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Friday, October 18, 2013

FDA rejects again Alimera eye implant; shares plunge

(Reuters) - Alimera Sciences Inc said U.S. health regulators rejected for a third time its eye implant device due to safety concerns, sending its shares down as much as 39 percent.

Shares of pSivida Corp, which sold the rights to Iluvien to Alimera in 2005 but is in line for a 20 percent share of profits, also dropped as much as 39 percent.

"We view running a new clinical trial as unrealistic, since it will require significant capital that Alimera does not currently have," Cowen and Co analyst Simos Simeonidis wrote in a client note.

As of June 30, 2013, Alimera had about $31.9 million in cash and cash equivalents.

Iluvien, used to treat retinal swelling brought on by diabetes, has been approved by some European regulators but the U.S. Food and Drug Administration has rejected it three times in the past three years.

The FDA raised concerns about the eye implant's safety profile in its complete response letter rejecting marketing approval, the company said on Friday. Marketing approval is the final OK needed to start selling a medical device in the United States.

The FDA also referred to deficiencies at the facility where Iluvien is manufactured, Alimera said.

Alimera said it did not believe that these deficiencies will affect its European commercial supply.

The FDA suggested at least 12 months of follow-up for all enrolled patients in a new trial and a meeting with the regulator's advisory panel to address the deficiencies.

Cowen and Co's Simeonidis said he found the panel meeting "rather unusual, and as a theoretical positive for Alimera, since it does leave the door open for something good to come out."

The panel would advise whether a patient population can be identified in which the benefits of the drug might outweigh the risks, the FDA said. The panel will convene on January 27.

In the second quarter ended June 30, Alimera generated revenue for the first time from its only commercial product Iluvien. The company reported revenue of $179,000.

Iluvien is a sustained-release implant used to treat vision impairment associated with chronic diabetic macular oedema.

Alimera shares were down 23 percent at $2.08, while pSivida shares were down 22 percent at $2.97 on the Nasdaq in early-afternoon trading.

(Reporting by Shailesh Kuber; Editing by Sriraj Kalluvila, Rodney Joyce and Maju Samuel)

Source: http://news.yahoo.com/fda-denies-approval-alimeras-eye-implant-shares-fall-112712681--finance.html
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Same-sex marriages to begin Monday in New Jersey

File-This Aug. 23, 2013 file photo shows Santa Fe County Commissioner Liz Stefonics, left, and Linda Siegle, a lobbyist for Equality New Mexico, holding hands after they were married in the Santa Fe County Commission Chambers, in Santa Fe, N.M. Siegle was first in line to get a marriage license with her partner of 22 years when the Santa Fe County clerk started in late August to issue marriage licenses to same sex couples. Now she’s waiting to see whether New Mexico’s highest court will legalize gay marriage in all 33 counties statewide. (AP Photo/The Albuquerque Journal, Eddie Moore,FILE) THE SANTA FE NEW MEXICAN OUT; MANDATORY CREDIT: EDDIE MOORE/THE ALBUQUERQUE JOURNAL

FILE - This undated file image provided by Lambda Legal shows plaintiffs Beverly Sevcik, 73, right, and Mary Baranovich, 76. A gay rights advocacy group is appealing a federal judge’s ruling that upheld Nevada’s constitutional ban against same-sex marriage. The appeal filed Friday, Oct. 18, 2013, by Lambda Legal on behalf of eight Nevada couples, including Baranovich and Sevcik, asks the 9th U.S. Circuit Court of Appeals in San Francisco to overturn a decision last year by U.S. District Judge Robert Jones in Reno. (AP Photo/Lambda Legal, File)

FILE - In this Thursday, Feb. 22, 2007 file photograph, Lambertville Mayor David Del Vecchio performs a civil union ceremony for Beth Asaro, left, and Joanne Schailey, right, at the Lambertville Municipal Court just after 12 a.m., in Lambertville, NJ. On Friday, Oct. 18, 2013, the New Jersey Supreme Court ruled, same-sex marriages will begin within days in New Jersey after the state's highest court ruled unanimously Friday to uphold a lower-court order that gay weddings must start Monday and to deny a delay that was sought by Gov. Chris Christie's administration. Asaro and Schailey plan to be married at 12:01 Monday morning. ( AP photo/Mel Evans)

Same-sex marriages can begin within days in New Jersey after the state's highest court ruled unanimously Friday to uphold an order that they must start Monday and to deny a delay that had been sought by Gov. Chris Christie's administration.

