FDA approves ketamine-derived nasal spray to treat depression

MJ_Prototype/iStock(NEW YORK) — The U.S. Food and Drug Administration has approved a ketamine-derivative nasal spray to treat depression.

The medication is called eskatamine and it’s developed by Johnson & Johnson subsidiary Janssen Pharmaceutical Companies. Esketamine can now be used for patients who have “treatment-resistant depression,” or patients who didn’t respond to at least two other medications. The FDA made the announcement on Tuesday.

Ketamine, which is commonly known as the street drug “Special-K,” has been used as an anesthetic for decades. It has also been used experimentally to treat depression since the late 90s and has previously been administered with an IV.

Kaiser Permanente offers the IV form of ketamine to treat depression, but representatives for the health care system did not answer repeated requests from ABC News for information about the program, its history and the number of providers and patients who have participated in the program.

Janssen’s new esketamine spray, which will be sold under the brand name Spravato, was developed to be three to four times more potent than regular ketamine, which would allow doctors to administer less and reduce side effects, according to Husseini K. Manji, a developer of the drug and global head of Janssen’s neuroscience therapeutic area.

“We could get away with a very low dose of the drug and fewer side effects,” he told ABC News.

The spray works within hours compared to the four to eight weeks most anti-depressants take to become effective, Manji said.

However, not everyone is enthusiastic about the prospect of a ketamine nasal spray.

“The whole concept is suspect,” Dr. Julie Zito, professor emerita of pharmacology and psychiatry at the University of Maryland, told ABC News.

Zito was one of the two doctors — out on an FDA panel of 16 — who voted against recommending that eskatamine go forward in the approval process, and said that she thinks it needs further review because the findings were “inconsistent.”

“The model of using a drug alone and expecting a magic bullet ignores 60 years of experience with antidepressants,” Zito said, explaining that to think anyone is going to “fix depression” is a mistake. “We can use a medication as a start, then psychotherapeutic treatment, like cognitive behavioral therapy, that’s evidence-based and shown to be effective, has to come into play and address the problems that are causing the suffering.”

With the new drug, patients will get esketamine doses twice a week for the first four weeks, according to Manji. Once they show signs of improvement, treatments can be spread out to once a week or once every two weeks.

“You can get people better rapidly with the nasal medication but depression is a chronic disease,” he added.

Leading up to its approval, researchers examined about 1,700 people over 29 studies, which were executed in various phases with the FDA, according to Manji.

The two major side effects are an increase in blood pressure and disassociation, or feeling disconnected from one’s thoughts, feelings or body. When experienced, both seem to begin about 30 minutes after the treatment and end about 90 minutes afterward.

“The side effects are manageable,” Manji said.

For about 90 percent of people who experience the blood pressure increase, Manji said it’s akin to “what you or I might have if we exercised.”

He added that with the dissociation, “colors might seem brighter, sounds might seem brighter, you might not seem real, the room might not seem real.” However, the severity of this feeling usually lessened after the first dose.

Because of the potential side effects,”you don’t go home with eskatamine,” Manji said. “You go to a clinic, it’s administered and you stay for 90 minutes and then go home.”

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Satellite photos show North Korea rebuilding missile launch facility

WORLD NEWS Satellite photos show North Korea rebuilding missile launch facility  https://linewsradio.com/satellite-photos-show-north-korea-rebuilding-missile-launch-facility/  http://abcnewsradioonline.com/world-news/

ANNECORDON/iStock(WASHINGTON) — Commercial satellite imagery released by a Washington think tank showed that North Korea has begun a rapid rebuilding of a missile launch site that has been inactive since last summer.

The development comes days after President Donald Trump’s summit with North Korean leader Kim Jong Un that did not result in a denuclearlization agreement between the two countries.

The satellite images, taken on March 2, 2019, were acquired by the Center for Strategic and International Studies’ (CSIS) Beyond Parallel and show new activity at the Sohae (Tongchang-ri) launch facility located in the northwestern part of North Korea.

The images showed that North Korea has begun to rebuild the launch stand at the location that is the country’s main site for long range satellite launches. The site has not been used for the launch of North Korea’s intercontinental ballistic missiles, which are fired from mobile launchers.

However, U.S. officials have said that the civilian satellite launches are a cover for military ICBM tests since the technologies are so similar.

Activity at the site includes two construction cranes, as well as several vehicles and supplies laying on the ground next to the vertical engine test stand.

The satellite photos also showed activity at the launch pad’s rail-mounted rocket transfer structure.

The covers that typically shroud the site’s umbilical launch tower have now been opened to show the launch pad itself.

