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Global home health management market expanding at CAGR of 10% through 2012

Remote health management is the fastest growing segment of a burgeoning home health management market. However, RHM’s full potential will materialize only if health insurers adopt reimbursement practices that encourage greater physician adoption, concludes Scientia Advisors, a global strategy consulting firm, in its review of the worldwide home health management market released today.

26 Mar 2010

Genentech, Biogen Idec file declaratory relief complaint against GSK regarding Arzerra

Genmab A/S announced today that on March 23, 2010 Genentech, Inc. and Biogen Idec, Inc. filed a declaratory relief complaint at the US District Court, Southern District of California against Genmab's collaboration partner GlaxoSmithKline (GSK) for patent infringement under US patent No 7,682,612 based on GSK's manufacture, marketing and sale of Arzerra™ in the United States for the treatment of fludarabine and alemtuzumab refractory chronic lymphocytic leukemia (CLL).

26 Mar 2010

FDA to take enforcement action regarding Genzyme's Allston plant

Genzyme Corporation announced today that the FDA notified the company yesterday afternoon that, while the agency recognizes Genzyme’s efforts, it intends to take enforcement action to ensure that products manufactured at the plant are made in compliance with good manufacturing practice regulations. The FDA enforcement action will likely result in a consent decree, under which a third party would inspect and review the plant’s operation for an extended period and certify compliance with FDA regulations.

26 Mar 2010

FIMM to launch cell microarray screening research program utilizing Aushon 2470 Arrayer technology

Aushon BioSystems, Inc., a leading provider of advanced microarray instrumentation and laboratory services for biomarker discovery, development and analysis announced today that the Institute for Molecular Medicine Finland will launch a cell microarray screening research program utilizing the Aushon 2470 Arrayer technology.

26 Mar 2010

Positive data from Shire's Phase III trial of TKT-034 in Type 1 Gaucher disease patients who switched to VPRIV

Shire plc, the global specialty biopharmaceutical company, today presented positive data from a Phase III clinical trial (TKT-034) designed to evaluate the safety of switching to VPRIV (velaglucerase alfa for injection), from imiglucerase, as well as an interim analysis of safety data from an ongoing multicenter open-label treatment protocol (HGT-GCB-058) implemented to provide VPRIV to patients affected by the continuing shortage of imiglucerase.

26 Mar 2010

Oramed Pharmaceuticals completes Phase 2b study of ORMD-0801 oral insulin capsule

Oramed Pharmaceuticals Inc. announced today the completion of its' pivotal Phase 2b clinical study of its oral insulin capsule, ORMD-0801. The Company expects to report results from this study within the coming weeks.

26 Mar 2010

FDA grants tentative approval for Teva Pharmaceutical Industries' generic Argatroban ANDA

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market a generic version of the anticoagulant, Argatroban® injection, 100mg/mL.

26 Mar 2010

Positive results from Stage A pivotal study of 2009 A/H1N1 VLP pandemic influenza vaccine

Novavax, Inc. announced today positive results from the entire 1,000 subject Stage A of its two-stage pivotal study evaluating the safety and immunogenicity of Novavax's unadjuvanted 2009 A/H1N1 virus-like particle pandemic influenza vaccine.

26 Mar 2010

IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay granted EUA from FDA

IMDx announced today that its IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay has been granted Emergency Use Authorization from the U.S. Food and Drug Administration.

26 Mar 2010

Independent DMC recommends continuance of enrollment in Eisai's Phase III ACCESS trial

Eisai Inc. announced today that the Phase III ACCESS (A Controlled Comparison of Eritoran and Placebo in Patients with Severe Sepsis) trial of the investigational compound eritoran (E5564) will continue enrolling to the preset goal of 2,000 patients. As part of a planned interim analysis, an independent Data Monitoring Committee (DMC) has evaluated efficacy and safety data on the first 1,500 subjects to complete the 28-day follow-up in the Phase III ACCESS trial.

26 Mar 2010

JCOM receives approval from KFDA to commercialize MuGard in Korea

ACCESS PHARMACEUTICALS, INC. announced that JCOM Co., Ltd., its Korean licensee for both MuGard™ and ProLindac™, has received approval from the Korean Food and Drug Administration of its Registration Dossier for MuGard, an oncology supportive-care treatment for the management of oral mucositis.

