BSD Medical Announces BSD-2000 Marketing Approval Submission; FDA Accepts Biogen's Biologics License Application For VIII Therapy Print E-mail
By Staff and Wire Reports   
Monday, 13 May 2013 18:57
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 13, 2013.

BSD Medical Corporation (NASDAQ: BSDM)
(www.BSDMedical.com), a leading provider of medical systems that utilize heat therapy to treat cancer, announced today that its exclusive Taiwan distributor Linden Bioscience Co., Ltd. (Linden), has submitted its BSD-2000 marketing approval application for the BSD-2000 Hyperthermia System (BSD-2000) to the Taiwan Food and Drug Administration (TFDA). The TFDA approval of the BSD-2000 could occur as early as November 2013.

“Since signing our exclusive distributor agreement with BSD, Linden has had ongoing and very productive meetings with the TFDA,” stated Mr. Tainang Huang, President of Linden. “We have filed the BSD-2000 marketing application with the TFDA, and we are working closely with the TFDA to obtain an expedited approval for marketing the BSD-2000 in Taiwan. We have also met with many prominent Taiwan physicians from several hospitals, including the very influential and largest hospital system in Taiwan, Chang Gung Memorial. As a result of our extensive efforts to introduce the BSD-2000 in Taiwan, we have been invited to present on the BSD-2000 at an international symposium on hyperthermia in Taipei, which will be held in November 2013 at Wan Fan Hospital, Taipei Medical University. We are excited about the interest expressed in the BSD-2000 in Taiwan.”


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Biogen Idec Inc (NASDAQ:BIIB)
announced that the U.S. FDA has accepted the Company`s Biologics License Application (BLA) for the marketing approval of ELOCTATE (recombinant factor VIII Fc fusion protein) for the treatment of hemophilia A.

ELOCTATE is the first hemophilia A product candidate in a new class of long-lasting clotting factor therapies being developed with the goal of providing long-lasting protection and reducing the burden of treatment for patients with this chronic condition. ELOCTATE is a clotting factor developed using Biogen Idec`s novel and proprietary monomeric Fc fusion technology, which makes use of a naturally occurring pathway to delay the destruction of factor and cycles it back into the bloodstream, resulting in a longer circulating half-life.


Also Monday:


Actinium Pharmaceuticals, Inc. (OTCBB: ATNM)
, a biopharmaceutical company that develops innovative targeted payload immunotherapeutics for treatment of advanced cancers, announced that the U.S. Patent and Trademark Office (USPTO) has allowed a key patent application in the Company's portfolio.

Adherex Technologies Inc. (TSX:AHX) (OTCQB:ADHXF)
, a biopharmaceutical company focused on the development of eniluracil and 5-fluorouracil, today reported its financial results and recent developments for the first quarter ended March 31, 2013.

Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE)
today announced that it will present at the following conference:  UBS Global Healthcare Conference, on Wednesday, May 22 2013 at 12:00 p.m. Eastern Time.

Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH)
, today announced financial results and business highlights for the quarter ended March 31st, 2013.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA)
today announced that it will present at the UBS Global Healthcare Conference being held in New York City. Harvey J. Berger, M.D., chairman and chief executive officer, will provide an overview of the Company’s business on Monday, May 20, 2013, at 8:30 a.m. (ET).

BIO-key International, Inc. (OTCQB: BKYI)
, a global leader in fingerprint biometric identification solutions, today reported that the company has executed an OEM agreement with Caradigm, a Microsoft and GE Healthcare company.

Bio-Rad Laboratories, Inc. (NYSE: BIO)
and (NYSE: BIO.B), today announced that it has been named one of "The Bay Area's Best Places to Work 2013" by a joint project of the San Francisco Business Timesand the Silicon Valley Business Journal. Bio-Rad appeared in the top 10 ranking in the category of companies that have over 1,501 employees in the Bay Area.

BioTime, Inc. (NYSE MKT: BTX)
and its subsidiary Cell Cure Neurosciences Ltd. (Cell Cure Neurosciences) today announced that Cell Cure Neurosciences has been awarded a grant of 5.34 million Shekels, approximately $1.5 million, for 2013 from Israel’s Office of the Chief Scientist (OCS) to help finance the development of OpRegen®, a cell-based therapeutic product in development by Cell Cure Neurosciences for the treatment of age-related macular degeneration.

