Edwards submitted application for FDA review of new heart valve. Print E-mail
By BioMedReports.com Staff   
Tuesday, 07 June 2011 19:08
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 7, 2011.

Edwards Lifesciences Corp (NYSE:EW) said a U.S. regulatory advisory panel will review its application on July 20 to sell the Sapien aortic heart valve that spares patients the need for open-heart surgery.

Edwards submitted its application to the U.S. Food and Drug Administration last fall based on data from the Cohort B portion of its Partner clinical trial for patients with severe aortic stenosis, a narrowing of the valve, who are considered too sick for open-heart surgery.

If approved, the Edwards valve would be the first so-called trans-catheter aortic valve sold in the United States. Edwards has been selling such a valve in Europe since 2007.

Wells Fargo Securities analyst Larry Biegelsen said the Edwards valve appears on track for a U.S. launch in the fourth quarter of this year.

He said he expects an FDA panel to review Cohort A data from the Partner trial late this year or in early 2012.


Also Tuesday:


TheDirectory.com, Inc. (PINKSHEETS: EYSM) today announced that it has signed a letter of intent to acquire a profitable online directory network with more than 500 active websites and URLs.

Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that a U.S. Food and Drug Administration (FDA) Advisory Panel is scheduled to review the company's Premarket Approval (PMA) application for its Edwards SAPIEN transcatheter heart valve on July 20, 2011.

Infrared Systems International (OTCBB: IFRS) is pleased to announce that its subsidiary, AquaLiv, Inc., has concluded a pilot study of its NatuRx™ HIV/AIDS treatment and will push forward with clinical trials in Kenya later this year.

Kendle (Nasdaq:KNDL), a leading, global full-service clinical research organization (CRO), today announced the appointment of Pierre Geoffroy, MD, CM, MSc, FCFP as Vice President, Early Stage, effective immediately.

Nektar Therapeutics (NASDAQ: NKTR) announced today positive interim data from an ongoing single-dose Phase 1 clinical trial evaluating NKTR-181, the company's novel mu-opioid analgesic candidate.

News announcements from Northwest Biotherapeutics (OTCBB: NWBO) have shown real movement, growing momentum, and interest from outside entities/partners in both the U.S. and Europe for its ongoing late-stage 240-patient clinical trial of DCVax® immune therapy for Glioblastoma multiforme (GBM), the most lethal form of brain cancer.

Onyx Pharmaceuticals, Inc. (Nasdaq:ONXX) today announced the presentation of several studies evaluating carfilzomib, a selective, next-generation proteasome inhibitor, at the 16th Congress of the European Hematology Association (EHA) Annual Meeting, June 9-12, 2011 in London, UK.

Regenicin, Inc. (OTCBB: RGIN) announces today that Dr. Craig Eagle who sits on the Regenicin Board of Directors, attended The World Stem Cells and Regenerative Medicine Congress 2011 in efforts to further Regencin's push towards obtaining FDA approval for the commercial sale of its first product candidate.

Sinovac Biotech Ltd. (NASDAQ:SVA), a leading developer and provider of vaccines in China, announced today that it will hold its 2011 Annual Meeting of Shareholders on Thursday, July 14, 2011 at 9:00 a.m. Beijing Time.

Telik, Inc. (Nasdaq:TELK) today announced the initiation of a Phase 2 clinical trial to evaluate oral Telintra in patients with Revlimid refractory or resistant, deletion 5q myelodysplastic syndrome (del 5q MDS).



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