FDA Advisory Committee to Review for Affymax's Peginesatide; WuXi Acquires China Based Clinical Research Services Print E-mail
By Staff and Wire Reports   
Monday, 24 October 2011 19:09
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 24, 2011.

Affymax, Inc. (NASDAQ:AFFY) announced the FDA Oncologic Drugs Advisory Committee will review the New Drug Application (NDA) for peginesatide proposed for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis on December 7, 2011 during the afternoon session. The FDA has established an action date of March 27, 2012 under the Prescription Drug User Fee Act (PDUFA).

If approved, peginesatide will be the first once-monthly ESA available for the treatment of anemia associated with CKD patients on dialysis in the United States.

Peginesatide is a synthetic, PEGylated peptidic compound that binds to and stimulates the erythropoietin receptor and thus acts as an ESA. The NDA included data from two Phase 3 studies (EMERALD 1 and 2) that evaluated the efficacy and safety of peginesatide, dosed once every four weeks, compared to epoetin alfa or epoetin beta, dosed more frequently (according to the product labels) in maintaining hemoglobin (Hb) levels in CKD patients on dialysis with anemia.

The company intends to begin a self-imposed quiet period on November 16, 2011 in anticipation of receipt of FDA briefing documents, and this quiet period will continue until after the Advisory Committee meeting is completed.

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WuXi PharmaTech (Cayman) Inc. (NYSE:WX), announced the acquisition of MedKey Med-Tech Development Co. Ltd. and Jiecheng Med-Tech Development Co. Ltd., two related contract clinical research services companies based in Shanghai, China. The financial terms of the transaction were not disclosed.

Founded in 2006, MedKey/Jiecheng have about 80 employees and operate in 15 cities in China, with offices in Shanghai, Beijing, and Guangzhou. The companies provide services in regulatory affairs, Phase I-IV clinical trial management, and clinical trial site management throughout most of the regions in China.


Also Monday:


Accuray Incorporated (Nasdaq: ARAY), the premier radiation oncology company, today announced that it will report results for its first quarter of fiscal year 2012, ended September 30, 2011 on Tuesday, November 8, 2011 after the market closes.

Affymax, Inc. (Nasdaq:AFFY) today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for peginesatide proposed for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis on December 7, 2011 during the afternoon session.

Array BioPharma Inc. (Nasdaq:ARRY) will report financial results for the first quarter of fiscal 2012 on Monday, October 31, 2011, and will hold a conference call on Tuesday, November 1, 2011 at 9:00 a.m. eastern time to discuss these results.

Arrowhead Research Corporation (NASDAQ: ARWR)
, today announced that it has acquired RNA therapeutics assets from Roche (SIX: RO, ROG; OTCQX: RHHBY) including the state-of-the-art research site in Madison, WI.

Bacterin International Holdings, Inc. (NYSE Amex: BONE), a leader in the development of revolutionary bone graft material and antimicrobial coatings for medical applications, has been awarded approved vendor status by American Medical Concepts (AMC), the largest multi-specialty Orthopedic, Spine and Neuro distribution company in the Northwest region of the U.S.

BioClinica®, Inc., (NASDAQ: BIOC), a global provider of clinical trial management solutions, today announced it ranked 30 on Deloitte’s 2011 Greater Philadelphia Fast 50 ranking of the 50 fastest growing technology, media, telecommunications, life sciences and clean technology companies in the Greater Philadelphia region.

Bruker Corporation (NASDAQ: BRKR) announced today that it plans to release its third quarter 2011 financial results on Thursday, October 27th, 2011 before the market opens.

Cigna Corporation (NYSE: CI) and HealthSpring, Inc. (NYSE:HS) today announced that they have signed a definitive agreement under which Cigna will acquire all the outstanding shares of HealthSpring for $55 per share in cash, a 37% premium over the closing stock price on Friday October 21, 2011, representing a total transaction value of approximately $3.8 billion.

Compugen Ltd. (NASDAQ: CGEN) today announced that the Company will host a conference call at 10:00 AM EST on Tuesday, November 8, 2011 to review third quarter 2011 results.

DxTerity Diagnostics, Inc. and Caliper Life Sciences, Inc. (NASDAQ: CALP) announced today that the companies have entered into a co-development and co-marketing strategic collaboration that will allow researchers to perform DxTerity's NEAT multiplex diagnostic assays on Caliper's LabChip Dx instrument platform minimizing sample processing time without compromising data quality.

Exelixis, Inc. (NASDAQ:EXEL) today reported top-line results from the ongoing phase 3 clinical trial of cabozantinib in patients with advanced medullary thyroid cancer (MTC), known as the EXAM trial.

