Noven’s niche: The Miami company is key producer of transdermal patches

At the Noven Pharmaceuticals plant in southwest Miami, scientists and technicians use highly specialized machinery to blend prescription medications and adhesives to make layered transdermal patches that release precise quantities of drugs over time after being applied to a patient’s skin.

Noven, a subsidiary of Japan’s Hisamitsu Pharmaceutical, has about 700 employees nationwide and ranks as a relatively small player among pharma giants. Nonetheless, the company, a leading research and development center for medicinal patches, produces a line of specialty pharmaceuticals and is the U.S. market leader in sales of estrogen patches for women.

“By industry standards, Noven is a small company,” said Jeffrey F. Eisenberg, Noven’s Miami-based president and CEO. “But we have a line of specialized products that competes successfully in the U.S. and overseas. We are experts in developing transdermal patches and produce other pharmaceutical products.”

In one key market — estrogen patches for women — Noven holds about a 68 percent share, he added. And the company has a robust research and development department in Miami at work on a variety of new drugs.

Medications may be delivered to patients orally, via injection or through transdermal patches, which can administer drugs slowly over an extended period of time. While Noven makes products other than medicinal patches, it devotes an important share of resources to transdermal patch technology.

“We have a talented group of scientists who are at the forefront of this specialty,” Eisenberg said. “We have M.D.s, PhDs in biology and chemistry and chemical engineers who specialize in pressure-sensitive adhesives and polymer chemistry.”

Noven has won more than 30 U.S. and 100 international patents and is developing several new drugs. The company recently announced it is making progress on studies to evaluate a new, amphetamine-based transdermal patch for treating Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents. Currently, there is no such patch approved for use with ADHD, the company said.

Noven also has applied to the U.S. Food & Drug Administration for approval of a new oral, non-hormonal medication to treat menopausal hot flashes.

Making patches is a complex process that requires the design and development of an ideal combination of drug, adhesive and backing, Eisenberg said. Patches must be formulated so that they will deliver a safe and effective dose of medication over a period of time and adhere to the skin as required.

At the Noven patch facility, which has the capacity for making 500 million patches per year, active drug compounds are mixed with custom adhesives in large, specialized kettles. The mix of drug and adhesive is then applied to sheets of release liner material under very precise tolerances. Noven removes a blending solvent from the compound and applies the backing material, making a three-layer patch. Laminate rolls subsequently are sent to punching, pouching and packing machines (Patches are punched into different sizes.). All of this occurs under strict quality control procedures and is not open to the public.

Noven was founded in 1987 by Steven Sablotsky, a chemical engineer, who had worked for another pharmaceutical firm and was an expert in transdermal patches. Noven went public in 1988 and operated as a publicly-traded company until it was taken over in 2009 by Hisamitsu, a Japanese pharmaceutical company that also manufactures and markets transdermal patches. (Salonpas, an over-the-counter analgesic patch widely advertised in South Florida, is made by Hisamitsu.)

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Two more Cuban dissidents allege abuse by former prison official now living in Miami

Two more Cuban dissidents have alleged that they were abused personally or on the orders of a former Villa Clara provincial prison chief Crescencio Marino Rivero, who now lives in Miami.

Rivero, 71, and his wife Juana Ferrer, both former officers in Cuba’s Interior Ministry and members of the ruling Communist Party, appear to have obtained their U.S. visas and residency without revealing their activities on behalf of the Cuban government.

Wilfredo Allen, one of the two Miami lawyers who referred the allegations against Rivero to U.S. prosecutors two weeks ago, has asked for the start of deportation procedures against the couple. Rivero has denied committing any abuses.

Arturo Conde Zamora said he was 12 or 13 years old and was being held in a reformatory when Rivero hit him with a stick two or three times on his back and legs. Rivero was in charge of the lockup in the Villa Clara village of Maleza.

“He beat me with a stick and then threw me into a cell,” Conde, now 47, told El Nuevo Herald by telephone from his home in the Villa Clara town of Placetas. “He tied me up with a rope and left me in a tapiada” – a cell with a solid steel door instead of bars.

