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FDA grants QLT's QLT091001 orphan drug designation for treatment of Retinitis Pigmentosa

QLT Inc. today announced that QLT091001, the Company's oral synthetic retinoid, has been granted orphan drug designation for the treatment of Retinitis Pigmentosa (RP) from the U.S. Food and Drug Administration (FDA). This follows the FDA grant of orphan drug designation for QLT091001 for the treatment of Leber Congenital Amaurosis (LCA) also on December 7, 2010.

8 Dec 2010

Concentrated nicotine in E-cigarattes poses unknown risks to consumers

What do some pesticides and "electronic cigarettes" have in common? According to a new report published in the American Journal of Public Health, the answer is unregulated concentrations of nicotine that may pose unknown risks to consumers who are exposed to them.

8 Dec 2010

Contrave, new weight loss pill gets FDA panel nod

A Food and Drug Administration (FDA) panel yesterday recommended the approval of Orexigen Therapeutics’ weight loss drug Contrave. This is the first time a weight loss drug has received the nod. The vote went 13 to 7 for Contrave’s approval and 11 to 8, with an abstention that additional studies be conducted on heart risks. Although experts agree to risks they believe the benefits outweigh the risks. Although the FDA is not compelled to go with the panel’s recommendation, it more often than not does. The FDA will deliver its verdict by Jan. 31 2011.

7 Dec 2010

Orthovita granted FDA marketing clearance for Vitoss Bioactive Foam-2X Bone Graft Substitute

Orthovita, Inc. , an orthobiologics and biosurgery company, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Vitoss Bioactive Foam-2X Bone Graft Substitute for use as a non-structural bone void filler for use in the spine, pelvis and extremities. Orthovita expects to launch the newest addition to its bone graft substitute product line by late February or early March of 2011.

7 Dec 2010

MP receives FDA IND approval for clinical trial with HTLV-I/II ELISA 4.0 and HTLV Blot.2.4

MP Biomedicals LLC announced today that it has received approval of its investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) to start pivotal clinical trials in the USA with the MP Diagnostics™ HTLV-I/II ELISA 4.0 and HTLV Blot.2.4. Studies will be conducted within the American Red Cross, the California Department of Public Health, and LABS, Inc. The company is working closely with the principal investigator of the American Red Cross sites, Dr. Susan Stramer, Executive Scientific Officer.

From MP Biomedicals, LLC 7 Dec 2010

$Seattle Genetics and Millennium announce positive data from SGN-35 Phase II trial in relapsed or refractory ALCL$

Seattle Genetics and Millennium announce positive data from SGN-35 Phase II trial in relapsed or refractory ALCL

Seattle Genetics, Inc. and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, today announced positive data from a phase II clinical trial of single-agent brentuximab vedotin (SGN-35) in relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). Brentuximab vedotin is an antibody-drug conjugate (ADC) targeted to CD30, a defining marker of ALCL. The data were presented today during an oral session at the 52nd American Society of Hematology (ASH) Annual Meeting in Orlando, FL.

7 Dec 2010

FEI launches Magellan extreme resolution scanning electron microscope for life science imaging

FEI Company, a leading instrumentation company providing electron microscope systems for applications in research and industry, today announced the Magellan™ extreme resolution scanning electron microscope (SEM) optimized specifically for life science imaging. The first of its kind, the Magellan SEM enables life science researchers and cell biologists to actually view the entire organization of a cell in its natural, fully-hydrated state.

7 Dec 2010

Lutheran Medical Center implements Medsphere's OpenVista EHR solution

Lutheran Medical Center (LMC) and Medsphere Systems Corporation today announced the successful implementation of Medsphere's OpenVista® electronic health record (EHR) solution throughout the hospital. The full service 476-bed teaching hospital is now on track to achieve meaningful use and qualify for millions of dollars made available by the American Recovery and Reinvestment Act of 2009.

7 Dec 2010

Mental Health Research Network receives grant to create data resource for mental health researchers

Ask anyone: There must be better ways to treat mental health problems. Treatment hinges on research. But traditional research is slow-and so expensive that it can't even ask many pressing questions in mental health. And findings from academic settings may not apply to patients or clinicians in the real world of health care.

7 Dec 2010

Inergetics, Muscle Maker Grill sign Product Development Agreement

Inergetics, Inc., a leader in targeted product development for the Clinical Nutrition and Sports Supplement Markets, today announced that the Company has entered into a Product Development Agreement with Muscle Maker Grill, one of the country's fastest growing health-food franchises, to be the exclusive provider of "Muscle Maker Ultra Pro, powered by Inergetics," a powdered proprietary nutritional product to be used in various platforms in Muscle Maker Grill restaurants.

7 Dec 2010

Researchers develop new method to reduce amount of radiation needed to kill pathogens

A team of Texas AgriLife Research engineers has developed a way to cut by as much as half the amount of irradiation needed to kill 99.999 percent of salmonella, E. coli and other pathogens on fresh produce.

