May 20, 2012
Jennifer Martinez

Eleven Indicted in Pharmaceutical Thefts

Wifredo A Ferrer, United States Attorney for the Southern District of Florida; John V Gillies, Special Agent in Charge, Federal Bureau of Investigation (FBI), Miami Field Office; Mark R Trouville, Special Agent in Charge, Drug Enforcement Administration (DEA), Miami Field Division; Hugo J Barrera, Special Agent in Charge, Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF), Miami Field Office; James K Loftus, Director, Miami-Dade Police Department (MDPD); and Captain Mary Lathrop, Southern Region Commander, Florida Highway Patrol (FHP), Bureau of Criminal Investigations, announce the indictment of 11 South Florida residents for their participation in the sale and distribution of stolen pharmaceuticals and other goods.

This prosecution, dubbed Operation Southern Hospitality, targeted individuals involved in the sale and distribution of goods stolen from warehouses and tractor-trailers across the United States. Charged in the 18-count indictment are Amaury Villa, 37, of Miami; Roberto Garcia-Amador, 46, of Miami; Ernesto Romero Vidal, 46, of Hallandale; Abel Mesa Samper, 39, of Miami; Michael Rangel, 38, of Hialeah; Suhong Wu, 42, of Miami; Geovanni Gonzalez, 40, of Hialeah; Pedro L Rangel, 27, of Miami; Carlos Alberto Valdes, 43, of Hialeah Gardens; Yanni A Sanchez, 39, of Hialeah; and Leonardo Manuel Guerra, 43, of Clewiston. All are in custody and will appear in federal court in Fort Lauderdale today and tomorrow.

In March 2010, an Eli Lilly warehouse in Connecticut was the target of what has been described as the largest pharmaceutical theft in the country. More than $75 million worth of medications were stolen.

The indictment charges three defendants (Villa, Garcia-Amador, and Wu) with conspiring to sell and the sale of anti-psychotic and anti-depressant medications stolen from the Eli Lilly warehouse in Connecticut. Villa is also charged with possession of approximately 4,654 boxes of medications, including Gemzar, an intravenous drug used for the treatment of cancer, stolen from the warehouse during the theft.

In addition, in a separate case announced today in the District of Connecticut, defendants Amaury Villa, and his brother Amed Villa, 46, were charged with conspiracy and theft offenses related to the March 2010 Eli Lilly burglary. The federal indictment in Connecticut indictment was unsealed earlier today (Thursday).

In addition, the United States Attorney for the Central District of Illinois today announced the unsealing of an indictment charging Amed Villa with the theft of more than 3,500 cases of cigarettes valued at more than $8 million from a warehouse in Tazewell County, Illinois on January 24, 2010.

The New Jersey United States Attorney’s Office also filed three separate criminal complaints charging 12 individuals for their respective roles in a conspiracy to steal and sell millions of dollars worth of prescription drugs, over-the-counter medications, and other products. Federal agents arrested 11 of the defendants in Florida and one in Nebraska this morning.

The New Jersey case and arrests arose from an investigation initiated by the FBI in Newark, NJ ., into the illegal trafficking of pharmaceuticals and other stolen goods. Four of the New Jersey defendants are scheduled to make their initial appearances later today before United States Magistrate Judge Robert L Dubé in Miami federal court.

In addition to the pharmaceuticals stolen from the Eli Lilly warehouse in March 2010, the Miami indictment also charges defendants Ernesto Romero Vidal and Roberto Garcia-Amador in connection with the sale of pharmaceuticals from three other thefts: (1) a cargo of Alprazolam, an anti-anxiety medication and Schedule IV controlled substance, stolen from a tractor-trailer at a truck stop in Pennsylvania; (2) a cargo of Clinda Reach, a prescription acne medication, stolen from a tractor-trailer at a truck stop in Ohio; and (3) other pharmaceutical products, including medications to treat diabetes and epilepsy, stolen from a GlaxoSmithKline warehouse in Virginia. These defendants are charged with conspiracy to distribute a controlled substance, distributing a controlled substance, conspiracy to sell the stolen medications, and the sale of the medications. Defendant Mesa is also charged with conspiring with Vidal and Garcia-Amador to sell the medications stolen from the GlaxoSmithKline warehouse.