Rivero has been identified as provincial head of youth reformatories and reeducation programs in the 1980s before he was promoted to head Villa Clara’s overall prison system.

Conde said he was sent to a reformatory for chronic school skipping, and was beaten by Rivero and two or three reformatory “re-educators” in 1981 or 1982 because he had fought with one of the other 100 or so youths in the Maleza lockup.

A decade later, Conde added, he was serving a new prison term in the maximum security Alambrada de Manacas prison in Villa Clara when Rivero turned up there following a clash between prisoners and guards.

“Not even 30 minutes later, they brought in dogs to attack the prisoners.” Conde was bitten on the thigh, he said.

Another Placetas dissident, Jorge Luis García Pérez, known as Antunez, said he never saw Rivero personally abuse prisoners. “Officers of that rank don’t have to,” he said, because they can order guards to abuse the inmates.

Antunez alleged that on Feb. 19, 1991, while serving a 5 ½-year sentence for “enemy propaganda” at the La Pendiente prison in Villa Clara, he was taken to see Rivero for his refusal to wear prison uniforms — a type of protest used by many political prisoners.

“Look, you black counterrevolutionary, we’re not going to allow that here,” Antunez, who is black, quoted Rivero as telling him.

Rivero told the guards “take him to the cell and if he takes off his clothes, bust his head,” the dissident added in a phone interview with El Nuevo Herald. Antunez said he did try to take off his clothes and got such a beating that he remembers the exact date.

Antunez and Conde’s allegations, and similar previous accusations against Rivero by three other dissidents, could not be independently confirmed. Rivero did not return an El Nuevo Herald call to his phone last week, and his daughter said he would not speak to the newspaper because his previous comments to other journalists were “distorted.”

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Top 5 Apps Your Kids Will Love This Week

Chris Crowell is a veteran kindergarten teacher and contributing editor to Children’s Technology Review, a web-based archive of articles and reviews on apps, technology toys and video games. Download a free issue of CTR here.

[More from Mashable: 4 Tips for Finding a Job in Your Niche]

Spot the Dot

$ 3.99 Ages 3-up Overall rating: 4.8 out of 5 stars Why we like it: Spot the Dot turns a children’s book into a lively, engaging experience. Based on the book by David Carter, Spot the Dot is a “needle in the haystack” or “I Spy” type of app, where the same item — a small colored dot, is hidden in nine screens. Need to know: On some pages the dot is hidden in a moving illustration, and the dot moves around, extending the utility of this app, despite the limited number of pages. This is a great app for a group of children to play together. Ease of use: 9/10 Educational: 10/10 Entertaining: 9/10

Click here to view this gallery.

[More from Mashable: Scientists Use Their Braaaaains to Find Perfect Product Tester [SUNDAY COMICS]]

If you’re getting in the mood for the holiday season, A Charlie Brown Christmas is one app that both kids and nostalgic parents are sure to enjoy. And while you’re sharing, why not stretch your brain and see if you remember those isosceles triangles and quadrilaterals as well as your kids do. Those are just some of the apps in store for you this week!

The folks at Children’s Technology Review shared with us these five top apps from their comprehensive monthly database of kid-tested reviews. The site covers everything from math and counting to reading and phonics.

Check back next week for more Top Kids Apps from Children’s Technology Review.

This story originally published on Mashable here.

Tech News Headlines – Yahoo! News

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BBC says its news chief, her deputy have 'stepped aside'

LONDON — The BBC says its news chief and her deputy have 'stepped aside' while the broadcaster deals with the fallout from a child abuse scandal that forced its director-general to resign.

Helen Boaden, the BBC's director of news and current affairs, and her deputy, Steve Mitchell, have handed over their responsibilities to others for the time being, BBC media correspondent Torin Douglas said Monday.

There was no formal announcement from the corporation.

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Self-publishing industry explodes, brings rewards, challenges

The publishing world is being upended, and reinvented, by people like Hugh Howey, Ily Goyanes and Kristy Montee.

