce isn't a value to you, don't buy it.

In contrast to public companies is private companies such as the much-maligned Koch Industries. If you think they make too much money, about all you can do is stop buying their products.

I’m not really aware of many U.S. companies that are government-owned or "run by the government for the benefit of all." Post office, maybe mass transit agencies, neither of which are efficient models of innovation. But I see ccorina is from Canada, so I would welcome examples of such companies in Canada.
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1831849_tn?1383231992
Very well said! These days companies like GM and AIG (Disclaimer: I worked for AIG during the bailout) blur the traditional lines between public companies and the public sector :-)
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1831849_tn?1383231992
This is an article about BG-12 from today's Boston Globe.

http://bostonglobe.com/metro/2012/02/29/biogen-idec-seeks-for-needle-treatment/Js75E1aV0yowHTiLFkf1sJ/story.html
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Avatar_f_tn
While your free to your views it seems that the USA is too capitalist to even see other ways and that is very sad. Government owned means government owned. I don't want to buy stock in the off chance of getting rich. I want affordable healthcare and medications for all including the rest of the world that can't possibly buy stock or drugs

Corina - slinking back to her lonely socialist corner
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1831849_tn?1383231992
Chacun a son gout :-)
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1936411_tn?1333835449
I don't know much about BG-12 yet. Does anyone care to give me a "quick and dirty" description of what all the fuss is about so I can satiate my appetite for knowledge until I find the time to hit Google Scholar? Is it just the fact that it's an oral med or do they expect it will be more effective than the currently available DMDs in some way?

- Jane
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1831849_tn?1383231992
That it's a pill is the big thing. It has also proved to be very effective.
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