Poll: George W. Bush’s approval rating rising post-White House

A new poll shows former President George W. Bush’s approval rating rising, four years after he left office and as he returns to the public spotlight for the opening of his presidential library.

A Washington Post-ABC News poll released on Tuesday shows 47 percent approve of Bush, with 50 percent disapproving. When Bush left office in 2009 after his second term, his approval rating was 33 percent positive to 66 percent negative, one of the lowest figures among presidents.

Among Republicans, Bush holds a strong 84-15 positive split. With Democrats, 25 percent approve of the former president’s performance to 73 percent disapproval. Forty-five percent of independents approve of Bush to 51 percent disapproving.

Among registered voters, the former president’s approval rating of 47 is equal to that of Obama’s in the last Post-ABC poll.

The decision to invade Iraq remains Bush’s most contentious issue, with a majority disapproving of his handling of that war. Fifty-seven percent disapprove of the decision to go to war, down from 65 percent in the spring of 2008.

Bush’s economic approval numbers have also improved with 43 percent approving of his handling of the economy to 53 percent disapproving. When he left office only 24 percent approved of Bush on the economy.

The poll’s findings come as Bush prepares to open his presidential library on Thursday, the George W. Bush Presidential Center in Dallas. He will be joined by President Obama and former Presidents Clinton, George H.W. Bush and Carter.

In an interview published Monday in USA Today, Bush said he felt “no need to defend" himself over the high-profile decisions that marked his term, saying he would leave those appraisals to history.

“There's no need to defend myself,” Bush said. “I did what I did and ultimately history will judge.”

Bush said the library would be a place to “lay out the facts” behind his key policy decisions and would let visitors make their own judgments about the Iraq war, the financial crisis and the response to Hurricane Katrina.

The president has kept a low profile since leaving office, staying out of the media spotlight. 

“I'm happy to be out of the limelight. I truly am,” Bush said. “My life is obviously much simpler than it was in the past, but in many ways, the simplicity creates contentment.”

Bush’s brother, former Florida Gov. Jeb Bush has said he would consider a run for the 2016 GOP presidential bid and is seen as a prime contender for the nomination.

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InVivo Therapeutics gets approval for human trials

CAMBRIDGE, Mass. -- InVivo Therapeutics Holdings Corp. said Friday that the Food and Drug Administration will allow it to start human trials of an experimental product that is intended to treat spinal cord injuries.

InVivo said it plans to start a trial of the device, called a biopolymer scaffold product, in the next few months. The company wants to study the device in five patients and said the initial study will last about 15 months.

The Cambridge, Mass., company said there are no FDA-approved treatments that intervene directly in the spinal cord following an injury.

On Thursday the FDA awarded the scaffolding a humanitarian use device exemption. Given to products intended to treat conditions that affect fewer than 4,000 people a year, the exemption could speed up approval of a product and reduce the amount of testing a company has to do. InVivo is trying to get a second exemption, a humanitarian device exemption, which would allow it to get marketing clearance if the FDA agrees the product's probable benefits outweigh its risks and that it doesn't pose a significant risk of illness or injury. InVivo would not have to prove the scaffolding is effective, although it would still have to run clinical tests.

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Valeant says generic approval could lower profit

Valeant Pharmaceuticals International Inc. said Thursday that a newly approved generic version of one of its drugs could significantly reduce its profits this year.

Mylan Inc. on Wednesday received final approval from the U.S. Food and Drug Administration to sell the first generic version of Valeant's Zovirax ointment, which is used in the treatment of herpes. It will start shipping the product immediately.

Valeant said that while the timing of the approval wasn't certain, the company knew it was coming and prepared for it. The Canadian company announced plans to launch its own generic version of the drug immediately.

But Valeant said that it didn't factor the approval into its original budget expectations and warned that the event could reduce its 2013 profit by between 30 and 40 cents per share.

It added that other actions, including several product acquisitions and the repricing of its term loan debt, which have taken place since it announced its financial guidance in January, could partially offset the effects of the Zovirax genericization.