They are part of a movement using the power of e-books and the Internet to lead publishing into a new frontier, and through the biggest upheaval of the industry since Guttenberg’s press.

“It’s the Wild West,” Montee said. “It is literally changing at the speed of light.”

Howey is a writer who authored, designed, formatted and self-published all but the very first of his 14 novelettes and stories as e-books — and saw his Wool series of sci-fi stories make the Top 100 Kindle Best Sellers of 2012, above J.K. Rowling’s The Casual Vacancy and the four-book bundle of George R. R. Martin’s A Game of Thrones.

Goyanes is one of a new breed of independent publishers filling the void between self-publishing and traditional publishing giants, offering technical, marketing and distribution help for do-it-yourself authors.

Montee is a Fort Lauderdale-based writer better known to her readers — along with her sister and writing partner, Kelly Nichols — as P.J. Parrish, the pseudonymous author of the Louis Kincaid and Joe Frye thriller series. She’s among the new “hybrid authors,” with a foot in both traditional and the self-published worlds.

“For a long, long, long time in our business anything that you published yourself just had a stench of amateurism about it,” she said. “That was just for desperate people who couldn’t make their way through the labyrinth of the New York system, so they resorted to paying pretty much scam artists to publish their books for them at great expense. And then, Amazon came out with the Kindle, which pretty much changed everything.”

With the stigma fading, and Amazon’s help, self-publishing has exploded. On its website, Publishers Weekly last month cited a new analysis of data from Bowker, which shows the number of self-published books produced annually in the U.S. has nearly tripled, growing 287 percent since 2006, with 235,625 print and e-titles released in 2011.

As a “mid-list author” with 13 moderately successful books to her name, Montee felt the pressure when her publisher began trimming its author list to reduce costs.

“So a lot of us, and this includes a lot of my friends,” began looking for ways to survive independently, Montee said. “Amazon made it extremely easy and very attractive to go self-publish through their model.”

She and her sister regained rights to two of their early books to re-publish and have a novella in the works they plan to self-publish.

The advantages, and the profits, can be huge. The downside, of course, would make a Vegas gambler sweat.

“The largest, by far, percentage of authors are making less than $500 a year self-publishing, because there’s a glut,” said M.J. Rose, a best-selling novelist and founder of the writer’s marketing company AuthorBuzz.com. “There’s over 350,000 books being self-published every year and readers are not finding them. There’s just no way to expose people to all of these books.”

Howey, however, who spends mornings writing at his home in Jupiter, might be the perfect example of what “making it” looks like in this thoroughly modern twist on every writer’s dream. He began writing while working at a bookstore, and he received a modest advance when a small press picked up his first novel.

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Course to explore Jewish communities in Asia, Africa

Florida International University research professors Nathan Katz and Tudor Parfitt, considered to be the world’s leading authorities on Eastern Jewish communities, will explore the Jewish experience in Asia and Africa in a new, 13-week course to be offered at the Jewish Museum of Florida-FIU, 301 Washington Ave. in Miami Beach.

The course will look at the Jewish experience far beyond Florida, which has been the traditional focus of the museum. Among the Jewish populations of Africa to be explored include the Lemba of Zimbabwe, the Beta Israel of Ethiopia, and the Ibo of Nigeria. The Asian communities include the Jews of Kochi; Mumbai and northeastern tribal peoples of India; Shanghai, China, a home in the 19th century to Sephardic Jews seeking business opportunities and refuge in the 1930s-40s to European Jews fleeing Nazi persecution; and a "Judaizing " movement in Papua New Guinea.

Classes start in January and are open to both degree-seeking FIU students and community members interested in taking it on an auditing

basis. The class will be the first FIU offering at the Miami Beach museum, which recently joined the FIU family.

The classes will feature guest speakers, including a visiting member of Zimbabwe’s Lemba Jewish community.