The renewed activity at the launch site was detected two days after the Trump-Kim summit in Hanoi, Vietnam, that failed to reach an agreement to eliminate North Korea’s nuclear weapons program.

The Sohae facility has been inactive since August 2018, when North Korea seemed to be following through with a commitment they made to President Trump at the Singapore summit that Kim would dismantle a launch facility.

CSIS analysts believe the current activity “is deliberate and purposeful” to show North Korea’s resolve in the wake of the Hanoi meeting.

Though no agreement was reached in Hanoi, President Trump told reporters that Kim had committed to continue not to conduct ballistic missile or nuclear tests, as he had following the Singapore summit.

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Posted On 05 Mar 2019

Queen Latifah says she needs “proof” before she condemns Jussie Smollet for alleged hoax

Entertainment News  Queen Latifah says she needs "proof" before she condemns Jussie Smollet for alleged hoax https://linewsradio.com/queen-latifah-says-she-needs-proof-before-she-condemns-jussie-smollet-for-alleged-hoax/ http://abcnewsradioonline.com/entertainment-news/

 

ABC(LOS ANGELES) — For now, Queen Latifah says she’s standing by her good friend Jussie Smollett.

In an interview with Yahoo‘s Through Her Eyes, Latifah says she’s not ready to condemn the Empire actor until she sees actual evidence that he staged his own attack back in January.

Until somebody can show me some proof otherwise, I’m going with him, ” she said. “The guy I’ve seen has always been someone who cares about people, who cares about others, and who’s very kind and who’s always been cool and sweet. And that’s just the guy I know.”

She continued, “So, until I can see some definitive proof — which I haven’t seen yet — then, you know, I gotta go with him until I see otherwise..”

As previously reported, Smollett turned himself in to police last month after reportedly staging the attack, in which he claimed two men had beat him while yelling racial and homophobic slurs and placing a noose around his neck. Now out on bond, the actor faces disorderly conduct charges for filing a false police report. 

Latifah, a cast member of Fox’s Star who once appeared in an Empire/Star crossover episode, admitted that she doesn’t “even know what to make of” the allegations against Smollett.

“All I know is that I hope everything works out in the end and everybody basically comes out unscathed,” she said.

Through Her Eyes airs every Tuesday at 8 p.m. ET on Roku.

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Posted On 05 Mar 2019

2nd ever HIV patient in remission after stem cell transplant: Doctors

Vasyl Dolmatov/iStock(SEATTLE) — A man who previously tested positive for HIV has shown no trace of the virus that causes AIDS since receiving a stem cell transplant more than a year ago, doctors say.

The patient, a resident of the United Kingdom who has chosen to remain anonymous, appears to be the second known person to be declared free of HIV since the pandemic began.

 The latest case study was published online Tuesday by the scientific journal Nature and will be presented at the Conference on Retroviruses and Opportunistic Infections in Seattle this month.

Both HIV-positive patients were diagnosed with cancer and received bone-marrow transplants from donors carrying two copies of a rare genetic mutation, known as CCR5-delta 32, that made them resistant to HIV-1, the most widespread and pathogenic strain of the human immunodeficiency viruses.

The first patient, later identified as American Timothy Ray Brown, underwent two such transplants in Berlin in 2007 and 2008 to treat acute myeloid leukemia after chemotherapy and radiation failed, according to the case report published in the New England Journal of Medicine in 2009.

Brown has been cancer-free and in sustained remission from HIV ever since, as far as doctors can tell.

The second patient received the transplant in London in 2016 after being diagnosed with advanced Hodgkin lymphoma and going through less intensive chemotherapy.

Regular testing confirmed the so-called “London patient” also has been in long-term remission for the past 18 months since discontinuing antiretroviral therapy, according to the case report, which was carried out by researchers at University College London and Imperial College London with teams at the Universities of Cambridge and Oxford.

“By achieving remission in a second patient using a similar approach, we have shown that the Berlin patient was not an anomaly, and that it really was the treatment approaches that eliminated HIV in these two people,” said Dr. Ravindra Gupta, lead author of the new study and University College London’s Division of Infection and Immunity professor, in a statement.

The researchers cautioned that a stem cell transplant is not appropriate as a standard treatment for HIV due to the toxicity of chemotherapy given before the transplant.

“While it is too early to say with certainty that our patient is now cured of HIV, and doctors will continue to monitor his condition, the apparent success of haematopoietic stem cell transplantation offers hope in the search for a long-awaited cure for HIV/AIDS,” said Dr. Eduardo Olavarria, medical director of London’s Hammersmith Hospital blood and marrow transplantation unit and Imperial College London haematology professor, in a statement.

