Archive for March, 2008

Wyeth Kidney-Cancer Drug Delayed By FDA

Monday, March 31st, 2008

In an unexpected development, Wyeth says the FDA wants another three months to review recently submitted data for its Torisel kidney-cancer drug. The application was filed Oct. 5, and given priority review, which meant agency approval was widely expected today.

As it turns out, Wyeth recently submitted additional info at the FDA’s request. A Wyeth spokeswoman tells Pharmalot the issue is not related to safety, but that the FDA wants to know whether Torisel was able to stop tumors from spreading to other parts of the body.

“We are encouraged by the review process so far, and, with the submission of these analyses, we remain optimistic about the prospects for strengthening the product labeling for launch in the third quarter of 2007,” says Bob Ruffolo, a Wyeth senior vp who heads research.

If approved, Torisel would be only the third new drug in two decades to fight advanced renal cell carcinoma. Along with Pfizer’s Sutent and Bayer’s Nexavar, these med block the growth of cancer cells, different from chemotherapy that kills tumors and can harm nearby tissues.

The Wyeth drug prolonged survival by 50 percent in a study of the sickest type of kidney-cancer patients, while Sutent and Nexavar, both introduced last year, slowed tumor growth in tests. About 51,000 Americans will be diagnosed with kidney cancer this year, and Wyeth has previously indicated its drug could one day generate $500 million in annual sales.

Wyeth statement;
Bloomberg News story today;
Bloomberg News story earlier this week that approval was imminent.

Criteo’s AutoRoll Widget - Must Have for Bloggers

Saturday, March 29th, 2008

The notion of providing custom content at the set-top box is the Holy Grail for TV/Cable advertisers as is personalized content for media is to, well, the media industry. Blogs are no different.

You may have noticed that The Recruiting Edge has installed Criteo’s AutoRoll Widget. What this widget will do is “provide [our] readers with a very entertaining blogroll, as it is based on other readers with similar reading habits. Moreover, another huge benefit is that [once you install the widget] you will receive highly qualified incoming traffic to your blog. Indeed, as other similar blogs display your blog on their AutoRoll, they will bring you new readers with a strong affinity for your blog. Last but not least, you will also get a complete private reporting module that contains valuable statistics on impressions and click-through rates to and from your own blog.”

In other words, it will enable you to track your blog’s traffic and perhaps offer more interesting and topical content to your readers.

So please click here to head over to Criteo and install their free AutoRoll Widget.

Bastard Brood of Che: #6: Disinformation

Thursday, March 27th, 2008

TITLE: Bastard Brood of Che #6: Disinformation

DESCRIPTION:

In response to PC Nazi accusations that Moshe’s show last month was racist, Moshe plays the most un-PC Lenny Bruce bit that he could find. Moshe exposes one of the many lies in Bush’s State of the Union address. Moshe plays a mean-ass Jay Severin mix and a brilliant C-SPAN caller pretending to be a redneck.

Direct Download URL: http://talkwarrior.com/show/bbc/bbc-6-pq.mp3

Podcast URL: http://talkwarrior.com/show/bbc/bbc-podcast.rss

Broadcast Quality

Size: 27 MB

Running Time: 29.30

CONTENT CREDITS:

C-SPAN/Washington Journal — Caller
Dickie Richards — “Che Lube”
DJ Slander Goebbels — “Slander Is Us”
Ernesto Swaggart — Phone conversation
History Channel — Unknown banal show about Nazi weapon technology
Jay Severin — “Jay Severin Has Issues”
Lenny Bruce — “Are There Any Niggers Here Tonight?”
Medicare Resource Center/US Federal Government — Phone conversation
Michael Graham — 969fmtalk.com promo ad
Moshe’s Mother — Phone conversation
Raymond Lafferty — Phone conversation
Shawn Lennon — “Minutemen in Vista, Ca.” (http://radio.indymedia.org/news/2006/02/8415.php)
Shawn Lennon — Phone conversation
Shrubby — Press conference, probably in India
Shrubby — 2006 State of the Union Address
Shrubby — Speech at WTC, ground zero
Walter Mosley — (Speaking with Harry Belafonte, recorded from C-SPAN)

MUSIC CREDITS:

“You’re Mined” by Wall Street Traitors

“Youria Youria” by Wall Street Traitors

“All the Flowers” by Dan Wilson (Hellebore Shew — see links below)

http://epistaxis.stodge.org

http://resonancefm.com

PRODUCED BY:

TalkWarrior.com and UpstartRadio.com

BROADCAST RESTRICTIONS:

May be BROADCASTED FREELY BY NON-COMMERCIAL ENTITIES ONLY. May not be modified without the express written consent of TalkWarrior.com

Copyright (C) 2006 TalkWarrior.com

THIS looks FUN!

Wednesday, March 19th, 2008

Sure, the Harry Potter saga is almost over, but we haven’t seen the last of Pottermania.

