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Novartis Oncology, Amgen, GlaxoSmithKline and Veridex honored with 2009 Prix Galien Award

The Prix Galien USA committee celebrated members of the science and biotechnology industries last night for the development and discovery of drugs and technologies that improve the human condition.

1 Oct 2009

NIH awards $10.5 million grant for OCD treatment research

A new research center exploring the science underlying a potential new treatment for obsessive-compulsive disorder has been established at the University of Rochester Medical Center, thanks to a $10.5 million award from the National Institute of Mental Health.

1 Oct 2009

Promising results from Cell Therapeutics' phase II OPAXIO study for advanced esophageal cancer

Cell Therapeutics, Inc. announced today that, in a study from Brown University to be presented by Howard Safran, M.D., head of the Brown University Oncology Group, in the proffered oral session at the Annual Meeting of the International Society of Gastrointestinal Oncology (ISGIO) in Philadelphia, Pennsylvania patients with cancer of the lower esophagus demonstrated a high rate of complete remission (CR) when given OPAXIO(TM) (paclitaxel poliglumex), a biologically enhanced paclitaxel, when administered in combination with standard cisplatin and concurrent radiation.

1 Oct 2009

Covidien receives 510(k) clearance to market Mallinckrodt Taperguard Evac endotracheal tube

Covidien, a leading global provider of healthcare products and recognized innovator in mechanical ventilation and respiratory care devices, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Mallinckrodt™ TaperGuard™ Evac endotracheal tube.

1 Oct 2009

Amicus brief filed against tobacco companies' lawsuit challenging FDA tobacco regulation law

Today, eleven public health and consumer advocacy organizations filed a friend of the court (amicus) brief asking a federal court to reject a lawsuit by R.J. Reynolds, Lorillard and other tobacco companies that seeks to block key provisions of the new federal law regulating tobacco products. The immediate issue before the court is the industry's challenge of a provision that requires FDA approval before tobacco companies can make claims about "modified risk tobacco products."

1 Oct 2009

EMD Serono submits NDA for Cladribine Tablets in the U.S.

EMD Serono, Inc. an affiliate of Merck KGaA, Darmstadt, Germany, announced today the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS).

1 Oct 2009

Reports: Climate change effects could increase hunger in developing countries by 2050

By 2050, climate change could lead to decreased outputs of corn, rice and wheat across the developing world resulting in price increases and hunger, according to an International Food Policy Research Institute (IFPRI) study, Bloomberg reports (Ruitenberg, 9/30).

1 Oct 2009

Trichodesmium has important role in nitrogen cycle and carbon sequestration

A new study of microscopic marine microbes, called phytoplankton, by researchers at Woods Hole Oceanographic Institution (WHOI) and the University of South Carolina has solved a ten-year-old mystery about the source of an essential nutrient in the ocean.

1 Oct 2009

MacuSight's clinical development update on its proprietary ocular sirolimus product

MacuSight, a developer of innovative therapeutics for the treatment of severe ocular diseases and conditions, today provided a clinical development update for Perceiva, the company's proprietary ocular sirolimus product.

30 Sep 2009

Inspirion Delivery Technologies completes Pre-IND meeting with the FDA

Inspirion Delivery Technologies, LLC ("IDT") announced today that last week the Company completed a pre-investigational new drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) to determine the clinical and regulatory pathway to advance its abuse deterrent, extended release formulation of oxycodone.

30 Sep 2009

Amicus Therapeutics to initiate Phase 1 study of AT2220

Amicus Therapeutics today announced it plans to initiate a Phase 1 study of AT2220 (1-deoxynojirimycin HCl), its investigational drug in development for the treatment of Pompe Disease.

30 Sep 2009

Global use of biofuels expected to double by 2015

Despite a number of key issues such as land use and competition for feedstocks supplies for traditional food and feed uses, global use of biofuels is excepted to more than double from 2009 to 2015, according to a new global analysis released today by Hart's Global Biofuels Center.

