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Evaluating patients for genetic variations impacts adherence to antiviral therapy

In two recent studies, researchers have identified two functional variants in the inosine triphosphatase (ITPA) gene that protect patients with hepatitis C virus (HCV) against anemia brought on by antiviral treatment. The ability to identify those patients protected against treatment-induced anemia will ensure completion of antiviral therapy and successful elimination of the virus.

25 Jan 2011

Emergent BioSolutions initiates TRU-016 Phase Ib/II study for chronic lymphocytic leukemia

Emergent BioSolutions Inc. today announced the initiation of a Phase Ib/II study (16201) of TRU-016 for chronic lymphocytic leukemia (CLL). TRU-016 is a CD37-directed Small Modular ImmunoPharmaceutical (SMIP™) protein therapeutic in development for the treatment of B-cell malignancies. TRU-016 is being developed in collaboration with Abbott.

25 Jan 2011

Eisai to seek marketing authorization for perampanel in the U.S. and EU

Eisai announced today that it will submit Marketing Authorization Applications in the United States and the European Union for the investigational compound perampanel (E2007) based on the results of three Phase III pivotal studies. Perampanel is a first-in-class, highly selective non-competitive AMPA-type glutamate receptor antagonist, discovered and being developed by Eisai for adjunctive treatment of partial onset seizures in patients with epilepsy.

25 Jan 2011

Scientists to develop enzyme that protects against nerve agents

Protection against nerve gas attack is a significant component of the defense system of many countries around the world. Nerve gases are used by armies and terrorist organizations, and constitute a threat to both the military and civilian populations, but existing drug solutions against them have limited efficiency.

25 Jan 2011

Eisai's eritoran ACCESS study in severe sepsis does not meet primary endpoint

Based on the preliminary findings from the ACCESS (A Controlled Comparison of Eritoran and Placebo in Patients with Severe Sepsis) trial, Eisai Inc. announced today that the company will not submit marketing authorization applications to regulatory authorities in the United States, the European Union and Japan by the end of the fiscal year (March 31, 2011), as previously planned.

25 Jan 2011

Patients with chronic depression can benefit from pioneering neurosurgical treatment

Pioneering neurosurgical treatment, a world first in Bristol, which very accurately targets brain networks involved in depression, could help people who suffer with severe and intractable depression.

25 Jan 2011

HealthStream, Laerdal launch Simcenter simulation management platform for healthcare institutions

Through their joint venture, SimVentures, HealthStream, Inc., a leading provider of learning and research solutions for the healthcare industry, and Laerdal Medical, a global leader in the provision of educational solutions for healthcare providers and educators, today announced the launch of SimCenter. The

From Laerdal 24 Jan 2011

Threshold reports positive results from TH-302 Phase 1/2 clinical trial in pancreatic cancer

Threshold Pharmaceuticals, Inc. today announced updated Phase 1/2 clinical trial results related to the Company's clinical stage hypoxia-activated prodrug, TH-302. The results were presented at the ASCO Gastro Intestinal Cancers Symposium that took place in San Francisco from January 20-22, 2011.

24 Jan 2011

Alexza's AZ-004 Phase 3 study in agitated patients with schizophrenia published in British Journal of Psychiatry

Alexza Pharmaceuticals, Inc. announced today that the British Journal of Psychiatry, a publication of the Royal College of Psychiatrists, has published the results of the pivotal Phase 3 study evaluating AZ-004 (inhaled or Staccato® loxapine) for the rapid treatment of agitation in patients with schizophrenia, in its January 2011 edition (198:51-58).

24 Jan 2011

Spectrum submits Post Approval Supplement for removal of bioscan requirement for Indium-111 ZEVALIN

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced that on Thursday, January 20, 2011, it submitted a Post Approval Supplement containing data supporting the removal of the Indium-111 ZEVALIN® pre-treatment imaging evaluation, more commonly referred to as the "bioscan" requirement.

24 Jan 2011

FDA approves Clinical Data's Viibryd for major depressive disorder

Clinical Data, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved vilazodone HCl tablets, to be marketed under the brand name Viibryd™, for the treatment of adults with major depressive disorder (MDD).

24 Jan 2011

Positive interim data from ongoing V5 Phase IIb imm01 trial against tuberculosis

Immune Network, a company in the business of development and commercialization of immune therapies, announced today that its newly acquired business, Immunitor, has published interim data from the ongoing Phase IIb imm01 clinical trial of V5 in tuberculosis conducted at its second site in Ukraine.

24 Jan 2011

R-Tech Ueno announces completion of RK-023 Phase 2a study for androgenetic alopecia

R-Tech Ueno, is pleased to announce that the Phase 2a clinical study of RK-023 to treat androgenetic alopecia was completed by January 21, 2011.

