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CytRx' bafetinib receives EMEA COMP positive opinion for treatment of CML

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced that bafetinib (formerly known as INNO-406) has received official notification from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) that a positive opinion was made regarding the application for orphan medicinal product for the treatment of chronic myeloid leukemia (CML).

20 Apr 2010

TYSABRI drives Biogen Idec's first-quarter revenues of $1.1 billion

Biogen Idec Inc., a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today announced its first quarter 2010 results.

20 Apr 2010

Acorda Therapeutics to initiate Phase 1 clinical trial of GGF2 for heart failure in mid-2010

Acorda Therapeutics, Inc. today announced plans to initiate a Phase 1 single-dose clinical trial of the Company's compound, Glial Growth Factor 2 (GGF2), in patients with heart failure in mid-2010, based on an IND filed with the U.S. Food and Drug Administration (FDA) on March 19, 2010. GGF2 has been shown to protect heart muscle and restore cardiac function in preclinical models of heart failure, myocardial infarction and cardiotoxicity.

20 Apr 2010

Medical device industry leaders to meet with lawmakers, government officials at MDMA annual meeting

As the U.S. Food and Drug Administration is reviewing pivotal regulatory procedures for one of America's fastest growing sectors, industry leaders will gather to meet with lawmakers and government officials at the 16th Annual Meeting of the Medical Device Manufacturers Association on May 24-26, 2010 at the Park Hyatt in Washington, DC.

20 Apr 2010

STERIS reaches agreement with FDA over liquid chemical sterilization system consent decree

STERIS Corporation today announced it has reached an agreement with the U.S. Food and Drug Administration (FDA) on the terms of a consent decree regarding its SYSTEM 1® liquid chemical sterilization system. Included in the agreement is a Transition Plan with a Rebate Program for current SYSTEM 1 Customers in the U.S. The consent decree is subject to approval by the U.S. District Court for the Northern District of Ohio.

20 Apr 2010

ATS Medical announces first ATS 3f Aortic Bioprosthesis commercial implant in China

ATS Medical, Inc., manufacturer and marketer of state-of-the-art cardiac surgery products and services today announced the first commercial implant of the ATS 3f® Aortic Bioprosthesis was recently completed by Liu Zhi Gang, MD at Fu Wai Hospital in Beijing, China. Fu Wai Hospital is the largest cardiac surgery center in Asia and a full line of ATS products are utilized by their surgeons. ATS received permission from the Chinese State Food and Drug Administration (SFDA) to market the ATS 3f Aortic Bioprosthesis in March.

20 Apr 2010

UnitedHealth Group's consolidated first-quarter 2010 revenues increase 5% to $23.2 billion

UnitedHealth Group today reported first quarter results, including better-than-projected membership and services growth and effective cost management across its businesses. Financial metrics were in line with or better than Company expectations.

20 Apr 2010

MicroStockProfit.com releases investment report on AEterna Zentaris

MicroStockProfit.com announces an investment report featuring AEterna Zentaris Inc. The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.

20 Apr 2010

FFHS food rating system now available on food manufacturer boxes

Foodfacts.com today announced that the Food Facts Health Score (FFHS) is now available on food manufacturer boxes, signaling a huge consumer advancement for the expanded use of the world's first food rating system of this type.

20 Apr 2010

Hematological malignancies conference to provide update on blood-borne cancer

John Theurer Cancer Center at Hackensack University Medical Center will host a hematological malignancies conference for physicians and patients on Friday, April 23 and Saturday, April 24. The event, entitled "Current and Innovative Modalities in the Management of Hematological Malignancies", is part of John Theurer Cancer Center's commitment to provide both healthcare professionals as well as patients with an update on the newest advances in the field of blood-borne cancers.

20 Apr 2010

Ga. couple allegedly took Medicare, Medicaid payments while patients were shorted food, medicine

The Atlanta Journal Constitution: "George D. Houser, 62, and his wife, 46-year-old Rhonda Washington Houser, were arraigned Friday on charges of conspiring to defraud the Medicare and Georgia Medicaid programs. George Houser also faces charges for allegedly failing to pay payroll taxes to the IRS and file personal income tax returns."

20 Apr 2010

Avian flu's endurance in 5 countries poses global threat to human health, FAO official says

Though the world has made "great strides" in eliminating H5N1 (avian flu) from poultry since the "peak of its outbreak in 2006" in 63 countries, the virus persists in Bangladesh, China, Egypt, Indonesia and Vietnam, VOA News reports (DeCapua, 4/16).

20 Apr 2010

ITI granted AOAC approval for additional Salmonella matrices

Idaho Technology, Inc. (ITI) has received AOAC Performance Tested Method approval for two additional Salmonella matrices—stainless steel environmental samples and dry pet food. These matrices join the list of already approved matrices in the Salmonella LT Food Security System including chocolate, cooked ham, fresh raw chicken, lettuce, raw ground beef, and liquid whole eggs. This assay uses real-time PCR technology to identify the presence of Salmonella in less than one hour after a pre-enrichment period.

