TruInject Medical Corporation has received U.S. Patent approval for its TruInject simulation training system, which includes a human head model and “smart” syringe to train physicians on proper injection. The system allows the trainee to receive real-time feedback about the injection–including how fast and how much he is injecting–and includes computer visuals that allow the trainee to “peel back” the...
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Bayer HealthCare has announced positive results from a Phase III trial that evaluated its 15% azelaic acid (AzA) foam formulation for the topical treatment of inflammatory papules and pustules of rosacea.
The randomized, double-blind, vehicle-controlled, multi-center study included more than 960 adult patients with rosacea, showing 12-50 inflammatory lesions at the time of inclusion in the study. The severity of the condition was based on Investigator Global Assessment (IGA) scale scoring as well as a count of the inflammatory lesions.
Patients were randomized in a 1:1 ratio to receive either AzA 15% foam or unmedicated vehicle foam twice daily for 12 weeks. Safety and tolerability were evaluated during the full 16-week study course, while the efficacy endpoints were assessed at the end of the 12-week treatment period.
Compared to vehicle, treatment with AzA 15% foam resulted in a higher clinician-assessed treatment success rate (32.0% vs. 23.5%, p=0.001) as well as statistically significant greater reduction in the mean nominal change of inflammatory lesions (-13.0 vs. -10.2, p<0.001).
The overall frequency of adverse events (AEs) was 31% in the AzA 15% foam group and 25% in the vehicle group....
Merz and Ulthera have entered into a definitive merger agreement, pursuant to which Merz will acquire global medical device company Ulthera, which developed the ultrasound-based Ultherapy technology for noninvasive skin tightening and lifting. Valued at up to $600 million in upfront cash and milestone payments, the acquisition is the largest in Merz’s history.
“This acquisition represents an important strategic milestone for Merz,” said Philip Burchard, CEO of Merz Pharma Group, which has affiliates in 18 countries around the world. “We have a vision to be the most innovative company in aesthetics, and expanding into the rapidly growing field of energy devices will position us for long-term success in this area. The addition of Ulthera’s energy device technology complements and expands our global presence in the aesthetics space.”
The transaction has been approved by the boards of both companies and is subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The transaction is expected to close in the third quarter of 2014.
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Valeant Pharmaceuticals International has completed its acquisition of PreCision Dermatology, which develops and markets high-quality dermatology products, including Locoid, Hylatopic, and Clindagel.
On July 14, 2014, Valeant announced it had filed a premerger notification under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR) with the U.S. Federal Trade Commission (FTC) relating to the proposed acquisition of Allergan.
On the same day, Allergan filed an investor presentation with the Securities and Exchange Commission ("SEC") and posted the presentation under the "Investors" section of the Company's website. Titled "Further Thoughts on Potential Business Risks and Issues with Valeant Pharmaceuticals International, Inc. ("Valeant"),” the presentation highlights Allergan’s concerns relating to a potential merger with Valeant, including the recent sale of filler and toxin products to Galderma and a lack of transparency in financial disclosures. The full presentation can be viewed at allergan.com.
