Showing posts with label fresh. Show all posts
Showing posts with label fresh. Show all posts

Sunday, June 9, 2013

Boehner: Pope Francis will bring ‘fresh eyes,’ reform to Vatican

By Molly K. Hooper - 03/17/13 11:50 AM ET

Speaker John Boehner (R-Ohio), a practicing Catholic, praised the election of Pope Francis and said he was optimistic the new pope would bring reform to the Vatican.

“I do believe that Pope Francis is the right person to really bring reform to the church,” said Boehner on ABC’s “This Week.”

The Speaker said the Vatican is plagued by “a number of issues” that he believes “need fresh eyes.”

“He’s clearly made a commitment to clean up some of the problems that the church has had,” said Boehner of the new pope. “And it's pretty clear-- from his humble nature that-- that his papacy will be one that I think a lot of people will appreciate.”

The Vatican cardinals last week elected Argentinian Cardinal Jorge Mario Bergoglio as the new pope. He took the name of Francis, succeeding Pope Benedict XVI, who formally resigned in February. 

“This is the first time that we've had a pope from the Americas,” Boehner added.  “So, I think it's a giant step forward for the church. Latin America is a very, very Catholic continent.”

Boehner declined an invitation from the White House to join a delegation that will attend the papal installation mass, saying that he would need to stay in Washington to move the House budget and to meet the Irish prime minister, who is arriving this week.

Boehner, though, said he was “grateful for the invitation” from the White House. 

"Unfortunately, my duties in the House next week -- including hosting President Obama and the prime minister of Ireland at the Capitol on Tuesday, and the debate on the budget -- make that impossible," Boehner said last week.

Vice President Joe Biden is leading the delegation to Rome, and will be joined by House Minority Leader Nancy Pelosi (D-Calif.).

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Monday, May 13, 2013

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))

Keywords: IMPAX FDA/


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