Valeant said in January that it expected a 2013 profit of $5.45 to $5.75 per share on $4.4 billion to $4.8 billion in revenue. Analysts polled by FactSet currently expect a profit of $5.63 per share on $4.62 billion in revenue.

The company said Thursday that it will update its 2013 guidance when it releases its first quarter financial results in May.

Valeant's U.S. shares fell $1.81, or 2.5 percent, to $70.06 in morning trading.

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New-look Sarepta eyes approval for muscular dystrophy drug

* Under new CEO, Sarepta focused on Duchenne muscular dystrophy drug

* Strong mid-stage trial more than doubles company's value

* Investors hope for fast-track approval; some analysts cautious

* Analysts expect company to relay FDA feedback in April

April 2 (Reuters) - After three decades without bringing a drug to market, Sarepta Therapeutics Inc stands on the verge of a breakthrough with its treatment for a crippling genetic disorder that affects one in every 3,500 newborn boys.

If U.S. regulators fast-track approval of its treatment for Duchenne muscular dystrophy, as some investors are betting, it would complete a remarkable turnaround for the company that began life as AVI Biopharma in Corvallis, Oregon, 33 years ago.

Sarepta's stock has more than doubled in value since October, when its drug, eteplirsen, yielded positive results in a mid-stage trial. The company has a market capitalization of $1.1 billion.

Duchenne muscular dystrophy, or DMD, is classed as an orphan disease -- a condition affecting fewer than 200,000 people. More than a quarter of the 39 new medicines approved in the United States last year were designated for such diseases.

It's an area that has grabbed the attention of drug developers in search of a unique product that can command a high price. There are no approved treatments for DMD.

"Sarepta has the product and development platform necessary to join the ranks of other successful companies that target rare diseases," William Blair & Co analysts said last month as they launched coverage with an "outperform" rating on the stock.

The company also has renewed focus, analysts say -- something that Chief Executive Chris Garabedian says was missing when he took over on Jan. 1, 2011.

"At that time, the company's potential was under-appreciated, because we didn't have robust clinical data in any disease area and our business lacked focus," he told Reuters.

Garabedian, formerly vice-president of corporate strategy at Celgene Corp, arrived at Sarepta - then AVI - following a management shake-up led by private investor George Haywood and Meldrum Asset Management. The name-change followed in July 2012.

"The change is night and day, frankly," Haywood, referring to the company before and after the management changes, said by telephone.

Haywood, who holds a bachelor's degree in biology from Harvard University, began investing in AVI in the early 2000s. He was the biggest single shareholder by 2005; his most recent filing, dated Dec. 31, 2011, discloses a 3.8 percent stake.

Meldrum Asset Management owned 4.9 pct as of Dec. 31, 2011.

"There are a lot of great technologies around, but some of them don't develop because you don't have the right management that can identify areas to focus on, like Chris identified DMD," Haywood said.

Sarepta's Nasdaq-listed shares closed at $35.79 on Monday, eight times the value of AVI's stock at the start of 2012 and up 139 percent since Oct. 2, the day before the company reported that eteplirsen had significantly improved the walking ability of patients in the trial.

Nine of the 10 brokerages tracked by Thomson Reuters StarMine recommend buying Sarepta stock. Their mean price target is $42; five of the analysts rate the company a "strong buy".

The one analyst who has a "sell" rating -- Steve Brozak of WBB Securities -- pointed out that the mid-stage trial responsible for the recent stock bump was conducted on just 12 patients.

Company officials met with the U.S. Food and Drug Administration last month, and analysts said the company probably asked that eteplirsen's approval be accelerated.

Its case is bolstered by support from such nonprofits as Parent Project Muscular Dystrophy, CureDuchenne, Action Duchenne and the Muscular Dystrophy Association.

"GREAT PROMISE"

DMD usually appears in infancy and leads to severe muscle loss and eventual death.

It is caused by the body's inability to produce a key protein called dystrophin, which helps in building muscles. To date, the disease has been treated by using corticosteroids -- a man-made replica of the cortisol hormone -- to slow progression.

