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First sulfite-free rectal suspension for UC

sfRowasa™ (mesalamine) Rectal Suspension 4g/60mL –Sulfite-Free Formulation, is the first sulfite-free rectal suspension available for Ulcerative colitis (UC). According to a study published in The American Journal of Gastroenterology, products containing sulfites may exacerbate natural sulfide levels in the colon and may increase inflammation in UC patients. With its sulfite-free preparation, sfRowasa™ offers a new treatment option for the treatment of active, mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis.

13 Jan 2010

Monsanto and Stokes Bio announce licensing agreement and R&D collaboration

Monsanto Company and Limerick-based biotechnology firm, Stokes Bio Limited, announced today that they have entered into a licensing agreement and R&D collaboration, which is expected to help accelerate the pace of new advancements in plant breeding.

13 Jan 2010

FDA, Biovista to collaborate in analysis of drug side effects

Biovista Inc. today announced that the U.S. Food and Drug Administration (FDA) has licensed its technology platform to help analyze, identify, and better understand the way certain drugs can cause harmful side effects.

13 Jan 2010

Jiangbo Pharmaceuticals obtains renewal of Good Manufacturing Practices Certificate for Pharmaceutical Products

Jiangbo Pharmaceuticals, Inc. (the "Company" or "Jiangbo"), a pharmaceutical company with its principal operations in China, today announced that one of its factories in China obtained a renewal of its Good Manufacturing Practices Certificate for Pharmaceutical Products ("GMP Certificate") from the State Food and Drug Administration (SFDA) for its tablets and granules.

13 Jan 2010

Positive results from Asthmatx's AIR2 Trial published in AJRCCM

Asthmatx Inc., developer of bronchial thermoplasty with the Alair® System, announced today the publication of positive results from its pivotal study, the Asthma Intervention Research 2 (AIR2) Trial, in the American Journal of Respiratory and Critical Care Medicine (AJRCCM).

13 Jan 2010

BDSI to discuss planned BEMA Granisetron IND with the FDA

BioDelivery Sciences International, Inc. announced that the company has been granted a meeting with the U.S. Food and Drug Administration (FDA) to discuss the planned Investigational New Drug (IND) application for BDSI’s antiemetic (anti-nausea and vomiting) product candidate, BEMA Granisetron. The meeting will take place on March 17, 2010. The company will discuss with the FDA clinical development and regulatory plans for BEMA Granisetron, which is anticipated to enter Phase 1 studies in the second quarter of 2010.

13 Jan 2010

Donald Danforth Plant Science Center researchers enter into research collaboration with Dow AgroSciences

Researchers working at the Donald Danforth Plant Science Center have entered into a research collaboration with Dow AgroSciences LLC, a wholly owned subsidiary of The Dow Chemical Company, to study how its EXZACTTM Precision Technology can help improve the root crop cassava for millions of people living in developing countries.

13 Jan 2010

First phase of FDA's Transparency Initiative designed to explain agency operations unveiled

The U.S. Food and Drug Administration today unveiled the first phase of its Transparency Initiative which is designed to explain agency operations, how it makes decisions, and the drug approval process.

13 Jan 2010

Spectrum Pharmaceuticals achieves its enrollment target in second of two apaziquone Phase 3 trials

Spectrum Pharmaceuticals today announced that the second of two Phase 3 pivotal clinical trials of apaziquone has achieved its enrollment target. The two trials enrolled more than 1600 patients with non-muscle invasive bladder cancer. As per the collaboration agreement with Allergan, a $1.5 million milestone payment will be paid to Spectrum Pharmaceuticals.

13 Jan 2010

Scientists identify fast-acting compound to improve cognitive function impairments

A fast-acting compound that appears to improve cognitive function impairments in mice similar to those found in patients with progressive Alzheimer's disease has been identified by scientists at Wake Forest University School of Medicine and the Vanderbilt University Medical Center Program in Drug Discovery.

13 Jan 2010

AARDA pleased with FDA's approval of RA drug ACTEMRA

Friday, January 8, 2010, the Food and Drug Administration (FDA) approved ACTEMRA® (tocilizumab), a new biologic response modifier for adult patients with moderately to severely active rheumatoid arthritis (RA).

13 Jan 2010

Patient enrollment in Spherix's global Phase 3 clinical trial NEET completed

Spherix Inc., an innovator in biotechnology for diabetes therapy, and a provider of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced the completion of patient enrollment in its global Phase 3 clinical trial NEET (70971-004), which is evaluating the safety and efficacy of D-tagatose as an oral treatment for Type 2 diabetes mellitus.

12 Jan 2010

TD2 and COTI work together to obtain approval of clinical trials for COTI-2

TGen Drug Development (TD2) and Critical Outcome Technologies Inc. (COTI) (TSXV:COT) announced today that they will work together to obtain approval of clinical trials for a promising new anti-cancer drug called COTI-2.

12 Jan 2010

Vion Pharmaceuticals files SPA for Onrigin-LDAC combination Phase II/III trial

VION PHARMACEUTICALS, INC. announced today that it had filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) related to a randomized Phase II/III trial of its oncology therapeutic Onrigin™ (laromustine) Injection in combination with low-dose Ara-C (LDAC) in elderly patients with newly diagnosed acute myeloid leukemia (AML). The primary objective for the Phase III part of this study is to determine if Onrigin™ plus LDAC improves overall survival compared with LDAC alone.

12 Jan 2010

Life Technologies to acquire AcroMetrix

Life Technologies Corporation, a provider of innovative life science solutions, today announced that it has signed a definitive agreement to acquire AcroMetrix, for an undisclosed amount.

12 Jan 2010

FDA approves Celsius RMT ThermoCool catheter for use with Stereotaxis' magnetic navigation system

Stereotaxis announced that the Celsius® RMT ThermoCool® catheter has been approved by the U.S. Food and Drug Administration for use with Stereotaxis' magnetic navigation system for the treatment of Type 1 atrial flutter. The product is the fifth advanced ablation catheter resulting from the on-going co-development agreement between Stereotaxis and Biosense Webster to design and distribute magnetically enabled catheters for mapping and ablation.

12 Jan 2010

Public health and environment at risk: Large tobacco company influences EU policymaking

One of the world's largest tobacco companies has been instrumental in pushing through fundamental changes to EU policymaking, researchers from the University of Bath have found.

12 Jan 2010

NeuroScience launches NEI Guided Nutrition Program

NeuroScience, Inc. has launched a comprehensive and customizable dietary program based on patients' food sensitivity test results. The NEI Guided Nutrition Program(TM) is the first offering through NeuroScience, Inc.'s new NEI Nutrition(TM) division.

12 Jan 2010

Prescribing culture of antipsychotic medications in nursing homes examined

Older adults newly admitted to nursing homes with high rates of antipsychotic prescribing in the previous year are more likely to receive antipsychotic agents, according to a report in the January 11 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. Of these treated patients, some had no identified clinical indication for this therapy.

12 Jan 2010

New standards proposed to enhance infant formulas and functional foods

New standards to help ensure the quality and enhance the safety of key ingredients widely used in infant formulas and a variety of functional foods are being proposed for inclusion in the Food Chemicals Codex (FCC), an internationally recognized compendium of quality standards for food ingredients.

12 Jan 2010