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Medicis and Revance Announce Agreement for Development of Next-Gen Neurotoxin

SCOTTSDALE, Ariz. and NEWARK, Calif., July 28, 2009 — Medicis Pharmaceutical Corporation (NYSE:MRX) (Medicis) and Revance Therapeutics, Inc. (Revance) today announced that the companies have entered into a license agreement granting Medicis worldwide aesthetic and dermatological rights to Revance’s novel, investigational, injectable botulinum toxin type A product (RT002) currently in pre-clinical studies. The objective of the RT002 program is the development of a next-generation neurotoxin with favorable duration of effect and safety profiles. Read more

               

Medicis Begins Shipping Dysport for Glabellar Lines

Medicis announced June 15 that it has begun shipment to physicians of DYSPORT (abobotulinumtoxinA) for the treatment of glabellar lines. DYSPORT is an acetylcholine release inhibitor and a neuromuscular blocking agent, approved by the U.S. Food and Drug Administration (FDA) in late April 2009. The approval included two separate indications, the treatment of cervical dystonia in adults to reduce the severity of abnormal head position and neck pain, and the temporary improvement in the appearance of moderate to severe glabellar lines in adults younger than 65 years of age. Medicis has rights to market DYSPORT in the United States for the aesthetic indication (glabellar lines). Read more

               

A new wrinkle for Botox users: Stronger warnings

Allergan Inc. was ordered by U.S. regulators to strengthen precautions on its wrinkle smoother Botox, hours after the first major competition to the treatment, Dysport, was approved for sale.  Botulinum toxins used to relax forehead lines and treat neurological disorders may cause muscle weakness or breathing difficulties if the poison spreads beyond the site of injection, the Food and Drug Administration said. Read more

               

FDA postpones review of botulinum toxin type A, Dysport

French pharmaceutical company Ipsen says the U.S. Food and Drug Administration (FDA) will not complete its first-cycle review of Ipsen’s botulinum toxin type A product Dysport until the end of the year, Reuters reports. Read more

               

Allergan Announces Positive Top-Line Results from Phase III BOTOX Headache Program

Phase III Studies Show Statistically Significant Decrease in Number of Headache Days –

IRVINE, Calif., Sep 11, 2008 (BUSINESS WIRE) — Allergan, Inc. (NYSE: AGN) today announced that it has completed a top-line analysis of its two Phase III clinical trials exploring the use of BOTOX(R) (botulinum toxin type A) for the prophylactic treatment of headache in adults suffering from chronic migraine — i.e., headaches and/or migraines that occur on 15 or more days each month. Read more

               

Allergan says Botox works on chronic migraines

CHICAGO (Reuters) - Allergan Inc said on Thursday that its popular Botox wrinkle-smoother worked as a treatment for adults suffering from chronic migraines, according to late-stage clinical data.

Shares of Allergan rose nearly 13 percent as the broad market stumbled.

Botox, or botulinum toxin type A, is the first therapy being investigated for chronic migraine, which affects an estimated 1.2 million to 3.6 million people in the United States, according to the company. Read more

               

The young face of Botox

Young women in their 20s turn to shots to prevent wrinkles from forming.

When Natalie Neal, 27, looks in the mirror she sees one faint line across her forehead. She knows no one notices but her, but “when I’m 40 and have a huge line across my forehead they’re going to notice.”

That’s why before her wedding last summer, Neal adopted a beauty routine from her 50-year-old mother – Botox. Read more

               

Botox: Pros & Cons

Better TV talks to Dr. Irwin about the pros and cons of fighting wrinkles with Botox.

               

Ipsen and Medicis Announce Submission of Reloxin BLA in Aesthetics to the FDA

PARIS and SCOTTSDALE, Ariz., March 17, 2008 (PRIME NEWSWIRE) — Medicis (NYSE:MRX) and Ipsen (Euronext:IPN) today announced that Ipsen has submitted a Biologics License Application (”BLA”) for the botulinum toxin type A, Reloxin(R) (Note 1), in aesthetic indications (glabellar lines) to the U.S. Food and Drug Administration’s (”FDA”) Division of Dermatology and Dental Products, within the Center for Drug Evaluation and Research. This BLA submission by Ipsen is intended to address the concerns cited by the FDA when it declined to file the Reloxin(R) BLA in January 2008, which Medicis had submitted in late 2007. Standard response timeframe from the FDA is expected approximately 10 months following receipt of the Reloxin(R) submission. Subject to approval of the BLA by the FDA, Medicis intends to commercialize Reloxin(R) in the U.S. in accordance with the long-standing arrangement between Medicis and Ipsen. Changes from the original BLA submission relate primarily to sponsorship and ownership of the filing. The substantive elements of the original submission remain unchanged. Read more

               

Allergan Clarifies FDA’s Inquiry Relates Primarily to High Dose Medical Uses of BOTOX

RVINE, Calif., Feb 08, 2008 (BUSINESS WIRE) — Allergan, Inc. (NYSE:AGN) today commented on and provided support for the U.S. Food and Drug Administration’s (FDA) “Early Communication” regarding a safety review of botulinum toxins in the United States.BOTOX(R) (botulinum toxin type A) is indicated and used to treat a variety of often serious medical conditions, and BOTOX(R) Cosmetic is approved by the FDA for the aesthetic treatment of wrinkles between the brows and involves very different doses.

The FDA announced this morning in an “Early Communication” that it was reviewing certain serious adverse events following the use of botulinum toxins, particularly for the management of juvenile cerebral palsy. This posting of an “Early Communication” is a routine protocol used by the FDA to provide early information regarding safety or other related reviews, often before any conclusions are or can be made. Specifically, the FDA made clear in its communication that “the posting of this information does not mean that there is a causal relationship between the products and the adverse events.” Read more

               

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