GeneLink BioSciences, Inc. (OTC Bulletin Board: GNLK)
, a leading consumer genomics biotech company, today announced that it ranked number 33 on Technology Fast 500™, Deloitte's ranking of 500 of the fastest growing technology, media, telecommunications, life sciences and clean technology companies in North America. GeneLink grew 4,363 percent during the period 2006-2010.

GeneLink BioSciences, Inc. (OTC Bulletin Board: GNLK)
, a leading consumer genomics biotech company, today announced that it ranked number 33 on Technology Fast 500™, Deloitte's ranking of 500 of the fastest growing technology, media, telecommunications, life sciences and clean technology companies in North America. GeneLink grew 4,363 percent during the period 2006-2010.

Generex Biotechnology Corporation (OTCBB: GNBT) (www.generex.com) announced today that the Company is planning an investor update conference call for late November.

Halozyme Therapeutics, Inc. (Nasdaq: HALO)
, a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, for the diabetes, cancer, dermatology and drug delivery markets, today announced its upcoming poster presentation for PEGPH20 at the 2011 EORTC-NCI-ASCO Annual Meeting, taking place October 27-29 in Brussels, Belgium.

Harwood Feffer LLP (www.hfesq.com) is investigating potential claims against the board of directors of Adolor Corp. (NASDAQ: ADLR) concerning the proposed acquisition of the Company by Cubist Pharmaceuticals, Inc. (“Cubist”).

Lakeland Industries, Inc. (NASDAQ: LAKE), a leading manufacturer of industrial protective clothing for industry, municipalities, healthcare and to first responders on the federal, state and local levels, today announced that it will be presenting at the Singular Research sixth annual "Best of the Uncovereds" Conference on Wednesday, October 26, at the Luxe Hotel in Los Angeles, CA.

Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) announced today that it will host a panel discussion in San Francisco, on Monday, November 7, 2011 to review and discuss the Promacta Phase III ENABLE 1 study results.

Marshall Edwards, Inc. (Nasdaq: MSHL), an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced today that Charles Baltic, Managing Director and Co-Head of Healthcare at Needham & Company, has been appointed to its board of directors.

Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company focused on the development and commercialization of next-generation antibodies for the treatment of cancer, today announced that it will host a conference call and audio webcast to review its third quarter 2011 financial results on Tuesday, November 8, 2011, at 8:30 AM ET.

Neoprobe Corporation (NYSE Amex: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced it would report its financial results for the third quarter of 2011 on Wednesday, October 26, 2011 after market close.

Omega Protein Corporation (NYSE : OME), a nutritional ingredient company and the nation's leading producer of Omega-3 fish oil and specialty fish meal products, today announced that it has retained Lipid Technologies, LLC as a strategic advisor in connection with its omega-3 fish oil and omega-3 concentrate research and development efforts.

ShangPharma Corporation (NYSE: SHP) ("ShangPharma" or the "Company"), a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today announced that it has, through its main Chinese subsidiary, Shanghai ChemPartner Co. Ltd. ("ChemPartner"), acquired the assets in Charles River Laboratories International, Inc.'s ("Charles River") Shanghai research facility.

Syneron Medical Ltd. (NASDAQ: ELOS), the leading global aesthetic device company, today announced that it will release third quarter 2011 financial results before the market opens on Thursday, November 10, 2011.

Unilife Corporation (NASDAQ: UNIS; ASX: UNS) today announced that the Company's fiscal 2011 annual report to stockholders and its proxy materials for its 2011 annual meeting of stockholders are now available via the Internet under the U.S. Securities and Exchange Commission's Notice and Access rules and may be viewed on Unilife's Investor Relations website at http://ir.unilife.com/financials.cfm.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the initiation of a Phase 3b study called CONCISE that will evaluate the potential for treatment with INCIVEK™ (telaprevir) combination therapy to be shortened to 12 weeks in people with genotype 1 chronic hepatitis C who have the ‘CC’ variation near the IL28B gene. INCIVEK (in-SEE-veck) is administered in combination with pegylated-interferon and ribavirin.

Wright Medical Group, Inc. (NASDAQ: WMGI) today announced that it will host a conference call on Tuesday, November 1, 2011 at 3:30 p.m. Central Time to discuss the Company’s operating results for its third quarter ended September 30, 2011.

WuXi PharmaTech (Cayman) Inc. (NYSE: WX), a leading pharmaceutical, biotechnology and medical device research and development services company with operations in China and the United States, today announced the acquisition of MedKey Med-Tech Development Co. Ltd. and Jiecheng Med-Tech Development Co. Ltd., two related contract clinical research services companies based in Shanghai, China. The financial terms of the transaction were not disclosed.



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