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Second Thoughts About That Tattoo? Here’s Some Advice

FRIDAY, Sept. 20, 2019 — If it’s time for that tattoo to go, here’s some advice from the American Academy of Dermatology.

Lasers removal of tattoos has become safer and more effective, but the results depend almost entirely on the person doing the work.

“For the best results and to reduce your risk of serious side effects, such as scarring, burns and other wounds, it’s important to make sure the person treating you is a physician who is extremely skilled in using lasers and has in-depth knowledge of the skin,” said New York City dermatologist Dr. Marie Leger.

“After that, it’s also important to properly care for the treated skin between sessions, as your skin needs time to heal and flush out the ink,” Leger added in an academy news release.

After each treatment, wash the treated area twice a day with water and a gentle cleanser. Use a clean cotton swab to apply petroleum jelly to the area to help keep the skin moist so it doesn’t dry out or form scabs. To prevent infection, cover the treated area with a dressing until the skin heals.

The treated skin is more susceptible to sun damage, so you should protect it from direct sun exposure. When outdoors, wear protective clothing, such as a lightweight, long-sleeved shirt, pants and a wide-brimmed hat, Leger advised.

After the treated skin heals, use a broad-spectrum sunscreen with an SPF of 30 or higher that contains zinc oxide. Zinc deflects the sun’s harmful ultraviolet rays.

Don’t pick at any flaking, peeling, blisters or scabs that form, and don’t pop any blisters. Doing so can cause infection.

After a laser tattoo removal session, it’s normal to see some redness, swelling and blistering as your skin heals. However, if you notice signs of an infection, such as increasing redness and pain, swelling or pus, see a doctor.

“Tattoo removal requires many treatments, with weeks between sessions,” Leger said. “For the best results, follow your dermatologist’s instructions for at-home care, and keep all of your appointments for laser tattoo removal, as each treatment removes more ink.”

More information

The U.S. Food and Drug Administration has more on tattoo removal

© 2019 HealthDay. All rights reserved.

Posted: September 2019

Drugs.com – Daily MedNews

French hoverboard inventor readies second Channel crossing bid

French inventor Francky Zapata holds a news conference as he prepares to cross the English Channel from Sangatte in France to Dover in Bleriot Plage, France, August 3, 2019. REUTERS/Johanna Geron

SANGATTE, France (Reuters) – A French inventor will on Sunday make his second attempt to cross the English Channel on a jet-powered hoverboard he designed, having abandoned a previous bid after failing to land on a refueling platform and falling into the sea.

Franky Zapata, who wowed crowds during France’s Bastille Day celebrations on July 14 by soaring over a military parade in Paris on the device, said he had changed refueling arrangements to give himself the best chance of a successful crossing.

“I just want to do it this time, we changed the boat, we took a bigger boat and built a bigger platform,” Zapata told a news conference on Saturday just outside the northern port of Calais.

Zapata will be carrying enough kerosene in his backback to fuel the hoverboard for about 10 minutes of flight, and as on his failed July 25 crossing will need to strap on a new supply for the second leg of his journey.

He is expected to take off from France at around 0600 GMT, making first for the refueling vessel mid-way across the 35-km wide Strait of Dover.

A champion on jetski-powered waterboards, Zapata steers his Flyboard Air craft which flies at up to 140 km per hour by leaning forward or backward, and controls thrust with a throttle connected to his 1,500 horsepower board.

“I hope to see you in England, for another press conference,” Zapata told reporters. “I hope I will be drier than last time.”

Reporting by Pascale Antonie; Writing by Sarah White; Editing by David Holmes

Reuters: Oddly Enough

FDA Approves Second Drug For Women With Low Libido

By EJ Mundell

HealthDay Reporter

FRIDAY, June 21, 2019 (HealthDay News) — The U.S. Food and Drug Administration on Friday gave its approval to Vyleesi, the second medication so far approved to help women with low sexual desire.

In a news release, the FDA said that Vyleesi (bremelanotide) is a drug that would be administered by injection prior to having sex.

It’s been specifically approved for premenopausal women with a condition known as acquired, generalized hypoactive sexual desire disorder (HSDD).

“There are women who, for no known reason, have reduced sexual desire that causes marked distress, and who can benefit from safe and effective pharmacologic treatment,” said Dr. Hylton Joffe, who directs the FDA’s Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products.

“Today’s approval provides women with another treatment option for this condition,” Hylton said in the news release.

According to the agency, HSDD is not caused by any medical or psychiatric condition, relationship issues or drug side effects.

Instead, women with HSDD have “previously experienced no problems with sexual desire,” the FDA said. “Generalized HSDD refers to HSDD that occurs regardless of the type of sexual activity, situation or partner.”

The exact way in which Vyleesi helps stimulate sexual desire remains unclear, but it works on melanocortin receptors on cells, the FDA said.

The drug is injected under the skin of the abdomen or thigh at least 45 minutes prior to a sexual encounter, although the best timeframe for dosing could vary from user to user.

Side effects can occur, the FDA added, and include nausea and vomiting, flushing, injection site reactions and headache. Nausea was especially common, affecting 40% of users in the clinical study that led to approval.

