Genzyme Expands Alliance With Alnylam Pharma, To Invest $700 Mln For 12% Stake

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Genzyme, a Sanofi company (SNY: Quote), and Alnylam Pharmaceuticals, Inc. (ALNY: Quote) Monday said they have significantly expanded their strategic agreement to develop and commercialize treatments for rare genetic diseases. As part of the expanded relationship, Genzyme will invest $700 million to become a major Alnylam shareholder.

Under the new agreement, Genzyme will have significant rights to Alnylam's portfolio of clinical and pre-clinical stage drug candidates.

Alnylam will retain most product rights in North America and Western Europe, and will have significantly expanded development and commercial opportunities for its genetic medicine pipeline through Genzyme's established global infrastructure in rare diseases.

David Meeker, Genzyme's President and CEO, said, "This collaboration is an important building block for our future. It strengthens our pipeline and provides us with the opportunity to meet the needs of patients with rare diseases around the world through our well-established global organization."

In 2012, Alnylam and Genzyme formed an exclusive alliance to develop and commercialize Alnylam's lead product, patisiran, which is in Phase 3 development for the treatment of transthyretin or TTR-familial amyloid polyneuropathy, a rare life-threatening disease that damages the nervous system.

In the new alliance, Alnylam benefits from Genzyme's proven global capabilities, enabling the firm to accelerate and expand market access for its 'Alnylam 5x15' products.

In the new relationship, Genzyme will obtain expanded rights to patisiran. Under the original agreement from 2012, Genzyme had rights to commercialize patisiran in Japan and the broader Asia-Pacific region where this disease has a disproportionately high prevalence.

Under the expanded agreement, Genzyme will now commercialize patisiran in all territories outside of North America and Western Europe, which are retained by Alnylam for their commercialization.

Secondly, Genzyme will obtain rights to commercialize worldwide three products in Alnylam's pipeline. Genzyme and Alnylam will co-develop and co-commercialize ALN-TTRsc, a product currently in Phase 2 development for the treatment of familial amyloid cardiomyopathy, in North America and Western Europe, while Genzyme commercializes the product in the rest of world.

Genzyme will have the rights to two additional products after the completion of early clinical trials. The firm will be able to choose between full global rights or co-commercialization rights, depending on the product.

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Genzyme Expands Alliance With Alnylam Pharma, To Invest $700 Mln For 12% Stake

Author and Entrepreneur Steven Zecola Highlights the Fallacies of the FDA’s Approach to Personal Genetic Information

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Washington, D.C. (PRWEB) January 13, 2014

The Food and Drug Administrations new approach to personalized medicine was sent in motion on November 22, 2013 with its warning letter to 23andme regarding the provision of personal genetic information to customers.

The FDA found that 23andmes offering to be a device that was intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease and that in certain circumstances it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing action. Accordingly, the FDA found 23andme in violation of the Federal Food, Drug and Cosmetic Act by marketing its product without acquiring prior approval from the FDA.

Zecola explains that such an approach is misguided for several reasons:

1) The provision of personal genetic information is just that, an information service. The FTC, not the FDA, has jurisdiction over information services in determining whether they are fraudulent. 2) The action is paternalistic and impinges upon personal liberty. The personal genetics companies include disclaimers on their websites and materials saying that their customers should not take action on the personal genetic information but rather should consult with a certified healthcare practitioner before taking any action. 3) The FDAs action, in effect, protects the status quo and undermines the potential for innovation in personalized medicine. 4) The FDA hasnt explained how it could carry out in a timely manner the massive amount of tests that it says is required for the personal genetic firms to provide information to their customers. Its track record suggests that it would take years to analyze and rule upon the upwards of a million tests that are being run by personal genetic firms.

Zecola argues that rather than protecting the status quo from new technology, the Department of Health and Human Services and its subsidiary Food and Drug Administration should be reorganized to better focus on how technology can be used to improve health care.

In essence, the burden should be on the FDA to improve its efficiency to match the exponential growth of technology, rather than constraining the gains from technology to the processing capability of the FDA.

The article is available at http://www.TheFDAandYou.com.

For additional work by the author describing how government should better manage science and technology, see The Major Forces Driving Humanity: Solutions for a Growing Divide (2008). Also see Obama Needs Better Tools to Drive Lasting Change (December 24, 2008).

