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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State courts struggle with Supreme Court ruling on young killers

Five months ago, the U.S. Supreme Court banned mandatory sentences of life in prison without the possibility of parole for juveniles convicted of murder.

But since the Miller v. Alabama decision, Florida courts have struggled to apply the ruling — and two Miami-Dade cases may help settle key lingering legal questions.

Does the ruling apply to past cases? A Miami appeals court, ruling on a South Miami-Dade killer convicted in 2000, doesn’t think so. That decision, which affects at least 180 cases statewide, is likely bound for higher courts.

When a judge last month gave convicted killer Benito Santiago 60 years in prison — making him the first South Florida juvenile sentenced after Miller — prosecutors immediately vowed to appeal, saying the sentence was illegal.

The nation’s high court in Miller, and a companion case, struck down laws in 28 states that handed out mandatory life sentences without the possibility of parole for minors convicted of murders. The ruling, while hailed by civil rights activists, doesn’t mean Florida judges can’t still impose a life sentence for murder. But they now must at least consider a defendant’s age.

The opinion follows the high court’s 2010 decision in a Jacksonville case that ruled that sentencing minors to life without the possibility of parole in non-homicide cases constituted “cruel and unusual punishment.” The reasoning: science has shown that youth’s brains are not fully developed, and they are susceptible to impulses and the influences of others.

The Supreme Court never explicitly said Miller should apply to past convictions for juveniles.

Florida has at least 180 defendants who could be eligible for new sentences under the Miller case, according to Barry University’s Juvenile Life Without Parole Defense Resource Center. At least 50 in Miami-Dade may be eligible, according to the Miami-Dade Public Defender’s Office. So far, none have been resentenced.

Within days of the Miller decision, defendants across the state began asking courts to get new sentencing hearings. Some prosecutors assumed the decision would be retroactive.

In Tallahassee, the Attorney General’s Office even agreed that “relief is appropriate” in the 2008 case of then 17-year-old Jose Gonzalez, who stabbed a man to death during a robbery, according to court documents.

In the case of Drewery Geter, he was 16 when he raped and slit the throat of nurse Helen Barker in front of her young son in 2000.

After the Miller decision, convicted killer Drewery Geter asked Miami-Dade’s Third District Court of Appeals to toss his murder sentence for raping and slitting the throat of nurse Helen Barker in front of her young son when Geter was 16 years old.

But the court in September ruled Geter couldn’t get a new sentence because judges considering youth during sentencing was merely “evolutionary” and a “procedural change.”

The court also ruled that applying Miller retroactively “would undoubtedly open the floodgates” of long-ago convicted killers seeking new sentences.

The effect: new judges and prosecutors would be unfamiliar with old cases, trial transcripts might have vanished and relatives of the dead would be forced to live through a new set of court hearings, the panel ruled.

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Ads are Invading Gadgets and Apps that You Already Paid For

Most of us are used to seeing ads on stuff that we get for free, like smartphone and tablet apps or online news websites. But you’re probably also used to being able to pay to remove ads, whether by getting the premium version of an app or even upgrading to a new computer that doesn’t have so much garbage on it.

As it turns out, this strategy doesn’t work so well anymore. That’s because companies are starting to put “special offers” all over things that you buy … and this time, it’s not just the usual preinstalled trashware. Here’s a look at some of the latest strikes in the war for your attention.

​Microsoft: Xbox Music and Xbox Live

Last year’s redesign of the Xbox 360 dashboard featured prominent ads, including videos that played automatically, even if you were paying for a $ 60/year Xbox Live Gold membership. This year, Microsoft introduced its new Xbox Music Pass, which allows you to stream millions of songs to your Xbox 360 or Windows 8 PC. It has an ad-supported free trial mode, which lets you listen to songs (and ads) for free for the first six months before imposing a monthly listening limit.

But according to Neowin.net editor Owen Williams, the ads stay even if you pay $ 99 per year for the subscription service. On top of that, you can’t use Xbox Music on the actual Xbox at all (beyond a 30-day trial) unless you ​also​ pay for an Xbox Live Gold Subscription. That’s almost $ 160 per year for two separate subscriptions, and in return you apparently get twice the ads.

​Microsoft: Windows 8

If the ads in the Xbox Music service aren’t enough, Microsoft has also put ads all over its Windows 8 operating system. Whether you buy a new Surface tablet or you pay for the upgrade from Windows 7 such as through buying a separate boxed copy, you still have to contend with ads in “many of the bundled [Modern] UI applications,” according to Williams.

​Amazon: The entire Kindle lineup

Amazon began selling Kindle e-readers with “special offers” a while back. These appeared on the lock screen, and replaced the normal screen saver, which was more literary.

When Amazon announced its new lineup of Kindle Fire HD tablets not too long ago, it turned out that every single one of them had advertisements. Not just on the lock screen, but now even in a corner on the home screen while you’re browsing through your books and apps.

At the time, Amazon wasn’t offering any way to get rid of these ads on the new Kindle Fire HD, but the company now gives people the option to buy Kindles sans ads for an extra $ 15. That won’t help you with in-app ads, though, if you use free apps.

Jared Spurbeck is an open-source software enthusiast, who uses an Android phone and an Ubuntu laptop PC. He has been writing about technology and electronics since 2008.