In addition, defendants Michael Rangel and Gonzalez are charged with two counts of selling Remicade, a prescription injectible medication used to treat Rheumatoid Arthritis, Crohn’s Disease, Ulcerative Colitis, and other autoimmune disorders, which was stolen from a tractor-trailer at a truck stop in Tennessee.

Lastly, defendants Guerra and Vidal are charged with one count of selling stolen Advair, an asthma medication, and defendants Valdes, Michael Rangel, Sanchez, and Pedro Rangel are charged with possessing, concealing, and disposing of approximately 200 stolen Zodiac brand inflatable boats.

United States Attorney Wifredo A Ferrer stated, “These defendants moved truckloads and pallets of stolen pharmaceuticals from other states to South Florida for storage and ultimate sale.

Along the way, they transported and handled these medications without any regard whatsoever for their proper storage and care, and—worse yet—with a callous disregard for the safety and health of the ultimate consumer who might buy and use these drugs, unaware of their questionable past. But, thanks to the outstanding efforts of the agents and officers involved in this multi-state investigation, these potentially altered and unsafe medications have been removed from the streets.”

“This investigation represents the largest takedown in United States history involving cargo theft. The theft involves more than $100 million, including $80 million worth of pharmaceuticals,” said John V Gillies, Special Agent in Charge for FBI Miami. “Today’s arrests have dealt a major blow to this Miami-based criminal organization.

Cargo theft is a growing multi-billion-dollar crime that significantly impacts consumers, local governments, manufacturers, and shipping companies.”

“Whether through rouge pill mills or stolen pharmaceuticals, the prescription abuse problem we face in Florida is still significant,” said DEA Miami Special Agent in Charge Mark R Trouville. “DEA continues its commitment to ensure that legitimate medicines get into the hands of legitimate patients.”

Hugo J Barrera, Special Agent in Charge for ATF Miami stated, “This case illustrates the commitment of law enforcement to stand united against all who attempt to profiteer from crime. We will continue to labor tirelessly and cooperatively to bring criminals to justice.”

Director James K Loftus of the Miami-Dade Police Department stated, “This case highlights what we can accomplish when federal, state, and local law enforcement in South Florida work together. Whether it is a long-term investigation, such as the one announced today, or the countless others our agencies are involved in everyday, the citizens of Miami-Dade County can count on our agencies to continue the fight against crime in our community.”

If convicted, the defendants face up to five years in prison on the controlled substance (Title 21, United States Code, Sections 841 and 846) and conspiracy (Title 18, United States Code, Section 371) charges and up to 10 years in prison on the sale or possession of stolen goods (Title 18, United States Code, Section 2315) charges.

Operation Southern Hospitality is a result of the ongoing efforts by the Organized Crime Drug Enforcement Task Force (OCDETF), a partnership between federal, state and local law enforcement agencies.

The OCDETF mission is to identify, investigate, and prosecute high level members of drug trafficking enterprises, bringing together the combined expertise and unique abilities of federal, state, and local law enforcement.

Mr Ferrer commended the investigative efforts of the FBI, DEA, ATF, Miami-Dade Police, and Florida Highway Patrol, as well as the many other state and local agencies involved in these operations. In addition, Mr Ferrer thanked the United States Attorney’s Offices for the Districts of New Jersey and Connecticut, and the Newark and New Haven FBI Field Divisions for their outstanding cooperation and assistance throughout this investigation. Mr Ferrer also thanked the United States Attorney’s Office in the Central District of Illinois for their cooperation in this matter. This prosecution is being handled by Assistant United States Attorneys Frank H Tamen and Monique Botero.

An indictment is merely an accusation and the defendants are presumed innocent until proven guilty.

Reported by: FBI

Published on: 2012-05-04

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May 19, 2012
Tina Lewis

Isotretinoin. Acne Drugs Linked to Risk of Eye Problems

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May 18, 2012
Jennifer Martinez

Drugs empire started with cough


Drugs empire started with cough

NICK KRAUSE

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It started with a cough, $500 in capital and a desire for a big challenge. That was the genesis back in 1957 for what has become Douglas Pharmaceuticals with an annual turnover of about $145 million.