30 Sep 2009

Caraco enters into a consent decree with the FDA regarding its drug manufacturing operations

Caraco Pharmaceutical Laboratories, Ltd. announced today that it has entered into a consent decree with the U.S. Food and Drug Administration (FDA) regarding the company's drug manufacturing operations. The decree provides a series of measures that, when satisfied, will permit Caraco to resume manufacturing and distributing those products that are manufactured in its Detroit area facilities.

30 Sep 2009

FDA approves Mylan Pharmaceuticals' Carbidopa and Levodopa tablets

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Carbidopa and Levodopa Tablets USP, 10mg/100mg, 25mg/100mg and 25mg/250 mg.

30 Sep 2009

Phase III clinical trial results demonstrate effectiveness of spinosad suspension

ParaPRO, LLC announced today the results of two Phase III clinical studies published online this month in the journal Pediatrics (Pediatrics 2009; 124:e389-e395) which concluded that a spinosad suspension was significantly more effective in eliminating head lice (pediculosis capitis) than permethrin.

30 Sep 2009

Sun Pharma Global issues notice to Labopharm regarding its generic versions of Ryzolt

Labopharm Inc. today announced it has received notice from Sun Pharma Global FZE advising that Sun has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for approval to market 100, 200 and 300 mg generic versions of Ryzolt(TM) (tramadol hydrochloride extended-release 100, 200 and 300 mg tablets) in the United States.

30 Sep 2009

Orphan drug designation for pixantrone applied by Cell Therapeutics

Cell Therapeutics, Inc. ("CTI") announced today that it has applied to the European Medicines Agency (EMEA) for orphan drug designation for pixantrone. CTI initiated the process of obtaining marketing approval in Europe in July, 2009, for the treatment of relapsed or refractory aggressive NHL.

30 Sep 2009

Hologic's ThinPrep integrated imager receives CE marking approval

Hologic, Inc., a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced it has received CE marking approval for its ThinPrep® integrated imager.

From Hologic, Inc. 30 Sep 2009

Polymedix commences Phase 1B study of novel anticoagulant reversing agent

PolyMedix, Inc., an emerging biotechnology company developing new therapeutic drug products to treat infectious diseases and acute cardiovascular disorders based on biomimetics, has initiated dosing and commenced a second clinical trial, a Phase 1B pilot proof of concept study, in the U.S. with its anticoagulant reversing agent PMX-60056 under an Investigational New Drug application (IND) filed with the U.S. Food and Drug Administration (FDA).

30 Sep 2009

Hitachi High-Technologies reaches milestone: More than 1000 units of TM-1000 shipped

Hitachi High-Technologies Corporation (TOKYO:8036) today announced that cumulative shipments of the tabletop microscope TM-1000, launched in April 2005, have now surpassed 1,000 units.

30 Sep 2009

Food News and Research

Novartis Oncology, Amgen, GlaxoSmithKline and Veridex honored with 2009 Prix Galien Award

NIH awards $10.5 million grant for OCD treatment research

Promising results from Cell Therapeutics' phase II OPAXIO study for advanced esophageal cancer

Covidien receives 510(k) clearance to market Mallinckrodt Taperguard Evac endotracheal tube

Amicus brief filed against tobacco companies' lawsuit challenging FDA tobacco regulation law

EMD Serono submits NDA for Cladribine Tablets in the U.S.

Reports: Climate change effects could increase hunger in developing countries by 2050

Trichodesmium has important role in nitrogen cycle and carbon sequestration

MacuSight's clinical development update on its proprietary ocular sirolimus product

Inspirion Delivery Technologies completes Pre-IND meeting with the FDA

Amicus Therapeutics to initiate Phase 1 study of AT2220

Global use of biofuels expected to double by 2015

Caraco enters into a consent decree with the FDA regarding its drug manufacturing operations

FDA approves Mylan Pharmaceuticals' Carbidopa and Levodopa tablets

Phase III clinical trial results demonstrate effectiveness of spinosad suspension

Sun Pharma Global issues notice to Labopharm regarding its generic versions of Ryzolt

Orphan drug designation for pixantrone applied by Cell Therapeutics

Hologic's ThinPrep integrated imager receives CE marking approval

Polymedix commences Phase 1B study of novel anticoagulant reversing agent

Hitachi High-Technologies reaches milestone: More than 1000 units of TM-1000 shipped

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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