7 Dec 2010

Matrix's NDA for Abacavir Sulfate receives tentative FDA approval under PEPFAR

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Abacavir Sulfate Tablets, 60 mg. The NDA is based on the reference listed drug Ziagen® by ViiV Healthcare.

7 Dec 2010

Watson, Natco confirm development agreement for generic Revlimid

Watson Pharmaceuticals, Inc. and Natco Pharma Limited today confirmed an exclusive, U.S. development and license agreement, to develop and commercialize lenalidomide 5, 10, 15 and 25 mg tablets. The companies also confirmed that Natco has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its lenalidomide 5, 10, 15 and 25 mg product. Natco's lenalidomide tablets are generic versions of Celgene's Revlimid ® Tablets.

7 Dec 2010

Breast cancer patients taking tamoxifen anxious to have CYP2D6 genetic test

While the medical community continues to debate the benefits of CYP2D6 genetic testing for women on the breast cancer treatment tamoxifen, patients using the medication are anxious to have the tests. According to a new survey of more than 700 women with breast cancer currently taking tamoxifen, almost 80 percent of respondents would choose to have a genetic test that determines CYP2D6 genotype, yet only 14 percent of these women have been tested. CYP2D6 is an enzyme that influences how well the body processes tamoxifen into its more active form.

7 Dec 2010

Intellipharmaceutics files generic 30 mg Focalin XR ANDA with FDA

Intellipharmaceutics International Inc., today announced that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for approval to market a generic of the 30 mg strength of Focalin XR® (dexmethylphenidate hydrochloride). The application for the 30 mg strength is filed as an amendment to the ANDA that Intellipharmaceutics had previously filed for the 5, 10, 15 and 20 mg strengths of the drug.

7 Dec 2010

Expansion of newborn screening throws some families on a journey of great uncertainty

Mandatory genetic screening of newborns for rare diseases is creating unexpected upheaval for families whose infants test positive for risk factors but show no immediate signs of the diseases, a new UCLA study warns.

7 Dec 2010

Medication and blood transfusion reduce risk of recurrent strokes in young patients with sickle cell anemia

St. Jude Children's Research Hospital investigators discuss results of research into managing iron overload associated with stroke prevention in young sickle cell patients and the search for genetic predictors of stroke risk.

7 Dec 2010

FAI releases comprehensive food allergy guidelines

The Food Allergy Initiative (FAI) today announced its endorsement of comprehensive food allergy guidelines, released by an Expert Panel sponsored by the National Institute of Allergy and Immunology (NIAID), a division of the National Institutes of Health (NIH). FAI, the largest private source of funding for food allergy research in the U.S., will underwrite the publication of the long-awaited Guidelines as a special supplement to the December 2010 issue of the prestigious Journal of Allergy and Clinical Immunology.

7 Dec 2010

Global phase III study to provide novel extended release of topiramate

Data presented yesterday showed that USL255, a novel extended-release (ER) formulation of topiramate, was associated with less fluctuation in topiramate plasma levels than immediate-release (IR) topiramate in healthy volunteers.

7 Dec 2010

Mayo Clinic scientists say JAK inhibitors may help treat patients with myelofibrosis

Two janus kinase (JAK) inhibitors are substantially improving treatment of myelofibrosis in patients, say Mayo Clinic researchers who are presenting results of several clinical trials at the 52nd annual meeting of the American Society of Hematology (ASH) Dec. 4 in Orlando.

7 Dec 2010

Food News and Research

FDA grants QLT's QLT091001 orphan drug designation for treatment of Retinitis Pigmentosa

Concentrated nicotine in E-cigarattes poses unknown risks to consumers

Contrave, new weight loss pill gets FDA panel nod

Orthovita granted FDA marketing clearance for Vitoss Bioactive Foam-2X Bone Graft Substitute

MP receives FDA IND approval for clinical trial with HTLV-I/II ELISA 4.0 and HTLV Blot.2.4

Seattle Genetics and Millennium announce positive data from SGN-35 Phase II trial in relapsed or refractory ALCL

FEI launches Magellan extreme resolution scanning electron microscope for life science imaging

Lutheran Medical Center implements Medsphere's OpenVista EHR solution

Mental Health Research Network receives grant to create data resource for mental health researchers

Inergetics, Muscle Maker Grill sign Product Development Agreement

Researchers develop new method to reduce amount of radiation needed to kill pathogens

Matrix's NDA for Abacavir Sulfate receives tentative FDA approval under PEPFAR

Watson, Natco confirm development agreement for generic Revlimid

Breast cancer patients taking tamoxifen anxious to have CYP2D6 genetic test

Intellipharmaceutics files generic 30 mg Focalin XR ANDA with FDA

Expansion of newborn screening throws some families on a journey of great uncertainty

Medication and blood transfusion reduce risk of recurrent strokes in young patients with sickle cell anemia

FAI releases comprehensive food allergy guidelines

Global phase III study to provide novel extended release of topiramate

Mayo Clinic scientists say JAK inhibitors may help treat patients with myelofibrosis

Enhancing confidence in chemical ionization spectrometry data eBook

A New Approach to Preventing Bladder Cancer Recurrence

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

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