The ruling puts New Jersey on the cusp of becoming the 14th state — and the third most populous among them — to allow same-sex marriage. The advocacy group Freedom to Marry said that as of Monday, one-third of Americans will live in a place where same-sex marriage is legal.

"The state has advanced a number of arguments, but none of them overcome this reality: Same-sex couples who cannot marry are not treated equally under the law today," the court said in an opinion by Chief Justice Stuart Rabner. "The harm to them is real, not abstract or speculative."

A judge on a lower court had ruled last month that New Jersey must recognize same-sex marriage and set Monday as the date to allow weddings. Christie, a Republican who is considered a possible 2016 presidential candidate, appealed the decision and asked for the start date to be put on hold while the state appeals.

A spokesman for Christie said that he will comply with the ruling, though he doesn't like it.

"While the governor firmly believes that this determination should be made by all the people of the State of New Jersey, he has instructed the Department of Health to cooperate with all municipalities in effectuating the order," spokesman Michael Drewniak said in a statement.

Same-sex marriage is being debated elsewhere. Oregon has begun recognizing same-sex weddings performed out of state, and it is likely that voters will get a chance next year to repeal the state's constitutional ban on gay marriage. The Hawaii Legislature also soon could take up a bill to legalize same-sex unions, while a similar measure has passed the Illinois Senate but not the House. Lawsuits challenging gay marriage bans also are pending in several states, including Michigan, Pennsylvania and Virginia.

New Jersey's top court agreed last week to take up the appeal of the lower-court ruling. Oral arguments are expected Jan. 6 or 7.

In Friday's opinion, Rabner wrote that the state has not shown that it is likely to prevail in the case, though it did present some reasons not to marriage to move forward now.

"But when a party presents a clear case of unequal treatment, and asks the court to vindicate constitutionally protected rights, a court may not sidestep its obligation to rule for an indefinite amount of time," he wrote. "Under these circumstances, courts do not have the option to defer."

Rabner also rejected the state's argument that it was in the public interest not to allow marriages until the court has had more time to rule fully on the issue.

"We can find no public interest in depriving a group of New Jersey residents of their constitutional right to equal protection while the appeals process unfolds," he wrote.

For those opposed to gay marriage, denying the request to delay was troubling.

"In what universe does it make sense to let the question at hand be answered before it's asked or argued?" Len Deo, president of the New Jersey Family Policy Council, said in a letter Friday to members.

On Thursday, some communities started accepting applications for marriage licenses from same-sex couples so that they would pass the 72-hour waiting period by 12:01 a.m. Monday.

Several communities, including Asbury Park, Lambertville and Newark — where Cory Booker, who was elected Wednesday to the U.S. Senate, is mayor — are holding ceremonies for multiple couples then.

"It's a great day to be gay in New Jersey," said Amy Quinn, a member of the city council in Asbury Park who is planning to marry Heather Jensen, her partner of 10 years, on Monday.

The court did not address the question of what would happen to the status of same-sex marriages entered into next week if it later decides that the state does not have to grant the marriages.

Whether gay couples should have the right to marry in New Jersey has been the subject of a battle in the state's courts and Legislature for a decade. There has been a flurry of movements in both venues since June, when the U.S. Supreme Court invalidated key parts of a federal law that prevented the federal government from recognizing same-sex unions.

Since then, gay rights advocates have asked New Jersey judges to force the state to recognize same-sex marriage, arguing that the current policy of civil unions but not marriage licenses amounts to denying them federal protections such as Social Security survivor benefits and the right to file tax returns jointly.

Since July, gay rights groups have also engaged in an intense campaign aimed at persuading lawmakers to override Christie's 2012 veto of a bill that would have allowed gay marriage. To get an override, the Legislature must act by Jan. 14.

Sheila Oliver, speaker of the state Assembly, issued a statement blaming Christie for not having gay marriage sooner in New Jersey.

"It's a shame it took this long to get to this point and that it took a court fight for same-sex couples to gain equal rights," she said. "New Jersey could have had marriage equality already if it wasn't for Gov. Christie, who has done everything he could to prevent this from happening, including wasting money and time continuing this court battle."

___

Follow Mulvihill at http://www.twitter.com/geoffmulvihill

___

Mulvihill reported from Haddonfield, N.J. Contributed to this report were Associated Press writers Samantha Henry in Newark, Mark Sherman in Washington and David Crary in New York.