The Wizarding World Of Harry Potter will open at the Universal Orlando Resort, in Florida, in 2009.

Harry Potter author JK Rowling said: “The plans I’ve seen look incredibly exciting, and I don’t think fans of the books or films will be disappointed.”

Touted as a “theme park within a theme park”, it will feature attractions and rides based on Harry Potter locations.

Based inside Orlando’s Islands of Adventure theme park, which already houses Marvel Super Heroes and Dr Seuss islands, the Harry Potter theme will be spread over 20-acres.

Woo hoo! I love theme parks and you can never have too many, in my opinion. Hopefully, the attractions will not be too frightening for Le Sweetie.

Senate Committee Passes Safety, Ad Bill

Monday, March 17th, 2008

Not surprsingly, the Senate Health Education Labor and Pensions Committee has passed the Kennedy-Enzi bill, which calls for drugmakers to pay 45 percent more to the FDA to speed reviews of new meds and improve safety monitoring.

The measure, which passed 15-5, would also give the FDA power to ban DTC ads of meds with dangerous side effects for up to two years and force drugmakers to complete studies after their products are on the market.

There’s more: the bill would renew and increase fees, paid by drugmakers, that otherwise would expire on Sept. 30. The FDA says this is needed to avoid staff layoffs and a slowdown in drug reviews. The FDA would also have new powers to fine companies that fail to do post-approval studies and to ban advertising of a new drug to consumers for two years. The safety of new meds would be reviewed 18 months and three years after reaching the market.

“We want the drugs to be as safe as possible,” said US Senator Mike Enzi of Wyoming, the committee’s top Republican, during the meeting. “We also want to be able to get new drugs to market as fast as possible - with the assurance that they will be safe.”

More here…
Reuters;
Bloomberg News.

Fresh Crop: Design Entrepreneurs

Sunday, March 16th, 2008

Fresh Crop: Design Entrepreneurs

School of Visual Arts presents “Fresh Crop: Design Entrepreneurs,

Like losing one’s virginity or the first drink of …

Friday, March 14th, 2008

Like losing one’s virginity or the first drink of a sweet stumble towards alcoholism, one’s inaugral Green Room experience should be documented with appropriate bruises and deeply hidden scars, I believe. So, yeah, there’s a couple of things I won’t forget about going to see Dizzee Rascal make his American TV debut on the Jimmy Kimmel Show last night. But comparitively speaking, the horrors were pedestrian. To wit: the Hollywood entertainment machine may be even less classy than I imagined. The hype man was a leering, unshaven, overweight late-thirties pig in a wrong-colors Padres hat, who thought humor meant ogling girls 10-15 years younger than he was, calling them “floosies” and “saucepots,” and wondering if he can come off the stage and spank them. Is it any wonder he was appearing at the Comedy Store later in the evening, for free? Then there was Jimmy, settling a visibly schvitzing Dizzee during the commercial break by also invoking the Rascal-mania nubiles - many of them Spectre radio promo girls - saying “Dizzee, these are American girls - they will sleep you with you after the performance.” Thankfully, Dizzee gave him a look that said “Wanker, can I just get through this?” Oh, they also ran out of the good beer — and the salmon on the crackers was dried. But this simply makes the Kimmel Show caterers culinary savages and mediocre hosts; it won’t monopolize my time in therapy. Now, on the other hand, seeing a respected NYTimes music crit looking porn star-rific in a beige leather blazer and platform shoes …

On the positive tip: Dizzee’s “Fix Up Look Sharp” was live and direct, with many lines thrown towards Kimmel and LA, and thus a high cheese factor but there certainly was nothing sculpted about it. Back in the GR afterwards, there was a great Music 2003 Kodak moment: Yeah Yeah Yeah Nick Zimmer and Dizzee in a short conversation. “Remix!” in either direction. Dizzee’s DJ was a very nice, large English dude who goes by the name of Marga Man - told me he’s got a new record coming out in the fall on XL, and described it as “comedy, like Eminem.”

Bottom-Up Environmental Planning: CT EarthNet

Thursday, March 13th, 2008

Traveling around Connecticut one hears similar discussions in towns from Greenwich to Thompson, Stonington to Salisbury.  More and more people are expressing concerns about the pace of change in their communities. In churches and synagogues, schools, libraries and meetings of community groups, the talk is about how local surroundings have enriched peoples’ lives for centuries–and about how decisions we make today will determine the sort of place Connecticut will be in the future.

This series of posts describes an idea to establish CT Earthnet, a network to support community-based environmental management in Connecticut, to foster real change from the bottom up.

The network would serve to assist community-based groups with fundamental needs, facilitate the sharing of information, learning and experience, build political support and foster collaboration toward the accomplishment of shared objectives. It aims to benefit all groups in Connecticut involved with environmental education, planning and management in ways that government cannot.