That study involved 1,247 premenopausal women with HSDD who received Vyleesi or a placebo in one of two 24-week trials.

“In these trials, about 25% of patients treated with Vyleesi had an increase of 1.2 or more in their sexual desire score (scored on a range of 1.2 to 6.0, with higher scores indicating greater sexual desire) compared to about 17% of those who took placebo,” the FDA noted.

Continued

Still, the overall benefit was not large. “There was no difference between treatment groups in the change from the start of the study to end of the study in the number of satisfying sexual events. Vyleesi does not enhance sexual performance,” the FDA said.

And there was one other caveat: Vyleesi can hike blood pressure, so people with heart disease or high blood pressure should not take it, the FDA said.

Vyleesi should also not be taken by anyone who is also taking the drug naltrexone, used to combat opioid dependency, because Vyleesi reduces naltrexone’s effectiveness.

Vyleesi is not the first drug approved to enhance flagging libido in women. In 2015 the FDA approved Addyi (flibanserin) for the purpose, but the drug did not become widely used because it cannot be taken with alcohol and only certain certified health care providers are allowed to prescribe it.

According to CNN, Vyleesi’s maker, AMAG Pharmaceuticals, said the new drug will not be available until September, and pricing and reimbursement have yet to be determined.

One expert in female sexual health said it remains to be seen how widely Vyleesi will be used.

Female sexual dysfunction is more complicated in some ways than male sexual dysfunction, so it’s more difficult to treat,” Dr. Nicole Cirino, co-director of the Menopause and Sexual Therapy Clinic at Oregon Health and Science University’s Center for Women’s Health, told CNN. She had no role in Vyleesi’s development.

Cirini suspects Vyleesi probably will not be the first option women with HSDD turn to, but it might prove a useful adjunct to standard psychotherapy and Addyi.

Vyleesi, like Addyi, probably won’t be overprescribed, Cirino added. When Addyi was introduced, there were concerns “that doctors would just be prescribing this medication to anybody that came in saying that they were having an issue with their libido,” she said. “And I think we have to give physicians more credit than that. In fact, that didn’t happen at all.”

Still, Vyleesi could help some women, Cirino said.

“There’s so many chemical factors that influence our libido,” she told CNN. “So you can’t discount using a chemical treatment as part of the broad approach to low libido.”

WebMD News from HealthDay

Sources

SOURCES: U.S. Food and Drug Administration, news release, June 21, 2019;CNN

Copyright © 2013-2018 HealthDay. All rights reserved.

‘); } else { // If we match both our test Topic Ids and Buisness Ref we want to place the ad in the middle of page 1 if($ .inArray(window.s_topic, moveAdTopicIds) > -1 && $ .inArray(window.s_business_reference, moveAdBuisRef) > -1){ // The logic below reads count all nodes in page 1. Exclude the footer,ol,ul and table elements. Use the varible // moveAdAfter to know which node to place the Ad container after. window.placeAd = function(pn) { var nodeTags = [‘p’, ‘h3′,’aside’, ‘ul’], nodes, target; nodes = $ (‘.article-page:nth-child(‘ + pn + ‘)’).find(nodeTags.join()).not(‘p:empty’).not(‘footer *’).not(‘ol *, ul *, table *’); //target = nodes.eq(Math.floor(nodes.length / 2)); target = nodes.eq(moveAdAfter); $ (”).insertAfter(target); } // Currently passing in 1 to move the Ad in to page 1 window.placeAd(1); } else { // This is the default location on the bottom of page 1 $ (‘.article-page:nth-child(1)’).append(”); } } })(); $ (function(){ // Create a new conatiner where we will make our lazy load Ad call if the reach the footer section of the article $ (‘.main-container-3’).prepend(”); });

Pagination

WebMD Health

FDA Approves Second Drug, Vyleesi, to Help Women With Low Libido

FRIDAY, June 21, 2019 — The U.S. Food and Drug Administration on Friday gave its approval to Vyleesi, the second medication so far approved to help women with low sexual desire.

In a news release, the FDA said that Vyleesi (bremelanotide) is a drug that would be administered by injection prior to having sex.

It’s been specifically approved for premenopausal women with a condition known as acquired, generalized hypoactive sexual desire disorder (HSDD).

“There are women who, for no known reason, have reduced sexual desire that causes marked distress, and who can benefit from safe and effective pharmacologic treatment,” said Dr. Hylton Joffe, who directs the FDA’s Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products.

“Today’s approval provides women with another treatment option for this condition,” Hylton said in the news release.

According to the agency, HSDD is not caused by any medical or psychiatric condition, relationship issues or drug side effects.

Instead, women with HSDD have “previously experienced no problems with sexual desire,” the FDA said. “Generalized HSDD refers to HSDD that occurs regardless of the type of sexual activity, situation or partner.”

The exact way in which Vyleesi helps stimulate sexual desire remains unclear, but it works on melanocortin receptors on cells, the FDA said.

The drug is injected under the skin of the abdomen or thigh at least 45 minutes prior to a sexual encounter, although the best timeframe for dosing could vary from user to user.

