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Allergan Receives FDA Approval for First-of-Its-Kind, Fully in vitro, Cell-Based Assay for BOTOX® and BOTOX® Cosmetic (onabotulinumtoxinA)

–Represents R&D Breakthrough in Commitment to Animal-Free Stability and Potency Testing for BOTOX® and BOTOX® Cosmetic–

 

IRVINE, Calif.–(BUSINESS WIRE)– Allergan, Inc. (NYSE:AGN) today announced the United States Food and Drug Administration (FDA) has approved a fully in vitro, cell-based assay for use in the stability and potency testing of BOTOX® (onabotulinumtoxinA) and BOTOX® Cosmetic. The newly approved assay will be implemented immediately for release of product for sale in the United States. Allergan estimates that use of the new assay will reduce the use of animal-based assay testing for BOTOX® and BOTOX® Cosmetic by up to 95 percent or more over the next three years, as other regulatory agencies around the world approve this new assay. The new assay is the first to be developed and approved for any botulinum neurotoxin currently available worldwide, and is specifically applicable to Allergan’s botulinum toxin type A product. Read more

               

Xeomin expected to drive down botulinum toxin prices when it reaches market

When it enters the U.S. market, Xeomin is expected to have a unit-to-unit equivalence to Botox, the standard aesthetic toxin in dermatology practices for years.

Current off-label use hasn’t shown any particular clinical advantage for Xeomin (incobotulinumtoxinA, Merz) over Botox (onabotulinumtoxinA, Allergan) or Dysport (abobotulinumtoxinA, Medicis), but the new toxin will broaden clinicians’ aesthetic options and may spur price competition in the U.S.

The unit-to-unit equivalence to Botox is one of Xeomin’s purported advantages over Dysport, says W. Philip Werschler, M.D., F.A.A.D., F.A.A.C.S., assistant clinical professor of medicine/dermatology, University of Washington, Seattle. Read more

               

New trial tests Botox as a treatment for asthma

A new medical trial in Australia is set to test whether Botox can be used to help people with asthma breathe more easily.

Botox is a drug which is most frequently used in cosmetic surgery as it can be injected to paralyse wrinkles and facial lines. The researchers hope the injections, which will be given into the voice box, will allow the muscles to relax and remove the sensation of breathlessness, a common symptom for people with asthma.

30 people with asthma will take part in the trial, which has been designed as a result of finding that people with asthma often suffer problems with their voice boxes as well as their lungs. Read more

               

IAPAM’s hCG Training is Consistent with Dr. Oz regarding hCG for Weight Loss

The IAPAM has trained over 350 physicians on how to safely offer hCG for weight loss, and well over 10,000 patients have successfully lost weight using the IAPAM’s Exclusive hCG Protocol. The core principles of the IAPAM’s hCG Training are consistent with those outlined by Dr. Oz in his recent interview for First for Women magazine.  The IAPAM agrees with the key messages in Dr. Oz’s article: it is imperative for patients to undertake an hCG program under the care of a trained physician, and never use hCG (homeopathic hCG) that is sold without a prescription.
 
In his recent interview in the June 27, 2011 issue of First for Women magazine (http://www.magazines.com/product/first-for-women), Dr. Oz delivers several key messages regarding the safe and effective use of pharmaceutical grade hCG in a physician-supervised weight loss program.  These key messages are consistent with those taught in the IAPAM’s Physician hCG Training (http://www.aestheticmedicinesymposium.com/physician-hcg-weight-loss-training):
 
1.  Physician Supervision for patients undergoing an hCG Program is essential.
2.  Never buy hCG over the internet.  Only use pharmaceutical grade hCG as prescribed by a physician. hCG that is not prescribed by a physician is homeopathic hCG and has been found to only contain trace amounts of real hCG. 
3.  Successful weight loss using hCG requires that the patient follow a proven hCG protocol precisely. Read more

               

IAPAM’s hCG Training Gives Physicians Best Practices

The IAPAM offers physicians the industry’s best practices and resources for adding hCG for weight loss to a practice. Attendees receive all the tools they need to help them launch their hCG program, and with their IAPAM Membership, they also receive a year of practice support including access to the IAPAM Members Portal, containing hCG resources like the “hCG Ask an Expert” Q & A Forum.

Physicians must be expertly trained in the administration of an hCG Protocol to ensure successful and safe weight loss for their patients.  The basis of the IAPAM’s Physician hCG Training (http://www.aestheticmedicinesymposium.com/physician-hcg-weight-loss-training), and echoed during the Dr. Oz Show of February 2011, are:

1.  Physician Supervision is Key.

2.  Never buy hCG over the internet.  Only use pharmaceutical grade hCG as prescribed by a physician. hCG that is not prescribed by a physician is homeopathic hCG and has been found to only contain trace amounts of real hCG. 

