Onyx Pharma's Phase 3 Trial of Regorafenib Meets Primary Endpoint; Amylin Completes Biologics License Application for Metreleptin

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By Staff and Wire Reports   
Tuesday, 03 April 2012 18:45
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 3, 2012.

Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX)
announced results from the Phase 3 trial GRID (GIST – Regorafenib in Progressive Disease) evaluating the investigational compound regorafenib (BAY 73-4506), a Bayer-owned compound, for the treatment of patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib. The trial met its primary endpoint of statistically significant improvement in progression-free survival.  In this trial, the safety and tolerability of regorafenib were consistent with what was seen in earlier studies. Data from the study are expected to be presented at an upcoming scientific meeting. The GRID study was sponsored by Bayer with academic leadership from the principal investigator George Demetri, M.D., Director of the Ludwig Center at the Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, U.S.A. The study started in January 2011 and completed enrollment by July 2011.

"GIST is a difficult disease to treat. Patients treated with currently available therapies have a high likelihood that their disease will progress, and there are no remaining treatment options for those patients whose prior therapies have failed," said Ted W. Love, M.D., Executive Vice President, Research and Development and Technical Operations at Onyx Pharmaceuticals. "These clinical data will show regorafenib's activity in patients with previously treated GIST."  

Bayer is in ongoing discussions with health authorities worldwide. The company has plans to file for U.S. approval of regorafenib in the treatment of metastatic GIST.


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Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) announced it has completed its Biologics License Application submission to the U.S. Food and Drug Administration for the use of metreleptin to treat diabetes and/or hypertriglyceridemia (high levels of triglycerides in the bloodstream) in pediatric and adult patients with rare forms of lipodystrophy.

The rolling BLA submission was initiated in December 2010 with the clinical and nonclinical sections; Amylin has now submitted the chemistry, manufacturing, and controls (CMC) section to complete the BLA. Metreleptin has Fast Track designation for use in lipodystrophy patients.



Also Tuesday:




Abiomed, Inc. (NASDAQ: ABMD)
, a leading provider of break-through heart support technologies, today announced the successful first human use of the Impella cVADTM device, a new, percutaneous Impella heart pump that provides peak flow of approximately 4 liters of blood per minute.

athenahealth, Inc. (NASDAQ: ATHN)
, a leading provider of cloud-based practice management, electronic health record (EHR), and care coordination services to medical groups, today named Dr. Abraham Verghese and Rosedale Infectious Diseases recipients of this year’s athenahealth Vision Award.

Bio-Path Holdings, Inc., (OTCBB: BPTH)
(“Bio-Path”), a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, today announced operational and financial results for the year ended December 31, 2011.

Biovest International, Inc. (OTCQB:BVTI)
, a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB:ABPI), today announced the international members of its Scientific Advisory Board (SAB) comprised of key opinion leaders from prestigious institutions such as the Sunnybrook-Odette Cancer Centre at the University of Toronto, University of Cologne and University of Nottingham.

Cerus Corporation (NASDAQ: CERS)
announced today that Al Shalan, Cerus’ exclusive distributor for Saudi Arabia, has signed a three-year agreement with the King Faisal Specialist Hospital, a leading medical center in Saudi Arabia, to supply the INTERCEPT Blood System for platelets.

Codexis, Inc. (Nasdaq:CDXS)
announced today that collaborative research conducted by Merck and Codexis scientists to develop a highly efficient, enzyme-based production method for a key intermediate in the production of boceprevir has been recently published in the Journal of the American Chemical Society (JACS).

CytoDyn Inc. (the "Company") (OTC QB:CYDY)
, a biotechnology company focused on the development of new therapies for combating infection with immune deficiency virus and other antibody applications, announced today that Kenneth J. Van Ness, the Company's President and Chief Executive Officer, will be presenting at The Wall Street Forum's 23rd Annual Analyst Conference on Tuesday, April 10, 2012 at 9:50 am EST.

EnteroMedics Inc. (NASDAQ: ETRM)
, the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that it has made the first commercial shipment of the Maestro® Rechargeable (RC) System to its distribution partner in Australia, Device Technologies Pty Ltd.

EnteroMedics Inc. (NASDAQ: ETRM)
, the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced 2.5-year diabetes, hypertension and weight loss data from the Company's DM2 ENABLE Study of VBLOC® vagal blocking therapy delivered via the Maestro® Rechargeable (RC) System.

Furiex Pharmaceuticals, Inc. (NASDAQ: FURX)
will release its first quarter 2012 financial results on Thursday, May 3, 2012, after the market closes. The earnings news release will be available on the Furiex website at www.furiex.com.

Navidea Biopharmaceuticals, Inc. (NYSE Amex: NAVB)
, a specialty pharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that data from a meta-analysis comparing 99m-Tc-Tilmanocept (Lymphoseek®) to sulfur colloid were presented at a session of the Sentinel Node Oncology Foundation and International Sentinel Lymph Node Working Group in Orlando, Florida, March 20-21, 2012.

Navidea Biopharmaceuticals, Inc. (NYSE Amex: NAVB)
today announced that yesterday it received notification from the United States Food and Drug Administration (FDA) that the Prescription Drug User Fee Act (PDUFA) date for 99m-Tc-Tilmanocept (Lymphoseek®), has been modified to September 10, 2012, a 90-day extension from the initial PDUFA date of June 10th. Lymphoseek is an investigational, proprietary radioactive tracing agent for lymphatic mapping and lymphoscintigraphy.

Nuvilex, Inc. (OTCQB:NVLX)
, an emerging biotechnology provider of cell and gene therapy solutions through acquisition of SG Austria assets, realizes the important role for Cell-in-a-Box® technology and aims to bring to light its use in the production of therapeutic antibodies for clinically important diseases.

SANUWAVE Health, Inc. (OTCBB: SNWV)
today reported publication of peer-reviewed, preclinical data conducted at Heidelberg University Hospital, the largest medical center in Germany, that demonstrates the ability of the Company’s dermaPACE® technology to improve skin flap survival after a specific type of tissue injury known as ischemia-reperfusion (IR) injury.

Walgreens (NYSE:WAG) (NASDAQ:WAG)
presented new data last week at the Centers for Disease Control and Prevention’s 2012 National Immunization Conference, providing evidence of the company’s leadership in expanding access to immunizations and support of disease prevention in the United States.



BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read in the About Us Section

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