Side effects can occur, the FDA added, and include nausea and vomiting, flushing, injection site reactions and headache. Nausea was especially common, affecting 40% of users in the clinical study that led to approval.

That study involved 1,247 premenopausal women with HSDD who received Vyleesi or a placebo in one of two 24-week trials.

“In these trials, about 25% of patients treated with Vyleesi had an increase of 1.2 or more in their sexual desire score (scored on a range of 1.2 to 6.0, with higher scores indicating greater sexual desire) compared to about 17% of those who took placebo,” the FDA noted.

Still, the overall benefit was not large. “There was no difference between treatment groups in the change from the start of the study to end of the study in the number of satisfying sexual events. Vyleesi does not enhance sexual performance,” the FDA said.

And there was one other caveat: Vyleesi can hike blood pressure, so people with heart disease or high blood pressure should not take it, the FDA said.

Vyleesi should also not be taken by anyone who is also taking the drug naltrexone, used to combat opioid dependency, because Vyleesi reduces naltrexone’s effectiveness.

Vyleesi is not the first drug approved to enhance flagging libido in women. In 2015 the FDA approved Addyi (flibanserin) for the purpose, but the drug did not become widely used because it cannot be taken with alcohol and only certain certified health care providers are allowed to prescribe it.

According to CNN, Vyleesi’s maker, AMAG Pharmaceuticals, said the new drug will not be available until September, and pricing and reimbursement have yet to be determined.

One expert in female sexual health said it remains to be seen how widely Vyleesi will be used.

“Female sexual dysfunction is more complicated in some ways than male sexual dysfunction, so it’s more difficult to treat,” Dr. Nicole Cirino, co-director of the Menopause and Sexual Therapy Clinic at Oregon Health and Science University’s Center for Women’s Health, told CNN. She had no role in Vyleesi’s development.

Cirini suspects Vyleesi probably will not be the first option women with HSDD turn to, but it might prove a useful adjunct to standard psychotherapy and Addyi.

Vyleesi, like Addyi, probably won’t be overprescribed, Cirino added. When Addyi was introduced, there were concerns “that doctors would just be prescribing this medication to anybody that came in saying that they were having an issue with their libido,” she said. “And I think we have to give physicians more credit than that. In fact, that didn’t happen at all.”

Still, Vyleesi could help some women, Cirino said.

“There’s so many chemical factors that influence our libido,” she told CNN. “So you can’t discount using a chemical treatment as part of the broad approach to low libido.”

More information

There’s more on HSDD at the American Sexual Health Association.

© 2019 HealthDay. All rights reserved.

Posted: June 2019

Drugs.com – Daily MedNews

FDA Approves Second Drug to Help Women With Low Libido

FRIDAY, June 21, 2019 — The U.S. Food and Drug Administration on Friday gave its approval to Vyleesi, the second medication so far approved to help women with low sexual desire.

In a news release, the FDA said that Vyleesi (bremelanotide) is a drug that would be administered by injection prior to having sex.

It’s been specifically approved for premenopausal women with a condition known as acquired, generalized hypoactive sexual desire disorder (HSDD).

“There are women who, for no known reason, have reduced sexual desire that causes marked distress, and who can benefit from safe and effective pharmacologic treatment,” said Dr. Hylton Joffe, who directs the FDA’s Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products.

“Today’s approval provides women with another treatment option for this condition,” Hylton said in the news release.

According to the agency, HSDD is not caused by any medical or psychiatric condition, relationship issues or drug side effects.

Instead, women with HSDD have “previously experienced no problems with sexual desire,” the FDA said. “Generalized HSDD refers to HSDD that occurs regardless of the type of sexual activity, situation or partner.”

The exact way in which Vyleesi helps stimulate sexual desire remains unclear, but it works on melanocortin receptors on cells, the FDA said.

The drug is injected under the skin of the abdomen or thigh at least 45 minutes prior to a sexual encounter, although the best timeframe for dosing could vary from user to user.

Side effects can occur, the FDA added, and include nausea and vomiting, flushing, injection site reactions and headache. Nausea was especially common, affecting 40% of users in the clinical study that led to approval.

That study involved 1,247 premenopausal women with HSDD who received Vyleesi or a placebo in one of two 24-week trials.

“In these trials, about 25% of patients treated with Vyleesi had an increase of 1.2 or more in their sexual desire score (scored on a range of 1.2 to 6.0, with higher scores indicating greater sexual desire) compared to about 17% of those who took placebo,” the FDA noted.

Still, the overall benefit was not large. “There was no difference between treatment groups in the change from the start of the study to end of the study in the number of satisfying sexual events. Vyleesi does not enhance sexual performance,” the FDA said.

And there was one other caveat: Vyleesi can hike blood pressure, so people with heart disease or high blood pressure should not take it, the FDA said.

Vyleesi should also not be taken by anyone who is also taking the drug naltrexone, used to combat opioid dependency, because Vyleesi reduces naltrexone’s effectiveness.