Most people would agree founder Sir Graeme Douglas rose to the challenge.

The chemist started with one small pharmacy in west Auckland’s Te Atatu at a time when New Zealand laws prohibited ownership of more than one shop. Chemists, or pharmacists as they’re more widely known today, made up their own medications.

For Douglas, manufacturing naturally followed. He started selling his own brand of products, beginning with a cough syrup called Kofsin.

The next step was to begin importing niche pharmaceuticals and packaging them at his shop before distributing them to other pharmacists. And so was born Douglas Pharmaceuticals. The shop was turning over $2 million when Sir Graeme sold it in the late 1970s to focus on the new business, which shifted to new offices and warehousing in Henderson, also in west Auckland.

Kofsin had a good run, says Douglas from the group’s now considerably expanded Henderson headquarters.

“We considered the active ingredient, which is noscapine, could be offered to advantage to the New Zealand public.”

Problem was the stuff wasn’t at all pleasant to taste, an issue that vexed him greatly at the time. “It’s a very difficult active ingredient to make palatable and if you don’t make cough mixtures palatable, then you immediately have problems with children.”

Their hard work on making the cough elixir taste better paid off when it was well received by consumers. However, he made it for only five years before marketplace consolidation put a stop to it. There were only two manufacturers of noscapine, both in Europe. “One of them sold the company and left a monopoly supplier who, like many monopolies, pushed up the prices. It was unviable,” he says.

Initial growth of the pharmaceutical manufacturer was slow but by the early 1980s Douglas Pharmaceuticals had about 40 products and a $5m turnover. By the late 80s revenue leapt to $25m – 90 per cent earned domestically. Ten years later it was clocking up sales of more than $70m a year.

Today, $85m of its $145m annual turnover is derived from exporting to more than 35 countries.

Last year Douglas Pharmaceuticals produced more than 455 million tablets, 270,000 litres and 31 metric tonnes of pharmaceutical medicines, liquids and creams.

After decades of expansion, it might be fair to ask whether Douglas has much left in business to get excited about.

But the group is still trying to break new ground. After 10 years of trying to break into the United States market, in January the company had its prescription acne medication isotretinoin approved by the Food and Drugs Administration. It is believed to be the first Kiwi- developed human medicine to be approved for use in the US. It is a big deal – the US accounts for more than half of the world’s total pharmaceutical spend, which is estimated by market research company IMS Health to reach almost US$1.1 trillion by 2015.

The newly-approved product is sold in New Zealand as Oratane and is the group’s biggest export product. It is also market leader in Spain, Austria, Germany and Mexico. Used to treat severe acne, it will be sold as Myorisan in the US. Released this week in the US, the drug has already had its first orders.

The wait was worth it.

“We have several [products] following that are happily making much faster progress.

“It couldn’t be any bloody slower.

“We’re expecting at least two more [FDA approvals] in the next 12 months, possibly earlier, with another two following that.”

These will significantly bolster the company’s turnover this year. The group has also had to increase staff from 470 to 520 to cope with anticipated demand.

Getting FDA approval is just the first step though, rather than a licence to print money. “We’ve now got to market it and convince the consumers, starting with the prescribing dermatologists, to the pharmacists who purchase the product to dispense that, indeed, this is a product of integrity.

“The supply chain is certainly very, very important, particularly in markets like the US.”

Throw in the considerable marketing budget and the company has racked up millions on the application before selling a single unit.

At 83, he is still content to stay at the helm as managing director. But one of Douglas and wife Ngaire’s two sons has worked his way through the firm. Jeff, 53, who holds a commerce degree, joined the business aged 20 and has been with the company since. He’s now the managing director of the group’s export division.

“He’s obviously got more energy than I have so he drives it harder. He’s a great salesman,” Douglas says. “I lean toward the manufacturing facility.”

His second son, Richard, 50, is a head and neck surgeon [formerly called an ear, nose, throat surgeon] with a private practice in Auckland.

Douglas was knighted in 2010 for services to philanthropy and athletics and in 1988 was appointed a member of the New Zealand Order of Merit for services to the New Zealand pharmaceutical industry.

