Pipeline Previews

is a clear injectable gel composed of hyaluronic acid, a natural substance that already exists in the body. Restylane^® Silk is nonanimal based and free from animal protein. Allergy pretesting is not necessary. Restylane^® Silk contains 0.3% lidocaine, which was added to reduce the discomfort associated with the treatment.

A clinical study was conducted with Restylane^® Silk to evaluate the safety and effectiveness of injections to enhance lip fullness and to improve the wrinkles around the lips. The study included 221 mostly female subjects and evaluated subjects with light and dark skin. Subjects with very dark skin were not studied. Ninety-eight percent (98%) of subjects reported improvement in their lip fullness 14 days after injection and 76% of the subjects still had lip improvement 6 months after their injection.

The majority of adverse events were mild in intensity and the most common symptoms were lip swelling, contusion, and lip pain. The incidence of adverse event decreased significantly after the second treatment. Restylane Silk is contraindicated for patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies; patients with a history of allergies to gram positive bacterial proteins; patients with bleeding disorders; for implantation in anatomical spaces other than the dermis or submucosal implantation for lip augmentation and should not be used in patients with previous hypersensitivity to local anesthetics of the amide type, such as lidocaine.

Ulthera, Inc, has announced that its ultrasound platform device, the Ulthera^® System, has received FDA clearance to non-invasively treat the chest to improve lines and wrinkles of the décolleté.

The Ultherapy Décolletage Treatment utilizes the System’s signature imaging and micro-focused ultrasound therapy capabilities and takes about 30 minutes to administer. The Treatment stimulates the natural formation of collagen and elastin in the skin’s foundation to gradually smooth chest wrinkles. Results are visible after about three months.

Ulthera reports that, as with its FDA-cleared Ultherapy procedure for lifting the neck, eyebrow and chin, meaningful results are achieved in just one treatment, and there’s no downtime or post-treatment care requirements.

The Ultherapy Décolletage Treatment will be available in more than 1,500 physician practices across the United States, starting third quarter 2014. The Treatment is already cleared in more than 40 other countries worldwide and has been selectively available since 2012.

Brickell Biotech, Inc. has announced that it has entered into a license agreement with Merz North America, Inc. which grants Merz an exclusive North American license, with certain additional international rights, to develop and commercialize a completely novel retinoid compound, BBI-3000, for the treatment of skin conditions known to be responsive to retinoid agents, such as acne and psoriasis.

Under the terms of the agreement, Merz will assume the full cost and responsibility for future development and commercialization of the compound, initially for North America.

Brickell reports that in preclinical studies performed by Brickell, BBI-3000 displayed activity that differentiated it from the leading topical retinoids currently available on the market.

brandMD^® Skin Care, introduce a new advanced technology for hair loss and innovative 3-step daily regimen, the Hair Regrowth System. Formulated by a group of leading dermatologists, scientists and market researchers, the Hair Regrowth System has been clinically proven to prevent and improve signs of hair loss by reducing the production of DHT, stimulating hair growth and improving hair follicle anchoring.

The new brandMD Hair Regrowth System is infused with peptides, nourishing essential oils and extracts. Many hair loss solutions have undesired side effects. brandMD HRS-10 breakthrough technology has no known side effects and can be used by both men and women.

This new hair care regimen was formulated to specifically target and prevent signs of hair loss using groundbreaking technology. The entire Hair Regrowth System as well as all of brandMD’s technology based skin care products, are available exclusively to medical professionals for in-office dispensing.

The FDA approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with skin infections. Dalvance is intended to treat acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes. The treatment is administered intravenously.

Dalvance is the first drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. It's safety and efficacy were evaluated in two clinical trials with a total of 1,289 adults with ABSSSI. Participants were randomly assigned to receive Dalvance or vancomycin, another antibacterial drug. Results showed Dalvance was as effective as vancomycin for the treatment of ABSSSI.