Vyleesi is not the first drug approved to enhance flagging libido in women. In 2015 the FDA approved Addyi (flibanserin) for the purpose, but the drug did not become widely used because it cannot be taken with alcohol and only certain certified health care providers are allowed to prescribe it.

According to CNN, Vyleesi’s maker, AMAG Pharmaceuticals, said the new drug will not be available until September, and pricing and reimbursement have yet to be determined.

One expert in female sexual health said it remains to be seen how widely Vyleesi will be used.

“Female sexual dysfunction is more complicated in some ways than male sexual dysfunction, so it’s more difficult to treat,” Dr. Nicole Cirino, co-director of the Menopause and Sexual Therapy Clinic at Oregon Health and Science University’s Center for Women’s Health, told CNN. She had no role in Vyleesi’s development.

Cirini suspects Vyleesi probably will not be the first option women with HSDD turn to, but it might prove a useful adjunct to standard psychotherapy and Addyi.

Vyleesi, like Addyi, probably won’t be overprescribed, Cirino added. When Addyi was introduced, there were concerns “that doctors would just be prescribing this medication to anybody that came in saying that they were having an issue with their libido,” she said. “And I think we have to give physicians more credit than that. In fact, that didn’t happen at all.”

Still, Vyleesi could help some women, Cirino said.

“There’s so many chemical factors that influence our libido,” she told CNN. “So you can’t discount using a chemical treatment as part of the broad approach to low libido.”

More information

There’s more on HSDD at the American Sexual Health Association.

© 2019 HealthDay. All rights reserved.

Posted: June 2019

Drugs.com – Daily MedNews

‘The Secret Life of Pets 2’: A Paw-sitively Perfect Second Act

***This article originally appeared in the June/July ‘19 issue of Animation Magazine (No. 291)***

Five years ago, the team at Illumination Entertainment, led by producers Janet Healy and Chris Meledandri, and directors Chris Renaud and Yarrow Cheney hit animation gold with their exploration into The Secret Life of Pets. The movie received great reviews and went on to gross over $ 875 million worldwide, becoming the animation studio’s biggest blockbuster to date.

This summer, Meledandri, Healy, Renaud and new co-director Jonathan del Val (animation director for the first Pets and The Grinch) offer fans another peek into the lives of Max the terrier, Duke the mutt, Snowball the rabbit and all the other animals they come to meet in a colorful new sequel.

The Secret Life of Pets 2

The Secret Life of Pets 2

The new chapter of the animals’ adventures finds Max (now voiced by Patton Oswalt, replacing Louis C.K.) facing empty nest anxieties as his owner’s child gets ready for preschool. Meanwhile, Gidget (Jenny Slate) tries to rescue Max’s favorite toy, and Snowball (Kevin Hart) attempts to free a white tiger (Nick Kroll) from a circus.

“We started working on concepts for the sequel to Pets while we were finishing the first film,” recalls Renaud, an Illumination studio veteran, who directed the first two Despicable Me movies and The Lorax and exec produced the two Minion movies and The Grinch. Everyone involved loved the characters and felt there was more story to tell. Very early in the process we began focusing on pets and kids.”

Renaud says a sequel is always a bit daunting, because as a director you want to deliver what people liked about the first film but within a completely new and unexpected package. “This means new characters, sets and situations,” he adds. “As filmmakers, creating these new elements becomes the fun part of developing a sequel.”

The Secret Life of Pets 2

The Secret Life of Pets 2

One of The Secret Life of Pets 2’s cool visual elements is the introduction of a farm. Renaud says this new environment allowed the team to create a whole new world with new characters. “Additionally, animals on a farm have a very different perspective on life than our pampered city pets,” he notes. “We used this to create some great comedic and dramatic conflict.”

The sequel, which is penned by Brian Lynch (Minions), brings back Duke (Eric Stonestreet), Gidget (Jenny Slate) and Chloe (Lake Bell), and also welcomes new cast members Rooster the farm dog (Harrison Ford in his first animated role!) and Daisy the Shih Tzu (Tiffany Haddish).

The Secret Life of Pets 2

The Secret Life of Pets 2

Janet Healy (Despicable Me movies, Sing), who also produced the first movie, adds “All the characters in The Secret Life of Pets 2 are in some way familiar, they represent the personalities and behaviors we see in our beloved pets every day. Just like we humans, these pets have close friendships, deep loyalties, big problems to solve and heroic deeds to accomplish. The pets in our franchise are a familiar and dear part of our families, and now they are a wonderful part of our film experience.”

According to Renaud, the movie utilized over 200 people in both France (at Illumination Mac Guff in Paris) and the U.S. Besides the Illumination team in Santa Monica, the writer and storyboard artists were based in the U.S. Everyone else on the production, from layout up through animation and final rendering, was located in Paris.

The Secret Life of Pets 2

The Secret Life of Pets 2

Weaving It All Together

One of the most challenging aspects of the production was the moment when the creative team had to tie all three storylines back together. “Through the course of the film, Max, Gidget and Snowball are operating somewhat independently within their own narrative,” notes Renaud. “But, to make the movie work and create a satisfying ending, we had to figure out how to connect these disparate elements and provide a catalyst into the third act action.”

