Pharmaceuticals News and Research

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Transcept Pharmaceuticals to discuss the Complete Response Letter for Intermezzo NDA

Transcept Pharmaceuticals, Inc. today announced that it is scheduled to meet with the U.S. Food and Drug Administration (FDA) on January 20, 2010 to discuss the Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). As previously announced, the Complete Response Letter, received by Transcept on October 28, 2009, indicated that the FDA could not approve the NDA in its present form.

24 Nov 2009

SJH Regional Medical Center implements Omnicell 14.0 with Anywhere RN software solution

Omnicell, Inc., a leading provider of system solutions to acute healthcare facilities, today announced that South Jersey Healthcare (SJH) Regional Medical Center has implemented Omnicell 14.0 with Anywhere RN(TM), a software solution used in conjunction with Omnicell's automated medication dispensing cabinets to ensure safe, efficient and accessible medication management throughout the hospital. South Jersey Healthcare was one of the first hospitals to implement Omnicell 14.0, which is now available to all Omnicell customers.

From Omnicell, Inc. 24 Nov 2009

Scientists determine how insulin resistant drugs alter core biochemical pathways through systems biology approach

Researchers from the University of California, San Diego recently offered the sharpest-yet picture of how core biochemical pathways in skeletal muscle cells and fat cells are altered in people who suffer from insulin resistance-a primary defect in type 2 diabetes and obesity. Taking a systems biology approach, the bioengineers and medical researchers also determined how a common class of drugs for treating insulin resistance-TZDs-alter these same core pathways.

24 Nov 2009

Clavis Pharma signs drug development and commercialisation agreement with Clovis Oncology

Clavis Pharma ASA, the clinical stage oncology focused pharmaceutical company, and Clovis Oncology, Inc., the newly formed oncology company led by former Pharmion Corporation executives, announced today an agreement for the further development and commercialisation of the Clavis Pharma drug candidate, CP-4126, currently in Phase II development in pancreatic cancer.

24 Nov 2009

Clavis Pharma announces $380 million agreement to develop its CP-4126 drug candidate

Clavis Pharma ASA, the clinical stage oncology focused pharmaceutical company, announced today a $380 million agreement for the further development and commercialisation of its drug candidate, CP-4126, currently in Phase II development in pancreatic cancer.

24 Nov 2009

Lysteda tablets to treat menorrhagia approved by the FDA

The U.S. Food and Drug Administration today approved Lysteda tablets (tranexamic acid), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot.

24 Nov 2009

Salix Pharmaceuticals raises $128.2 million for business development activities

Salix Pharmaceuticals, Ltd., a specialty pharmaceutical company, today announced it has closed its previously announced public offering of 5,500,000 shares of its common stock at a price of $21.00 per share.

24 Nov 2009

Neuromed discusses Exalgo NDA application with the FDA

Covidien today announced that on November 13, 2009, representatives of Neuromed discussed the pending New Drug Application (NDA) for the product candidate ExalgoTM (hydromorphone HCl extended release) tablets with staff from the United States Food and Drug Administration (FDA). Mallinckrodt Inc., a Covidien company, obtained the commercial rights to Exalgo in the United States from Neuromed Development Inc., a subsidiary of Neuromed Pharmaceuticals Ltd., in June 2009.

24 Nov 2009

Jubilant Organosys, UAB and Southern Research Institute announce joint venture to accelerate global drug development

Jubilant Organosys, the University of Alabama at Birmingham (UAB), and Southern Research Institute today announced a joint venture that will focus on leveraging their collective innovation and enabling technologies in the areas of Oncology, Metabolic Disease and Infectious Diseases. It is a unique U.S.-India arbitraged and leveraged partnership that will accelerate the development of affordable therapies for patients worldwide.

24 Nov 2009

AmKor and Hengdian Group sign license agreement to develop and market new drug candidate in China

AmKor (AmKor Pharma, Inc.) and Hengdian Group (Hengdian Group Ltd) today announced the signing of licensing agreement for further development and commercialization of Neu2000 in China.

24 Nov 2009

Mutated IDH1 gene linked to the progression of gliomas

23 Nov 2009

AP/News-Observer examines state of vaccine research

The Associated Press/News-Observer examines revitalized vaccine research, including for such conditions as malaria, TB and HIV. "Vaccines are no longer a sleepy, low-profit niche in a booming drug industry.

23 Nov 2009

Lobbying is up as health industry examines impact of reform proposals

"Companies and groups hiring lobbying firms on health issues nearly doubled this year as special interests rushed to shape the massive revamp of the nation's health care system now in its final stretch before Congress." As many as 1,000 groups "have hired lobbyists since January, compared with 505 during the same period in 2008, according to a USA TODAY analysis of congressional records compiled by the nonpartisan CQ MoneyLine."

