DynaVox Under Intense Scrutiny

Law Offices of Howard G. Smith announces that it is investigating potential claims on behalf of purchasers of the securities of DynaVox Inc. (“DynaVox” or the “Company” ) concerning possible violations of federal securities laws. DynaVox designs, manufactures and distributes electronic and symbol-based augmentative communication equipment, software and services. The Company offers speech generating technology and special education software solutions for individuals with speech, language, physical or learning disabilities.

The investigation concerns allegations that certain statements made by the Company concerning its business and financial prospects were materially false and/or misleading. On September 30, 2010, the Company issued a press release stating that during its first quarter of fiscal 2011, DynaVox “experienced a softening of demand for both its speech generating devices and software products.” As a result, the Company announced, it is withdrawing its previously issued earnings guidance for fiscal year 2011. A subsequent article published by TheStreet.com noted “the weakness in DynaVox is striking given the company just went public in late April, selling upwards of 9 million shares at $15 each. The stock is now down 65% off a high of $19.20 on June 16.”

Important Information for DynaVox Shareholders

If you are a shareholder of DynaVox, if you have information or would like to learn more about these claims, or if you wish to discuss these matters or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, Toll Free at (888) 638-4847, or by email to howardsmith@howardsmithlaw.com, or visit our website at http://www.howardsmithlaw.com.

DynaVox is based in Pittsburgh, PA.

Popularity: 1% [?]

Ryan & Maniskas, LLP (www.rmclasslaw.com/cases/scln) have a class action lawsuit filed in the United States District Court for the Northern District of California on behalf of purchasers of SciClone Pharmaceuticals securities between May 11, 2009 and August 10, 2010.

SciClone develops therapeutics for the treatment of cancer and infectious diseases in China and internationally. The Complaint alleges the defendants were engaged in illegal and improper sales and marketing activities in China and abroad regarding its products.

The activities eventually caused SciClone to become the focus of a joint investigation by the SEC and the Department of Justice for possible violations of the Foreign Corrupt Practices Act.

Investors didn’t learn about the Company’s operations until it was reported the SEC and DOJ were investigating the Company for violations of the Act, and then Company shares declined almost 40% in one day, on abnormally large trading volume.

For more information about the case or to participate online, visit: www.rmclasslaw.com/cases/scln,
or contact Richard A. Maniskas, Esquire toll-free at (877) 316-3218, or
by e-mail at rmaniskas@rmclasslaw.com.

Popularity: 1% [?]

Acne Scar Treatment Study Sent To FDA

Fibrocell Science, a biotechnology company based in Exton PA, working on the development of autologous cell therapies submitted a clinical study report to the FDA, on it’s acne scar treatment.

The company says thorough analysis of study data contained in the report demonstrates that the study was statistically significant, and a significant regulatory milestone for the Company.

The Phase II/III, placebo-controlled study investigating the efficacy and safety of azficel-T for the treatment of moderate to severe acne scars evaluated a total of 109 individuals at seven U.S. clinical sites. In the study, both the Patient and Evaluator assessments met the co-primary endpoints four months after the final study treatment, and were statistically significant, achieving p-values of <0.0001 and 0.0109, respectively (p-values less than or equal to 0.05 are considered statistically significant).

“This is an important step towards another potential indication for our azficel-T lead therapy, which is currently under review by the FDA for use in the treatment of nasolabial fold wrinkles. Our therapy would be the first product of its kind available to address the large unmet need in treatment of acne scars, if approved by FDA.”

Chairman and CEO David Pernock

Acne Scars

The company says 43 percent of patients reported a response to the side of the face treated with azficel-T four months after the final study treatment, while 18 percent of patients reported a response on the placebo-treated side of the face. With respect to the Evaluator assessments, evaluators reported that 59 percent of patients responded on the side of the face treated with azficel-T, and that 42 percent of patients responded on the placebo-treated side of the face. Notably, significant improvement was also observed as soon as one month after the final azficel-T treatment.

Acne Scar Treatment Side Effects

No serious adverse events related to azficel-T were reported during the course of the Acne Scar Treatment study. Similar to the results from previous studies with azficel-T, the occurrence of local adverse event in this study was low, and the events reported were mostly mild in nature and of short duration.

“This is a unique product and may be life changing for patients with acne scarring,” said Girish Munavalli, M.D., MHS, Medical Director, Dermatology, Laser and Vein Specialists of the Carolinas, Charlotte, North Carolina. “I remain extremely excited about the study results and the activity seen with the use of azficel-T to treat acne scars. Since the study concluded, some of the study patients have returned to my clinic. During these visits, I have noticed sustained improvement in the appearance of their scarring, which I believe is the result of the azficel-T treatment administered during the clinical trial. Based on these observations and my overall experience with azficel-T, I am very positive about the use of Fibrocell’s product for this indication.”

Information for this Acne Scar Treatment story came from a Fibrocell Science, Inc press release.

Popularity: 2% [?]