Renaud admits, “Sometimes you can get trapped into worrying about logic, but you usually find that you need less than you think. It’s the emotion and character stakes that carry the day.”

One of the director’s favorite sequences of the movie arrives in the end. “I don’t want to give anything away, but it truly turned out the way I had originally hoped,” he says. “The whole movie is really a metaphor for modern parenting, and I think this scene captured the genuine emotion of what parents go through as they recognize they can’t control or safeguard every aspect of their children’s lives.”

The Secret Life of Pets 2

The Secret Life of Pets 2

Renaud points out that the first Pets movie clearly struck a chord with audiences around the world purely because it was about pets. “We really tried to capture animals as they are, in both attitude and animated performance,” he explains. “I also feel that the question about what your pets do when you’re not home was so simple and compelling, people couldn’t resist watching a movie that attempted to answer that conundrum.”

When asked to compare the sequel to the original, Renaud says the second movie may have a stronger, more nuanced and layered story. “In the first film, we found that we had to tell a very simple story just to have the space to introduce our huge cast of pets,” he says. “In this one, we can forgo the introductions and get right into storytelling.

The Secret Life of Pets 2

The Secret Life of Pets 2

In Pursuit of Perfect Fur

In the five years since the first movie came out, CG animation technology has obviously improved. However, according to Renaud, no new tools were used to produce the animation. It’s just that the old tools kept improving. “For instance, we now review our animation hardware renders with fur on the characters. This is important because a character like Duke can have his whole facial expression wiped out by all of that shaggy fur!”

Since The Secret Life of Pets 2 comes out in the middle of a very jam-packed family movie season — sandwiched between UglyDolls, Pokémon: Detective Pikachu, Toy Story 4, The Lion King and The Angry Birds Movie 2 — we asked Renaud how he feels about the growing competition. “In reality, every movie made right now seems to be an ‘all audience four quadrant’ family film,” he replies. “This used to be where animated films were unique. However, those days have passed since most parents are happy bringing their young children to the latest superhero movie, science-fiction fantasy or animated reboot. In my view, we have to strive to retain our distinction through unique visual stylization and strong comedy that can only be achieved through broader character animation.”

Snowball vs. Monkey pic

As Healy sees it, the Pets franchise has lasting appeal and will hopefully continue to capture the hearts of moviegoers. “We think this franchise is unique and special because it connects us to our beloved pets in an intriguing and humorous way,” she says. “People in every part of the world adore their pets and wonder what really goes on in their pets’ minds. When they see The Secret Life of Pets films they get a magical, fun insight. The Secret Life of Pets is far more thrilling and busy than we ever could have imagined!”

Renaud says he also hopes moviegoers will relish reconnecting with these lovable, hilarious characters. “I hope the audience will leave the movie theater glad that they had another chance to spend some time with these characters,” says the director. “I know we had a great time working with these guys again, and I’m hoping that joy and fun comes across in this movie!”

Universal/Illumination’s The Secret Life of Pets 2 begins its U.S. theatrical run on June 10.

Everything’s Illumination

Chris Meledandri’s Illumination Entertainment empire is showing no signs of slowing down.

After unleashing The Secret Life of Pets 2 in theaters this month, the studio will release Minions 2 in July 2020 and Sing 2 in December 2020. Here’s a look at the studio’s amazing box office record to date:

Rank Title Domestic Gross Release Date
1. The Secret Life of Pets $ 368,384,330 7/8/16
2. Despicable Me 2 $ 368,061,265 7/3/13
3. Minions $ 336,045,770 7/10/15
4. Seuss’ The Grinch $ 270,620,950 11/9/18
5. Sing $ 270,395,425 12/21/16
6. Despicable Me 3 $ 264,624,300 6/30/17
7. Despicable Me $ 251,513,985 7/9/10
8. Seuss’ The Lorax $ 214,030,500 3/2/12
9. Hop $ 108,085,305 4/1/11

Source: boxofficemojo.com

Janet Healy

Janet Healy

Chris Renaud

Chris Renaud

Animation Magazine

FDA OKs a Second New MS Drug

By Robert Preidt

HealthDay Reporter

MONDAY, April 1, 2019 (HealthDay News) — The U.S. Food and Drug Administration has approved another new multiple sclerosis drug — the second in one week.

Mavenclad (cladribine) pills can be used to treat relapsing forms of MS in adults, including relapsing-remitting disease and active secondary progressive disease. The drug is not recommended for MS patients with a course of the disease known as clinically isolated syndrome.

Due to safety concerns, Mavenclad is generally recommended for patients who have not responded to or can’t tolerate other MS drugs, the FDA said. The drug is from EMD Serono, Inc.

“The approval of Mavenclad represents an additional option for patients who have tried another treatment without success,” Dr. Billy Dunn said in an agency news release. Dunn is director of neurology products in the FDA’s Center for Drug Evaluation and Research.

Last week, the FDA approved Mayzent (siponimod) pills, also for relapsing forms of MS.

Patients with relapsing MS have periods of worsening symptoms followed by recovery periods.