Both he and his wife have given back significantly to the community, one of the criteria for becoming a Hall of Fame laureate. They’ve provided funding for a research fellow for the Neurological Foundation and bought lifesaving equipment and an MRI scanner for Starship children’s hospital which, at $3m, remains the hospital’s largest single, personal donation. Douglas also supports the West Auckland Hospice, Medical Air Abroad, the Heart Foundation, Cancer Society, the Liggins Institute (University of Auckland’s cancer research institute) and the Oliver Smales Memorial Trust which educates and trains therapists and nursing staff working with children and youth in Hawke’s Bay. Douglas was an Auckland representative shot-putter and also supports the Waitakere City Athletics Club.

He has been one of the major sponsors of the Waitakere City Stadium, sited just opposite his company precincts, and the field and all-weather running track bear his name.

The Fairfax Media New Zealand Business Hall of Fame was established in 1994 by The Young Enterprise Trust. Each year, six individuals who have contributed to New Zealand’s economic and social development are recognised. The 2012 laureates will be inducted into the Hall of Fame at a gala dinner on Thursday, June 28. More information and tickets are available from Young Enterprise, ph 04 570 0452 or at businesshalloffame.co.nz

– © Fairfax NZ News

Sponsored links

May 18, 2012
Tina Lewis

Zion Health’s Popular Line of Native Home Remedies is Now Available at New …

Zion Health’s Natural Healing Clay Body Care line expands it reach to Health Conscious consumers with the availabilty of its full Organic Minerals Skin Care line at New Leaf Community Health food store in San Jose, CA

San Francisco, CA (PRWEB) May 17, 2012

Zion Health, a California-based maker of popular clay-based toothpaste for gum problems, organic shampoo, soaps and detox treatments announced today that New Leaf Community Markets at 5667 Silver Creek Valley Road in San Jose will carry its new line of natural body care products. The key ingredient in Zion Health’s natural home remedies is Calcium Montmorillonite Clay, “Kanwa”, an effective detoxifier that has been used to treat wounds, acne, dry skin, wrinkles, stomach ulcers, and a variety of other ailments.

The benefits of Kanwa have been known since Native Americans and Aboriginal medicine men first discovered its healing qualities generations ago. Kanwa is now attracting the interest of the scientific community with recent MIT and NASA-sponsored research confirming the healing and beneficial qualities of this native home remedy.

Kanwa clay contains small particles as a result of the natural crystallization process making it easy for the body to absorb. The clay’s negative charge gives it the ability to absorb or attract positively charged toxic matter. Kanwa is also touted by homeopathic practitioners and known in the scientific community for its bacteriostatic properties. An article published by Ronald Whitmont, MD in May of 2008 entitled ‘MRSA and Its Treatment’ states: “Applications of medicinal clay have proven to be quite helpful inhibiting bacterial activity.”

New Leaf Community Markets, located at 5667 Silver Creek Valley Road, San Jose is a locally owned natural grocery store with six locations on the Central Coast of California. It has been serving the community for over 25 years. New Leaf’s mission, to nourish and sustain our community, is reflected in the 10% of profits given annually to support local non-profits working to improve the quality of life. New Leaf is committed to offering customers choices that have the most beneficial impact on their health, and the health of the environment. (http://www.newleaf.com)

Zion Health provides its consumers with the purest, natural skincare products available on the market today including organic hair care products, organic soaps, toothpaste for gum problems and natural acne treatment. All Zion products are 100% vegan, free of parabens, aluminum, sulfates, and are formulated using certified organic ingredients whenever possible.

Zion Health products are available online at http://www.kanwaminerals.com and in select Whole Foods Markets in California, and in health food stores and local markets throughout the U.S. and Canada including New Leaf Community Markets in San Jose. For more information on Zion products, visit http://www.zionhealth.net.

For the original version on PRWeb visit: http://www.prweb.com/releases/prweb2012/5/prweb9496352.htm

May 17, 2012
Jennifer Martinez

Eleven South Florida suspects indicted in largest-ever U.S. pharmaceutical theft

The FBI is calling it the “largest takedown in U.S. history involving cargo theft.”