This treatment, however, comes with side-effects such as weight gain, growth retardation, glucose intolerance, said Dr. Valerie Cwik, director of the Tucson, Arizona-based Muscular Dystrophy Association.

The gene responsible for producing dystrophin contains a series of 79 sections, called exons. When one or more of these exons are absent, the entire chain is disrupted and the body is unable to produce the muscle-building protein.

Eteplirsen is designed specifically for DMD patients whose 51st exon is absent. It helps the body to skip this particular exon so that dystrophin can continue to be produced.

"Eteplirsen not only treats one of the underlying causes of the disease, but also helps produce dystrophin and appears to be very safe," said Cwik, who has treated DMD patients for 15 years.

Christopher Marai, a San Francisco-based analyst at Wedbush Securities, estimated the annual price of a course of eteplirsen therapy at between $350,000 and $400,000.

"It's probably a $400 million to $600 million drug, conservatively," he said in estimating the annual contribution of eteplirsen sales to Sarepta's revenue.

Accelerated approval is not a foregone conclusion. The company, headquartered these days in Cambridge, Massachusetts, is expected to release details of the FDA's guidance this month.

Dr. Ravindra Singh, professor of RNA Biology & Molecular Genetics at Iowa State University, said the study had shown that the drug holds "great promise", but that its effectiveness in larger studies has yet to be tested.

Improvement during the 12-patient study was measured by a test called the six-minute walk that checked each patient's cardiac, respiratory, circulatory and muscular capacity.

Jeffrey Spaeder, chief medical and scientific officer at Quintiles, the largest U.S. pharmaceutical outsourcing services firm, said smaller clinical studies for rare diseases were sometimes accepted by the FDA as fewer patients are available.

Some analysts -- including Deutsche Bank, which began coverage of Sarepta with a "buy" rating last month -- have said they believe the company is unlikely to get accelerated approval. Mid-2015 is more realistic, Deutsche analysts said.

"Sarepta is highly controversial because so much investor attention is focused on accelerated approval," the analysts wrote in a note. "Fundamentally, timing of approval does not matter ... but we do expect volatility around this decision."

Liisa Bayko, director and senior analyst for biotechnology equities research at JMP Securities, said Sarepta's stock would probably fall if the FDA does not grant accelerated approval.

"But I think there are many investors who are willing to invest in the company," she said. "There is a lot of support for the technology in the investment community."

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U.S. FDA delays approval of GSK bird flu vaccine

LONDON, March 25 (Reuters) - U.S. regulators have delayed approval of an H5N1 bird flu vaccine from GlaxoSmithKline , designed to be used in a pandemic.

The vaccine had been backed by an expert panel in November but GSK said on Monday the Food and Drug Administration (FDA) had informed it that additional review time was needed before approval.

Britain's biggest drugmaker said the delay was "due to an administrative matter that has recently been rectified", adding the company and the FDA were working to complete to review in a timely manner.

(Reporting by Ben Hirschler; editing Keith Weir)

((ben.hirschler@thomsonreuters.com; +44 20 7542 5082; Reuters Messaging: ben.hirschler.thomsonreuters.com@reuters.net))

Keywords: GLAXOSMITHKLINE BIRDFLU/

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UPDATE 1-U.S. FDA delays approval of GSK bird flu vaccine

* GSK says U.S. delay not related to narcolepsy controversy

* Similar vaccine linked to sleeping disorder in Europe

(Adds comment from GSK spokesman, background)

LONDON, March 25 (Reuters) - U.S. regulators have delayed approval of an H5N1 bird flu vaccine from GlaxoSmithKline , designed to be used in a pandemic.

A spokesman for Britain's biggest drugmaker said the delay was not related to recent controversy over links between a similar flu vaccine made by the company and narcolepsy.

Rather, the U.S. Food and Drug Administration (FDA) decided it needed more time to assess the product "due to an administrative matter that has recently been rectified", GSK said in a statement on Monday.

"GSK and the FDA are actively working together to complete the review in a timely manner," it added.