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Author and Entrepreneur Steven Zecola Highlights the Fallacies of the FDA’s Approach to Personal Genetic Information

Tory Starbuck performs the song Veraline in Futurist Manifesto. 1988 Galactic Rebel Revolution. – Video

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Tory Starbuck performs the song Veraline in Futurist Manifesto. 1988 Galactic Rebel Revolution.
Tory, Stacey Halstead (Space), Brian Hayes (Brain Wave) and J.C. play at Bernards Pub in St. Louis Mo. Tory #39;s vocals are almost inaudible due to soundman pro...

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Tory Starbuck performs the song Veraline in Futurist Manifesto. 1988 Galactic Rebel Revolution. - Video

African refugees strike for Freedom, second day, demo in front of embassies, Tel Aviv 6.1.2014 – Video

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African refugees strike for Freedom, second day, demo in front of embassies, Tel Aviv 6.1.2014
Around 20000 African refugees and supporters participate in the main demonstration in front of the US, France and Britain embassies, calling to support thei...

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African refugees strike for Freedom, second day, demo in front of embassies, Tel Aviv 6.1.2014 - Video

US holds talks with Cuba: Washington calls for more politican freedom in communist island nation – Video

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US holds talks with Cuba: Washington calls for more politican freedom in communist island nation
US State Department officials have said the migration talks held with the Cuban government this week in Havana have been productive, but Washington wants to ...

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US holds talks with Cuba: Washington calls for more politican freedom in communist island nation - Video

Freedom camping sites very popular

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A new rule allowing freedom camping for non self-contained vehicles at three sites around Dunedin is proving so popular the Dunedin City Council might alter its servicing arrangements for toilets and rubbish bins to cope with demand.

The council has been alerted several times this summer to overflowing rubbish bins and increased use of toilet facilities at the three sites next to public toilets at Macandrew Bay, Ocean View and Warrington.

''It's nothing unexpected, or particularly terrible, just an increase in use, and we are just working out when that use is spiking to work out what we need to put in place to deal with that,'' council reserves policy and planning officer Paula Dickel said.

The council eased freedom camping rules in the city late last year, to allow up to three self-contained campervans - those with toilets on board - within a 50m radius to stay on sealed areas of reserves and other public land for up to two nights.

Vehicles without toilets previously could not stay anywhere overnight, but now up to five vehicles were allowed to stay for one night in the three designated areas.

Ms Dickel said staff had been getting feedback from council contractors, the public and from the hall committee near where the toilets were at Macandrew Bay, and hoped to enlist more people to give them more feedback on demand peaks and troughs, so the council could work out what cleaning needed to be included in future contracts.

The bins and toilets were cleared regularly, but there would be a small lapse as the council worked out how much more cleaning was required.

In the meantime, anyone who saw bins overflowing or toilets needing cleaning was encouraged to report them immediately to the council, and contractor would be sent out to deal with them.

For people staying in the wrong places, the council was reliant on people reporting campers.

Any information people needed on camping around the city was available on the council's website, Ms Dickel said.

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Freedom camping sites very popular

dna exclusive: Savarkar’s Urdu poetry gets Amitabh Bachchan’s touch

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Amitabh Bachchan will introduce ghazals written by Savarkar

Bollywoods most famous baritone will introduce the Urdu compositions of Swatantryaveer Vinayak Damodar Savarkar in a CD which will be released on January 21.

Amitabh Bachchan is well known for his distinct voice. We thought his would make for a befitting voice for introducing the ghazals written by Swatantryaveer Savarkar while serving a life sentence in Andaman in 1921, said Ranjit, Savarkars grand-nephew and chairman of Swatantryaveer Savarkar Rashtriya Smarak (SSRS).

Moved on meeting Ranjit who presented him a copy of Veer Savarkars memoirs of his struggle at Andaman and a replica manuscript of his verse penned in prison, Bachchan tweeted: Incomprehensive to fathom what freedom fighters went through to gain independence for nation ! Are they acknowledged enough? Had visited Andaman island, Kala paani and the prisons where freedom fighters were kept. Atrocious stories of their torture!

A manuscript of Urdu ghazals by Savarkar was found in in July last year. The ghazals were written by the freedom fighter during his 11-year torturous incarceration in the Andaman Cellular Jail. The wholly patriotic works were found in a notebook kept by Savarkar in prison. Even the family was unaware of this brave freedom fighters proficiency in Urdu, recalls the SSRS head, adding: Except for certain Persian words, the ghazals have been written in such a way that they can be understood easily. To make it easy, the facing pages have works written in Devanagri.