The Mavenclad trial involved more than 1,300 patients with relapsing forms of MS who had at least one relapse in the previous 12 months. Those who took Mavenclad had a significant decrease in the number of relapses and slower progression to disability, according to the FDA.

But Mavenclad has a Boxed Warning for an increased risk of cancer and fetal harm.

The drug should not be used in patients with current cancer. In patients who’ve had cancer or have an increased risk of cancer, doctors should weigh the benefits and risks of Mavenclad, the FDA said.

Because of the potential for fetal harm, Mavenclad should be avoided in pregnancy. And it should not be taken by women and men who do not plan to use effective contraception during treatment or for six months after treatment ends. If a woman becomes pregnant, she should stop taking Mavenclad, the FDA noted.

Other warnings include the risk of decreased white blood cell counts, increased risk of infections, and liver injury.

The most common side effects among patients taking the drug were upper respiratory tract infections, headache and a decrease in white blood cells.

MS is an autoimmune disorder targeting the central nervous system. It is one of the most common causes of neurological disability in young adults. It occurs more often in women than in men.

WebMD News from HealthDay

Sources

SOURCE: U.S. Food and Drug Administration, news release, March 29, 2019

Copyright © 2013-2018 HealthDay. All rights reserved.

‘); } else { // If we match both our test Topic Ids and Buisness Ref we want to place the ad in the middle of page 1 if($ .inArray(window.s_topic, moveAdTopicIds) > -1 && $ .inArray(window.s_business_reference, moveAdBuisRef) > -1){ // The logic below reads count all nodes in page 1. Exclude the footer,ol,ul and table elements. Use the varible // moveAdAfter to know which node to place the Ad container after. window.placeAd = function(pn) { var nodeTags = [‘p’, ‘h3′,’aside’, ‘ul’], nodes, target; nodes = $ (‘.article-page:nth-child(‘ + pn + ‘)’).find(nodeTags.join()).not(‘p:empty’).not(‘footer *’).not(‘ol *, ul *, table *’); //target = nodes.eq(Math.floor(nodes.length / 2)); target = nodes.eq(moveAdAfter); $ (”).insertAfter(target); } // Currently passing in 1 to move the Ad in to page 1 window.placeAd(1); } else { // This is the default location on the bottom of page 1 $ (‘.article-page:nth-child(1)’).append(”); } } })(); $ (function(){ // Create a new conatiner where we will make our lazy load Ad call if the reach the footer section of the article $ (‘.main-container-3’).prepend(”); });
WebMD Health

Cory Gardner Hopes Second Attempt at Marijuana Banking Will Be Last

On December 17, Senator Cory Gardner introduced an amendment to a federal prison reform bill that would protect a state’s right to legalize marijuana and determine how to regulate it within its borders.

Republican Gardner first helped introduce the legislation as its own bill, in a bipartisan effort with Democratic Senator Elizabeth Warren known as the States Act. Despite gaining considerable attention over the summer, including an expression of support from President Donald Trump, the bill gained only ten co-sponsors after its introduction in June.

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Similar to hemp’s anticipated legalization through the 2018 Farm Bill, Garner’s current proposal is an amendment to a much broader bill, the First Step Act, which is expected to pass whether his amendment does or not. If Garner’s measure is approved (and the entire bill passes), it would essentially protect tribal- and state-compliant marijuana programs, businesses and users from federal repercussion under the Controlled Substances Act.

According to Gardner’s staff, the amendment:

Marijuana Deals Near You

  • Amends the Controlled Substances Act so that — as long as states and tribes comply with a few basic protections — its provisions no longer apply to any person acting in compliance with state or tribal laws relating to marijuana activities.
  • Clearly states that compliant transactions are not trafficking and do not result in proceeds of an unlawful transaction.
  • Prohibits endangering human life while manufacturing marijuana.
  • Prohibits employment of persons under age 18 in drug operations.
  • Prohibits the distribution of marijuana at transportation safety facilities such as rest areas and truck stops.
  • Prohibits the distribution or sale of marijuana to persons under the age of 21 other than for medical purposes.

Gardner had been expected to introduce the amendment since last week, when Marijuana Moment first reported his intentions. The senator has been a proponent of reforming federal laws that severely hamper the legal marijuana industry’s access to banking, business loans, public shareholders and tax exemptions, since the plant is still federally illegal.

“Saturday marked the 227th anniversary of the ratification of the Tenth Amendment to the Constitution. … I can think of no better way to honor that milestone than to pass the bipartisan States Act, and I can think of no better legislation to attach the States Act to than the First Step Act,” Gardner says in a statement. “And it’s not just Colorado: 47 states now allow some form of legalized cannabis. … It’s time for Congress to act to protect states’ rights. I call on my colleagues on both sides of the aisle to take up and pass this important amendment today.”

Short for the Formerly Incarcerated Reenter Society Transformed Safely Transitioning Every Person Act, the First Step Act is a broad set of legislative reforms to the federal prison system; the Senate is expected to vote on the bill and its amendments on Tuesday, December 18.