Before joining FIU earlier this year, Parfitt was director of the Jewish Studies Center at the School of Oriental and African Studies at the University of London, where he was dubbed "Britain’s Indiana Jones" for his pursuit of the Ark of the Covenant and his discoveries of remote Jewish communities.

Katz is Bhagwan Mahavir Professor of Jain Studies and is director of FIU’s Program in the Study of Spirituality. He spent many years living in South Asoa and is a recipient of four Fulbright research and teaching awards. He was instrumental in bringing the Dalai Lama to Miami three times and has played an influential role in the interreligious dialogues between Jews and Hindus, Buddhists and Jains.

Degree-seeking FIU students may register for the class though Nov. 18. Community members who want to audit the class should contact the Center for the Advancement of Jewish Education at 305-576-4030, ext. 128 or by emailing carlaspector@caje-miami.org. The cost for the 13-week course is $295.

Books club at the garden

The Green Book Club will begin its monthly meetings on Nov. 13, at the Miami Beach Botanical Garden, 2000 Convention Center Dr. in Miami Beach.

My sources tell me the meetings, which are from noon to 2 p.m., are a great place to meet new people and become a better reader/writer by experiencing books in a whole new way.

The group reads and discusses environmentally-themed books chosen and read during the month preceding each meeting, which is on the second Tuesday of every month. This month’s pick is "Vita’s Other World: A Gardening Biography of V. Sackville-West," by Jane Brown (Viking, 1985).

Also, floral design classes, taught by accredited floral designers, will begin at the garden on Nov. 27. The designers will combine lectures, demos, and critiqued hands-on workshops to develop an understanding of the art of flower arranging. The class runs from 9:30 a.m. to 2 p.m. and is the first part of a six-part floral design study hosted by the Miami Beach Garden Club.

The cost is $26 per class, or $150 for all six. A certificate from the Florida Federation of Garden Clubs will be awarded those who complete the six courses. Lunch is included in the cost. To register, email Nina Worth at ninanevanu@gmial.com or call 305-532-9987.

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Mail.Ru cuts stakes in Groupon, Facebook, Zygna

MOSCOW (Reuters) – Russian email-to-social networking group Mail.Ru cut its stakes in U.S. internet firms Groupon, Facebook, and Zygna, according to the company’s website.

Mail.Ru now has a 0.52 percent stake in the world’s largest social networking site Facebook, 0.16 percent of U.S. game maker Zynga and 0.84 percent of daily deal website Groupon.

As of October 30, it had a 1.17 percent stake in Zynga, a 0.75 percent stake in Facebook and 4.12 percent of shares in Groupon.

It could raise between $ 200 million and $ 250 million from the sales, said Anastasia Obukhova, an analyst at VTB Capital in Moscow. Mail.Ru declined to comment on the disposals.

“We’ve always been very clear that Groupon, Zynga and Facebook, positioned inside of Mail, are financial assets, not strategic ones,” said Matthew Hammond, the investor relations director at Mail.Ru Group.

At the end of October, Mail.Ru, part-owned by metals tycoon Alisher Usmanov, sold 16 million Facebook shares, worth around $ 370 million, on top of a more than $ 700 million sale as part of Facebook’s initial public offering. That was followed by a hefty dividend payout to Mail.Ru’s shareholders.

(Reporting by Maria Kiselyova and Anastasia Teterevleva; Editing by Elaine Hardcastle)

Social Media News Headlines – Yahoo! News

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Buzzmakers: Brooke's Cancer Fight & World War Z

What had ET readers buzzing this week?

1. It's Brad vs. Zombies in World War Z

Zombie attack!!! Brad Pitt plays a family man and United Nations employee who faces a deadly zombie pandemic in World War Z -- we gave you an exclusive first look and now we've got the intense trailer!

Just when you thought that the zombie genre may be starting to generate less screams and more Zzzz's, World War Z arrives with an adrenaline shot in the arm for the genre -- complete with insane special effects and a claustrophobic urgency and realism not seen since the introduction of those "speed zombies" in 28 Days Later.

Directed by Marc Forster (Quantum of Solace), World War Z invades theaters June 21, 2013.