Indictments were announced Thursday against 11 South Florida suspects accused of stealing more than $75 million worth of pharmaceutical products, including prescription drugs, according to U.S. Attorney Wifredo A. Ferrer.

Operation Southern Hospitality targeted those involved in the theft of property from warehouses and tractor-trailers across the country that was brought to South Florida for redistribution.

Federal agents arrested the 11 suspects around Florida on Thursday morning. All were scheduled to appear in federal court in Fort Lauderdale on Thursday and Friday.

Separate yet related cases were filed against some or all of the suspects in Connecticut, Illinois and New Jersey as well. A 12th suspect was arrested in Nebraska on Thursday, agents said.

“[They] moved truckloads and pallets of stolen pharmaceuticals from other states to South Florida for storage and ultimate sale,” Ferrer said. “[They] handled these medications without any regard whatsoever for their proper storage and care, and — worse yet — with a callous disregard for the safety and health of the ultimate consumer who might buy and use these drugs.”

In March 2010, more than $75 million worth of prescription and over-the-counter medications were stolen from an Eli Lilly pharmaceuticals warehouse in Connecticut, considered the largest theft of its kind in the country. The property included 4,654 boxes of anti-psychotic and antidepressant medications, and Gemzar, an intravenous drug used for the treatment of cancer.

In addition, some suspects were linked to three other thefts, including the anti-anxiety medication alprazolam, stolen from a tractor-trailer at a truck stop in Pennsylvania; the prescription acne medication ClindaReach, stolen from a big rig at an Ohio truck stop; and other medications used to treat diabetes and epilepsy, stolen from a GlaxoSmithKline warehouse in Virginia.

Also stolen were Remicade, a prescription injectable medication used to treat rheumatoid arthritis, Crohn’s disease, ulcerative colitis and other disorders,taken from a tractor-trailer at a truck stop in Tennessee; more than 3,500 cases of cigarettes valued at more than $8 million from a warehouse in Tazewell County, Ill.; and approximately 200 stolen Zodiac brand inflatable boats.

Among those charged in the 18-count indictment were Ernesto Romero Vidal, 46, of Hallandale; Leonardo Manuel Guerra, 43, of Clewiston; Amaury Villa, 37, of Miami; Roberto Garcia-Amador, 46, of Miami; Abel Mesa Samper, 39, of Miami; Michael Rangel, 38, of Hialeah; Suhong Wu, 42, of Miami; Geovanni Gonzalez, 40, of Hialeah; Pedro L. Rangel, 27, of Miami; Carlos Alberto Valdes, 43, of Hialeah Gardens, and Yanni A. Sanchez, 39, of Hialeah.

All face between 5 and 10 years in prison if convicted, prosecutors said.

May 17, 2012
Tina Lewis

What to do about open pores

Good day Dr Campbell-Chambers,

I have acne and open pores. I have tried several ways of treating same, but it seems as if I am having more and more open pores. What can be done to eliminate these open pores and to prevent others? Sometimes it is advised not to squeeze pimples in the face, but what happens to what is inside them?

I think that if they are not squeezed they develop into open pores. What do you think? I have used home remedies such as drinking more water, making a paste with oats and honey, baking soda etc, but there is not much improvement. I’ve also used clindoxyl gel, but this only makes my face look lighter and does not do much.

Dear Reader,

In my last article, we addressed similar concerns from another reader. Some of that information may be repeated as we answer your specific questions. Acne is an inflammatory disorder involving the hair follicle and its attached oil-producing (sebaceous) gland. The oil (sebum) reaches the surface of the skin through the hair pore. While we all have pores, individuals with acne tend to have enlarged pores and oily skin. This is so because of the excess production of oil due to hormones stimulating the sebaceous gland. There is also clogging of the pores by dead skin cells, bacteria and inflammation which causes acne.

Don’t squeeze

It is advised that you avoid squeezing acne lesions because this can make them go deeper and cause more scarring and dark spots. If they are not squeezed, most acne pimples are reabsorbed by the body with time. However, in some cases, scars may be left behind. A type of acne scarring called ice pick scars may be mistaken for open pores. It is best to use acne treatment to improve acne and prevent complications like scarring.