Cambrex Corporation (NYSE: CBM)
is pleased to announce that Steven Klosk, President and Chief Executive Officer, will make a presentation on the Company at the UBS Global Healthcare Conference on May 20, 2013 at 1:00 p.m. EDT.

Cempra, Inc. (Nasdaq: CEMP)
, a clinical-stage pharmaceutical company focused on developing differentiated antibiotics to meet critical needs in the treatment of bacterial infections, today announced the signing of an exclusive license and development agreement for solithromycin with Toyama Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings Corporation in Japan.

Covidien plc (NYSE: COV)
today announced that its wholly-owned subsidiary, Covidien International Finance S.A. (CIFSA), launched an underwritten offering of senior notes.

Diagnostic Imaging International Corp. (OTCQB:DIIG)
announced today that it has filed its 10-Q report for the first quarter of 2013.

Dyax Corp. (NASDAQ: DYAX)
announced today that it has priced a registered direct offering with RA Capital Management, Venrock, Federated Investors, Inc. and one other institutional investor for gross proceeds of approximately $30 million.

Insmed Incorporated (NASDAQ: INSM)
, a biopharmaceutical company focused on developing and commercializing an inhaled anti-infective to treat patients battling serious lung diseases that are often life-threatening, today announced that Will Lewis, President and Chief Executive Officer of Insmed, will be presenting a corporate overview at the UBS Global Healthcare Conference taking place at The Sheraton New York Hotel in New York City from May 20-23, 2013.

Isis Pharmaceuticals, Inc. (NASDAQ: ISIS)
, the leader in antisense therapeutics, today announced that management will present a company overview at the 2013 UBS Global Healthcare Conference on Monday, May 20, 2013 at 9:00 a.m. ET in New York, NY.

La Jolla Pharmaceutical Company (OTCBB: LJPC)
(the "Company" or "La Jolla"), a leader in the development of therapeutics targeting galectin proteins, today reported the financial results for the three months ended March 31, 2013 and highlighted recent corporate progress.

Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX)
announced today that Arthur Sands, M.D., Ph.D., president and chief executive officer, will present at the Bank of America Merrill Lynch Healthcare Conference on Wednesday, May 15, at 3:00 PM PDT (6:00 PM EDT) in Las Vegas, Nevada.

Robert H. "Bob" Lorsch, CEO of MMRGlobal, Inc. (OTCQB: MMRF)
, blogs about the Company and humanitarian and philanthropic efforts to Free Dr. Shakil Afridi. This blog and others can also be viewed at http://blog.mmrglobal.com.

MYOS Corporation (OTCBB: MYOS)
, a company focused on the discovery, development and commercialization of muscle health nutritional supplements, functional foods, and therapeutic products, today issued a letter to its shareholders from the Company's Board of Directors.

Nanosphere, Inc. (NASDAQ: NSPH)
, a leader in the development and commercialization of advanced molecular diagnostics systems, announced today it has signed a distribution and collaboration agreement with Hitachi High-Technologies Corporation (Hitachi High-Tech).

Nuvilex, Inc. (OTCQB: NVLX)
COO Dr. Gerald Crabtree is no stranger to late stage clinical trials or dealing with blockbuster therapies for cancer patients. It's likely that is exactly why he is the COO at the small Silver Spring, Maryland, biotech.

Optimer Pharmaceuticals (NASDAQ: OPTR)
(the "Company" or "Optimer") today announced the appointment of Mr. Eric Sirota as Chief Operating Officer.  Mr. Sirota will be responsible for directing Optimer's corporate strategy with regard to DIFICID®.

PDI, Inc. (Nasdaq: PDII)
, today reported financial and operational results for the first quarter ended March 31, 2013.

Response Biomedical Corp. (TSX:RBM) (OTCBB:RPBIF)
today reported financial results for the quarter ended March 31, 2013.

Sigma-Aldrich Corporation (Nasdaq: SIAL)
today announced the launch of a novel scientific search engine designed to give researchers easier access to peer-reviewed articles and abstract information on the Company's website, sigma-aldrich.com.

TriStar Wellness Solutions, Inc. (OTCBB: TWSI)
, a health and wellness company that targets opportunities in the self-care and professional marketplace, has acquired HemCon Medical Technologies Inc., a Portland, Oregon-based leading researcher and manufacturer of products for bleeding and wound management.



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