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Covidien contraindicates use of its Optimark gadoversetamide injection

Covidien, a leading global provider of healthcare products, today announced that it will voluntarily contraindicate the use of its Optimark™ gadoversetamide injection, a gadolinium-based contrast agent (GBCA), in magnetic resonance imaging (MRI) procedures involving patients with severe renal impairment.

9 Nov 2009

Ikano Therapeutics' midazolam granted Orphan Drug designation

Ikano Therapeutics, Inc. announced today that it has received Orphan Drug designation for midazolam in the acute treatment of certain forms of epileptic seizure known as cluster seizures or alternatively, as acute repetitive seizures.

9 Nov 2009

Progenics Pharmaceuticals reports financial results for the third quarter of 2009

Progenics Pharmaceuticals, Inc. today announced its results of operations for the third quarter and nine months ended September 30, 2009.

9 Nov 2009

Plex Systems announces $6 million investment from multiple sources

Plex Systems, Inc., provider of the No. 1 rated ERP software for manufacturers, today announced the company has received an investment totaling $6 million USD from multiple sources. Plex will use the growth capital to build on its strong customer base, expand its product development, and accelerate sales and marketing efforts.

9 Nov 2009

GTx reports financial results for the third quarter of 2009

GTx, Inc. today reported financial results for the third quarter of 2009. The net loss for the third quarter and nine months ended September 30, 2009 was $12.8 million and $35.4 million, respectively, compared with a net loss of $11.9 million and $37.9 million for the same periods in 2008. At September 30, 2009 GTx had cash, cash equivalents and short-term investments of $55.5 million.

9 Nov 2009

Chinese SFDA approves China Medical Technologies' Leukemia BCR/ABL fusion gene detection FISH Probe

China Medical Technologies, Inc., a leading China-based medical device company that develops, manufactures and markets advanced in-vitro diagnostic products, today announced that the Company has received approval for its Leukemia BCR/ABL fusion gene detection FISH Probe (the "Leukemia BCR/ABL FISH Probe") from the State Food and Drug Administration of China (the "SFDA").

9 Nov 2009

Caliper Life Sciences announces financial results for third quarter ended September 30, 2009

Caliper Life Sciences, Inc. today reported results for its third quarter ended September 30, 2009. GAAP revenues increased by 4% to $32.2 million, from non-GAAP revenues of $31.0 million in the same period of 2008, which represents GAAP revenue of $34.0 million in the third quarter of 2008 reduced by $3.0 million for the impact of divested product lines.

9 Nov 2009

Bovie Medical Corporation total revenues decreases in third quarter 2009

Bovie Medical Corporation, a manufacturer and marketer of electrosurgical products, today announced its financial results for the third quarter ended September 30, 2009.

9 Nov 2009

Renewal Laboratories to produce functional beverages with anti-oxidants and omega3 fatty acids

Renewal Laboratories announced today that it has developed a patent pending process to produce functional beverages with important anti-oxidants and omega3 fatty acids. Natural, nutritionally important supplements such as Coenzyme Q10, resveratrol, and omega3 fish oil may now be offered in appealing and refreshing drinks.

9 Nov 2009

New data on diagnosis and treatment of allergic diseases to be presented at the ACAAI meeting

Researchers are unveiling new data on investigational findings in nearly 450 abstracts on the diagnosis and treatment of allergic diseases at the ACAAI Annual Meeting in Miami Beach, Fla., Nov. 5-10.

9 Nov 2009

Daval International receives award for its anti-inflammatory agent AIMSPRO

Following the provision of clinical and scientific data to the US Food and Drug Administration (FDA), privately owned UK company Daval International Limited (http://www.davalinternational.com) has been informed that its innovative anti-inflammatory agent AIMSPRO(R) has been awarded an Orphan-Drug designation for the treatment of Amyotrophic Lateral Sclerosis (ALS).

9 Nov 2009

Health Canada accepts for review the EpiCept’s New Drug Submission for Ceplene

EpiCept Corporation today announced that Health Canada has accepted for review the Company’s New Drug Submission (NDS) for Ceplene® (histamine dihydrochloride) for the remission maintenance of acute myeloid leukemia (AML) patients in first complete remission.

