News

FDA gives 510(k) approval for the HydraSolve autologous fat transfer system (Andrew Technologies) for Lipoplasty

Andrew Technologies has received 510(k) clearance from the FDA for its HydraSolve Lipoplasty system for autologous fat transfer, in which adipose tissue is harvested and can be reinjected into the same patient for rejuvenation or augmentation. HydraSolve achieves liquefaction of fat tissue by cell disaggregation, not by emulsification and the lysing of cell membranes. The system rapidly removes fat and ...

Revance Therapeutics to initiate Phase III trial for RT 001 for treatment of Facial Wrinkles

Revance Therapeutics inc has secured the funding necessary to initiate a Phase III trial for Botulinum Toxin Type A Topical Gel for the treatment of facial wrinkles (crows feet) that is intended to compete with injected therapies such as Botox.

RT 001 is also currently in Phase II trials for the topical treatment of hyperhidrosis (excessive sweating), and chronic migraine ...

Phase III study of ATX 101 (Kythera Biopharmaceuticals) shows treatment helps reduce submental fat

Kythera Biopharmaceuticals has announced positive interim results from a Phase IIIb multi-center open-label study (ATX-101-11-26) to evaluate the safety and efficacy of ATX 101 (sodium deoxycholate) for the reduction of unwanted submental fat commonly known as double chin. Results show that 87 percent of patients achieved at least a one-grade improvement from baseline on the Clinician-Reported Submental Fat Rating Scale. ...

FDA approves Natazia (Bayer HealthCare) for Heavy Menstrual Bleeding

The FDA has approved a new indication for Natazia (estradiol valerate and estradiol valerate/dienogest) tablets, from Bayer HealthCare, for the treatment of Heavy Menstrual Bleeding (HMB) that is not caused by any diagnosed conditions of the uterus (womb), in women who choose an oral contraceptive (OC) for contraception. Natazia is the first and only oral contraceptive indicated for the treatment ...

Humira (Abbott) in 2 Phase III trials for Hidradenitis Suppurativa

Abbott Labs announces the initiation of two Phase III clinical trials designed to evaluate the safety and efficacy of Humira(adalimumab) in adult patients with moderate to severe Hidradenitis Suppurativa (HS). The Phase III trials (M11-313 and M11-810) are 36-week, multinational, randomized, double-blind, placebo-controlled studies designed to evaluate clinical outcomes and safety of adalimumab in approximately 600 patients with moderate to ...

Oral powder formulation of Fosrenal (Shire) approved in EU

The Swedish Medical Products Agency acting as reference member state through the European Decentralised Procedure has approved a new oral powder formulation of Fosrenal (lanthanum carbonate), from Shire. Submissions for national marketing authorisations of Fosrenol in oral powder form have been made to Sweden and the other 27 European markets. The oral powder formulation was developed to give patients more ...