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General Discussion / Re: Senate Takes Major Step Toward ACA Repeal
« Last post by Fais on Today at 04:36:36 PM »
The Obama Administration might have influenced a big blow to big pharma on the way out of office.  I find the timing of this release compelling for that arguement.  To understand, know that a Bio-similar is to a Biologic Drug the equivalent of a generic drug to a brand name drug at your pharmacy.  The difference is that the molecule is not exactly the same but very close to the same.   As these molecules are generated by harvesting mice or other living hosts there is a tiny difference between mouse genetic strains for example and the contaminants that can't be filtered out.


I don't think this was expected, there had been agreement in non-interchangeability up until this latest draft guidance was released by the FDA and didn't make the news until this morning. If they do make bio-similar interchangeable it will mean a significant decrease in drug price.  If Obama helped orchestrate this on the way out of office then in the long term(30 years from now) it could be more important then the ACA as far as cost of care.  In the short term it is likely to only save 10-20 billion $'s but its significant.  There is still room for big pharma to manipulate the FDA, but this is a big reversal of the way things were going with Hillary about to take office.  I like to think Obama said, "I have nothing to loose," and big pharma doesn't have any control over me anymore, screw em, I'll do right by the people.

Here is the link to the guidance(don't read it unless your crazy)  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537135.pdf

Here is ~my info latest.



FDA Flurry of Releases: First Up, Interchangeable Biosimilars
 
 This week, the Food and Drug Administration (FDA) released draft guidance on how companies can demonstrate interchangeability between biological products and branded counterparts. A biological product deemed interchangeable with a branded product may be automatically substituted for the branded product when a prescription is written for the branded product.

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created an abbreviated licensure pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological reference product. To demonstrate interchangeability of a biological product to a branded product, the BPCIA states that companies should submit an application to support that the biological product:
•   Produces clinically similar results to the branded product if given to any patient (ie, biosimilar), and
•   Will not add additional risk in regard to safety or lowered efficacy if a patient switches between the biological product and branded product (for products that are administered more than once)
The draft guidance provides an overview of the scientific evidence manufacturers should consider for inclusion on the application to support interchangeability, including:
•   Data and information needed to support a demonstration of interchangeability
•   Considerations for the design and analysis of a switching study or studies to support a demonstration of interchangeability
•   Recommendations regarding the use of a US-licensed reference product in a switching study or studies
•   Considerations for developing presentations, container closure systems, and delivery device constituent parts for proposed interchangeable products
Companies are not required to submit an application for a proposed interchangeable product for all of the branded product’s approved conditions of use, but it is recommended.

In a discussion of interchangeability, Leah Christl, Associate Director for Therapeutic Biologics and lead of the Therapeutic Biologics and Biosimilars Staff in the Office of New Drugs, commented how the data needed to demonstrate interchangeability will be determined on a case-by-case basis and that “no single data package that will work for all proposed interchangeable products.”

The FDA is seeking general comments on its draft guidance document and comments on how to regulate interchangeable products if there are manufacturing changes to an approved interchangeable product or if there are changes to a branded product’s approved conditions of use after the interchangeable counterpart is approved. The public has until March 20, 2017 to submit comments and suggestions.

Biosimilars determined to be interchangeable can potentially change the current biosimilar market. Payers would have a stronger clinical argument for covering only the interchangeable, and pharmacists could potentially substitute an interchangeable for a prescribed biologic without consulting the ordering physician. And patients—representing perhaps the greatest hurdle—might be more comfortable using an interchangeable than a biosimilar.

Here is another public article http://seekingalpha.com/article/4038295-fda-baits-biosimilar-makers-switching-guidance
 
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Definitely tapping into nationalism and religion in that speech, sounded like something Putin might have said.

In other news: http://www.cnbc.com/2017/01/20/trump-to-proclaim-national-day-of-patriotism-spokesman-says.html

4th of July isn't patriotic enough for Trump.
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Quote
We will reinforce old alliances and form new ones. And unite the civilized world against radical Islamic terrorism, which we will eradicate completely from the face of the earth.

At the bedrock of our politics will be a total allegiance to the United States of America and through our loyalty to our country, we will rediscover our loyalty to each other. When you open your heart to patriotism, there is no room for prejudice.

The Bible tells us how good and pleasant it is when God's people live together in unity...

There should be no fear. We are protected, and we will always be protected. We will be protected by the great men and women of our military and law enforcement. And most importantly, we will be protected by God...

...A new national pride will stir ourselves, lift our sights and heal our divisions. It’s time to remember that old wisdom our soldiers will never forget -- that whether we are black or brown or white, we all bleed the same red blood of patriots.

