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Genta announces EMA Orphan Drug designation for tesetaxel

Genta Incorporated today announced that tesetaxel, the leading oral taxane in clinical development, has been designated as an Orphan Drug by the European Medicines Agency for gastric cancer. The drug has previously received Orphan Drug designation by the U.S. Food and Drug Administration for both gastric cancer and melanoma, as well as Fast Track designation by FDA for gastric cancer.

11 Oct 2010

FDA approves Warner Chilcott's ACTONEL for postmenopausal osteoporosis

Warner Chilcott plc today announced that the United States Food and Drug Administration (FDA) has approved its next generation ACTONEL® (risedronate sodium) product for the treatment of postmenopausal osteoporosis in the United States. The product will be marketed as ATELVIA™ (risedronate sodium) delayed-release tablets.

11 Oct 2010

Micromet to initiate MEDI-565 Phase 1 trial in patients with advanced gastrointestinal cancer

Micromet, Inc. today announced that its licensee for MT111, MedImmune, plans to initiate a Phase 1 trial in patients with advanced gastrointestinal cancers based on an investigational new drug (IND) application recently accepted by the U.S. Food and Drug Administration (FDA).

11 Oct 2010

Valeant announces Alexza's receipt of FDA CRL for AZ-004 NDA

Valeant Pharmaceuticals International, Inc. announced today that Alexza Pharmaceuticals, Inc. has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding Alexza's New Drug Application (NDA) for AZ-004 (Staccato® loxapine) submitted as Adusuve™ Staccato® (loxapine) inhalation aerosol, 5 mg and 10 mg.

11 Oct 2010

PlastiPure, ReliaBrand partner to produce EA-Free plastic consumer products

PlastiPure, a safer-plastics technology company, has announced a partnership with ReliaBrand to license infant feeding, sports bottle, food packaging, and medical products free of harmful chemicals that cause estrogenic activity (EA). Chemicals with EA have been strongly linked to adverse health effects such as birth defects, reproductive cancers, and behavioral and learning disorders. The widely known chemicals BPA and phthalates are only a few of thousands of chemicals suspected to have EA.

11 Oct 2010

ACT Biotech reports positive interim data from Telatinib Phase 2 trial for advanced gastric cancer

ACT Biotech Inc., a privately held biotechnology company based in San Francisco, California, today announced positive interim data from a Phase 2 trial of the Company's lead oral kinase inhibitor, Telatinib, for the first-line treatment of patients with advanced gastric cancer. This proof-of-concept, multi-center, open label trial was designed to test the efficacy and safety of full-dose Telatinib, administered continuously, as a first-line treatment in combination with a standard regimen of capecitabine and cisplatin in US and European patients.

11 Oct 2010

Eli Lilly presents ALIMTA Phase III trial results at ESMO Annual Meeting

Eli Lilly and Company announced today that its global Phase III trial evaluating ALIMTA (pemetrexed for injection) in combination with cisplatin in patients with recurrent or metastatic squamous cell cancer of the head and neck (SCCHN) did not meet its primary endpoint for overall survival. Data were presented for the first time today at the 35th Annual Meeting of the European Society for Medical Oncology (ESMO).

11 Oct 2010

TTF therapy with chemotherapy increases survival time in patients with non-small cell lung cancer

Novocure reported today that patients with advanced non-small cell lung cancer (NSCLC) achieved a significant increase in survival time when tumor treating fields (TTF) therapy was added to chemotherapy, as compared to previously reported outcomes for patients receiving chemotherapy alone.

11 Oct 2010

Millennium, Seattle Genetics announce positive top-line results of SGN-35 phase II clinical trial

Seattle Genetics, Inc. and Millennium The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, today announced positive top-line results from a phase II clinical trial of single-agent brentuximab vedotin (SGN-35), an antibody-drug conjugate (ADC) targeted to CD30. The trial was conducted in 58 relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) patients.

11 Oct 2010

GSU professor receives USDA grant to study dynamics of childhood obesity

A Georgia State University professor has received a U.S. Department of Agriculture grant to look at the obesity trends from childhood to adolescence.

11 Oct 2010

FDA issues CRL for AZ-004 NDA application

Alexza Pharmaceuticals, Inc. announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA or Agency) regarding its New Drug Application (NDA) for AZ-004 (Staccato loxapine), submitted as Adusuve Staccato (loxapine) inhalation aerosol, 5 mg and 10 mg.

11 Oct 2010

Auxilium commences dosing in global XIAFLEX phase III program for Peyronie's disease

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced that the first subject has been dosed in the global phase III program of XIAFLEX® for the treatment of Peyronie's disease. Peyronie's disease is the development of scar tissue on the penis that can cause the penis to curve during erection, often interfering with or preventing intercourse and resulting in psychological distress or bother for the patient.

11 Oct 2010

FDA issues CRL to Jazz for JZP-6 NDA for fibromyalgia

Jazz Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has sent the company a complete response letter (CRL) regarding the company's New Drug Application (NDA) for JZP-6 (sodium oxybate) for the treatment of fibromyalgia. The CRL states that the FDA cannot approve the NDA in its present form.

11 Oct 2010

VBI researchers receive grant to study immune responses to gut pathogens

The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, has awarded a $10.6 million grant to researchers at the Virginia Bioinformatics Institute (VBI) and collaborators to determine how the human immune system responds to infection by pathogens of the gut. The funding will be used to apply mathematical modeling to the study of immune responses to gut pathogens.

11 Oct 2010

Childcare centers address food allergies of ethnically diverse population

Attention to children's food allergies at childcare centers can be a life-or-death issue. As these centers wrestle with the problem, some also have unique needs to address, such as an ethnically diverse child population.

11 Oct 2010

University of Missouri creates National Botanical Research Center with $7.5M NIH grant

Americans spend $25 billion a year on dietary supplement products such as herbs and other botanicals. While the Nutrition Business Journal forecasts that sales of botanical dietary supplements will increase by about 19 percent over the next five years, scientists still don't know the precise properties that make certain plants helpful or harmful to humans. Now, with a new $7.5 million grant from the National Institutes of Health, University of Missouri researchers have created a National Botanical Research Center to answer these questions.

11 Oct 2010

FDA warns of harmful stimulant in Slimming Beauty capsules

The U.S. Food and Drug Administration today advised consumers who have Slimming Beauty Bitter Orange Slimming Capsules not to use the product. FDA warns that Slimming Beauty Bitter Orange Slimming Capsules contain the active pharmaceutical ingredient sibutramine, a prescription-only drug which is a stimulant. Sibutramine is not listed on the product label and could harm consumers, especially those with cardiovascular conditions.

11 Oct 2010

DTC genetic tests require innovative approach to enter global market

Direct-to-consumer (DTC) genetic tests available from retailers and the Internet let people learn about their genomes without going to a doctor, but they raise the question of who is responsible for oversight and regulation of these tests. Critics worry about safety risks if consumers base important lifestyle or medical decisions on inaccurate or misunderstood test results.

11 Oct 2010