Associated PressSource: http://hosted2.ap.org/APDEFAULT/3d281c11a96b4ad082fe88aa0db04305/Article_2013-10-18-Gay%20Marriage-NJ/id-106d480bb0ed4ec4bb885f41a9a77d71
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Mexico's 'Prison Angel', Sister Antonio Brenner, Dies At 86

Sister Antonia Brenner touches the statue of San Pablo Encandenado (St. Paul chained) outside the chapel at the La Mesa State Penitentiary in a photograph taken in 2005.

Lenny Ignelzi/AP

Sister Antonio Brenner, a twice-divorced mother of seven turned "prison angel" who spent the last three decades of her life ministering to inmates at a Mexican penitentiary, has died at 86.

Brenner moved into a 10-by-10 cell at Tijuana's notorious La Mesa penitentiary, where she came to be known as 'La Mama' by the prisoners, who she called her children. She spent her time "mending broken lives, easing tensions and dispensing everything from toothbrushes to bail money," according to The Los Angeles Times.

The Times says:

"She was born Mary Clarke in Los Angeles on Dec. 1, 1926, to Irish immigrant parents. Her father grew wealthy running an office supply business, and the family counted Hollywood stars such as Cary Grant among their neighbors. She married and raised four daughters and three sons, all the while becoming deeply involved in charity work.

In 1977, after her children were grown and two marriages had ended in divorce — a source of sadness that she rarely talked about — Brenner gave away her expensive clothes and belongings, left her Ventura apartment and moved to La Mesa penitentiary. She had delivered donations in the past to the prison, each visit filling her with compassion.

'Something happened to me when I saw men behind bars. ... When I left, I thought a lot about the men. When it was cold, I wondered if the men were warm; when it was raining, if they had shelter,' Brenner told The Times in a 1982 interview. 'I wondered if they had medicine and how their families were doing. ...You know, when I returned to the prison to live, I felt as if I'd come home.'"

The San Diego Tribune adds:

"With her small frame, sunny disposition, and heavily accented Spanish, she delved fearlessly into a world riddled with poverty and violence, once quelling a riot by walking into the darkened penitentiary taken over by armed and angry inmates.

She urged guards to respect the petty thieves, rapists, murderers and drug traffickers in their custody, speaking out against beatings and torture of inmates. But she also reached out to those in law enforcement, raising funds for the families of those killed in the line of duty.

'I think prison freed me,' she once said in an interview."

Brenner was the subject of a book, The Prison Angel: Mother Antonio's Journey From Beverly Hills To A Life Of Service In A Mexican Jail and a 2010 documentary, La Mama: An American Nun's Life in a Mexican Prison.

The Times says she established her own religious order, the Eudist Servants of the Eleventh Hour, in the late 1990s. The newspaper quotes Tijuana Archbishop Rafael Romo as saying Brenner possessed the qualities of a saint and that her death was a "terrible loss."

Source: http://www.npr.org/blogs/thetwo-way/2013/10/18/236990583/mexicos-prison-angel-sister-antonio-brenner-dies-at-86?ft=1&f=1001
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Watch The Grossest, Goriest Scenes In Film With This Very Bloody Supercut

From 'Fargo' to 'Cabin in the Woods,' we've compiled the bloodiest of the bloody.

By Kase Wickman

Source:
http://www.mtv.com/news/articles/1715828/halloween-bloody-movies-supercut.jhtml

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Woody Allen's new film: 'Magic in the Moonlight'

LOS ANGELES (AP) — Woody Allen has given his next film a name.

Continuing his European intrigue, "Magic in the Moonlight" is set in southern France and stars Colin Firth, Emma Stone, Eileen Atkins, Marcia Gay Harden, Hamish Linklater, Simon McBurney and Jacki Weaver. Co-stars include Erica Leerhsen, Catherine McCormack, Paul Ritter and Jeremy Shamos.

The Gravier Productions film is being produced by Letty Aronson and Stephen Tenenbaum. They've worked on a number of Allen's films, from his latest "Blue Jasmine" to 2001's "The Curse of the Jade Scorpion."

Allen has delivered a full-length feature every year since 1982. "Magic in the Moonlight" marks his 47th time in the director's chair and his first time casting both Firth and Stone.

The film has already begun production and is tentatively set to release in 2014.

Source: http://news.yahoo.com/woody-allens-film-magic-moonlight-211959766.html
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