Toke of the Town

Second Contaminant Found in Valsartan Drugs

Sept. 14, 2018 — One brand of recalled blood pressure and heart failure medicines has been found to include a second, potentially cancer-causing, impurity.

The FDA on Thursday announced that three lots of Torrent Pharmaceuticals’ valsartan drugs contain NDEA, which is known to cause cancer in animals and is thought to be a human carcinogen.

Those drugs were already part of August’s recall of valsartan products for possible contamination with NDMA, another impurity that may cause cancer.

According to the FDA, China-based Zhejiang Huahai Pharmaceuticals discovered the NDEA in several batches of its valsartan ingredients.

If you take a valsartan drug for high blood pressure or heart failure, the FDA recommends you continue to take it until you can speak with your doctor or pharmacist. Even if your medication is part of the recall, the agency says continue to take it and consult your doctor for possible alternatives.

© 2018 WebMD, LLC. All rights reserved.

WebMD Health

Join MPP at the Second Annual Cannabis Law Institute September 7 and 8 in Washington, D.C.

This year, the National Cannabis Bar Association’s Second Annual Cannabis Law Institute will take place on September 7 and 8 in Washington, D.C. at the George Washington University Law School.

Featuring some of the nation’s leading attorneys, academics, and politicians, this event will convene the best minds and visionaries working in the cannabis industry and reform movement for two days of panels and discussion. Programming is focused on education for attorneys, and you can receive 11+ CLE credits for select jurisdictions. Evenings will feature networking events.

We’re excited to announce that MPP’s Deputy Director Matt Schweich will be moderating the panel discussion on Federalism & States’ Rights, which will also include MPP’s Director of Federal Policies, Don Murphy.

You’re invited to attend by registering here. Use the code “friendsofncba” to receive $ 200 off the full ticket price, and if you are a member of NCBA, you get an additional $ 100 off.

With over 60 speakers and panelists from organizations like the Brookings Institution, the National Cannabis Industry Association, Americans for Safe Access, and leading cannabis law firm Vicente Sederberg, the conference will address the most challenging areas of law as they relate to the cannabis industry, including banking, tax, finance, intellectual property, labor and employment, corporate governance, and more. Congressmen Earl Blumenauer of Oregon and David Joyce of Ohio will also be in attendance as part of the keynote conversation on Friday morning.

If you live in the D.C. metro area, you don’t want to miss this important event. We hope to see you there!

The post Join MPP at the Second Annual Cannabis Law Institute September 7 and 8 in Washington, D.C. appeared first on MPP Blog.


MPP Blog

Iowa’s Second Cannabis Oil Maker Will Be in Cedar Rapids

CEDAR RAPIDS, Iowa (AP) — Iowa’s second medical cannabis oil manufacturer will be in Cedar Rapids. The Iowa Department of Public Health said Monday, July 2, 2018, that Iowa Relief LLC, a subsidiary of New York-based cannabis company Acreage Holdings, was awarded the state’s second license to manufacture cannabis oil in Cedar Rapids. Iowa Relief […]
Marijuana

Serious Lunch Serves Second Raft of Deals for Ghibli’s ‘Ronja’

Ronja, the Robber’s Daughter

Ronja, the Robber’s Daughter

London-based exec production and distribution company Serious Lunch Ltd. has secured a second raft of major territory deals for Studio Ghibli’s 26-part animated series Ronja, the Robber’s Daughter, based on the novel by Astrid Lindgren and directed by Goro Miyazaki (From Up on Poppy Hill). New orders have come from GKIDS (US), UYoung Media (China) and PTS (Taiwan); sales to RTBF (French Belgium), RTS (French Switzerland) and TF1 Max (France) instigate the production of a French-language version.

“We are pleased to expand the reach of this exquisite animated family program for our partners Studio Ghibli and the Astrid Lindgren Company and hope to close further French-speaking rights deals at MIFA in Annecy next month. We are also seeking deals in Italy for all platforms,” said Genevieve Dexter CEO of Serious Lunch.

Serious Lunch previously secured sales which brought the English-language version — starring Gillian Anderson — to the US and UK via Amazon Prime Video in 2017, VRT (Belgium), Jeem TV (Middle East), Canal Once (Mexico), Czech TV, and also home video releases by Universum (Germany), StudioCanal (UK), Madman (Australia), Yowu (Spain) and Asiana (Korea).

Ronja, the Robber’s Daughter tells the story of a 10-year-old girl born on a stormy night in a mountain fort, surrounded by her parents and a loving band of robbers. She grows to be a strong and active girl, and discovers that the forest is both a beautiful and frightening place inhabited by strange creatures. She befriends the son of her father’s rival and so begins the drama of her friendship and family loyalties. We watch as she discovers that seemingly irresolvable choices can finally be made with the help of love and understanding.

The series was produced by NHK, NHK Enterprises and Dwango in collaboration with Studio Ghibli and The Astrid Lindgren Company, with animation created by renowned animation studio Polygon Pictures. Ronja has earned critical acclaim and ratings success on both NHK BS and NHK Educational TV as well as SVT’s Barnkanalen in Sweden. The title also won the Kids Emmy for Best Animation at MIPTV 2016. A new Ronja global publishing and merchandising program is being launched in parallel.

