FDA reviewers say Titan drug results not as strong as hoped

March 19 (Reuters) - Titan Pharmaceuticals Inc's experimental drug to treat opioid addiction was shown to be more effective than placebo in a clinical trial, but the results were not as strong as might be hoped, reviewers for the U.S. Food and Drug Administration said in documents published on Tuesday.

The reviewers' commentary was published on the FDA's website ahead of an advisory panel meeting to be held on Thursday. The reviewers said results of the trial prompt speculation that Titan's drug needs to be given at a higher dose and they asked the panel to advise on whether the company should explore dosing further before the product is approved.

(Reporting by Toni Clarke in Washington; Editing by Gerald E. McCormick)

((toni.clarke@thomsonreuters.com)(617-856-4340)(Reuters

Messaging: toni.clarke.reuters.com@reuters.net))

Keywords: FDA TITAN/

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Guardian: ‘White House Officials … Gave Strong Indications The President Is Inclined To Approve The Keystone XL Pipeline’

The Obama Administration has, tragically, signaled it may retreat on two major climate issues.

The UK Guardian reported Friday:

Barack Obama’s grand vision of action on climate change shrank to $200m a year to fund research into clean fuel cars, with signs of retreat on the big environmental issues of the day….

But on the most immediate environmental decision in his in-tray — the future of the controversial Keystone XL pipeline project – White House officials indicated on Friday that Obama’s green and liberal supporters would be in for a disappointment. Officials signalled that the president was inclined to approve the project.

I must say that this $200 million a year, which has zero chance of seeing the light of day in the Tea-Party-controlled House of Representatives, is perhaps the tiniest bone one could imagine throwing the climate community in return for a decision to help unleash the uber-dirty tar sands.

And as if that wasn’t enough to suggest Obama’s recent strong words on climate (“If Congress Won’t Act Soon To Protect Future Generations, I Will“) were just that — words – the Washington Post reported on Friday:

The Obama administration is leaning toward revising its landmark proposal to regulate greenhouse gas emissions from new power plants, according to several individuals briefed on the matter, a move that would delay tougher restrictions and could anger many environmentalists.

I have also heard from a source very familiar with the regulatory process that EPA now believes it screwed up the initial proposal, potentially subjecting it to court challenge.

Rewriting the proposal would significantly delay any action…

While the move could bolster the administration’s legal justification for regulating power plants’ carbon emissions, any delay on the rules would be a blow to environmental groups and their supporters, who constituted a crucial voting block for President Obama and other Democrats in last year’s elections.

As is typical of the WashPost, the administration’s moved is framed entirely as “a blow to environmental groups” rather, than, say, a blow to the environment itself or as a blow humanity.

The White House appears utterly clueless about the importance of these issues and the self-destructive nature of its “all of the above” energy strategy, as the WH official quoted by the Guardian makes clear:

The official dismissed environmental groups’ contention that building the pipeline would open up vast deposits of the Alberta tar sands, and so increase the emissions that cause climate change. “There have been thousands of miles of pipelines that have been built while President Obama has been in office, and I think the point is, is that it hasn’t necessarily had a significant impact one way or the other on addressing climate change,” the official said.

He added that Obama’s environmental policies would more than make up for any negative impacts from the Keystone XL project. “There’s no question of that.”

Seriously, that’s the White House defense for Keystone: We’ve opened thousands of new spigots for oil (and gas), so what’s one more?

Memo to White House: We are far past the point where breaking even on carbon emissions – or doing a little better than break even —  is a rational goal.

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Latest Polling Finds Strong Support For Clean Energy And Stricter Carbon Pollution Standards

Evidence of a striking shift in public opinion has begun to crystalize over the last few months: Poll after poll is finding staunch majorities of Americans view global warming as a “serious problem” and that human activity is a major driving cause.