 Some 36.9 million people worldwide were living with HIV/AIDS in 2017, and just 59 percent were receiving antiretroviral therapy, which is the use of HIV medicines to suppress the virus.

Acquired immunodeficiency syndrome, or AIDS, is the third and most advanced stage of HIV infection. Almost one million people died from AIDS-related illnesses around the world in 2017, according to data from the Joint United Nations Program on HIV/AIDS (UNAIDS).

Early diagnosis and prompt treatment of HIV can help prevent progression.

“At the moment, the only way to treat HIV is with medications that suppress the virus, which people need to take for their entire lives, posing a particular challenge in developing countries,” Gupta said. “Finding a way to eliminate the virus entirely is an urgent global priority, but is particularly difficult because the virus integrates into the white blood cells of its host.”

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The producers of ‘Magic Mike The Musical’ are looking for a few good men

Entertainment News  The producers of 'Magic Mike The Musical' are looking for a few good men https://linewsradio.com/the-producers-of-magic-mike-the-musical-are-looking-for-a-few-good-men/ http://abcnewsradioonline.com/entertainment-news/

 

(NEW YORK) — The producers of the Broadway musical based on the hit Channing Tatum male stripper movie Magic Mike are looking for more than a few good men to shake their moneymakers onstage.

Trip Cullman, Magic Mike The Musical‘s director, said in a statement, “We are looking for actors who can surprise and dazzle us in that same unprecedented way. We are especially open to men of any race, ethnicity or creed as long as they are that elusive unicorn who can act, dance and sing brilliantly. So that should be easy!”

The casting call is searching for “phenomenal actors, dancers and singers” between the ages of 18-30 who are in “excellent physical shape.” 

If you’re interested, send your headshot, height, weight, contact info and a video audition to casting@magicmikebroadway.com. 

That video audition must consist of a link to a YouTube video that features you singing a “pop/rock song…not longer than one minute…with piano accompaniment.”  You also have to perform a “brief contemporary or hip-hop dance no longer than two minutes in length that shows off your athleticism, technique and any special skills (gymnastics, tumbling, etc).”

Oh, and the producers were sure to include this warning: “Please do not send any tapes that include nudity.”

Magic Mike The Musical, is being co-produced by Tatum, along with Steven Soderbergh and Gregory Jacobs, who, respectively, directed both the original film and Magic Mike: XXL.

The production will preview at Boston’s newly refurbished Emerson Colonial Theatre starting on Saturday November 30, 2019, and run from Sunday, December 15 through January 5, 2020, prior to a Broadway engagement.

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Posted On 05 Mar 2019

US B-52 flies over disputed islands in the South China Sea

WORLD NEWS US B-52 flies over disputed islands in the South China Sea  https://linewsradio.com/us-b-52-flies-over-disputed-islands-in-the-south-china-sea/  http://abcnewsradioonline.com/world-news/

drial7m1/iStock(WASHINGTON) — The U.S. has flown a B-52 bomber mission near disputed islands in the South China Sea, according to U.S. Pacific Air Forces.

The last reported B-52 mission in the vicinity of the South China Sea was in November.

“Two B-52H Stratofortress bombers took off from Andersen Air Force Base, Guam, and participated in routine training missions, March 4, 2019,” said a statement from the U.S. Pacific Air Forces.

“One bomber conducted training in the vicinity of the South China Sea before returning to Guam, while the other conducted training in the vicinity of Japan in coordination with the U.S. Navy and alongside our Japanese air force counterparts before returning to Guam,” it continued.

The B-52 aircraft involved in the mission are part of the U.S. Air Force’s Continuous Bomber Presence (CBP) based in Guam. Since 2004, the U.S. has rotated B-1, B-52 and B-2 long-range bombers out Andersen AFB in Guam to conduct training missions in Asia.

Much like the U.S. Navy’s freedom of navigation operations when it sails past two disputed island chains claimed by China in the South China Sea, the Air Force missions are intended to assert that the area is international airspace as well, much to China’s chagrin.

In the South China Sea, China claims as its own territory the Paracel Islands as well as seven artificial islands in the Spratly Islands chain. It has militarized both chains and claims sovereignty over the waters and airspace surrounding the islands.

U.S. Pacific Air Forces last confirmed a B-52 mission in the South China Sea on Nov. 20 of last year.

That mission was one of a series of B-52 flights in the region that had taken place in the vicinity of the South China Sea last fall.

