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Impax initiates challenge of patent listed by Shionogi Pharma concerning Fenoglide

Impax Laboratories, Inc. today confirms that it has initiated a challenge of a patent listed by Shionogi Pharma, Inc. in connection with its Fenoglide® (fenofibrate) tablets, 40 and 120 mg.

30 Apr 2010

Study shows organic snackers underestimate calorie counts

Could organic labels lead you to overeat? These labels certainly appear to make people think their organic snack has a lot fewer calories than it really does.

30 Apr 2010

Provenge cellular immunotherapy for men with advanced prostate cancer receives FDA approval

The U.S. Food and Drug Administration today approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease.

30 Apr 2010

EndoChoice granted FDA marketing clearance for BONASTENT Esophageal and Biliary Stent platforms

EndoChoice, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its BONASTENT® Fully Covered Esophageal Stent for the treatment of malignant esophageal obstructions, and its BONASTENT Uncovered Biliary Stent for the treatment of malignant biliary obstructions.

30 Apr 2010

Bristol-Myers Squibb reports 11% increase in first-quarter 2010 revenue

Bristol-Myers Squibb Company today reported strong sales and earnings growth for the first quarter of 2010.

30 Apr 2010

FDA approves Provenge prostate cancer vaccine

Cancer may now be fought with a vaccine. The FDA has finally approved an immune boosting vaccine which is said to extend survival of patients at an advanced stage of prostate cancer by four months. This is twice as long as what could be expected with regular chemotherapy. There is also an increase of three years survival after detection in initial stage by 38% thanks to the vaccine.

30 Apr 2010

IMD seeks FDA regulatory clearance for NADiA ProsVue prostate cancer prognostic test

IRIS International, Inc., a leading manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide, announced today that its IRIS Molecular Diagnostics (IMD) subsidiary has submitted a 510(k) pre-market notification application to the U.S. Food and Drug Administration (FDA) requesting regulatory clearance for NADiA®ProsVue™, a prostate cancer prognostic test. The test is designed to help physicians identify patients at low risk of cancer recurrence post radical prostatectomy.

29 Apr 2010

FDA grants Bavarian Nordic Fast Track designation for PROSTVAC

Bavarian Nordic A/S announced today that PROSTVAC™ has been granted Fast Track designation by the U.S. Food & Drug Administration (FDA) for its proposed use in the treatment of men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).

29 Apr 2010

Nutraceutical International reports net sales of $47.9M for second-quarter fiscal 2010

Nutraceutical International Corporation today reported results for the fiscal 2010 second quarter ended March 31, 2010. Net sales for the fiscal 2010 second quarter were $47.9 million compared to $42.0 million for the same quarter of fiscal 2009. For the second quarter of fiscal 2010, net income was $5.1 million, or $0.49 diluted earnings per share, compared to a net loss of $(23.4) million, or $(2.15) per diluted share, for the same quarter of fiscal 2009.

29 Apr 2010

Investment report on Somaxon Pharmaceuticals from MicroStockProfit.com

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

29 Apr 2010

Labopharm, Gruppo Angelini sign agreement to commercialize OLEPTRO in the U.S.

Labopharm Inc. and Gruppo Angelini today announced they have entered into an agreement to establish a joint venture in the United States for the commercialization of OLEPTRO, a novel once-daily formulation of the antidepressant trazodone approved by the U.S. Food and Drug Administration on February 3, 2010.

29 Apr 2010

Celgene's first-quarter non-GAAP total revenue up 31% to $789 million

Celgene Corporation announced non-GAAP net income of $294.6 million, or non-GAAP diluted earnings per share of $0.63 for the quarter ended March 31, 2010. Non-GAAP net income for the first quarter of 2009 was $205.1 million or non-GAAP diluted earnings per share of $0.44. Based on U.S. GAAP, Celgene reported net income of $234.4 million, or diluted earnings per share of $0.50 for the quarter ended March 31, 2010. GAAP net income for the first quarter of 2009 was $162.9 million, or diluted earnings per share of $0.35.