Ronja, the Robber’s Daughter

Ronja, the Robber’s Daughter

Animation Magazine

‘Elena’ Continues Disney Junior Reign with Second Season

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Latin culture and folklore-inspired CG animated series Elena of Avalor has been greenlit for a second season, following its successful premiere on Disney Channel and Disney Junior last month. The season two announcement coincides with Princess Elena’s character debut at Walt Disney World in Orlando (she will make her first royal appearance at Disneyland in Anaheim tsi fall). The news was announced by Nancy Kanter, EVP and General Manager for Disney Junior Worldwide.

“It’s just a few weeks into the launch of Elena of Avalor and we are already seeing what an impact and connection she is making with kids and families,” said Kanter. “We’re eager to make sure that we will have many new stories of bravery, adventure and leadership for our audience to enjoy and are delighted to begin production on our second season and continue to find ways for her story to be heard both on and off screen.”

Elena’s simulcast premiere on July 22 ranks as 2016’s No. 1 series telecast among all kid-targeted TV networks in Total Viewers (4.5 million), Kids 2-11 (2.4 million) and Adults 18-49 (1.2 million). Elena of Avalor has reached over 24 million Total Viewers and delivered over 8.6 million viewer engagements on the Disney Channel and Disney Junior apps to-date.

In addition to the Princess’ debut at Disney’s U.S. parks, extensions for the series include print and e-book titles from Disney Publishing; dolls, role-play products, accessories, home decor and apparel from Disney Store and licensees including Hasbro, Jakks Pacific, Franco Manufacturing and Children’s Apparel Network; an EP soundtrack from Walt Disney Records; and a DVD coming later this year.

Created and executive produced by Craig Gerber, Elena of Avalor is a timeless fable incorporating influences from Latin and Hispanic cultures. Elena is a brave, adventurous teen who saves her kingdom from an evil sorceress and now must learn to rule as crown princess. More on the show and a behind the scenes look in our prior coverage.

Elena of Avalor

Elena of Avalor

Animation Magazine

Second ‘Sing’ Trailer Takes the Stage

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A new trailer for Illumination Entertainment’s holiday release Sing has arrived from Universal Pictures, putting its assorted animal stars in the spotlight. Written and directed by Garth Jennings (Son of Rambow, The Hitchhiker’s Guide to the Galaxy) and produced by Chris Meledandri and Janet Healy, the music-driven CG animated comedy arrives in theaters December 21.

Trailer No. 2 gives us a taste of the more than 85 hit songs the film crams in, plus a more intimate look at the dream-filled contestants of the show’s central competition — including an overworked and underappreciated mother of 25 piglets, who at the end of the spot takes a brief break from reality to boogie down in a grocery store in a wonderfully relatable moment. Same, mama pig. Same.

Set in a modern world inhabited solely by animals, Sing centers on a dapper koala named Buster Moon (voiced by Oscar winner Matthew McConaughey), whose once grand theater is on the verge of closing. He has one last shot to save his life’s work: producing the world’s greatest singing competition. Out of the many contestants, five leaders emerge: A crooning con-artist mouse (Seth MacFarlane), a teenage elephant with massive stage fright (Tori Kelly), a mother pig run ragged by her huge litter (Reese Witherspoon), a young gorilla who wants to leave the gangster life (Taron Egerton), and a punky porcupine trying to shake off her arrogant boyfriend (Scarlett Johansson). They all have one thing in common: the dream of changing their life’s course.

Sing

Sing

Animation Magazine

Second ‘BFG’ Trailer Glimpses More Giant World

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Having premiered at the Cannes Film Festival, Walt Disney Pictures has unveiled a second trailer for Steven Spielberg’s The BFG, adapted from the classic tale by Roald Dahl. Trailer number two gives us a better look at the much bigger and unfriendlier giants that populate the film’s world of magic. The CG-laced live-action feature arrives in theaters July 1, coinciding with the 100th anniversary of Dahl’s birth.

The film follows a 10-year-old London girl named Sophie, who one night is taken on an alarming journey to Giant Country by one of its denizens: a 24-foot tall, big-eared and dim-witted brute. But this creature is not like his countrymen, as Sophie discovers he is actually a Big Friendly Giant (voiced by Mark Rylance). But the girl’s arrival in this world has attracted the attention of the sinister giants Bloodbottler (Bill Hader) and Fleshlumpeater (Jermaine Clement), who are twice as tall and many times meaner than the BFG. The unlikely friends head back to London to see the Queen (Penelope Wilton) and warn her about the giants — if they can first convince her and her maid Mary (Rebecca Hall) that the beasts exist.

Directed by Spielberg from a screenplay by Melissa Mathison (E.T., The Black Stallion) based on Dahl’s 1982 novel, The BFG is also produced by Spielberg along with Frank Marshall and Sam Mercer, with Kathleen Kennedy, John Madden, Kristie Macosko Krieger, Michael Siegel, Frank Smith and Naia Cucukov as executive producers.

The BFG

The BFG

Animation Magazine