20 Apr 2010

FDA launches CDRH Transparency Web site as part of agency's transparency initiative

The U.S. Food and Drug Administration launched the Center for Devices and Radiological Health Transparency Web site today as part of the agency's transparency initiative. The site will provide information about medical device and radiation-emitting product regulatory processes and decisions, and summaries of data that provide the rationale for agency actions.

20 Apr 2010

FDA approves Lannett's ANDA for Ondansetron Injection USP, 2 mg/mL, Multi-Dose Vials

Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Ondansetron Injection USP, 2 mg/mL, Multi-Dose Vials. Ondansetron Injection USP, 2 mg/mL is the generic equivalent of GlaxoSmithKline's Zofran® Injection, 2 mg/mL. For the 12 months ending December 2009 U.S. sales of Ondansetron Injection USP, 2 mg/mL were approximately $58 million at Average Wholesale Price (AWP). A launch date for the product has not yet been set.

20 Apr 2010

Higher intake of vitamin K from dietary sources associated with lower risk of Non-Hodgkin lymphoma

In the first study of vitamin K and Non-Hodgkin lymphoma risk, researchers at the Mayo Clinic campus in Minnesota have found that people who have higher intakes of vitamin K from their diet have a lower risk of developing Non-Hodgkin lymphoma.

20 Apr 2010

Updated survival data from Phase I/II trial of nab-paclitaxel, gemcitabine combination for pancreatic cancer

Abraxis BioScience, Inc., a fully integrated biotechnology company, today announced updated overall survival findings from a phase I/II study of nab®-paclitaxel (ABRAXANE® for Injectable Suspension) (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) given in combination with gemcitabine, demonstrated increased survival of the first-line treatment of patients with advanced pancreatic cancer.

19 Apr 2010

Generex Biotechnology announces plan to obtain cost reimbursement coverage for Generex Oal-lyn

Generex Biotechnology Corporation, the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has established an action plan for obtaining cost reimbursement coverage for Generex Oal-lyn™, including the development of an insurance product that covers the costs of Generex Oral-lyn™ and any additional and/or comparable diabetes products.

19 Apr 2010

Hospira enters definitive merger agreement to acquire Javelin Pharmaceuticals for $145M

Hospira, Inc., a global specialty pharmaceutical and medication delivery company, and Javelin Pharmaceuticals, Inc., today announced that the companies have entered into a definitive merger agreement providing for the acquisition of Javelin by Hospira for $2.20 per share in cash, or approximately $145 million. Hospira expects to commence a tender offer for all outstanding shares of Javelin common stock on or about April 21, 2010, in accordance with the terms of the merger agreement.

19 Apr 2010

ConvaTec's Vitala Continence Control Device receives 2010 Medical Design Excellence Award

ConvaTec, a world-leading developer and marketer of innovative medical technologies for community and hospital care, announced today that the Vitala™ Continence Control Device (CCD) has received a 2010 Medical Design Excellence Award.

19 Apr 2010

Food News and Research

CytRx' bafetinib receives EMEA COMP positive opinion for treatment of CML

TYSABRI drives Biogen Idec's first-quarter revenues of $1.1 billion

Acorda Therapeutics to initiate Phase 1 clinical trial of GGF2 for heart failure in mid-2010

Medical device industry leaders to meet with lawmakers, government officials at MDMA annual meeting

STERIS reaches agreement with FDA over liquid chemical sterilization system consent decree

ATS Medical announces first ATS 3f Aortic Bioprosthesis commercial implant in China

UnitedHealth Group's consolidated first-quarter 2010 revenues increase 5% to $23.2 billion

MicroStockProfit.com releases investment report on AEterna Zentaris

FFHS food rating system now available on food manufacturer boxes

Hematological malignancies conference to provide update on blood-borne cancer

Ga. couple allegedly took Medicare, Medicaid payments while patients were shorted food, medicine

Avian flu's endurance in 5 countries poses global threat to human health, FAO official says

ITI granted AOAC approval for additional Salmonella matrices

FDA launches CDRH Transparency Web site as part of agency's transparency initiative

FDA approves Lannett's ANDA for Ondansetron Injection USP, 2 mg/mL, Multi-Dose Vials

Higher intake of vitamin K from dietary sources associated with lower risk of Non-Hodgkin lymphoma

Updated survival data from Phase I/II trial of nab-paclitaxel, gemcitabine combination for pancreatic cancer

Generex Biotechnology announces plan to obtain cost reimbursement coverage for Generex Oal-lyn

Hospira enters definitive merger agreement to acquire Javelin Pharmaceuticals for $145M

ConvaTec's Vitala Continence Control Device receives 2010 Medical Design Excellence Award

The future is bioengineered: Synthetic biology and global sustainability eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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