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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

Pediatric specialists and pharmacists may get boost from health bills

News outlets report on how the health care bill pending in Congress might affect pediatric specialists and pharmacists.

13 Jan 2010

Research suggests variation of CETP gene is linked to lowered risk of dementia and AD

Preliminary research suggests that variation of a gene for a plasma protein is associated with slower age-related memory decline and a lower risk of dementia and Alzheimer disease (AD), according to a study in the January 13 issue of JAMA.

13 Jan 2010

European trial casts doubt over the viability of prostate cancer screening

A large European trial has cast doubt over the viability of prostate cancer screening, concluding that one in eight men receive a positive test result when they do not have the disease.

13 Jan 2010

UNAIDS chief calls for reduction in MTCT in Africa

UNAIDS Executive Director Michel Sidibe on Monday during a five-day trip in Kenya, called for a drastic reduction in mother-to-child transmission (MTCT) of HIV in sub-Saharan Africa, Capital News reports. "In our continent we still have 400,000 babies born every year with HIV and we know if we are capable of making sure that testing will become available universally to all our pregnant women, (and) that pregnant women also have access to treatment, we will prevent the transmission," Sidibe said (Karong'o, 1/11).

13 Jan 2010

NOVAVAX completes pre-clinical safety and efficacy study of its RSV vaccine candidate

Novavax, Inc. announced today that it has successfully completed a pre-clinical safety and efficacy study of its RSV vaccine candidate in cotton rats. Results from this study are needed to support an Investigational New Drug (IND) application to advance this novel recombinant F protein particle based RSV (RSV-F) vaccine candidate into clinical development. This vaccine candidate is composed of recombinant 'F' or 'fusion' protein of RSV which is used by the virus to infect and fuse with cells in the respiratory tract and cause disease.

13 Jan 2010

Lewis & Clark LTC RRG merges with Sophia Palmer Nurses RRG

Lewis & Clark LTC RRG, Inc., the nationwide provider of liability insurance to long-term care facilities, has merged with Sophia Palmer Nurses RRG, Inc., Sanford Elsass, President of The Uni-Ter Group, administrator of both Risk Retention Groups (RRG), announced.

13 Jan 2010

NitricBio chooses Clinipace Worldwide to manage and conduct two phase 3 trials

Clinipace Worldwide, a global technology-driven clinical research organization (CRO), announced today that NitricBio has selected the company to manage and deploy multiple studies in support of medical applications of topical nitric oxide gas (gNO).

13 Jan 2010

Sarnova acquires CVC

Sarnova, Inc., the nation's leading specialty distributor of health care products in the emergency medical services (EMS) and respiratory markets, announced today that it has acquired CVC, Inc. Headquartered in Arlington, Texas, CVC is a supplier of products to the acute care respiratory and emergency medical services markets.

12 Jan 2010

Media outlets examine U.S. plans for leftover H1N1 vaccine, efforts to keep flu vaccine production on track

After working to ensure the U.S. had access to enough H1N1 (swine flu) vaccine, health officials may now face a new dilemma - a vaccine surplus, the Associated Press reports.

12 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

Scientists go beyond single-gene models to probe inborn heart defects

Studying genes that regulate early heart development in animals, scientists have solved a puzzle about one gene's role, finding that it acts in concert with a related gene. Their finding contributes to understanding how the earliest stages of heart development may go awry, resulting in congenital heart defects in humans.

12 Jan 2010

Labor leaders confront Obama on 'Cadillac' tax proposal

Labor leaders were invited to the White House to discuss negotiations to merge the House- and Senate-passed health overhaul packages.

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

Pall acquires U.S. biotechnology company

Pall Corporation, a global leader in filtration, separation and purification, today announced its acquisition of MicroReactor Technologies, Inc. (MRT), a privately held U.S. biotechnology company. MRT has developed a reliable, easy-to-use and cost-effective miniature bioreactor technology platform.

From Pall Corporation 12 Jan 2010

Preliminary results from Nektar Therapeutics' NKTR-102 Phase 2 study in platinum-resistant ovarian cancer

Nektar Therapeutics today announced preliminary results from the first stage of a two-stage Phase 2 clinical study evaluating NKTR-102 in women with platinum-resistant ovarian cancer. In the first stage of the study, 39 patients enrolled with platinum-resistant disease were evaluable for the primary endpoint of overall response rate using Gynecologic Cancer InterGroup (GCIG) criteria, i.e., a combination of response by tumor imaging

12 Jan 2010

Miami resident pleads guilty to conspiring in Medicare fraud program

Miami resident Ingrid Mazorra pleaded guilty today in U.S. District Court in Miami to participating in a conspiracy to defraud the Medicare program, announced Assistant Attorney General Lanny A. Breuer of the Criminal Division; U.S. Attorney Terrence I. Berg of the Eastern District of Michigan; Andrew G. Arena, Special Agent-in-Charge of the FBI's Detroit Field Office; and Daniel R. Levinson, Inspector General of the Department of Health & Human Services (HHS).

12 Jan 2010

TTI enters into definitive license agreement with Biogen Idec

Trillium Therapeutics Inc. , a biopharmaceutical company developing innovative immune-based biologics, today announced that it has entered into a definitive license agreement with Biogen Idec , granting the latter exclusive worldwide rights to one of Trillium's development programs.

12 Jan 2010

Thames Valley Cancer Network implements ARIA system for Medical Oncology

A chemotherapy software solution that enables patients to become more involved in managing their own care has been successfully rolled out across a network of hospitals in the UK. The Thames Valley Cancer Network has implemented Aria for Medical Oncology™ from Varian Medical Systems and already has more than 850 clinical staff routinely using the system.

12 Jan 2010