There is growing evidence of a link between GSK's earlier H1N1 flu vaccine, Pandemrix, and an increase in narcolepsy cases among children who received it in Europe - a fact which has raised questions as to whether the FDA should approve the similar H5N1 product.

Both vaccines contain AS03, a new adjuvant, or booster, that turbo-charges the body's immune response to a vaccine.

A 14-member panel of advisers to the FDA voted unanimously in November to recommend the H5N1 vaccine to protect against bird flu. The panel considered early studies from Europe showing an increase in the number of narcolepsy cases but concluded that the potential benefit of the vaccine outweighed the risk.

Since then, however, new data, including study results from Britain, suggest the scale and strength of the narcolepsy link to Pandemrix during the 2009-10 H1N1 swine flu pandemic could be greater than first thought.

Officials at the FDA were not immediately available to comment on the case.

(Reporting by Ben Hirschler; editing Keith Weir)

((ben.hirschler@thomsonreuters.com)(+44 20 7542 5082)(Reuters Messaging: ben.hirschler.thomsonreuters.com@reuters.net))

Keywords: GLAXOSMITHKLINE BIRDFLU/

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BRIEF-pSivida says Alimera to resubmit marketing approval application for Iluvien to FDA by end March

March 22 (Reuters) - pSivida Corp :

* Reports updates on Iluvien for planned resubmission to FDA and European

launch

* Says Alimera announced it intends to resubmit its NDA for Iluvien for DME to

FDA by end of March 2013 * Source text * Further company coverage

((Bangalore Newsroom; +1 646 223 8780))

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UPDATE 1-Medical device maker Cytori loses approval fight

WASHINGTON, March 22 (Reuters) - A U.S. appeals court ruled on Friday that the Food and Drug Administration acted correctly when it denied fast-track approval of two stem cell-related medical devices made by Cytori Therapeutics Inc.

The FDA had reasonable evidence to find that the devices were not substantially equivalent to devices already on the market, according to the unanimous ruling from the U.S. Court of Appeals for the District of Columbia Circuit.

The FDA's decision meant that Cytori had to conduct extensive clinical research as part of premarket approval.

Tom Baker, Cytori's director of investor relations, said the court ruling does not change the status quo because the company has a clinical trial under way.

"That will continue to be our priority and primary path to market," Baker said in a phone interview on Friday.

The clinical trial started last year and the company plans to have initial data in the first half of 2014, he said.

Cytori is hoping to develop a treatment for heart failure in which regenerative stem cells from a patient's own fat tissue would be injected into heart muscle, all in one procedure.

The appeals court ruling relates to two medical devices designed to extract stem cells from fat tissue, the Celution 700 and the StemSource 900.

Cytori and the FDA disagreed over how similar the devices are to existing devices that extract stem cells from blood or bone marrow. Devices that are similar to already approved ones require less testing.

Judge Brett Kavanaugh wrote for a three-judge panel that the appeals court must be careful when questioning the scientific judgment of an agency such as the FDA.

"FDA concluded and explained that fat is not blood and that the difference matters. A court is ill-equipped to second-guess that kind of agency scientific judgment," Kavanaugh wrote.

An FDA spokeswoman declined to comment.

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Medical device maker Cytori Therapeutics loses approval fight

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BRIEF-FDA staff does not recommend approval of Abbott's MitraClip

March 18 (Reuters) - Abbott Laboratories :

* FDA staff says approval of Abbott's MitraClip not appropriate at the

time as major questions of safety, efficacy & risks remain unanswered

* FDA staff recommends Abbott's MitraClip to remain available for high risk

patients so Abbott can conduct its trials in an optimal manner

* FDA staff says the analyses included in Abbott's MitraClip marketing

application do not have valid scientific evidence of safety & efficacy

* Source text * Further company coverage ((Bangalore Newsroom; +1 646 223 8780))

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UPDATE 1-FDA staff does not recommend approval of Abbott's heart device

(Adds details, Abbott and analyst comments, stock movement)

March 18 (Reuters) - Staff reviewers for the U.S. Food and Drug Administration did not recommend the approval of Abbott Laboratories' implantable heart device MitraClip, citing a lack of "valid scientific evidence" of safety and effectiveness.

