BG Medicine's Launch of Automated BGM Galectin-3 Test; FDA Acknowledged Resubmission of NDA for Merck's Ezetimibe, Atorvastatin Tablets Print
By Staff and Wire Reports   
Wednesday, 02 January 2013 20:09
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 2, 2013.

BG Medicine, Inc. (Nasdaq: BGMD)
, a company focused on the development and commercialization of novel cardiovascular diagnostics, announced the first automated version of the BGM Galectin-3(r) blood test has obtained a CE Mark, an important step in the company's commercial strategy.

The BGM Galectin-3 test will be distributed through bioMerieux's VIDAS(r) immunoassay platform which includes about 27,000 installed instruments worldwide. bioMerieux is one of four diagnostic instrument manufacturers partnering with BG Medicine to commercialize automated versions of the BGM Galectin-3 test, and the first to obtain a CE Mark. bioMerieux is preparing a phased launch of the test in Europe and in certain other territories that recognize the CE Mark.


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Merck (NYSE: MRK),
known as MSD outside the United States and Canada, announced the U.S. FDA has acknowledged the resubmission of a New Drug Application (NDA) for ezetimibe and atorvastatin tablets, an investigational combination medicine. The updated NDA was deemed complete for review after Merck submitted additional data in response to the FDA's Complete Response Letter issued last year. Merck expects the FDA's review to be completed in the first half of 2013.

Merck is continuing to move forward with planned filings for the ezetimibe and atorvastatin combination tablet in additional countries around the world.



Also Wednesday:



AbbVie (NYSE:ABBV)
today marks its launch as an independent biopharmaceutical company, with employees from more than 40 countries and patients joining AbbVie leaders as they ring the first opening bell of 2013 at the New York Stock Exchange.

ADVENTRX Pharmaceuticals, Inc. (NYSE MKT: ANX)
today announced that the Company's Chief Executive Officer, Brian M. Culley, will present at the 6th Annual OneMedForum Emerging Company Finance Conference on Tuesday, January 8, 2013 at 9:20 a.m. Pacific Time at The Sir Francis Drake hotel in San Francisco.

Align Technology, Inc. (NASDAQ: ALGN)
today announced that Thomas M. Prescott, president and chief executive officer of Align Technology, is scheduled to speak at the 31st Annual J.P. Morgan Healthcare Conference.

China Biologic Products, Inc. (NASDAQ: CBPO)
, a leading fully integrated plasma-based biopharmaceutical company in China, today announced that the construction of a new production facility at its Guizhou Taibang subsidiary could be delayed due to slower-than-expected government approval of land use rights.

DATATRAK International, Inc. (OTCQX: DATA)
, a leader in developing cloud-based, unified eClinical® technologies and delivering related services for the clinical trials industry, today announced its participation at industry events during the month of January.

EastBridge Investment Group Corporation (OTCQB: EBIG)
, a provider of financial consulting services to companies in Asia ("EBIG") today announced Cellular BioMedicine Group ("CBMG") has been invited to give a keynote speech at the 8th Annual New York Stem Cell Summit, February 19, 2013.

Edwards Lifesciences Corporation (NYSE: EW)
, the global leader in the science of heart valves and hemodynamic monitoring, is scheduled to present at the J.P. Morgan Healthcare Conference at the Westin St. Francis in San Francisco, California on Monday, January 7, 2013.

FluoroPharma Medical, Inc. (OTCQB: FPMI)
, a company specializing in the development of novel diagnostic imaging products that utilize positron emission tomography (PET) technology for the detection and assessment of disease before clinical manifestation, today announced that Thijs Spoor, Chairman, CEO and President of FluoroPharma Medical, will be presenting at two conferences in San Francisco on January 7 & 8, 2013.

Insulet Corporation (NASDAQ: PODD)
, the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, today announced the Company will participate in the 31st Annual J.P. Morgan Healthcare Conference at the Westin St. Francis Hotel in San Francisco. Management is scheduled to present an overview of the Company on Tuesday, January 8, 2013 at 2:30 p.m. PT (5:30 p.m. ET).