In defiance of received Beltway wisdom, voters even told a recent Yale poll that a candidate’s views on global warming will affect their vote, and that the issue should be a top priority for the President and the Congress. Majorities have even stated that when it comes to deficit reduction, they prefer a tax on carbon emissions to cuts in education, Social Security, Medicare, or environmental protection.

Yesterday, Pew Research released new poll research that re-confirms the trend. When asked to choose between developing “alternative sources such as wind, solar and hydrogen” and expanding “exploration and production of oil, coal and natural” gas as their preferred priority for addressing America’s energy needs, 54 percent of Americans went with alternative energy. Only 34 percent chose continued prioritization of fossil fuels. That’s a drop from the 63 percent high in 2011, but an uptick over the 52 percent response last year.

Furthermore, Independents and Democrats were largely in concert, preferring alternative energy sources by 64 and 59 percent, respectively. Only 33 percent of Republicans went with solar and wind, in contrast to the 54 percent who preferred expanded fossil fuel use. But the distance between the two positions within the Republican group was smaller than the distance in the other two collections of voters.

And that wasn’t all. 62 percent of overall voters favored “setting stricter emission limits on power plants to address climate change,” with Democrats once again taking that position by a wide margin of 72 percent, and Independents coming in at a lower-but-still-impressive 64 percent. Republicans opposed the stricter standards by a 48 percent majority, but were again much more evenly split — the minority of GOP voters who favored the emissions limits close at the majority’s heels with 42 percent.

The age divide also stood out: Voters 18 to 29 supported alternative energy by a whopping 71 percent, and it wasn’t until voters crossed the age 65 that majorities flipped in favor of coal, oil and natural gas expansion.

And if the recent behavior and pronouncements of top lawmakers are any indication, this shift in the national mood is being felt. Newly minted Secretary of State John Kerry, who will shortly decide the fate of the Keystone XL pipeline, declared in his first big speech since his confirmation that, “We as a nation must have the foresight and courage to make the investments necessary to safeguard the most sacred trust we keep for our children and grandchildren: an environment not ravaged by rising seas, deadly superstorms, devastating droughts, and the other hallmarks of a dramatically changing climate.” President Obama came out swinging on the issue of climate change in both his Second Inaugural address and the State of the Union speech calling for new renewable electricity and energy efficiency targets, and warming that “if Congress won’t act soon to protect future generations [from climate change] I will.”

The latest signs from the White House are that Obama may very well use his executive authority to limit the carbon existing power plants may emit, on top of the regulations the Environmental Protection Agency is finalizing for new power plants.

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Intuitive Surgical rises 9 pct. on strong earnings

WASHINGTON -- Shares of robot surgical company Intuitive Surgical Inc. rose 9 percent Wednesday after the company reported continuing demand for its remote-controlled surgical devices.

THE SPARK: On Tuesday Intuitive Surgical said that it sold another 175 da Vinci surgical systems in the fourth quarter, up from 152 a year ago. The da Vinci system uses robotic arms, cameras and a remote control console to help doctors perform surgery with tiny incisions. Intuitive Surgical's business model is built around sales of the $1.5 million devices, plus disposable instruments that must be replaced after each procedure. Intuitive said procedures with the robot increased 25 percent in the fourth quarter, with the largest areas of growth in gynecology and general surgery procedures.

THE ANALYSIS: The company said Tuesday that it expects procedures with da Vinci to increase by 20 to 23 percent in the coming year. Analysts say the actual figure could be higher. Stifel Nicolaus & Co. analyst Rick Wise said Intuitive Surgical "starts new fiscal years with a conservative outlook that is frequently exceeded." Wise raised his 2013 sales projections for the company to $2.56 billion from $2.49 billion.

Cantor Fitzgerald analyst Jeremy Feffer said there are "limited opportunities for revenue upside" compared with 2012. However he still expects "continued solid growth" and raised his price target for the stock to $500 from $525.

SHARE ACTION: Intuitive Surgical shares rose $47.10, or 9.1 percent, to $565.59 in afternoon trading.

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