The notebook has a cover designed by sticking jail records together. During the last few months in the Andamans, Savarkar was made foreman of the jails oil godown. For the first time he got ink and paper to write. His earlier works were written on prison walls with nails. These were memorised and then sent via prisoners who had to memorise them to bring them back to the mainland.

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dna exclusive: Savarkar's Urdu poetry gets Amitabh Bachchan's touch

Jet Edge Introduces Waterjet Cutting System Designed and Priced for Farm Machine Shops

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St. Michael, Minnesota (PRWEB) January 13, 2014

Jet Edge, Inc. introduces the FARM-JET waterjet cutting system, a 55,000 psi waterjet cutting system designed and priced especially for the farm machine shop.

An industry first, FARM-JET brings the power and versatility of ultra-high pressure water jet cutting technology to farm machine shops for the price of a new fully loaded 1 ton 4X4 pickup truck, without requiring special electrical service.

The FARM-JET system includes a 40x40 (1 m x 1m) waterjet cutting table and a Jet Edge Eco-Jet PTO direct drive waterjet pump that utilizes a tractor's PTO shaft to produce 1 gpm of 55,000 psi water. The system includes one abrasivejet cutting head and a motorized Z axis with 5 inches (130 mm) of travel.

The FARM-JET system is controlled with a Windows PC (sold separately) and uses a FlashCut Pro-Series Stepper Controller and FlashCut CNC software. It also includes IGEMS path generation software and a hand-held controller pendant for operator convenience. FARM-JET is available for 540 RPM and 1000 RPM PTO shafts and Category 1 and 2 three point hitches (tractor sold separately). It requires a115v 60 Hz or 230v 50Hz power source, fresh water source and a suitable tractor.

The FARM-JET is the first waterjet cutting system that is designed and priced for the farm shop, said Jude Lague, Jet Edge president. Until now, if you wanted a waterjet, it meant a six-figure investment and access to 460 volt power. Now you can own a waterjet for the price of a new truck and you can run it off standard household electric and your tractor PTO. With a waterjet system, you can create a nice source of additional revenue, and if you need a part fast, you can cut it in minutes instead of waiting for days or weeks to have it fabricated and shipped. You also can have some fun with it cutting custom tile inlays for your house or racecar parts for your dirt track team.

Waterjet cutting has numerous advantages over other cutting methods. Waterjet cuts virtually any material and thickness without creating a heat-affected zone (HAZ), case hardening or recast, or molecular change of the material. Unlike plasma, waterjet cuts without creating any noxious fumes.

Find out more about FARM-JET at http://www.jetedge.com, or call 1-800-JET-EDGE (538-3343) or 763-497-8700.

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Jet Edge Introduces Waterjet Cutting System Designed and Priced for Farm Machine Shops

The sea reclaiming Kelantan beaches

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Long before Bangkok, Bandung or Barcelona became a travel itinerary, it was the local beaches that beckoned many people to spend their holidays in Kelantan.

Even with cheap flights and ease of travel abroad, beaches in Kelantan still remain one of the favourite spots to many families for their getaway.

Then, or only about 15 to 20 years ago, most of the beaches were a soft carpet of white powder that stretched until the next curve at the far reaches ended the vision.

For this and various other folklore tales, a particular beach just on the outskirts of Kota Baru has become so popular that people know it by heart only by its acronym PCB, or specifically Pantai Cahaya Bulan.

However, nature with a mind of its own has unleashed its fury every now and then to distort the idyllic view of what beaches should look like.

Go to PCB now and the new generation of beach goers may grow up to have a crooked sense of what their parents call a holiday spot.

Instead of being marvelled by the travel brochures' cliche of "white sandy beach", visitors to PCB will be greeted with grey granite boulders that look right at home at a rock-blasting site.

The sight of rocky beach front, unfortunately, will be the first lesson in beach erosion.

Long rows of jagged rocks now take over from what used to be the strip of sand where the surf lands.

It would be redundant to point out that the scenery made poor photographs for visitors to take home.

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The sea reclaiming Kelantan beaches

Artificial Intelligence – on Gour Mahavidyalaya (at start time) ! – Video

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Artificial Intelligence - on Gour Mahavidyalaya (at start time) !
This video is indicate to some lectures of Artificial Intelligence by some teachers of India in English and Bengali Language ! I believe that it will help you all to earn education of Computer...

By: Ranesh Gupta

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Artificial Intelligence - on Gour Mahavidyalaya (at start time) ! - Video