FDA reviewers said in briefing documents, posted on the regulator's website on Monday, that approval of the device would not be appropriate at the time as major questions of safety, efficacy and overall benefit-risk profile remained unanswered.

The device is being tested to treat mitral valve insufficiency - a disorder where a heart valve does not close properly when the heart pumps blood, causing blood to flow back into the heart - in patients considered high risk for open surgery.

The device is inserted into the blood stream using a catheter.

"The FDA staff is asking for more information. Abbott is conducting multiple trials on MitraClip, including the COAPT study, and the staff would want to look at that data," BMO Capital Markets analyst Joanne Wuensch said.

The COAPT trial is testing the device in high-risk inoperable and high-risk mitral valve patients. Abbott has also recently developed a European trial for the patient population.

Abbott had changed the proposed use for the device after the FDA expressed concerns that there was a lack of evidence to support its approval for a broader use in patients with significant mitral valve insufficiency, the reviewers said in the documents. ()

"FDA firmly believes that the currently enrolling COAPT and European trials are well-designed trials that will help to answer the many important questions posed by the very limited data analyses presented in this (approval application)," the reviewers said.

However, the reviewers recommended that MitraClip continue to remain available to high-risk patients as an investigational device so that Abbott can conduct its trials in an optimal manner.

"The MitraClip device represents a true advance for (high-risk) patients and we look forward to discussing the totality of the clinical evidence with the advisory committee members and hearing their recommendations on Wednesday," Abbott said in an emailed statement to Reuters.

An advisory panel of independent experts will discuss the data submitted by Abbott on the device and will vote on its safety, efficacy and risk profile.

BMO's Wuensch said her earnings estimate on Abbott did not include any expected revenue from MitraClip, adding that she believed the Street consensus also excluded any potential sales from the device.

Abbott shares were down 1.2 percent at $33.72 on the New York Stock Exchange on Monday.

(Reporting by Esha Dey in Bangalore; Editing by Maju Samuel and Roshni Menon)

((esha.dey@thomsonreuters.com; within U.S. +1 646 223 8780, outside U.S. +91 80 4135 5800; Reuters Messaging: esha.dey.thomsonreuters.com@reuters.net))

Keywords: ABBOTT FDA/MITRALVALVEDEVICE

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UPDATE 1-FDA advisers vote to reject approval of Depomed's menopause drug

(Updates with details) March 4 (Reuters) - Advisers to the U.S. Food and Drug Administration on Monday recommended the agency reject a drug made by Depomed Inc to reduce the frequency and severity of hot flashes associated with menopause. The panel of advisers voted 13-1 that company failed to prove convincingly that the drug worked. They voted 12-2 that its efficacy, when balanced against risk, did not warrant approval. The drug, Sefelsa, is a long-acting version of the epilepsy drug gabapentin. A short-acting version of gabapentin made by Pfizer Inc and marketed as Neurontin was approved in 1993. Clinical trials of Depomed's drug showed it only partially reduced the frequency and severity of hot flashes while side effects included dizziness, sleepiness, headache and nausea. Gabapentin has also been shown to increase the risk of suicide. The FDA does not have to follow the recommendations of its advisory panels but it generally does. Sefelsa is one of two drugs designed to reduce hot flashes being considered on Monday. The second is a drug from a unit of Hisamitsu Pharmaceutical Co Inc that comprises a low dose version of the antidepressant paroxetine. Depomed's drug was approved in the United States in 2011 to treat shingles-related pain and is marketed under the brand Gralise. Depomed's shares were halted pending the panel's vote at $6.52 on Nasdaq.

(Reporting By Toni Clarke; Editing by Gerald E. McCormick and Sofina Mirza-Reid)

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U.S. FDA panel votes against approval of Noven's menopause drug

March 4 (Reuters) - A panel of advisors to the U.S. Food and Drug Administration recommended that the agency reject a drug for hot flashes associated with menopause made by Hisamitsu Pharmaceutical Co Inc's subsidiary Noven Pharmaceuticals Inc.