29 Apr 2010

Provectus reports on end-of-Phase 2 meeting with FDA on licensure of PV-10 for metastatic melanoma

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announced today that it has held an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to seek consensus on clinical program scope and endpoints for licensure of PV-10 for metastatic melanoma. The meeting was held at the Agency's White Oak Campus in Silver Spring, MD.

29 Apr 2010

Jiangsu Yanshen receives SFDA disciplinary notice for substandard quality human use rabies vaccine

Simcere Pharmaceutical Group, a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, today announced that Jiangsu Yanshen Biological Technology Stock Co., Ltd. has received disciplinary notice from China's State Food and Drug Administration regarding its production of substandard quality human use rabies vaccine.

29 Apr 2010

China Medical Technologies' AUTOMAGLIA 90 analyzer and Down Syndrome Screening receive SFDA approval

China Medical Technologies, Inc., a leading China-based advanced in-vitro diagnostic company, today announced that it received approval for its AUTOMAGLIA 90 fully-automated ECLIA analyzer as well as Down Syndrome screening kit from the State Food and Drug Administration of China.

29 Apr 2010

AVEO Pharmaceuticals reports net loss of $14.4 million for first-quarter 2010

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced financial results for the quarter ended March 31, 2010, provided an update on progress towards achievement of 2010 goals as well as 2010 financial guidance.

29 Apr 2010

FDA calls for public comments and information about front-of-package nutrition labeling, shelf tags

The U.S. Food and Drug Administration today asked for comments and information from the public and other interested parties about front-of-package nutrition labeling and on shelf tags in retail stores.

29 Apr 2010

Gilead announces bioequivalence of Truvada in combination with Tibotec Pharmaceuticals' TMC278 NNRTI

Gilead Sciences, Inc. announced today it has obtained data supporting bioequivalence of a formulation of the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride, 25 mg).

29 Apr 2010

Oncology unit of Jewish General Hospital focuses on Smart for Life cookies

Smart for Life cookies will be the focus of a study in the oncology unit of the Jewish General Hospital, acknowledged as a world leader in many fields of investigation and a key teaching site for McGill University.

29 Apr 2010

Bristol-Myers Squibb to present on belatacept at American Transplant Congress

Bristol-Myers Squibb Company announced today that belatacept, an investigational selective T cell co-stimulation blocker being studied for use in solid organ transplantation, will be the subject of eight clinical presentations related to kidney transplantation at the American Transplant Congress, being held May 1 - 5 in San Diego.

29 Apr 2010

Food News and Research

Impax initiates challenge of patent listed by Shionogi Pharma concerning Fenoglide

Study shows organic snackers underestimate calorie counts

Provenge cellular immunotherapy for men with advanced prostate cancer receives FDA approval

EndoChoice granted FDA marketing clearance for BONASTENT Esophageal and Biliary Stent platforms

Bristol-Myers Squibb reports 11% increase in first-quarter 2010 revenue

FDA approves Provenge prostate cancer vaccine

IMD seeks FDA regulatory clearance for NADiA ProsVue prostate cancer prognostic test

FDA grants Bavarian Nordic Fast Track designation for PROSTVAC

Nutraceutical International reports net sales of $47.9M for second-quarter fiscal 2010

Investment report on Somaxon Pharmaceuticals from MicroStockProfit.com

Labopharm, Gruppo Angelini sign agreement to commercialize OLEPTRO in the U.S.

Celgene's first-quarter non-GAAP total revenue up 31% to $789 million

Provectus reports on end-of-Phase 2 meeting with FDA on licensure of PV-10 for metastatic melanoma

Jiangsu Yanshen receives SFDA disciplinary notice for substandard quality human use rabies vaccine

China Medical Technologies' AUTOMAGLIA 90 analyzer and Down Syndrome Screening receive SFDA approval

AVEO Pharmaceuticals reports net loss of $14.4 million for first-quarter 2010

FDA calls for public comments and information about front-of-package nutrition labeling, shelf tags

Gilead announces bioequivalence of Truvada in combination with Tibotec Pharmaceuticals' TMC278 NNRTI

Oncology unit of Jewish General Hospital focuses on Smart for Life cookies

Bristol-Myers Squibb to present on belatacept at American Transplant Congress

Understanding cultivated meat and its global potential 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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