Medications like retinoids and procedures like dermal needling, chemical peels, lasers and/or surgery can improve the appearance of acne scarring and open pores. However, the scars and pores cannot be totally eliminated. Blackheads and whiteheads can be extracted by a trained skin-care professional, if desired. However, this cannot prevent new ones from forming.

Oats and honey

While water is vital to our health, drinking lots of it cannot necessarily get rid of acne. Oatmeal can help unclog pores by removing dead skin cells (exfoliating) while honey is both exfoliating and antibacterial. Baking soda might be irritating in treating facial acne. Additionally, although some of these ingredients may help, other treatments may be needed to control acne effectively.

Acne is treated on an individual basis, based on its severity and psychosocial impact. Mild to moderate acne can be treated with topical retinoids, topical benzoyl peroxide, topical salicylic acid, topical sulfur and topical and/or oral antibiotics. Clindoxyl TM (5% benzoyl peroxide and 1% clindamycin) is a medicated gel which studies have shown to be very effective at reducing acne lesions. However, some individuals may experience redness, peeling, burning and drying of the skin. It is not a skin-bleaching cream, although the benzoyl peroxide in it can fade clothing. Perhaps your face appeared lighter while on it as a result of irritation and dryness. To minimise potential irritation, these treatments may be initially used on alternate nights, with gentle cleansers and oil-free moisturisers and sunscreens in the day as supportive therapy.

In moderate to severe acne, oral antibiotics, oral anti-hormonal pills (eg some oral contraceptives for women) can be added. Severe acne can be treated with an oral retinoid. Other optional treatments include chemical peels, microdermabrasion, injectable medication into deep lumps, light therapy and lasers. Scarring, dark spots, keloids and psychosocial problems can also be treated. Although there is no permanent cure for acne, long-term treatment can give great results. So don’t give up!

Dr Arusha Campbell-Chambers is a dermatologist and founder of Dermatology Solutions Skin Clinics Medi-Spas; email: yourhealth@gleanerjm.com.

 

May 16, 2012
Jennifer Martinez

Accutane Inflammatory Bowel Disease Lawsuit Transfers to MDL – Accutane Lawsuit Center

An Accutane side effects lawsuit originally filed in the State Court of Cobb County, Georgia on April 2, 2012, is slated for removal to the current Accutane MDL (multidistrict litigation) in the U.S. District Court, Middle District of Florida. The plaintiff claims that manufacturer Hoffman-LaRoche is liable for injuries suffered as a result of his ingestion of the acne medication, Accutane. This case was deemed appropriate for transfer because of complete diversity, and because the plaintiff seeks in excess of $75,000 in damages.

Patients across the country who believe they have suffered from gastrointestinal side effects, such as Accutane ulcerative colitis, have consulted with an Accutane lawyer to determine if they are eligible to bring litigation.

Plaintiff alleges Accutane inflammatory bowel disease

Plaintiff Nelson Eddie Caviness, a citizen of Georgia, claims he began taking Accutane on or about June 8, 1999. As a result of his ingestion of the medication, he claims to have suffered from gastrointestinal problems, musculoskeletal problems, and Accutane inflammatory bowel disease. As a result of these health issues, he has suffered disability, depression, mental anguish, and loss of capacity for enjoyment of life. His injuries and damages are permanent, according to his Accutane lawyer.

Though Accutane was withdrawn from the market in 2009, those who took the drug for the treatment of severe acne are still coming forward seeking damages for their injuries. Many claim to have suffered from Accutane IBD, an incurable condition that causes inflammation, diarrhea, vomiting, weight loss, anemia, and intestinal ulcers. Two main types of inflammatory bowel disease—Accutane ulcerative colitis and Accutane Crohns disease—differ mainly in which part of the digestive tract they effect.

Accutane IBD case moves to MDL

Caviness’ case was originally removed from state court in Georgia to the U.S. District Court for the Northern District of Georgia, Atlanta Division on April 9, 2012. The transfer was appropriate because Caviness was a resident of Georgia, but the defendants (Hoffman-LaRoche) were not. On April 26, 2012, however, the case was again transferred to the Accutane MDL in Florida.