We all enjoy the same glorious freedoms, and we all salute the same great American flag.

And whether a child is born in the urban sprawl of Detroit or the windswept plains of Nebraska, they look up at the same night sky, they fill their heart with the same dreams and they are infused with the breath of life by the same Almighty Creator.

So to all Americans in every city near and far, small and large, from mountain to mountain, from ocean to ocean, hear these words -- you will never be ignored again.

Your voice, your hopes and your dreams will define our American destiny. And your courage and goodness and love will forever guide us along the way. Together, we will make America strong again. We will make America wealthy again. We will make America proud again. We will make America safe again. And yes, together, we will make America great again. Thank you, God bless you, and God bless America. Thank you. God bless America.

http://www.npr.org/2017/01/20/510629447/watch-live-president-trumps-inauguration-ceremony
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Hail to the Chief!
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That was an overtly religious speech he gave.
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Up to 11 Russian warships allowed simultaneously in port of Tartus, Syria – new agreement

https://www.rt.com/news/374372-syria-russia-tartus-agreement/

An agreement signed by Russia and Syria stipulates that up to eleven Russian warships will be able to dock in the Syrian port of Tartus at any one time. The move is designed to boost defense capabilities, the document states.
“The maximum number of the Russian warships allowed at the Russian naval facility at one time is 11, including nuclear-powered warships, providing that nuclear and ecological security rules are observed,” the agreement says.

URGENT: Russia plans permanent naval facility in Syrian port of Tartus – MoD https://t.co/INcCSpfgJ7

— RT (@RT_com) October 10, 2016
The agreement has been signed for 49 years and could be prolonged by 25 more years if both sides agree.

“The Syrian Arab Republic gives consent to the Russian Federation to expand the territory of its naval facility and upgrade its infrastructure to conduct repair works, restock supplies and give crews time for rest,” the document says, adding that the use of the naval facility will be free of charge.

Under the agreement, signed on Wednesday and made public on Friday, Russian warships will be allowed to enter the port after an appropriate Syrian body has been notified, not later than 12 hours before the planned entry.

However, “in case of operational need Russian warships may enter the port after an appropriate Syrian body has been notified, not later than six hours before the entry.”

Russia is allowed to bring in and out any kind of “weaponry, ammunition, devices and materials” to provide security for the facility staff, crew, and their families throughout the territory of the Syrian Arab Republic “without any duties or levies.”

According to a protocol signed on Wednesday and released on Friday, Russia has also been given the right to use the Syrian Khmeimim Air Base in the Latakia province free of charge.

“The Syrian side gives the Russian side a part of the Khmeimim airbase territory to locate the Russian air group there for the duration of the agreement and the protocol, according to attachment documents 1 and 2,” the agreement says.
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Shia executing Mosul people, most likely their neighbors ratted them out for helping ISIS or they were ISIS supporters

This is why when people say there will be an insurgency, no, not after the ISF, PMU's, IRGC, and Hezbollah dig people out of their homes and holes who supported Al Qaeda or ISIS. Their entire family will die.

https://twitter.com/rafidenchannel/status/822384182357655552
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Agreement between Russia and Turkey to halt Turkish incursion into Al Bab, and make it a Syrian army operation.

https://twitter.com/BBassem7/status/822510154780319744

Deputy Prime Minister of Turkey: We can't say that Assad must go anymore.A deal without Assad isn't realistic

http://odatv.com/turkiye-artik-esad-gitsin-diyemez-2001171200.html

Turkish deputy PM at Davos: "Turkey can no longer insist on a deal without Assad."

http://www.cumhuriyet.com.tr/haber/turkiye/663126/_Esed__yine__Esad__oldu..._AKP_den__Esad_siz_bir_anlasmada_israr_edilemez__aciklamasi.html

https://twitter.com/p_zalewski/status/822411377369346049

Turkey announcing the loss of 5 more Turkish soldiers and 9 wounded in a new attack

http://www.cnnturk.com/turkiye/son-dakika-el-babda-turk-askerine-deas-saldirisi-sehit-ve-yaralilar-var
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Either way the Republicans are going to slam through stuff at break neck speeds, they might even change voter rules some more.

I feel like people aren't concerned enough about this. Republicans have been pushing unethical voter restrictions in an effort to roll back their increasing demographic disadvantage for years--they certainly aren't going to get any better now that they control every branch of the federal government in addition to most state governments.

I'm also not that confident we can rest assured that backwards conservatism is going to just get old and die off, anymore. Milo Yianopolous--whatever you wanna say about the guy--seems to have blown open a pretty wide niche for rightism among young people.

And I definitely don't have much faith that whatever catastrophe Trump brings down on us will be sufficient to turn his voter base against him.
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