Number of new drugs picks up in Europe and U.S.

* EU agency sees more new drug applications in 2013

* U.S. new drug approvals running at eight-year high

* Encouraging signals for industry as patent losses peak

LONDON, Dec 18 (Reuters) - The number of new medicines approved or pending approval is on the rise on both sides of the Atlantic, painting an encouraging picture for the global drugs industry as it emerges from a wave of patent expiries.

European regulators said on Tuesday that they expect an increase in new drug applications to about 54 in 2013. In the United States, a total of 34 new drugs have been approved for sale so far in 2012 - the highest level in eight years.

The sector badly needs a pick-up in productivity as companies try to refill their medicine chests after a wave of patient expiries that have peaked this year, depriving leading U.S. and European drug companies of more than $30 billion of revenue.

"It bodes well," said Standard & Poor's (S&P) analyst Olaf Toelke, who predicts that strong pipelines will allow most large drugmakers to emerge unscathed from the spike in sales losses.

"It shows that companies are addressing the need to find new drugs to replace those facing patent expiration. They have done their homework and it looks as if the industry will be at least stable in future and not fall off the threatened patent cliff."

The U.S. Food and Drug Administration (FDA), gatekeeper to the world's biggest pharmaceuticals market, still has just over a week to add more approvals to this year's tally - and there are signs that the number will increase further.

Three new products for leukaemia, anthrax and Cushing's disease from Ariad Pharmaceuticals, GlaxoSmithKline and Novartis were approved last Friday alone, and the FDA is scheduled to hand down decisions on a further four drugs before the end of the month.

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A green light for all these would take the 2012 tally of new molecular entities (NMEs) approved by the agency's Center for Drug Evaluation and Research to 38 - two more than the 2004 total of 36.

The European Medicines Agency painted a different picture of improving productivity by announcing that its work programme for the year ahead included a forecast for 54 new drug applications, up from 52 in 2012, 48 in 2011 and 34 in 2010. These figures exclude medicines designated for "orphan", or rare, diseases.

Significantly, the London-based agency is also expecting a sharp drop in the number of applications from companies to sell generic versions of drugs, to 20 in 2013 from 39 in 2012, given the slowdown in patent expiries next year.

Major U.S. drug companies will lose a total of about $21 billion in revenue this year from lucrative medicines coming off patent, while the hit for European businesses is about $10 billion, according to S&P.

This year's expiries have included Sanofi and Bristol-Myers Squibb's heart drug Plavix and AstraZeneca's antipsychotic Seroquel.

Winning approval from regulators, however, is only part of the battle for drugmakers.

Investors will also be watching closely to see how the new drugs perform commercially once they reach the market, since securing payment for innovative medicines is an increasingly tough fight - especially in austerity-hit Europe.

An analysis by Deloitte and Thomson Reuters this month found that while new drug approvals were increasing, this was offset by lower expected revenues from many individual products.

(Editing by David Goodman)

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FDA approves Roche's Tamiflu for infants with new flu symptoms

Dec 21 (Reuters) - The U.S. Food and Drug Administration on Friday expanded the use of Tamiflu, the flu drug from Roche , to children as young as two weeks old who have shown flu symptoms for no more than two days.

The FDA said the drug cannot be used to prevent flu infection in this age group. The drug is currently approved as both a flu treatment and preventative flu drug for children ages 1 and older, and adults. It aims to help lessen the length and severity of the flu.

Tamiflu was approved in 1999 and is distributed in the United States by Genentech, part of Roche. It was co-developed by Gilead Sciences. Its most common side effects include vomiting and diarrhea.

The FDA said its expanded use is based on extrapolating data from previous study results in adults and older children, and supporting studies by the U.S. National Institutes of Health and Roche.

Tamiflu, which had peak sales of $3 billion in 2009 because of the H1N1 swine flu epidemic, is approved by regulators worldwide but some researchers claim there is little evidence it works and have asked Roche to hand over data so they can study its effectiveness.