Linux/Open Source News Headlines – Yahoo! News

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STREAMING: Soundgarden Live on Letterman

Soundgarden is the latest band to headline the Live on Letterman concert series, streaming now!

RELATED: New Music Tuesday!

The Grammy Award-winning rockers are performing at the Ed Sullivan Theater in New York City preceding the release of King Animal, their first album in 16 years. Former acts to appear on the live concert series include Adele, Coldplay, Taylor Swift, Katy Perry, Carrie Underwood and more.

Late Show with David Letterman airs weeknights at 11:35/10:35c on CBS. King Animal drops tomorrow, November 13.

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Good gas news in Jersey

“The power restoration and fuel-delivery efforts of the past two weeks have allowed lines to subside, lessening the need for this type of rationing system. Now is an appropriate time to end it.” — Kevin Roberts, spokesman forGov. Chris Christie, announcing that post-Sandy
gas rationing would end in New Jersey at 6 a.m. today

Have an opinion on this Post editorial? Send it in to LETTERS@NYPOST.COM!

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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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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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Holiday trimming

Here’s a word to the wise: When you go home for the holidays next week, get there a couple of days early and bring along one of these magazines. They can only help.

Bon Appétit’s November issue deserves kudos for being stuffed with 42 pages of Thanksgiving tips, from how to prepare a succulent bird to how to drum up a savory plate of fresh side dishes. Those looking for the tried-and-true and perhaps a few novel gobble-worthy entrees won’t be disappointed. However, it does come up short in one feature, which all-too briefly discusses carving knives, giving just the prices rather than discussing the utility of various carvers. Elsewhere, the glossy does its best to justify shelling out $63 for a gravy ladle or, worse, $70 for a salad-tossing set.

Gourmet’s special holiday print issue serves it up right. There are no boring articles in the now all-digital mag about life on the farm, no interviews with self-promoting chefs. There is nothing but page after page of holiday deliciousness offered up through pictures and recipes. It’s pure, unadulterated food porn, and we thank the editors for that. We also thank them for not shoving a giant turkey dinner down our throats, as most foodie mags are wont to do this time of year. Instead, we get interesting takes on potato latkes, Brussels sprouts and even deviled eggs, which are marinated in pickle juice to give them a pretty, purple hue. There are also plenty of cocktail recipes — a must for this time of year. A big concern is whether the recipes will hold up to the test at home. We noticed, for example, that the apple pie recipe didn’t specify what type of apples to use, and as any pie maker knows, not just any apple will work. It’s a pretty major oversight — one that could leave Gourmet readers serving apple sauce with a crust for Christmas.

Saveur exists to remind us that food is all about culture, and there is no better time than Thanksgiving to make that point. How better to point out the multicultural fabric of America than the story of the Mexican immigrants who spice the turkey with a chile rub? There are plenty of traditional Turkey day recipes here, too. Better yet, Saveur also lets you dream of roaming the streets of Paris to find mouthwatering Moroccan tagines. That’s something worth leaving home for.

Even if you’re no bon vivant, Food + Wine will lure you to gluttony (or at least the thought of it) with its sumptuous shots of pneumatic beer-brined turkeys. We love its deconstructed food features, which give a new spin on old Thanksgiving ingredients: butternut squash tart, cranberry custard tart or pumpkin pie bread pudding anyone? Our only regret is that we’re not at the Napa Valley ranch home of “farmer to the stars” Lee Hudson this holiday.

Kid Rock has said many shocking things over the years, but he may have topped them all in telling The New Yorker why he endorsed Mitt Romney for president. “Romney strikes me as super f--kin’ honest,” Rock said — an assertion that many of his staunch backers wouldn’t exactly insist upon. Meanwhile, editor David Remnick prods Obama to tackle global warming once and for all, noting that even the Pentagon acknowledges it. But he fails to mention that even worrywart scientists are unsure whether it can be reversed.

New York’s John Heilemann gives Kid Rock’s potty mouth a run for its money as he writes that Obama’s second-term goal is “getting s--t done — and not just any s--t, but big s--t, the kind of s--t that scholars will scrutinize with care and ideally marvel at.” We’ll leave it to the reader to decide whether that’s silly, shocking or merely scatological. Elsewhere, a piece on the post-Sandy mess notes Mayor Bloomberg suffers from an “empathy deficit” as he faces a costly cleanup. “If he doesn’t think an issue is important, he doesn’t think it should be important to anyone else, either.”

Time delivers a post-election issue on tight deadlines that is not only thick but pithy. Most rags have been content with charging that Romney lost because Republicans are out of touch with women and minorities. But writer Michael Grunwald goes a step further to warn that the GOP will “double down on a losing strategy” because it’s “superglued to the past.” These are words that conservatives may not like to hear, but the wise ones will have to listen if they’re serious about 2016.

Last week, Newsweek did a bang-up job delivering the news, despite the fact that its Manhattan offices had been flooded and without power. But this week, it looks more banged-up itself, with its same-old panel of columnists jawboning disjointedly. Increasingly, we wonder: what is the point of pseudo-conservative Harvard blowhard Niall Ferguson, whose August cover story “Hit the Road, Barack” didn’t jibe too well with the subsequent pro-Obama cover story? “I endorsed John Kerry in 2004 in a fit of frustration” over Iraq and the budget crisis, he writes, evoking the image of an ass rather than an elephant.

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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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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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