FDA approves Shire drug for HAE. Pluristem's PLX Cells Receive Orphan Drug Status for Treatment of Buerger's Disease. Print E-mail
By Staff and Wire Reports   
Thursday, 25 August 2011 19:07
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 25, 2011.

The U.S. Food and Drug Administration gave the go ahead to Shire Plc's (NASDAQ:SHPGY) drug for a rare genetic disease and also let patients self-inject the medication, giving the company a boost over rivals.

FDA  said on Thursday that Shire's drug, Firazyr, could be used by people ages 18 and older to treat attacks of hereditary angioedema (HAE).  HAE can cause sudden attacks of swelling in areas such as the hands, arms, feet, face or breathing passages. It affects less than 30,000 people in the United States, Shire said.

The FDA also said patients could inject the drug themselves without needing a hospital visit, following recommendations of an advisory panel in June.

The decision gives the drug a boost versus similar treatments from Dyax Corp (NASDAQ:DYAX) and CSL Ltd's CSL Behring, which must be injected by doctors or intravenously for acute attacks.


Pluristem Therapeutics, Inc. (NASDAQ:PSTI) announced the U.S. Food and Drug Administration (FDA) designated Pluristem’s PLX cells orphan status for the treatment of thromboangiitis obliterans (Buerger's disease). The Company also announced that a concurrent application in Europe at the EMA’s Committee for Orphan Medicinal Products is pending.

Buerger’s Disease, or thromboangiitis obliterans, is a rare and severe disease affecting the blood vessels of the extremities. It is characterized by inflammation and clotting of the vessels that result in a reduced blood flow to these areas. Severe pain and ulcers or necrosis of the extremities may occur, which may lead to amputation.

Zami Aberman, Chairman, President and CEO of Pluristem commented, “We are extremely pleased that our PLX cells have been designated orphan status by the FDA and look forward to receiving a similar designation in Europe. In anticipation of this designation, we have been working diligently in readying clinical sites, primarily in India, where there is a high prevalence of Buerger's. In addition, the inclusion of Buerger's completes our plan to make our PLX cells available for the entire spectrum of peripheral vascular disorders and allows us to benefit from the market exclusivity and other regulatory and financial advantages that accompany this designation."

Also Thursday:

BioElectronics Corp. (OTCQB: BIEL) (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free topical pain devices, today announced a new clinical study designed to prove the efficacy and safety of its products for post-operative pain reduction following Cesarean Section surgical procedures. Jose Carvalho, MD, PhD, FANZCA, FRCPC, Professor and Director of Anesthesia and Obstetrics and Gynecology, University of Toronto, Mount Sinai Hospital, a leading authority on pain management, is the lead investigator for this significant post-operative pain study. As of today, approximately 20% of the 200 patient IRB-supervised, double blinded, placebo-controlled study has been completed.

Cyberonics, Inc. (NASDAQ:CYBX) today announced results for the quarter ended July 29, 2011.

Merlin Nexus and New Leaf Venture Partners (NLV Partners) have contested the terms of Icagen's (Nasdaq:ICGN) proposed acquisition by Pfizer Inc (NYSE:PFE) in a letter filed today with the SEC.  

NeoStem, Inc. (NYSE Amex:NBS) ("NeoStem" or the "Company"), an international biopharmaceutical company with a focus on cell-based therapeutic development, today announced that the Company was featured on CBS's Eye on New York City on Wednesday evening, August 24, 2011.

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today submission of its New Drug Application (NDA) clinical data package to the United States Food and Drug Administration (FDA) for MoxDuo IR, an immediate-release Dual Opioid® pain therapy comprised of a patented 3:2 fixed ratio combination of morphine and oxycodone.

Shire plc (LSE: SHP, NASDAQ:SHPGY), the global specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for FIRAZYR® (icatibant injection) for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

SyntheMed, Inc. (OTC Bulletin Board:SYMD; Pink Sheets:SYMD) announced that its stockholders approved the planned merger with Pathfinder, LLC at SyntheMed's special meeting of stockholders held today.

TheraBiogen, Inc. (OTCBB: TRAB), a manufacturer and distributor of homeopathic nasal sprays for aiding in the relief of allergies, cold and flu symptoms and migraine headaches, today announced the recent publication of an independent study by Donald F. Smee, Brett L. Hurst and Min-Hui Wong of Utah State University, published in Antiviral Chemistry & Chemotherapy 2011.

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