2. Oprah Reveals Her 2012 'Favorite Things'

It's officially the holiday season!

Oprah just revealed her "Favorite Things" for 2012, which includes such items as a $1,800 Jetson E-Bike, a $192 hand-picked Tom Ford lipstick palette and a $238 Lafco soap set.

"This luxuriously oversize, deliciously scented soap is my new go-to gift. I even brought a set to Mr. and Mrs. Colbert when I interviewed Stephen for Next Chapter," she says about the pricey soap set.

But of course if you don't have the income of Oprah, you can pick up O's December issue to learn how you can win all 49 of Oprah's favorite things, which hits newsstands November 6.

"Oprah's Favorite Things" is also getting its own two-hour, prime time special airing Nov. 18 on OWN. The special will surprise unsuspecting military spouses with items from the media mogul's exclusive must-have gift selections for the holiday season, and for the first time, viewers of Oprah's Favorite Things: 2012 will have the opportunity to watch and win select items featured in each segment of the show.

3. Brooke Burke-Charvet Reveals Cancer Diagnosis

Brooke Burke-Charvet released a video online Thursday to announce that she was recently diagnosed with a cancerous growth on her thyroid gland. In the video posted on her Modern Mom blog, the 41-year-old actress and TV host explained that a nodule was discovered on her thyroid and after a series of tests over the last few months, it was eventually determined to be cancerous and her thyroid will have to be removed.

"Which means that I'm going to have a nice big scar right her across my neck," Brooke said. "And I don't get to just walk around and pretend like nothing happened or not follow up or not share it, because it's going to be pretty much dead center."

Brooke said the discovery -- which originated from a regular physical -- came as a complete shock because she's otherwise healthy. "As crazy as it is, my head is in the right place, and it's going to be good," she said, adding that the doctors consider this a form of "good cancer" compared to many others and the prognosis is good. "I'm just going to make a positive out of this negative thing."

She said the surgery has been scheduled and she promised to keep her fans updated through her blog. "Now I'm ready to deal with it and I'm going to be fine. And I feel really, really strong."

Speaking on Thursday's episode of The Talk, Brooke's co-host on Dancing with the Stars, Tom Bergeron, commented on her cancer diagnosis. "My love and support are with you -- we are all there with her," he said. Bergeron added that he personally has a very positive outlook. "I've known about this for a few months. I have had experience with this in my family. You never want to hear the word cancer. But thyroid cancer is one of the most treatable cancers. It has an incredibly high success rate."

4. Kirstie on Secret Relationship with Swayze

Kirstie Alley reveals to ET's Chris Jacobs intimate details about what she says was a powerful attraction and hidden relationship with her North and South co-star, Patrick Swayze. Although both stars were married during filming of the mini-series, Alley tells Jacobs when she first saw Swayze, they had an intense attraction and she tried to avoid "going down that road," but they ultimately fell in love.

"Both of us were married. We did not have an affair. But again, I think what I did was worse. Because I think when you fall in love with someone when you're married, you jeopardize your own marriage and their marriage. It's doubly bad," said Alley.

Alley goes on to say that although she's friends with Patrick's wife, Lisa Niemi, who asked Alley to speak at Swayze's funeral, she is uncertain if Lisa is aware of their relationship.

5. One Direction & Drew Brees Play Catch - Exclusive

One Direction and Drew Brees teamed up last month to film an adorable Pepsi spot and during Thursday night's episode of The X Factor, the band will not only perform their newest singles, Live While We're Young and Little Things, but also reveal an alternate ending to the ad!

For those who missed the spot, the original ended with Drew Brees sacrificing his last can of Pepsi in order to become an unofficial member of One Direction. But, according to Angelique Krembs, VP Marketing for Pepsi, they also wanted to show fans what would happen if Drew won the last can of Pepsi. "Our latest Live For Now spot has received an enormous amount of buzz and online excitement," Krembs said. "And of course everyone wants to see the boys from 1D suit up in football gear and have some fun."