9 Nov 2009

TNS files Provisional Use Patent application on the ability of a natural organic mushroom formula

Total Nutraceutical Solutions, Inc. (TNS), announced that it has filed a Provisional Use Patent application on the ability of a proprietary natural organic mushroom formula to control oxidative stress.

9 Nov 2009

Experts gather to outline the latest creative applications of DNA barcoding

The scientific ability to quickly and accurately identify species through DNA "barcoding" is being embraced and applied by a growing legion of global authorities - from medical and agricultural researchers to police and customs authorities to palaeontologists and others.

7 Nov 2009

Transatlantic task force to address antibiotic resistance established, experts welcome initiative

Experts on both sides of the Atlantic applaud President Barack Obama and Swedish Prime Minister Fredrik Reinfeldt, representing the European Union (EU) Presidency, for establishing a transatlantic task force to address antibiotic resistance, an urgent and growing problem that threatens patient safety and public health worldwide.

7 Nov 2009

FDA's approval time for medical devices increases

According to MassDevice.com, the online business journal of the medical device industry, medical device approval times under the Food & Drug Administration's 510(k) clearance process jumped 30 percent between 2005 and 2008. MassDevice's exclusive investigation of 10 years of FDA data, Eye on the FDA: H1 2009, shows that approval times for medical devices increased nearly 2 percent — while the number of 510(k) applications declined more than 19 percent — even as the FDA's budgets and staff levels rose.

7 Nov 2009

FDA extends review date of New Drug Application for GSK1838262/XP13512

GlaxoSmithKline and XenoPort, Inc. (Nasdaq: XNPT) today announced that the U.S. Food and Drug Administration (FDA) has extended the original Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) for GSK1838262/XP13512 (gabapentin enacarbil) to February 9, 2010. The original PDUFA date for this NDA review was November 9, 2009.

7 Nov 2009

Experts applaud the EU Presidency for establishing a transatlantic task force to address antibiotic resistance

7 Nov 2009

SNM commends the U.S. House of Representatives for its passage of medical isotope legislation

SNM applauds the U.S. House of Representatives for its passage of H.R. 3276-the American Medical Isotopes Production Act of 2009.

7 Nov 2009

NHLBI stops enrollment in study comparing resuscitation strategies

Enrollment has ended early in a large, multicenter clinical trial comparing two distinct resuscitation strategies delivered by emergency medical service (EMS) providers to increase blood flow during cardiac arrest. The study's independent monitoring board and the National Heart, Lung, and Blood Institute (NHLBI), the lead sponsor of the study, stopped enrollment based on preliminary data suggesting that neither strategy significantly improved survival.

7 Nov 2009

Food News and Research

Covidien contraindicates use of its Optimark gadoversetamide injection

Ikano Therapeutics' midazolam granted Orphan Drug designation

Progenics Pharmaceuticals reports financial results for the third quarter of 2009

Plex Systems announces $6 million investment from multiple sources

GTx reports financial results for the third quarter of 2009

Chinese SFDA approves China Medical Technologies' Leukemia BCR/ABL fusion gene detection FISH Probe

Caliper Life Sciences announces financial results for third quarter ended September 30, 2009

Bovie Medical Corporation total revenues decreases in third quarter 2009

Renewal Laboratories to produce functional beverages with anti-oxidants and omega3 fatty acids

New data on diagnosis and treatment of allergic diseases to be presented at the ACAAI meeting

Daval International receives award for its anti-inflammatory agent AIMSPRO

Health Canada accepts for review the EpiCept’s New Drug Submission for Ceplene

TNS files Provisional Use Patent application on the ability of a natural organic mushroom formula

Experts gather to outline the latest creative applications of DNA barcoding

Transatlantic task force to address antibiotic resistance established, experts welcome initiative

FDA's approval time for medical devices increases

FDA extends review date of New Drug Application for GSK1838262/XP13512

Experts applaud the EU Presidency for establishing a transatlantic task force to address antibiotic resistance

SNM commends the U.S. House of Representatives for its passage of medical isotope legislation

NHLBI stops enrollment in study comparing resuscitation strategies

Enhancing confidence in chemical ionization spectrometry data 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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