3.  Successful weight loss using hCG requires that the patient follow a proven hCG protocol precisely. Read more

               

Battle for Beauty: Botox or Dysport

Botox’s stranglehold on the ‘de-wrinkling’ market may have found a match. A new randomized study published online in the Archives of Facial Plastic Surgery, has found that Botox’s competitor Dysport is better at treating crow’s feet.

The study compared the effectiveness of both cosmetic drugs is smoothing wrinkles in 90 volunteers. The researchers from the Mass Clinic in San Francisco and University of California, San Francisco randomly injected Botox in one side of the face and Dysport in the other. Read more

               

PurTox, A New BOTOX Competitor?

Allergen’s blockbuster botulinum neurotoxin BOTOX may have a new competitor in the near future: PurTox by Mentor.
 
Chances are you’ve either had BOTOX done or you’ve heard of it - it is often brought up as controversial points in the press such as: Who is too young for BOTOX? or Which celebrity has gotten BOTOX done? Love it or hate it, the business of botulinum toxin is booming and BOTOX is at the forefront of the anti-wrinkle injectable race. Dysport, another botulinum neurotoxin was FDA approved in June of 2009 but BOTOX still has the strong hold in the market. Could a new contender, PurTox be the first to give BOTOX a run for it’s money?

Read more

               

New Sunscreen Rules from FDA

Sunscreen labels will carry a “broad spectrum” label to show they offer some protection against UVA radiation as well as UVB radiation, according to a long-awaited new rule from the FDA.

The old “SPF” designation still will show how well a product protects against UVB, although the highest SPF level a product can claim will be “50+.”

The “broad spectrum” designation carries a lot less information than a zero-to-four-star system the FDA originally proposed for UVA protection. But the FDA did hold firm on insisting that sunscreens claiming swim/sweat protection say how many minutes such protection lasts.

“FDA has evaluated the data and developed testing and labeling requirements for sunscreen products, so that manufacturers can modernize their product information and consumers can be well informed on which products offer the greatest benefit,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. Read more

               

Allergan’s survival strategy: Botox everlasting

FORTUNE — Big pharmaceutical companies aren’t at a crossroads so much as on the edge of a cliff. Thanks to a special provision in patent laws for drugs, companies lose intellectual property protection on pharmaceuticals after 20 years. After that, exclusive rights to the drugs fall into an abyss of competition from other companies making much cheaper generic versions. The point at which pharma companies lose exclusive rights to their drugs is called the patent cliff.

Yet one company, Allergan (AGN, Fortune 500), has managed to steer clear of the edge. Most big, mainstream pharma companies are desperately working to develop new expensive drugs and filing lawsuits to extend patents on old ones. But to dodge that deadline, Allergan is using another strategy; let’s call it the “stay small and make weird products” approach.

The company behind Botox, the “face-lift in a bottle,” is itself aging rather gracefully. Net sales increased by 13.3%, to roughly $1.3 billion, in the first quarter of 2011 compared with the same period last year, and the company has given analysts no reason to think it won’t put together a string of good quarters. Read more

               

IAPAM’s Physician hCG Training Leads the Industry

The IAPAM is committed to educating physicians in the industry’s best practices for hCG for weight loss. In support of this commitment, the IAPAM’s hCG Training offers physicians an hGG Training program of unsurpassed clinical and business content on hCG and medical weight management.  Attendees receive all the tools needed to launch an hCG for weight loss program, and graduates of the IAPAM’s hCG Training say it is the best in the industry.
 
Obesity is an epidemic in the United States, and more and more patients are requesting hCG for weight loss programs from their physicians.  In a recent interview to KATV in Arkansas (http://www.katv.com/story/14688505/hcg-diet-helps-shed-weight-fast-but-is-it-safe), Dr. Suzanne Yee, a cosmetic surgeon in Little Rock and an attendee of the IAPAM’s hCG Physician Training (http://www.aestheticmedicinesymposium.com/physician-hcg-weight-loss-training), attested to the popularity and success of hCG for weight loss.  “It decreases your appetite,” says Dr. Yee,  “so you don’t feel hungry even though you’re on a 500-calorie diet. And it mobilizes 1000 to 1500 calories of fat from your own body.”
 
However, before launching an hCG for Weight Loss program, physicians must be expertly trained in the delivery of an hCG Protocol to ensure success and safety for their patients.

Read more

               

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