The panel voted 10-4 against approval, with the majority saying the drug's benefit was not sufficient to offset its risks. The panel was evenly divided over whether the drug was in any way effective.

(Reporting By Toni Clarke. Editing by Andre Grenon)

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

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

Keywords: MENOPAUSE/NOVEN

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FDA advisers vote against approval for Depomed's menopause drug

March 4 (Reuters) - Advisers to the U.S. Food and Drug Administration on Monday recommended the agency reject a drug made by Depomed Inc to reduce the frequency and severity of hot flashes associated with menopause.

The panel of advisers voted 12-2 against the drug, Sefelsa, which is a long-acting version of the epilepsy drug gabapentin. The panel concluded that the drug's modest efficacy did not outweigh the side effects.

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

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

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

Keywords: MENOPAUSE DEPOMED/

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Pharmacyclics jumps on drug approval plans

NEW YORK -- Shares of Pharmacyclics Inc. climbed to an all-time high Friday after the company said it expects to file for marketing approval of its cancer drug ibrutinib this year. If approved, it would be Pharmacyclics first drug for sale.

Pharmacyclics announced earlier this week that the Food and Drug Administration has deemed ibrutinib a breakthrough therapy as a treatment for mantle cell lymphoma. The FDA created the breakthrough therapy program in 2012 as a way to speed up the approval process for drugs that could be significant improvements in the treatment of serious or life-threatening diseases from what's currently on the market.

Through a partnership with Johnson & Johnson, Pharmacyclics is studying ibrutinib as a treatment for several types of lymphoma and leukemia, including mantle cell lymphoma, chronic lymphocytic leukemia, and diffuse large B-cell lymphoma.

Shares of Pharmacyclics rose $6.79, or 8.5 percent, to close at $87 on Friday and set an all-time high of $87.82 during the session. The stock has surged nearly 24 percent over the three trading days since the company announced that the drug won breakthrough status.

Stifel Nicolaus analyst Joel Sendek said the company is filing for approval sooner than he expected, and said he now thinks ibrutinib will reach the market in late 2014 as a treatment for mantle cell lymphoma and chronic lymphocytic leukemia. He said sales could reach $158 million in 2015.

Pharmacyclics also reported its quarterly results after the market closed on Thursday. Over the three months ended Dec. 31, the Sunnyvale, Calif., company said it earned $41.9 million, or 56 cents per share, down from $56.3 million, or 78 cents per share. Excluding one-time items, adjusted earnings totaled 62 cents per share, compared with 82 cents per share in the prior-year period.

Revenue fell to $58 million from $77.9 million as the amount of money that it received for licensing and reaching drug development milestones declined. Most of Pharmacyclics' revenue comes from license payments from its drug development partners. In the latest quarter, that included a $50 million payment from Johnson & Johnson and $5 million from Novo Nordisk AS. Operating costs linked to research and development expenses also increased, shrinking profit margins.

The company is switching from a fiscal year ending in June to one ending in December. Over the last six months Pharmacyclics said its net income nearly tripled to $117.5 million, or $1.58 per share. Revenue more than doubled to $160.7 million from $77.9 million.

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Isis Pharma shares rise on Kynamro approval

NEW YORK -- Shares of Isis Pharmaceuticals Inc. soared Wednesday on news that the U.S. Food and Drug Administration approved its new drug application for its Kynamro cholesterol drug.

THE SPARK: The approval clears the way for Kynamro, the company's first drug, to reach market.

Carlsbad, Calif.-based Isis has a deal with Genzyme, a unit of French drugmaker Sanofi SA, to market the drug if it is approved. The FDA approval triggers a $25 million milestone payment to Isis from Genzyme.

THE BIG PICTURE: Kynamro is an injectable drug designed to treat patients who are genetically predisposed to have high levels of LDL cholesterol, known as the "bad" cholesterol. The drug has been approved for use as an adjunct to lipid-lowering medications and diet for patients with homozygous familial hypercholesterolemia.