Senior District Judge James S. Moody, Jr. has overseen nearly 60 Accutane lawsuits in Florida, with over 13 cases currently pending. Many plaintiffs who brought claims of liability and failure to warn against Hoffman-LaRoche were awarded damages by a jury. All of the plaintiffs suffer from similar side effects including Accutane inflammatory bowel disease and Accutane ulcerative colitis.

Plaintiff seeks damages in Accutane ulcerative colitis lawsuit

Caviness brings counts of liability, negligence, breach of warranties, fraudulent misrepresentation, negligent and reckless misrepresentation, and conspiracy against the defendants, Hoffman-LaRoche Inc. He didn’t originally specify a demand for damages, but in the notice of removal, it’s stated that the amount in controversy requirement ($75,000) is met, as it is facially apparent from the complaint that the amount will exceed the jurisdictional minimum.

May 16, 2012
Tina Lewis

Mommy Makeover Surgery: Free Doctor Video Chat Discusses Options to Restore …

Hosted by RealSelf.com, participants will get firsthand insight about the plastic surgery procedure captivating women all over the globe

Seattle, WA (PRWEB) May 14, 2012

For women who are contemplating plastic surgery to get their pre-baby body back, a free doctor video chat on Wednesday, May 16 will provide critical information about all that is involved with a “Mommy Makeover.” During the live chat, hosted by RealSelf.com, participants will get firsthand insight about the plastic surgery procedure, which can involve a powerful combination of tummy tuck, breast augmentation, liposuction and beyond. The video chat takes place at 8:15 p.m. EST and participants can reserve their spot by registering today at bit.ly/realselfmommymakeover.

Everyone knows even the most excellent of physiques can be subject to sagging, stretch marks and stomach pooches following pregnancy and breast feeding, and exercise alone often won’t do the trick. Webinar host Dr. Shahram Salemy, a plastic surgery expert and board-certified doctor with a private practice in Seattle, will share various procedure options, how the surgeries work, risks, satisfaction rates and more. Anybody who has questions about mommy makeovers can ask Dr. Salemy for real-time answers during a QA at the end.

The Mommy Makeover is a popular procedure captivating women all over the globe as a fix for stubborn post-pregnancy body concerns. To participate, attendees need to sign up in advance for this FREE online doctor chat and get the information you need to make a confident, empowered decision about what’s right for you. If you have ever considered surgery to restore your body to its pre-childbirth form, this is an informative session not to be missed!

Plus, all attendees at the event will be entered to win a CLARO IPL Acne Treatment Device. This new, more effective treatment targets the cause of acne with up to 94% effectiveness and, with only two 6-second applications per pimple, will deliver visible results within 24 hours of the first treatment.

About RealSelf

RealSelf is the most visited online community for learning about and sharing information and results for medical-beauty treatments. Dedicated to helping people make suitable and empowered elective decisions, the site features consumer reviews, Worth It ratings, pricing information, and thousands of before and after photographs that collectively tell the ‘real story.’ The site also includes safety information and a QA with more than 4,000 board-certified doctors so visitors can interact with qualified experts and make safe decisions. RealSelf covers thousands of topics ranging from cosmetic dermatology to plastic surgery, cosmetic dentistry vision correction and more. http://www.realself.com.

For the original version on PRWeb visit: http://www.prweb.com/releases/prweb2012/5/prweb9507062.htm

May 15, 2012
Jennifer Martinez

Deciphering Cipher Pharma


(RTTNews.com) – In just another two weeks, Canada based Cipher Pharmaceuticals Inc. (DND.TO) (CPHMF.PK) will learn the outcome of its New Drug Application for acne medication CIP-Isotretinoin resubmitted to the U.S. regulatory agency.

CIP-Isotretinoin is a novel, patented formulation of acne medication Isotretinoin. CIP-Isotretinoin is designed to offer more consistent bioavailability of the compond compared to the current Isotretinoin formulations, according to Cipher Pharma.

