FDA

Kensey Nash Corporation (Nasdaq: KNSY) announced that it has received 510(k) clearance for its first extracellular matrix (ECM) product, Medeor(TM) Matrix, from the U.S. Food and Drug Administration. The clearance allows for the use of Medeor Matrix in general surgery for the reinforcement and repair of soft tissue, including hernia repair and plastic and reconstructive surgical applications.

Medeor Matrix is a porcine-based dermal extracellular matrix designed to act as a biologic scaffold to stimulate the deposition of organized tissues specific to an injured site. These ECM products facilitate rapid revascularization and are therefore quickly repopulated with cells from the host tissue and ultimately converted into functional living tissue. Medeor Matrix is manufactured using Kensey Nash's proprietary Optrix(TM) process, which gently disinfects tissues, inactivates viruses and removes cells while preserving extracellular matrix components.

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Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Tap Pharmaceutical's proton pump inhibitor Prevacid (lansoprazole) Delayed-Release Capsules, 15 mg and 30 mg. Customers will begin receiving product on November 11, 2009.

Annual sales of Prevacid Delayed-Release Capsules were approximately $2.97 billion in the United States for the twelve months that ended June 30, 2009 based on IMS sales data.

Mylan Inc. (Nasdaq: MYL) received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Lansoprazole Delayed-release (DR) Capsules, 15 mg and 30 mg. This product is shipping immediately and will be sold under the Mylan Pharmaceuticals brand.

Lansoprazole DR Capsules are the generic version of Tap Pharmaceuticals' proton pump inhibitor Prevacid® DR Capsules.

Hemispherx Biopharma, Inc. (NYSE Amex: HEB) reports a Q3 loss of $0.02, 1 cent better than estimates.

On the seasonal and pandemic influenza prevention front, the Company continued discussions with its Japanese collaborative partners regarding proposed means to enhance the effectiveness of vaccines via its experimental therapeutic, Ampligen(R). In the prophylactic influenza protection area, the Company planned new clinical studies directed at North American clinical sites for Alferon(R) LDO, a new experimental oral formulation of its Food and Drug Administration (FDA) approved biologic, Alferon N Injection(R).

The FDA has not informed the Company as to any outstanding responses required in order to take action on the pending New Drug Application (NDA). The target date for action on the NDA under the Prescription Drug User Fee Act (PDUFA) was extended by the FDA in May, 2009. The Company is finalizing certain responses with respect to third-party based animal toxicology and manufacturing programs it believes should be considered post-approval issues and that do not constitute new or additional FDA requests.

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Wright Medical Group, Inc. (NASDAQ: WMGI) said the FDA has given approval to the Company to market its original CONSERVE® Plus Total Hip Resurfacing System. Now available in the United States, this innovative total surface arthroplasty system provides surgeons and their patients a bone-conserving alternative to traditional total hip replacement.