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Posted On 05 Mar 2019

In new ‘Game of Thrones’ final season trailer, dragons and armies are spoiling for a fight

Entertainment News  In new 'Game of Thrones' final season trailer, dragons and armies are spoiling for a fight https://linewsradio.com/in-new-game-of-thrones-final-season-trailer-dragons-and-armies-are-spoiling-for-a-fight/ http://abcnewsradioonline.com/entertainment-news/

 

Helen Sloane/HBO(LOS ANGELES) — “Our enemy doesn’t tire. Doesn’t stop. Doesn’t feel.”

That’s what Jon Snow says in the trailer for the final season of Game of Thrones, released Tuesday by HBO, and he’s obviously referring to the ultimate showdown between our heroes and the zombie-like White Walkers. 

The tense trailer shows armies massing, on land and on sea, and Dany’s dragons flying through the air as she and Jon lead men into battle. Sansa Stark looks up from the top of Winterfell to see dragons flying over her head; Tyrion Lannister looks at — something — in wonder, while his sister Cersei smiles wickedly. 

There’s also Arya Stark, running for her life from something we can’t see — but as the Faceless Assassin notes, “I know death. He has many faces. I look forward to seeing this one.”

Meanwhile, referring to their pact last season to team with Jon and Dany against the White Walkers, Jaime Lannister vows, “I promised to fight for the living. And I intend to keep that promise.”

And Bran Stark is seen telling someone, possibly Sam, “Everything you did brought you where you are now. Where you belong. Home.”

The eighth final season of Game of Thrones starts April 14 on HBO.  It will consist of six 90-minute episodes.

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Posted On 05 Mar 2019

Grand Slam: Will Smith to play Venus and Serena Williams’ father in upcoming biopic

Entertainment News  Grand Slam: Will Smith to play Venus and Serena Williams' father in upcoming biopic https://linewsradio.com/grand-slam-will-smith-to-play-venus-and-serena-williams-father-in-upcoming-biopic/ http://abcnewsradioonline.com/entertainment-news/

 

ABC/Randy Holmes(LOS ANGELES) — Will Smith is taking on a pivotal role in his next project. The actor has signed on to play Richard Williams, father of tennis stars Venus and Serena Williams, in the upcoming film, King Richard.

According to Variety, Smith, who is currently filming Bad Boys For Life, will also produce the project, which centers on Mr. Williams’, “overcoming hardship, skepticism, controversy, and his own troubled past” to help bring his talented daughters from Compton, California to the world’s most prestigious tennis courts.

The movie’s script, written by Zach Baylin, was noted as a runner-up on the 2018 Black List, which rounds up the best unproduced screenplays in Hollywood.

This is the latest project for Smith, who plays the Genie in Disney’s upcoming live-action version of Aladdin.

Copyright © 2019, ABC Radio. All rights reserved.

Posted On 05 Mar 2019

Senators hear from Ohio teenager who rebelled against parents by getting vaccinated

JIM WATSON/AFP/Getty Images(WASHINGTON) — Ethan Lindenberger, an Ohio teenager who has spoken out about growing up in an anti-vaccine household, told a Senate committee Tuesday that misinformation and fear put children at risk.

Lindenberger said growing up he never received standard vaccines that protect against diseases like chickenpox, hepatitis, measles, mumps, polio, or rubella. In his prepared testimony, he described debates he’d had with his mother, who he has described as an “anti-vaccine advocate.” But by the time he became a legal adult, he said, he had educated himself on the topic and decided to seek inoculations on his own.

“Anti-vaccine parents and individuals are in no way evil. With that said, I will state that certain individuals and organizations which spread misinformation and instill fear into the public for their own gain selfishly put countless people at risk,” Lindenberger said.

John Boyle, president and CEO of the Immune Deficiency Foundation, spoke about parents who fear that their communities aren’t being sufficiently vaccinated.

“They are afraid to send their child to school — even when their child is not sick and should be able to participate. They’re afraid because they understand the science, the math, and the history. They know the stakes: if people stop vaccinating and the safety net of “community immunity” fails, their children will be among the first casualties,” Boyle said in prepared testimony.

The term “herd immunity” refers to the percentage of a community that needs to be vaccinated against a particular disease to prevent the spread of the disease in the population.

For measles, herd immunity is reached when about 93 to 95 percent of the population is vaccinated.

“The rate of protection against measles is hovering dangerously close to the ‘herd immunity threshold,’” said Saad Omer, a professor of epidemiology and pediatrics at Emory University, in prepared testimony.

The committee also heard from a public health official from Washington state, where an ongoing measles outbreak has drawn national attention to the issue of vaccinations.

As of Monday afternoon, the state Department of Health had confirmed 70 cases of measles in Washington’s Clark County.

Washington has had three measles outbreaks over the last 10 years, according to testimony from John Wiesman, secretary of health at the Washington State Department of Health.

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