(Reporting By Caroline Humer; Editing by Grant McCool)

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McKibben To Wall Street Journal: ‘Fossil-Fuel Companies Have Become Outlaws Against The Laws Of Physics’

Bill McKibben has a letter responding to an error-riddled Wall Street Journal op-ed — though I guess that’s redundant. This one attacks clean energy and the fossil-fuel divestment effort McKibben supports.

McKibben writes:

Robert Bryce’s Dec. 17 op-ed (“Harvard Needs Remedial Energy Math“) attacking campus efforts to have universities divest themselves of holdings in fossil-fuel companies is interesting for what it omits: even the slightest attempt to rebut the mathematical logic that shows fossil-fuel companies have become outlaws against the laws of physics. Here are the numbers: In order to prevent the two-degree Celsius rise in temperature that even the most conservative governments on earth have committed to avoiding, scientists tell us we can burn enough coal and oil and gas to produce 565 gigatons of CO2. Unfortunately, the planet’s fossil-fuel companies, and the countries that operate like fossil-fuel companies (think Venezuela and Kuwait), have five times that much in their reserves. It’s what their share prices are based on; they obviously plan to burn it; indeed, they spend hundreds of millions of dollars daily looking for more. If their business plan is carried out, the planet tanks.

Mr. Bryce is entirely correct that it will be hard to move away from fossil fuels, an enormous engineering challenge. But the Germans are demonstrating it can be done, and the most recent studies shows that we could rely on renewables for our power upwards of 99% of the time as early as 2030 if we got to work. Which we won’t, if the fossil-fuel industry continues to exert its massive financial muscle to block change. That’s why students in 189 campuses have so far risen up to demand divestment—this is the great moral challenge of our time, and maybe, given the stakes, of all time.

Bryce, of course, is one of the most debunked disinformers on the face of the Earth, who famously wrote (in the WSJ of course), “If serious scientists can question Einstein’s theory of relativity, then there must be room for debate about the workings and complexities of the Earth’s atmosphere” (see “Robert Bryce Makes Mockery of Science, Is Mocked in Return“). Hmm, if Bryce can be dead wrong about Einstein, then he’s probably dead wrong about everything else.

Bryce works for the Manhattan Institute, which “has received millions of dollars from donors tied to the fossil fuel industry” and the Kochs to spread pro-fossil-fuel messages.  Media Matters’ post, “Who Is Robert Bryce?” has more detail.  See also

Bryce’s nonsense is not worth debunking in detail — one could waste a lifetime doing that. But given that he claims “Harvard Needs Remedial Energy Math,” it’s worth noting one of his own countless instances of innumeracy, the tired “wind power uses too much land” myth:

Here’s where the math becomes college-freshman obvious: In 2011, the world had 240,000 megawatts of wind-generation capacity. That fleet of turbines produced 437 terawatt-hours of electricity. Therefore, just keeping up with the growth in global electricity demand—while not displacing any of the existing need for coal, oil and natural gas—would require the countries of the world to install about as much wind-generation capacity as now exists, and they’d have to do so every year.

Put another way, just to keep pace with demand growth, the wind industry will need to cover a land area of some 48,000 square miles with wind turbines per year, an area about the size of North Carolina. Even if that much land were available, no humans would want to live on the land because of the irritating noise generated by those turbines.

That paragraph would get any student in remedial energy math an ‘F’. The actual footprint used up by the wind turbines is quite tiny — so most of the land they occupy can be used for other purposes, notably farming.

Let’s go into the National Renewable Energy Laboratory’s wind farm area calculator, plug in 0.25 acres per turbine and 240,000 megawatts (240,000,000 kW), and use 2 MW for wind turbines since “most of the commercial-scale turbines installed today are 2 MW in size. “The estimated land area required is: 30000 acres.” [For more detail, see Land-Use Requirements of Modern Wind Power Plants in the United States.]

As one can quickly find out on Google, “1 square mile is equal to 640 acres.”  So these wind turbine would take out of use about 50 square miles of land. And that doesn’t even count offshore wind.