24 Jan 2011

Bayer's gadobutrol injection for CNS imaging receives FDA Advisory Committee approval

Bayer HealthCare Pharmaceuticals Inc. announced today that the Peripheral and Central Nervous System Drugs Advisory Committee to the U.S. Food and Drug Administration voted unanimously that clinical trial and postmarketing data for gadobutrol injection, a macrocyclic 1.0 molar gadolinium-based contrast agent (GBCA), support approval of the product for proposed use in diagnostic magnetic resonance imaging (MRI) in adults and children.

24 Jan 2011

SuppreMol completes successful pre-IND meeting with U.S. FDA

SuppreMol GmbH, a privately held biopharmaceutical company developing innovative therapeutics for the treatment of autoimmune diseases, today announced that it has successfully completed a pre-Investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for its lead compound SM101, which is being developed for the treatment of Primary Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE).

24 Jan 2011

CRI, Oncovir sign new investment agreement to produce immunological stimulant

Cancer Research Institute, a U.S. nonprofit organization founded in 1953 to advance the science of tumor immunology and foster the discovery and development of new cancer immunotherapies, announced today that its Cancer Vaccine Acceleration Fund, a joint initiative with the Ludwig Institute for Cancer Research, has completed a new investment agreement with Oncovir, a biotechnology company based in Washington, D.C., to enable the production of the immunological stimulant Hiltonol- (Poly-ICLC).

24 Jan 2011

First U.S. implant of RespiCardia System for treatment of sleep apnea

Cardiac Concepts, announced today the first U.S. clinical implant of the RespiCardia System at The Ohio State University Medical Center, Columbus, Ohio.

21 Jan 2011

CVAF completes new investment agreement with Oncovir for production of Hiltonol

Cancer Research Institute, Inc. (CRI), a U.S. nonprofit organization founded in 1953 to advance the science of tumor immunology and foster the discovery and development of new cancer immunotherapies, announced today that its Cancer Vaccine Acceleration Fund (CVAF), a joint initiative with the Ludwig Institute for Cancer Research (LICR), has completed a new investment agreement with Oncovir, Inc., a biotechnology company based in Washington, D.C., to enable the production of the immunological stimulant Hiltonol® (Poly-ICLC).

21 Jan 2011

Approaches designed to motivate drug development for children needed

Recent legislative and regulatory actions make great strides toward establishing much needed incentives for pharmaceutical companies and others to develop and test more medications for pediatric rare diseases, including pediatric cancers, according to commentary by experts from Children's National Medical Center. The commentary appears in the January 19 issue of Science Translational Medicine.

21 Jan 2011

RBM, SMA Foundation collaborate to develop plasma protein biomarkers for spinal muscular atrophy

The Spinal Muscular Atrophy Foundation and Rules-Based Medicine, announced today that they have reached the first milestone in a program to develop a panel of plasma protein biomarkers for SMA using RBM's Multi-Analyte Profiling technology platform.

21 Jan 2011

Efficacy News and Research

Evaluating patients for genetic variations impacts adherence to antiviral therapy

Emergent BioSolutions initiates TRU-016 Phase Ib/II study for chronic lymphocytic leukemia

Eisai to seek marketing authorization for perampanel in the U.S. and EU

Scientists to develop enzyme that protects against nerve agents

Eisai's eritoran ACCESS study in severe sepsis does not meet primary endpoint

Patients with chronic depression can benefit from pioneering neurosurgical treatment

HealthStream, Laerdal launch Simcenter simulation management platform for healthcare institutions

Threshold reports positive results from TH-302 Phase 1/2 clinical trial in pancreatic cancer

Alexza's AZ-004 Phase 3 study in agitated patients with schizophrenia published in British Journal of Psychiatry

Spectrum submits Post Approval Supplement for removal of bioscan requirement for Indium-111 ZEVALIN

FDA approves Clinical Data's Viibryd for major depressive disorder

Positive interim data from ongoing V5 Phase IIb imm01 trial against tuberculosis

R-Tech Ueno announces completion of RK-023 Phase 2a study for androgenetic alopecia

Bayer's gadobutrol injection for CNS imaging receives FDA Advisory Committee approval

SuppreMol completes successful pre-IND meeting with U.S. FDA

CRI, Oncovir sign new investment agreement to produce immunological stimulant

First U.S. implant of RespiCardia System for treatment of sleep apnea

CVAF completes new investment agreement with Oncovir for production of Hiltonol

Approaches designed to motivate drug development for children needed

RBM, SMA Foundation collaborate to develop plasma protein biomarkers for spinal muscular atrophy

Industry Focus eBook - Forensics & toxicology (2nd edition) eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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