CORAL SPRINGS, Florida, December 29, 2015 /PRNewswire/ --

Biotechnology companies continue to forge ahead with advancing clinical trials and development of next-generation treatments for rare diseases through new orphan drug designations and cutting edge drug delivery products. Today's companies in the spotlight with achievements and recent developments are Amarantus BioScience Holdings, Inc. (OTCQX: AMBS), pSivida Corp. (NASDAQ: PSDV), Adamas Pharmaceuticals, Inc. (NASDAQ: ADMS), Auris Medical Holding AG (NASDAQ: EARS) and Cerus Corporation (NASDAQ: CERS).

Amarantus BioScience Holdings, Inc. (OTC: AMBS), a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, announced that it has requested Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) to treat GCMN with Engineered Skin Substitute (ESS). It is estimated that the incidence of GCMN, a rare dermatological condition present at birth, is between 8 and 80 births annually in the United States.

Read the full Amarantus (AMBS) Press Release at http://financialnewsmedia.com/profiles/ambs.html

The FDA defines a "rare pediatric disease" as a disease that affects fewer than 200,000 individuals in the U.S. primarily aged from birth to 18 years. Under the FDA's Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives an approval of a new drug application (NDA) or biologics license application (BLA) for a rare pediatric disease may be eligible for a voucher, which can be redeemed to obtain expedited FDA review for any subsequent marketing application. Vouchers  may be sold or transferred by the recipient; in the last 6 months, 2 priority review vouchers have been sold for a combined $595M in cash.  The FDA Orphan Drug Designation program provides a special status to drugs and biologics intended to treat, diagnose or prevent diseases and disorders that affect fewer than 200,000 people in the U.S. This designation provides for a seven-year marketing exclusivity period against competition, as well as certain incentives, including federal grants, tax credits and a waiver of PDUFA filing fees.

In other Biotech developments to watch this week:  pSivida Corp. (NASDAQ: PSDV), a leader in the development of sustained release drug delivery products for treating eye diseases, today announced that it plans to file for EU marketing approval of Medidur™ for chronic non-infectious uveitis of the posterior segment of the eye (posterior uveitis) based on data from a single pivotal trial as a result of the high statistical significance achieved in its first Phase 3 clinical trial. The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) advised pSivida that, consistent with the published Points to Consider (PtC) of the European Agency for Evaluation of Medicinal Products, an application for a product treating a condition like p