Most of the best wind is not where many people live, so his non-issue about noise is, well, a non-issue.

Of course, global warming will devastate North Carolina and indeed all coastal areas and much of the cropland in this country and around the world — so using up a little land to save the rest seems like the smart choice.

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Progressive Resolutions For 2013

1. Reform the broken immigration system.

Following President Obama’s re-election — supported by a large majority of Latino voters — even House Speaker John Boehner (R-OH) came out in support of comprehensive immigration reform. The president is preparing to “begin an all out drive” for immigration reform in January, so 2013 needs to be the year that Congress passes a comprehensive plan that includes a path to citizenship.

2. Enact sensible gun safety laws.

Tens of thousands of Americans signed a petition calling on the White House to introduce legislation to address the weak gun laws in the United States, members of Congress pledged to introduce billsregulating assault weapons, and President Obama has formed a task force to address gun violence. Lawmakers must act decisively in to prevent any more tragedies in 2013.

3. Secure higher wages and benefits for workers.

Union advocates launched campaigns to organize more service sector workplaces this year, and those efforts need to continue. In New York, fast food workers are fighting for the fair wages and health benefits that union membership could help bring. Across the country, Walmart workers are demanding labor rights and fair wages at a company that tells them that joining a union could mean the loss of their benefits. Unions built America’s middle class, and in the face of continued attacks on workers, they’re an important piece in the fight to strengthen it again.

4. Enhance oversight of the drones program.

Though the Obama administration’s policy of killing al-Qaeda and affiliated groups from afar may be weakening terrorist organizations, it is almost certainly killing innocent civilians as well. Given the level of secrecy surrounding the program, it’s almost impossible for the public to know whether the program is doing more good than harm.

5. Adopt a more effective federal drug policy.

In 2012, two states for the first time voted to legalize and regulate the marijuana industry. The move has prompted nationwide discussion and increasing support for a move away from the failed War on Drugs. In 2012, members of Congress and the administration should divert federal resources away from minor drug crimes, and clear the way for states to experiment with an alternative to the failed War on Drugs.

6. Embrace progressive monetary policy.

The latest announcement from the Federal Reserve that it will continue monetary stimulus until unemployment is below 6.5 percent or inflation rises above 2.5 percent was a historic shift in how the Fed strategizes and conceptualizes its role. It reorders the Fed’s priorities towards emphasizing employment. Bloggers and policymakers from across the political spectrum helped push forward the proposal by Chicago Fed president Charles Evans, but progressives certainly played a role. And this lays the foundation for eventually establishing even more worker-friendly Fed policies, such as NGDP targeting and a hike in the NAIRU — the level of employment the Fed believes the economy can tolerate before the danger of inflation becomes too great.

7. Reform the filibuster.

For President Obama’s entire term, Senate Minority Leader Mitch McConnell (R-KY) has been the king of the Senate. And he’s wielded this power to more interested in sabotaging Obama than in actually governing. The solution is a robust filibuster reform package, including major confirmations reforms.

8. Minimize risky bank transactions.

The Volcker Rule, meant to rein in the sort of risky bank trading that helped fuel the 2008 financial crisis, is supposed to be implemented in early 2013. Wall Street lobbyists — and their Republican counterparts in Congress — are trying to water it down, even though it is necessary to safeguard the financial system.

9. Repeal the anti-gay Defense of Marriage Act.

With the Supreme Court set to consider a challenge to the Defense of Marriage Act (DOMA), 2013 could prove to be a historic year for same-sex couples. Regardless of how the Court rules, the Respect for Marriage Act, legislation to repeal DOMA, enjoys record support in Congress.

10. Advance national standards for federal elections.

Americans had to overcome major obstacles and long lines to vote in 2012 due to Republican voter supppression efforts. To keep this from happening again, Congress needs to pass minimum standards for election procedures that states must abide by during federal elections.

