BRIEF-FDA advisers find Titan's Probuphine useful, express concerns on REMS plan

March 21 (Reuters) - Titan Pharmaceuticals Inc :

* FDA advisers vote 10-5 to agree clinical study data on Titan'S Probuphine

give substantial proof of its effectiveness to treat opioid dependance

* FDA advisers vote 12 yes, 2 no, 1 abstain on whether Titan adequately

characterized safety profile of Probuphine in the intended patient population

* FDA advisers vote 5 yes, 4 no, 6 abstain on whether rems proposed by Titan

are adequte to address risks of potential complications of Probuphine use

* FDA advisers vote 10 yes, 4 no, 1 abstain on whether efficacy, safety and

risk-benefit profile of Titan'S Probuphine support drug's approval

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

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CVS Health Screening Sparks Privacy Concerns

 Highlight transcript below to create clipTranscript:  Print  |  Email Go  Click text to jump within videoThu 21 Mar 13 | 06:50 AM ET Troy Brennan, MD, CVS Caremark chief medical officer, addresses concerns about a new health and wellness policy for employees that has some critics complaining it's an invasion of privacy.

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Impax shares tank as FDA flags fresh concerns on manufacturing plant

March 4 (Reuters) - Impax Laboratories Inc said U.S. health regulators raised fresh concerns related to manufacturing practices at the drugmaker's Hayward, California facility, sending its shares down more than 20 percent after the bell.

The company's hopes of securing an approval for its Parkinson's drug Rytari are tied to its ability to resolve issues at the plant, where the drug is partly manufactured.

The U.S. Food and Drug Administration completed its re-inspection of the Hayward facility and outlined 12 "observations", three of which had already been pointed in earlier communications, Impax said on Monday.

The regulator typically outlines observations from conditions that may constitute violations of standard manufacturing practices.

The FDA had rejected approval to Rytari in January, pending a satisfactory re-inspection of the Hayward facility.

"We have committed significant resources in our efforts to meet FDA requirements and are clearly disappointed by this news," Impax Chief Executive Larry Hsu said.

The FDA first expressed concerns related to the facility in a warning letter in June 2011.

The company said on Monday the FDA did not inform it on the impact the new concerns would have on resolving the warning letter, or if the agency planned to take further regulatory action.

Impax plans to respond to the FDA's new observations within 15 business days.

The company's shares, which were halted pending the release of its statement, fell about 21 percent to $15.80 in after-market trading on Monday afternoon.

(Reporting By Vrinda Manocha in Bangalore; Editing by Saumyadeb Chakrabarty)

((Vrinda.Manocha@thomsonreuters.com)(within U.S. +1 646 223 8780, outside U.S. +91 80 4135 5800)(Reuters Messaging: vrinda.manocha.thomsonreuters.com@reuters.net))

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NFL commissioner ‘optimistic’ about league’s future despite safety concerns

National Football League (NFL) commissioner Roger Goodell "couldn't be more optimistic" about the future of professional football, despite growing concern about the sport's injuries.

President Obama said in a recent interview with The New Republic that if he had a son, he would "have to think long and hard" about letting him play football. Concerns have mounted over the long-term health impacts of the sport, particularly when it comes to repetitive head injuries.

But Goodell said the NFL was doing everything it could to keep the sport entertaining for fans, but safe for players.

"What you have to do is make sure the game is as safe as possible," he said on CBS's "Face the Nation." "In the NFL, we're changing the rules."

On Super Bowl Sunday, Goodell touted the NFL's efforts to update equipment to protect against injuries, and its investment in medical research on head injuries and brain damage.

"We take those issues very seriously," he said. "We're going to let the medical individuals make those points. We're going to give them the money to advance that science."

Furthermore, the NFL is studying how the game is played, looking for further ways to keep players healthy.

"The game of football has always evolved," he said. "If we see techniques that we think lead to injuries, we're going to get them out of the game."

He also pointed out that women's soccer has the second-highest rate of head injuries of any sport. Like Obama, the commissioner said he has two daughters.

"I'm concerned when they play any sport," he said.

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Arena slumps on continued concerns for Belviq

NEW YORK -- Shares of Arena Pharmaceuticals Inc. slumped Tuesday after the company said European Union regulators still have questions about its weight-loss drug Belviq.

THE SPARK: Arena said a committee that advises the European Medicines Agency is asking for more information about Belviq, including heart valve issues and psychiatric side effects as well as tumors that were observed during studies on rats. The advisory panel also asked the company to justify the risks and benefits that Belviq offers.

THE BIG PICTURE: Arena asked European Union regulators to approve Belviq in March 2012. The company has been working to address concerns raised by regulators as it tries to win marketing clearance. Arena expects the advisory committee to issue a recommendation during the first half of 2013.

The Food and Drug Administration approved Belviq in late June, and Arena and its partner Eisai Co. plan to start selling it in the U.S. soon. The FDA approved another weight-loss pill, Vivus Inc.'s Qsymia, around the same time it approved Belviq. However Qsymia went on sale before the end of 2012.

THE ANALYSIS: Jefferies & Co. analyst Thomas Wei said he thinks Arena shares will be volatile because investors don't think Belviq will be approved in the EU, and have taken a dim view about the sales potential of Belviq by itself. Wei said he is more optimistic about the potential of a combination of Belviq and phentermine.

SHARE ACTION: Arena shares lost 99 cents, or 10 percent, to $8.79 in afternoon trading. The stock traded as high as $13.50 on June 27, the day Belviq was approved.

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Cardin voices concerns over Hagel nomination

Sen. Ben Cardin (D-Md.) said Tuesday that he had "concerns" over President Obama's nomination of former Sen. Chuck Hagel (R-Neb.) to serve as secretary of Defense. 

Cardin argued the president's nominee needed to clarify his positions on a slew of issues, from Iran sanctions to the service of gays in the military. 

"He's a good person. I agree with a lot of his positions in regard to Iraq. I certainly believe the president should be able to have his team. But the advice and consent of the Senate is a very important responsibility, we have to do it independently, and there are questions that need to be answered," Cardin told CNN's "Starting Point."

The Maryland lawmaker said he had requested a private meeting with Hagel to address some of his concerns, including Hagel's reluctance to support sanctions on Iran.

"I want an explanation in regard to his position [on] Iran," Cardin said. "He's been very reluctant to support sanctions on Iran. Iran is a very dangerous country."

Hagel has said previously that while he did not support "unilateral" sanctions on Iran, he did support efforts that involved other nations. On Monday, White House press secretary Jay Carney defended Hagel's record on the subject, calling the nominee a "supporter of the broad sanctions regime that this president has put into place against Iran."

Carney went on to herald the program as "a sanctions regime that is unprecedented and which as recently as, I think, last spring, Sen. Hagel wrote about favorably and urged Washington as a whole to continue."

Cardin also said he wanted to know what Hagel's position was on gays in the military, after Hagel opposed the appointment of an openly homosexual ambassador during the Clinton administration. And Cardin said he wanted Hagel to better explain his philosophy on the use of military force.

"It's going to be about, I understand his reluctance to use our military, but will he stand strong against those who threaten us in support of terrorism?" Cardin said.

The Maryland senator said he hoped for "an open and fair nomination process," but refused to guess how Hagel's nomination would turn out.

"I think it's too early to make a prediction as to how his confirmation process will go," Cardin said.

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