This is CIP-Isotretinoin’s third go-around with the FDA. Cipher’s investigational acne medication was rejected twice by the FDA – in May 2006 and April 2007, and the company was asked to provide additional clinical safety data. Accordingly, the company conducted a phase III safety study for CIP-Isotretinoin under a Special Protocol Assessment, and resubmitted its NDA last November. The resubmitted NDA for CIP-Isotretinoin was considered as a class 2 response by the FDA with a decision date set for May 29, 2012.

In August 2008, Cipher Pharma granted Ranbaxy Pharmaceuticals Inc. exclusive right to market, sell and distribute CIP-Isotretinoin in the United States, its territories and possessions. Following the FDA acceptance of the amended NDA as a complete response last December, Cipher Pharma received a US$1.0 million milestone payment from its marketing partner, Ranbaxy. Under the U.S. distribution and supply agreement with Ranbaxy, Cipher is eligible to receive pre- and post-commercialization milestone payments of up to US$19 million and a royalty in the mid-teens on net sales. CIP-Isotretinoin is also under review in Canada.

According to IMS Research, the U.S. Isotretinoin market in 2011 was valued at US$0.5 billion.

The company has two approved drugs:

- Lipofen for high cholesterol, marketed in the U.S. by Kowa Pharmaceuticals. Cipher receives a royalty in the range of mid-teens to mid-twenties on net sales of the drug.

- CIP-Tramadol ER for moderate to moderately severe pain, marketed in the U.S. by Vertical Pharmaceuticals and in Canada by Medical Futures as Durela. The royalty rate on net sales of CIP-Tramadol ER received by Cipher is mid-teens.

A quick look at Cipher’s balance sheet…

Barring 2010, in all other years, Cipher has incurred losses. The company generates revenue under four distribution and supply agreements.

In 2011, the company incurred a loss of C$2.31 million or C$0.10 per share on licensing revenue of C$3.57 million. This compares with a profit of C$172 thousand on licensing revenue of C$5.38 million in 2010.

In the first quarter ended March 31, 2012, net income was C$0.1 million, compared with a loss of C$1.1 million in the year-ago comparable quarter. Revenue for the first quarter of 2012 was C$1.8 million, a 168% increase over the first quarter of 2011.

Cipher Pharma ended the first quarter of 2012 with cash of C$10.1 million, compared with C$9.6 million as at December 31, 2011.

Shares of Cipher Pharma, which are listed on the Toronto Stock Exchange, have thus far hit a 52-week low of C$0.64 and a 52-week high C$1.35. As the FDA decision date nears, it will be interesting to watch how the stock price plays out in the coming days. Stay tuned…

For comments and feedback: contact editorial@rttnews.com

http://www.rttnews.com


May 15, 2012
Tina Lewis

New acne treatment: GSK’s topical Fabior Foam gets FDA approval

lips, skin, cheek, mouth, noseA new acne treatment from GlaxoSmithKline (NYSE:GSK) now has marketing approval in the United States to tackle pimples and blackheads in acne sufferers.

Tazarotene, which will be marketed under the name Fabior Foam, is a topical foam developed to treat acne vulgaris. Fabior now has U.S. Food and Drug Administration approval to treat the moderate-to-severe acne in patients who are 12 or older.

Fabior was developed by GSK subsidiary Stiefel Laboratories, the dermatology products company that GSK acquired in 2009 for $2.9 billion as the company made a play to diversify its drug portfolio beyond the slate of blockbuster drugs set to lose patent protection. GSK folded its dermatological products business into Stiefel, which operates in Research Triangle Park, North Carolina, a short distance from GSK’s own RTP campus. The combined skin products unit operates under the Stiefel name.

Between 40 million and 50 million Americans struggle with acne, according to the American Academy of Dermatology. It’s hardly an underserved population, but it is a growing market. Research firm Global Industry Analysts projects that the global market for medicated skin care products, including acne treatments, will reach $6.2 billion by 2017. Consumer products are seen as a more stable source of revenue. The Global Industry Analysts report notes that although women have driven sales for skin care products, men are increasingly shelling out money for skin products.

Fabior should not be used by pregnant women because it could cause harm fetuses. GSK said that the most common adverse reactions reported were at the site Fabior was applied. Those reactions included irritation, dryness, redness and exfoliation.

[Photo from stock.xchng user Mrinkk]

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