Isis Pharmaceuticals, Inc. (NASDAQ: ISIS),
the leader in antisense therapeutics, today announced that management will present a company overview at the 31st Annual J.P. Morgan Healthcare Conference on Wednesday, January 9, 2013 at 1:30 p.m. PT in San Francisco, CA.

Merus Labs International Inc. (TSX:MSL) (NASDAQ:MSLI)
is pleased to announce today its financial results for its fiscal year 2012.

Neogen Corporation (Nasdaq: NEOG)
announced today that it has acquired the assets of Scidera Genomics, LLC, an animal genomics business based in Davis, California.

NeuroMetrix, Inc. (Nasdaq: NURO),
www.neurometrix.com, a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, today announced that Shai N. Gozani M.D., Ph.D., President and Chief Executive Officer, is scheduled to speak at the 6th Annual OneMedForum at the Sir Frances Drake Hotel, San Francisco, CA on January 7-9, 2013.

NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today that Alex Lukianov, Chairman of the Board and Chief Executive Officer, is scheduled to present at the J.P. Morgan Healthcare Conference at the Westin St. Francis Hotel located at 335 Powell Street, San Francisco, CA, on Wednesday, January 9, 2013, at 9:00 a.m. PST.

Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX)
today announced that it will present at the 31st Annual J.P. Morgan Healthcare Conference on Monday, January 7, 2013 at 9:30 a.m. Pacific Time.

Phase Technologies, Inc. (OTCBB: XDSL)
reported today that it has been issued patent number 8,344,543 from the U.S. Patent & Trademark Office (USPTO).

Quidel Corporation (NASDAQ: QDEL)
, a leading provider of rapid diagnostic testing solutions and cellular-based virology assays, announced today that it will present at the 31st Annual J.P. Morgan Healthcare Conference to be held at The Westin St. Francis hotel in San Francisco, California on Wednesday, January 9, 2013.

Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR)
today announced that it has signed a definitive agreement to acquire all issued and outstanding shares of BioVectra Inc., for an upfront payment of C$50 million.

SafeCode Drug Technologies Corp. (OTCBB: SAFC)
, a developer of a voice recognition drug administration safety application announced today that the share Buyback Program which was authorized by the Board Of Directors will commence during the month of January 2013 and is expected to last approximately 1-3 months.

Sangamo BioSciences, Inc. (Nasdaq: SGMO)
announced today that Edward Lanphier, Sangamo's president and CEO, will provide an update on the progress of Sangamo's ZFP Therapeutic®development programs and an overview of the company's business strategy at 10:30 am PT (1:30 pm ET) on Wednesday, January 9, 2013, at the 31st Annual J.P. Morgan Healthcare Conference which will be held in San Francisco.

Soligenix, Inc. (OTCQB: SNGX)
(Soligenix or the Company), a development stage biopharmaceutical company, announced today that the Office of Orphan Products Development of the US Food and Drug Administration (FDA) has granted orphan drug designation to OrbeShield™ (oral beclomethasone 17,21-dipropionate or oral BDP) for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.

Stellar Pharmaceuticals Inc. (OTCQB:SLXCF) (OTCBB:SLXCF) (PINKSHEETS:SLXCF) (OTCQB:TBUFF) (OTCBB:TBUFF) (PINKSHEETS:TBUFF) ("Stellar" or "the Company"), a Canadian specialty pharmaceutical company, today announced it has changed the Company's name to Tribute Pharmaceuticals Canada Inc. and it has been assigned a new ticker 'TBUFF'.

The Medicines Company (NASDAQ: MDCO)
will present at the JP Morgan Healthcare Conference on Tuesday, January 8th in San Francisco at 4:00 pm Pacific Time (7:00 pm Eastern Time).

University General Health System, Inc. (OTCQB: UGHS)
, a diversified, integrated multi-specialty health care delivery system, today announced that it will be presenting at the Sidoti & Company Annual New York Micro-Cap Conference.



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