23 Nov 2009

Caldolor Injection effective in treating fever in hospitalized burn patients

Cumberland Pharmaceuticals Inc. today announced positive new top-line results from a study evaluating the safety and efficacy of Caldolor (ibuprofen) Injection in treating fever in hospitalized burn patients.

23 Nov 2009

GI Dynamics to present interim data on its EndoBarrier Gastrointestinal Liner study

GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2 diabetes and obesity, today announced that interim data from its ongoing clinical study of the EndoBarrier™ Gastrointestinal Liner in obese patients with type 2 diabetes will be presented by Eduardo G. Moura, M.D., Ph.D., director of endoscopy, digestive surgery department, Hospital das Clinicas, University of Sao Paulo, on Monday, November 23, 2009 at GASTRO 2009.

23 Nov 2009

Mutated IDH1 gene has novel enzyme activity consistent with cancer-causing gene: Study

Agios Pharmaceuticals today announced that its scientists have established, for the first time, that the mutated IDH1 gene has a novel enzyme activity consistent with a cancer-causing gene, or oncogene. This breakthrough discovery shows that the mutated form of IDH1 produces a metabolite, 2-hydroxyglutarate (2HG), which may contribute to the formation and malignant progression of gliomas, the most common type of brain cancers.

23 Nov 2009

Top-line data from Lexicon Pharmaceuticals' LX1031 Phase 2 study for IBS to be presented

Lexicon Pharmaceuticals, Inc., announced today that top-line data from its Phase 2 clinical study with LX1031 in patients with non-constipating irritable bowel syndrome (IBS) will be presented at GASTRO 2009 in London this week. Results from the study, which showed a significant improvement in IBS symptoms, will be presented by Dr. Philip M. Brown, Lexicon's senior vice president of clinical development, on November 25, 2009 at 2:30 pm local time at the session entitled, "Therapeutic insights in functional digestive disorders."

23 Nov 2009

Asterand extends its collaboration agreement with Bristol-Myers Squibb

Asterand plc, a leading provider of human tissue and human tissue-based services to pharmaceutical and biotechnology companies engaged in drug discovery research, today announced that it has extended its collaboration with Bristol-Myers Squibb Company (NYSE: BMY) for access to Asterand's products and services for up to three years.

23 Nov 2009

Isis Pharmaceuticals CEO's letter to shareholders

I would like to start by thanking you for your continuing support of Isis. We believe we are at one of the most successful moments in our history. We are truly at the end of the beginning of creating a unique company with a novel drug discovery platform, which we believe addresses many of the issues haunting the pharmaceutical industry.

23 Nov 2009

Positive interim results from Nereus Pharmaceuticals' plinabulin VDA study for advanced NSCLC

Nereus Pharmaceuticals, Inc., a pioneer in drug discovery from marine microbial sources, today announced positive interim results from a randomized Phase 2 clinical trial evaluating the vascular disrupting agent (VDA) plinabulin (NPI-2358) in combination with standard chemotherapy (docetaxel) in patients with advanced non-small cell lung cancer (NSCLC).

23 Nov 2009

Pharmaceuticals News and Research

Transcept Pharmaceuticals to discuss the Complete Response Letter for Intermezzo NDA

SJH Regional Medical Center implements Omnicell 14.0 with Anywhere RN software solution

Scientists determine how insulin resistant drugs alter core biochemical pathways through systems biology approach

Clavis Pharma signs drug development and commercialisation agreement with Clovis Oncology

Clavis Pharma announces $380 million agreement to develop its CP-4126 drug candidate

Lysteda tablets to treat menorrhagia approved by the FDA

Salix Pharmaceuticals raises $128.2 million for business development activities

Neuromed discusses Exalgo NDA application with the FDA

Jubilant Organosys, UAB and Southern Research Institute announce joint venture to accelerate global drug development

AmKor and Hengdian Group sign license agreement to develop and market new drug candidate in China

Mutated IDH1 gene linked to the progression of gliomas

AP/News-Observer examines state of vaccine research

Lobbying is up as health industry examines impact of reform proposals

Caldolor Injection effective in treating fever in hospitalized burn patients

GI Dynamics to present interim data on its EndoBarrier Gastrointestinal Liner study

Mutated IDH1 gene has novel enzyme activity consistent with cancer-causing gene: Study

Top-line data from Lexicon Pharmaceuticals' LX1031 Phase 2 study for IBS to be presented

Asterand extends its collaboration agreement with Bristol-Myers Squibb

Isis Pharmaceuticals CEO's letter to shareholders

Positive interim results from Nereus Pharmaceuticals' plinabulin VDA study for advanced NSCLC

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