HoFH is a rare inherited condition that makes the body unable to remove LDL cholesterol from the blood, causing abnormally high levels of circulating LDL cholesterol. In the United States, HoFH occurs in about one in one million individuals, according to the company.

THE ANALYSIS: BMO Capital markets analyst Dr. Jim Birchenough backed his "Outperform" rating for the stock, estimating the drug's peak sales at about $400 million. He added that the approval also bodes well for Isis' platform of more than 20 drug candidates.

Jefferies analyst Eun Yang backed an "Underperform" rating for Isis, but raised her price target by 50 cents to $7. Yang said that while the approval is a good thing for the company, she still thinks that the drug's commercial potential is low given the numerous side effects identified while it was being tested, including links to both benign and cancerous tumors. As a result, Yang said the drug's peak U.S. sales potential is probably less than $100 million.

THE SHARES: Up $1.51, or 11 percent, to $14.89 in afternoon trading, after peaking at $15.60 and coming within a penny of its 52-week high. Isis shares have risen steadily since November, gaining about 74 percent.

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Furiex jumps after diabetes drug approval

NEW YORK -- Shares of Furiex Pharmaceuticals Inc. surged Monday after regulators approved three new diabetes drugs that Japanese drugmaker Takeda developed with help from Furiex.

THE SPARK: On Friday, Takeda said the Food and Drug Administration approved the type 2 diabetes drug Nesina and the combination drugs Oseni and Kazano. Furiex, which teams up with drug companies to speed clinical development programs, said it will receive $25 million from Takeda as a result of the approval. It will also get royalties on sales of the drugs.

Nesina, or alogliptin, is designed to treat insufficient levels of insulin. The other two drugs also contain alogliptin, pairing it with other drugs in a single pill. Oseni combines the drug with the main ingredient in the diabetes medication Actos, an older drug made by Takeda that treats resistance to insulin. Kazano combines alogliptin and metformin, which has been used to treat diabetes for decades.

THE BIG PICTURE: Japanese regulators approved Nesina in 2010 and Oseni in 2011, and Furiex gets royalty payments on sales of those products. The Morrisville, N.C., company also has the rights to the premature ejaculation treatment Priligy, which is marketed in some countries by its partner Menarini Group.

Furiex reported a total of $5.6 million in royalty revenue in the third quarter.

Furiex is also studying treatments for irritable bowel syndrome and other diabetes drugs.

THE ANALYSIS: Canaccord Genuity analyst Randall Stanicky started covering Furiex shares with a "Buy" rating and a price target of $45 per share. He said the company should get a steady flow of cash in the form of royalty payments, adding that the Takeda diabetes drugs should be approved in Europe in the second half of the year. Stanicky said investors may be overlooking the value of Furiex's experimental drugs.

SHARE ACTION: Furiex shares rose $11.14, or 52.4 percent, to $32.38 in afternoon trading. Earlier the stock reached an all-time high of $32.97. The company completed its IPO in May 2010.

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Novartis meningitis vaccine wins EU approval

European regulators have approved the first vaccine against meningitis B, made by Swiss drugmaker Novartis.

Novartis said Tuesday that the European Commission approved Bexsero for use in patients ages 2 months and older, and the company will make the vaccine available as soon as possible.

Meningitis mainly affects infants and children. The disease can be fatal or can leave patients with lifelong consequences such as brain damage or impaired hearing.

There are five types of bacterial meningitis, and while vaccines exist to protect against four, none has previously been licensed for type B meningitis. In Europe, type B is the most common, causing 3,000 to 5,000 cases every year.

Novartis said a vaccination is the best defense against the rare disease, since its symptoms often resemble the flu, and it can be easily misdiagnosed.

The European Medicines Agency had said in November that it recommended the vaccine's approval. Novartis also is seeking to test the vaccine in the United States.

Its shares closed at $65.64 on Friday.