I’ve spent the past three years traveling the state speaking to people about local natural history. Afterwards I have a chance to listen. I’ve heard what people have to say about what they feel is special about Connecticut. Many recall combing freshly plowed fields for arrowheads, turning over rocks to looke for salamanders and exploring nearby woods and streams as some of their most treasured memories. All wish for the state to remain the kind of place where their grandchildren can grow up having similar experiences.

There is a dissatisfaction with our current direction and a frustration that not enough is being done to protect what we have and change the way we’re planning for our communties’ and the state’s future, and a real recognition that changes need to be made–and quickly.

“Countless residents have come to see their towns at a crossroads. So is the state. Sprawl diminishes open lands that support agriculture, water supplies, wildlife habitat and the character of the Connecticut countryside. It isolates poor and senior citizens, and limits housing variety…” Relentless, helter-skelter development is chewing up CT landscape, The Hartford Courant, editorial, October 10, 2005.

“It’s great to live in Connecticut; we have a quality of life that is the envy of much of America…but that quality of life is threatened…”As we held public hearings in municipalities across the state, we heard from Nutmeggers…We noted that expensive infrastructure is crumbling and going unused in our core cities while being rebuilt at great expense in formerly rural areas.  Connecticut is losing open space at a rate twice the national average…”Growth management should come from the bottom up, not the top down…now is the time for a bold agenda for transportation and land use in Connecticut.” Groundwork’s Been Laid For Smarter Growth,The Hartford Courant, commentary,July 9, 2006. By Lewis J. Wallace, Jr.Chairman, Planning & Development Committee, Connecticut General Assembly

“A wide variety of recent reports, polls and policy documents agree that Connecticut is at a crossroads…The overriding conclusion is that Connecticut must improve how it manages its public resources if it hopes to…maintain its quality of life.  All types of communities—central cities, fully-developed suburbs, newly developing suburbs, and even affluent areas—are hurt by the way Connecticut is growing…Current land use, zoning and tax laws encourage sprawl, traffic, pollution, and poor planning, and contribute to increased segregation of poor people and racial minorities in a few towns and cities.” Connecticut’s Future:  An Emerging Consensus, CenterEdge ProjectOffice of Urban Affairs, Archdiocese of Hartford.
 
“The most significant threats to Connecticut’s land and waterscapes include habitat loss, degradation and fragmentation from development;  changes in land use;  and competition  from invasive species. “Other threats include insufficient scientific knowledge regarding wildlife and their habitats (distribution, abundance, and condition);  the lack of landscape-level conservation;  insufficient resources to maintain or enhance wildlife habitat;  and public indifference toward conservation.” Connecticut Comprehensive Wildlife Conservation Strategy, November, 2005. State of Connecticut, Department of Environmental Protection.

In light of such local environmental debates, there are questions to be asked about what is the best approach to addressing environmental issues facing Connecticut. Will the answer be in top-down governmental regulation? Is it in bottom up community-based collaborations, or some combination of both? This series of posts aim to inform consideration of such questions.

American League Baseball returns to Milwaukee

Wednesday, March 12th, 2008

American League Baseball returns to Milwaukee as inclimate weather forces the Cleveland Indians and Los Angeles Angels to play their series in Milwaukee Wisconsin.The Cleveland Indians moved their series against the Los Angeles Angels to Milwaukee’s Miller Park after a strong snowstorm wiped out Cleveland’s series against the Seattle Mariners. Both teams will play a three game series starting Tuesday in a stadium which guarantees they’ll play. Milwaukee’s Miller Park has a retractable roof, so there won’t be any more cancellations. At least for now. Travis Hafner made light of the 4 game layoff saying: “I thought we were going to move it to North Dakota, but we got Milwaukee instead.” Seattle and Cleveland will have to make up their games later on in the season.Speaking of Snow, check out my It’s time for winter baseball article.

Praized is worth a million bucks!

Monday, March 10th, 2008

We learn from Technaute that Praized, a Quebec web2.0 startup, just got an 1M$ investment from the canadian branch of Garage Technology Venture, the venture capital company behind Pandora. Knowing that Pandora is now unaccessible to canadians, lets hope the same will not happen to Praized… It should not be the case due to the type of application they are developping. Here is a quote from their website:

Praized Media is a startup company working on a web-based application that will enable you to find and discover local places and merchants with help from people you can trust. It’s also a tool that will structure local conversations within blogs and a new platform for local search providers to generate leads from the untapped social media market.
For the moment, you have to sign up for an invite. I will try it and comment shortly! Moreover, we should have an idea of what its uses could be by looking at TreeHugger which, as reported by La Presse, is interested…

The guys behind this initiative are well known in the web2.0 arena. Harry Wakefield is MoCoLoco.com (Technorati top 1000) who was general manager at Groupe Pages Jaunes for the web version. Sébastien Provencher was also with GPJ. Quant à Sylvain Carle, on peut le lire sur Afroginthevalley.

You can also have a look at Praized’s blog or subscribe to their feed to be kept up to date.