11. Secure paid sick and parental leave.

The U.S. is one of the only developed countries in the world that doesn’t guarantee paid maternity leave for expecting mothers. Federal policy should encourage employers to provide parents with time off to adjust to life with a newborn and additional time off to take care of their children in times of need.

12. Invest in infrastructure.

Our roads and bridges are literally crumbling, and analysts say the nation will need to make $2 trillion in immediate investments to update infrastructure. Hurricane Sandy underlined the problem, when 8.1 million people -– in homes, businesses, and hospitals — lost power.

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Obamacare Could Double Health Care Premiums: Aetna CEO

Bertolini said that insurance premiums could double in some places just on the basis of what types of policies people buy today.

He also said that when Obamacare is fully implemented, it won't start the way people had hoped and it won't be cheaper.

Over the longer run, the key to bringing down premiums will be controlling health care costs, he added. "It'll be fits and starts, but we'll get there," Bertolini said.

Higher premiums also will not necessarily mean higher margins for Aetna. "The people coming into the system will be sicker because they have not used services," Bertolini said. "So in the initial part of this program it will cost more to take care of people because they have been going without health care for so long."

The Aetna executive also weighed in on the debate over the country's fiscal situation.

(Read More: Forget the 'Fiscal Cliff,' Look at These Cliffs)

Bertolini said a big deal would be the best deal for the country, but that it's looking increasingly unlikely that politicians do anything more than a short-term fix which won't be enough to restore confidence.

And confidence is key to increasing business investment and spurring economic growth. "A grand bargain won't create a slow economy," Bertolini said. "It will restore confidence and we'll all invest."

He added, "Americans don't want Plan B, they don't want a short term fix. They want the very best we can come up with. They want Plan A."

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FDA approves Tamiflu for children 2 weeks and up

WASHINGTON -- Children as young as 2 weeks old can take Roche's Tamiflu for flu symptoms, the Food and Drug Administration said Friday.

The FDA approved the drug for babies who have had had flu symptoms for no more than two days. Regulators stressed that the drug is not approved as a preventive measure against flu in children that young. It is also not approved to treat flu in children younger than 2 weeks old.

The FDA had already approved the drug for adults and children ages 1 and older who have shown flu symptoms for no longer than two days.

The agency said doctors must calculate the dosing for Tamiflu in patients younger than 1 based on their exact weight. These children should receive 3 milligrams of Tamiflu per kilogram twice daily for five days.

Tamiflu is distributed by Roche's South San Franscisco-based unit, Genentech.

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Barrasso: Obama ‘slowing down’ fiscal talks

Sen. John Barrasso (R-Wyo.) on Monday accused President Obama of being disengaged from negotiations on avoiding the “fiscal cliff” as lawmakers race for a deal.

Barrasso, speaking on CBS’s “This Morning,” said that Obama was refusing to address the nation’s spending problems, hampering efforts on Capitol Hill to broker an agreement

"The president is, I think, slowing down the process, not helping," Barrasso said on the show.

Barrasso's comments come as legislators have less than 24 hours before the end-year deadline to prevent tax-rate rises and spending increases from taking effect.

On Sunday, although both chambers of Congress reconvened in anticipation of a deal, Democratic and Republican negotiators were unable to agree on a number of sticking points such as the estate tax and how to offset the cost of the sequester. 

"The bottom line is the president's the only one with a pen who can sign into law something and he ought to be very involved with making sure that he gets something that he can sign that can pass a Republican-controlled House and a Democrat-controlled Senate," Barrasso said. 

In an interview aired Sunday on NBC’s “Meet the Press,” Obama placed the blame for the protracted negotiations on Republicans and said he had made a concerted effort to reach a deal. 

"I offered not only a trillion dollars in — over a trillion dollars in spending cuts over the next 10 years, but these changes would result in even more savings in the next 10 years and would solve our deficit problem for a decade," Obama said in the interview.

Barrasso, though, said Monday that Obama had shown little interest in pushing meaningful deficit reduction. 

"The president doesn't seem too eager to actually get involved and find solutions to deal with the number one problem in our country,” he said.

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