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Santarus rises on drug approval and 2013 outlook

NEW YORK -- Shares of Santarus Inc. climbed Tuesday after the company received marketing approval for a new drug and issued a strong sales outlook for 2013.

THE SPARK: The company said Monday that the Food and Drug Administration approved its drug Uceris, which is intended to put symptoms of ulcerative colitis, an inflammatory bowel disease, into remission. Santarus plans to launch the drug in March.

THE BIG PICTURE: The company said it should meet or surpass its previous guidance in 2012, and its revenue outlook for 2013 was better than analysts had expected.

The San Diego company had forecast net income of $12 million to $14 million and $210 million in revenue for 2012. FactSet says analysts had projected net income of $14.2 million, or 20 cents per share, and $209.3 million in revenue.

In 2013 Santarus expects net income of $50 million to $54 million and revenue of $320 million to $325 million. Analysts had expected income of $54 million, or 76 cents per share, and $301.3 million in revenue on average.

Santarus also makes the acid reflux drug Zegerid. It is not currently marketing Zegerid, but is getting ready to resume sales because of a favorable court ruling regarding the patents on the drug.

THE ANALYSIS: Santarus should have a good year in 2013, said Roth Capital Markets analyst Scott Henry, who has a "Buy" rating on the company's shares. He said Uceris was a key drug for the company, and was optimistic about Santarus bringing Zegerid back to market and filing for marketing approval of a new drug.

SHARE ACTION: Santarus stock rose $1.26, or 11 percent, to $12.54 in late afternoon trading. The shares are up more than 80 percent since the end of August and have nearly tripled in value of the last 12 months.

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Supreme Court Reconsiders Allowing Judges To Increase Sentences Without Jury Approval

Among the major contributors to the U.S. incarceration epidemic are harsh schemes for sentencing, and some of the most disproportionate sentences come about as a result of statutorily mandated minimum sentences.

Just last week, a former medical marijuana distributor who declined to plead guilty was sentenced to a ten-year minimum prison sentence by a federal judge who said, “the court’s hands are tied.”

But for some defendants, being sentenced to the mandatory minimum prison term for the crime of which they are convicted is just the tip of the iceberg. Judges may also use their discretion to add additional time up to a maximum allowable sentence. A case before the U.S. Supreme Court today considers the scope of that discretion when judges decide unilaterally that the defendant committed acts other than that for which they were convicted.

Allen Alleyne was convicted for robbing a convenience store owner as he drove to make a bank deposit. The jury found Alleyne guilty of both having committed the robbery, and having used or carried a firearm. They acquitted him, however, of brandishing a firearm during the crime.

Nonetheless, in sentencing Alleyne, the judge independently found that Alleyne should have known his accomplice would brandish a firearm during the robbery – a finding that added two additional years to Alleyne’s  sentence above the mandatory minimum of five years. Unlike a jury, which is tasked with finding guilt “beyond a reasonable doubt,” the judge made this finding under the much lower standard of “preponderance of the evidence.”

It is easy to view Alleyne and his accomplice as serious criminals who may very well deserve to serve either a five or a seven-year sentence. But allowing a judge the discretion impinges on a criminal defendant’s constitutional right to a trial by jury. The U.S. Supreme Court has already ruled that a judge cannot use this discretion to increase a defendant’s sentence above the maximum allowable sentence. And a similar rationale prompted a controversial but landscape-changing decision to limit the enforceability of federal sentencing guidelines.

Although the severity of statutory sentencing schemes has led to grossly unjust results, particularly in drug crimes, their purpose was and is to limit the variability and bias that can be introduced by any given judge in imposing a criminal sentence. Letting judges make factual determinations that are the purview of the jury undermines this goal – and allows for the sorts of even longer prison terms that have contributed to our ever-bloated prison population.

Somewhat surprisingly, the U.S. Supreme Court agreed to hear this case on the argument that an earlier high court decision on just this issue was wrongly decided. With four new justices since the 2002 decision and Justice Stephen Breyer on the fence, the Supreme Court now has a second chance to get it right.

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