While you have to wait until Thursday to see the entire surprise ending to Pepsi's Live For Now television commercial, ETonline scored an exclusive sneak peek of One Direction tossing the pigskin around with Brees!

Tune in to The X Factor on November 8 at 8 p.m. to see the alternate ending!

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Home leveled, other houses ablaze in Indianapolis explosion

INDIANAPOLIS — Authorities say a loud explosion has leveled a home in Indianapolis and set four others ablaze in a neighborhood, causing several injuries.

Capt. Rita Burris with the Indiana Fire Department told The Associated Press that firefighters are still working to put out the flames after the explosion around 11 p.m. Saturday.

She told AP early Sunday there were multiple injuries but details remain sketchy and there are no fatalities reported at this point. She says the fire occurred in a south Indianapolis residential area and there's no immediate report on the cause. But she says authorities would be checking if gas was involved in the explosion heard for miles around.

Burris says firefighters will search the area once the fires are under control.

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Gov. Rick Scott may shift stance on health reform law

With the reelection of President Barack Obama, Florida’s Republican leaders are reconsidering their fervent opposition to federal healthcare reform, triggering a discussion that could have huge repercussions for South Florida.

At stake is more than $6 billion in federal funding for Miami-Dade and Broward over the next decade and the possibility of health insurance for a large percentage of the 1.4 million people in the two counties who now lack coverage.

After the defeat of Mitt Romney, who vowed to halt Obama’s healthcare overhaul, the Republican leaders of the Florida House and Senate quickly said the Legislature needed to reexamine the federal act. On Friday evening, Gov. Rick Scott said he agreed there needed to be a discussion.

“Just saying ‘no’ is not an answer,” Scott said in a statement that repeated exactly what Sen. Don Gaetz, R-Destin, the incoming Senate president, told The Miami Herald on Thursday.

“I don’t like this law,” Gaetz also said, “but this is the law, and I believe I have a constitutional obligation to carry it out.” He added that he thinks “there needs to be some adult debate between Republicans and Democrats” on finding ways to make the law work.

Still, Gaetz, Scott and others in the Republican leadership, which controls both the Florida House and Senate, have many criticisms of what both parties now call “Obamacare.” Some are searching for compromises on how it is carried out in the state. What this means for patients and the healthcare industry in Florida — particularly South Florida — remains an enormous question mark.

Time is running short for decisions as the once-distant consequences of the Affordable Care Act are scheduled to kick in during the next 14 months.

The first deadline is Friday. That’s when states must tell Washington whether they plan to set up exchanges — marketplaces where individuals can purchase insurance at discounted group rates and cannot be denied because of pre-existing conditions.

Florida’s political leaders acknowledge they won’t make the deadline. The exchanges are scheduled to start Jan. 1, 2014, and if a state doesn’t set up an exchange, its residents can participate in a federal exchange.

The next provision starts Jan. 1 with an increase in Medicaid fees for primary care physicians. Primary care physicians, who have long complained about low rates for Medicaid, which provides coverage for the poor, are scheduled to be paid at considerably higher Medicare rates — with the feds picking up all of the added cost. But such a pay hike can only happen with the approval of the governor and Legislature, and it’s unclear whether that will happen.

The following year, on Jan. 1, 2014, the biggest changes are slated to start, including a major expansion of people covered by Medicaid. An analysis from the Safety Net Hospital Alliance of Florida shows that if the state doesn’t expand coverage, Florida will lose $27.9 billion in federal funds over 10 years.

That breaks down to a $4.5 billion loss for Miami-Dade during that time, and a $2.3 billion loss for Broward, according to the alliance’s analysis.

Under the law, Washington will pay all Medicaid expansion costs for the first three years, but then the states would have to pay up to 10 percent of the costs in following years — an expense that the Safety Net Alliance calculates will come to $1.7 billion over 10 years in Florida. The expansion could provide coverage to an additional million-plus Floridians. Reform supporters say the expansion would provide cheaper basic care that would help prevent serious illnesses that lead to expensive hospital stays.

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