Apricus to File for Market Authorization to Sell Vitaros. Pluristem To Expand Manufacturing With New GMP Facility. Print E-mail
By Staff and Wire Reports   
Monday, 08 August 2011 19:11
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 8, 2011.

Apricus Bioscience Inc (NASDAQ:APRI) announced it will file for market authorization to sell its erectile dysfunction drug, Vitaros, in Latin America.

The Company also stated that it has engaged the services of Quintiles Global Regulatory Affairs, a international regulatory consultancy, to prepare its regulatory filings for Vitaros for marketing approval in the following Latin American countries: Mexico, Brazil, Argentina, Colombia, Chile and Peru.

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Pluristem Therapeutics Inc. (Public, NASDAQ:PSTI) announced its wholly owned Israeli subsidiary, Pluristem Ltd., has entered into an agreement with MTM -- Scientific Industries Center Haifa Ltd., for the leasing and construction of a new GMP manufacturing facility. The new facility will be located near the company's headquarters and existing facilities in MATAM Park, Haifa, Israel and will support the manufacturing of Pluristem's PLX (PLacental eXpanded) cell product candidates for the treatment of critical limb ischemia (CLI), intermittent claudication (IC), adjuvant hip replacement surgery, muscle injuries, pulmonary hypertension (PH) and other diseases.

According to the agreement, the lease of the new facility will start as of January 2012 for a period of approximately five years with an option to extend the lease for an additional five years.

Pluristem's new regenerative medicine facility will be cGMP/GTP compliant for clinical cell manufacturing and designed specifically to meet both EMA and FDA regulatory requirements, as well as the standards outlined by the Israeli Ministry of Health. Once constructed, the new facility would have the capacity to produce PLX cells for the treatment of over 150,000 patients annually.


Also Monday:


ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, has hired Edelman, the leading full service global public relations firm, to support its media outreach initiatives.  

Ardea Biosciences, Inc. (Nasdaq:RDEA), a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases, today reported recent accomplishments and financial results for the second quarter and six months ended June 30, 2011.

Bacterin International Holdings, Inc. (NYSE Amex:BONE), a leader in the development of revolutionary bone graft material and anti-infective coatings for medical applications, achieved its most productive processing month in July.

Bionovo, Inc. (NASDAQ:BNVI) today announced second quarter highlights and financial results for the three months ended June 30, 2011.

China Biologic Products, Inc. (Nasdaq:CBPO) ("China Biologic" or the "Company"), a leading plasma-based biopharmaceutical company in China, today announced that it will host its earnings conference call covering its second quarter 2011 results on August 10, 2011 at 7:00 a.m. EDT (New York), which is also 7:00 p.m. in China on the same day.

China Medical Technologies, Inc. (CMED) (Nasdaq:CMED), a leading China-based advanced in-vitro diagnostic ("IVD") company, and Leica Biosystems, a division of Leica Microsystems, a world leader in microscopes and scientific instruments, today announced that they have established a sales, research and development collaboration to co-develop and market automated FISH kitsto be used on the Leica BOND

China Sky One Medical, Inc. ("China Sky One Medical" or "the Company") (NASDAQ:CSKI), a leading fully integrated pharmaceutical company in the People's Republic of China ("PRC"), today announced that it will conduct a conference call at 9:30 a.m. Eastern Time (ET) on Wednesday, August 10, 2011, to discuss second quarter 2011 financial results.

Dendreon Corporation (Nasdaq:DNDN) today announced that management will present at the Canaccord Genuity Growth Conference in Boston, MA on August 10 at 5:00 PM EDT.

Hospira, Inc. (NYSE:HSP), the world leader in generic injectable pharmaceuticals, today announced U.S. Food and Drug Administration (FDA) approval of gemcitabine injection, a solution form of the drug.

Inovio Pharmaceuticals, Inc. (NYSE AMEX:INO) today reported financial results for the quarter ended June 30, 2011.

Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, today updated its drug development progress and reported financial results for the three and six months ended June 30, 2011.

Luminex Corporation (NASDAQ:LMNX) today announced financial results for the second quarter ended June 30, 2011.

NeoStem, Inc. (NYSE Amex:NBS) ("NeoStem" or the "Company"), an international biopharmaceutical company with a focus on cell based therapeutics development, today announced that the Department of Defense (DOD) Peer Reviewed Medical Research Program (PRMRP) of the Office of the Congressionally Directed Medical Research Programs (CDMRP) has awarded NeoStem $1,780,049 to be applied towards funding the Company's VSELā„¢ Technology.

Neuland Laboratories Ltd., (NSE: NEULANDLAB) a pharmaceutical manufacturer providing active pharmaceutical ingredients (APIs), complex intermediates, and contract research and manufacturing services to customers located in 85 countries, today announced financial results for the first quarter of fiscal year (FY) 2012, ended June 30, 2

NeurogesX, Inc. (Nasdaq:NGSX), a biopharmaceutical company focused on developing novel pain management therapies, today announced that it has entered into a $20 million loan agreement with Hercules Technology Growth Capital, Inc. (Nasdaq: HTGC).  

Oncothyreon Inc. (NASDAQ:ONTY) today reported financial results for the second quarter ending June 30, 2011.

Sinovac Biotech Ltd. (Nasdaq:SVA), a leading provider of biopharmaceutical products in China, announced today the resignation of Jacob Chik Keung Ho, its Chief Financial Officer, for personal reasons.

VIVUS, Inc. (NASDAQ:VVUS) today announced that additional data from the phase 3 QNEXA studies will be presented today during the American Association of Diabetes Educators (AADE) meeting in Las Vegas, NV.



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