26 Mar 2010

Arena Pharmaceuticals initiates patient screening for phase 1 clinical trial of APD916

Arena Pharmaceuticals, Inc. announced today the initiation of patient screening in a Phase 1 clinical trial of APD916, a novel oral drug candidate discovered by Arena that targets the histamine H3 receptor for the treatment of narcolepsy and cataplexy.

25 Mar 2010

Venn Life Sciences completes $3 mn funding, acquires Dutch CRO UpToYou

Venn Life Sciences has just completed a significant funding round of over $3 million, to enable it to further accelerate the growth of its business.

25 Mar 2010

NIH grants $1.4 Million to WPI to continue study of arterial plaque

A Worcester Polytechnic Institute research team has received a four-year, $1.4 million award from the National Institutes of Health to continue a groundbreaking study of arterial plaque. This research could lead to tools that will enable physicians to predict the likelihood of plaque rupture, which is responsible for most heart attacks and strokes.

25 Mar 2010

Keryx Biopharmaceuticals reports net loss of $4.7M for 2009 fourth quarter

Keryx Biopharmaceuticals, Inc., a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease (the "Company"), today announced its results for the fourth quarter and year ended December 31, 2009.

25 Mar 2010

Clinical Reference Laboratory completes validation testing of DNA Genotek's Oragene-DNA saliva collection kits

Clinical Reference Laboratory today announced that it has completed validation testing of DNA Genotek's Oragene-DNA saliva collection kits and will adopt Oragene-DNA for use with its molecular diagnostic services.

25 Mar 2010

Public and private sectors fund bioprocessing research for drug development

The search for new medicines will receive a £10M boost this week as the public and private sectors unite to fund bioprocessing research. The money is now available for scientists to apply for from the Bioprocessing Research Industry Club (BRIC) which aims to bring academics and industry together to find ways of delivering new medicines from biological materials more quickly and effectively.

25 Mar 2010

Biogen Idec and Elan begin comparative trial of MS treatments

Biogen Idec and Elan Corporation, plc (NYSE: ELN) today announced enrollment of the first patient in a global Phase IIIb, randomized, rater-blinded, active-controlled study designed to evaluate switching to TYSABRI® (natalizumab) from Copaxone® (glatiramer acetate) or Rebif® (interferon beta-1a) in patients with relapsing remitting multiple sclerosis.

25 Mar 2010

Campylobacter cells can survive with biofilm protection

In research published in the journal Applied and Environmental Microbiology, IFR researchers have found that Campylobacter will readily form a biofilm under laboratory conditions, and that, when the bacteria were left in air, they respond to these stressful conditions by more rapidly forming this biofilm.

25 Mar 2010

SCOLR Pharma's total revenue dips 2% in 2009, but significant improvements in operating expenses

SCOLR Pharma, Inc. today reported financial results for the twelve months ended December 31, 2009. The Company will host a live conference call on March 31, 2010, at 11:30 a.m. (Eastern Standard Time).

25 Mar 2010

Biotechnology News and Research

Global home health management market expanding at CAGR of 10% through 2012

Genentech, Biogen Idec file declaratory relief complaint against GSK regarding Arzerra

FDA to take enforcement action regarding Genzyme's Allston plant

FIMM to launch cell microarray screening research program utilizing Aushon 2470 Arrayer technology

Positive data from Shire's Phase III trial of TKT-034 in Type 1 Gaucher disease patients who switched to VPRIV

Oramed Pharmaceuticals completes Phase 2b study of ORMD-0801 oral insulin capsule

FDA grants tentative approval for Teva Pharmaceutical Industries' generic Argatroban ANDA

Positive results from Stage A pivotal study of 2009 A/H1N1 VLP pandemic influenza vaccine

IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay granted EUA from FDA

Independent DMC recommends continuance of enrollment in Eisai's Phase III ACCESS trial

JCOM receives approval from KFDA to commercialize MuGard in Korea

Arena Pharmaceuticals initiates patient screening for phase 1 clinical trial of APD916

Venn Life Sciences completes $3 mn funding, acquires Dutch CRO UpToYou

NIH grants $1.4 Million to WPI to continue study of arterial plaque

Keryx Biopharmaceuticals reports net loss of $4.7M for 2009 fourth quarter

Clinical Reference Laboratory completes validation testing of DNA Genotek's Oragene-DNA saliva collection kits

Public and private sectors fund bioprocessing research for drug development

Biogen Idec and Elan begin comparative trial of MS treatments

Campylobacter cells can survive with biofilm protection

SCOLR Pharma's total revenue dips 2% in 2009, but significant improvements in operating expenses

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