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FDA clears Novavax's Phase I clinical trial to evaluate new RSV vaccine candidate

Novavax, Inc. announced today that the company's Phase I clinical trial to evaluate a new vaccine candidate to prevent respiratory syncytial virus (RSV) infection has been cleared by the U.S. Food and Drug Administration (FDA) and is no longer on clinical hold. In November, the company reported that it had received a question from the FDA regarding chemistry, manufacturing and controls (CMC) that has now been resolved.

16 Dec 2010

MDA commits to invest funds in FSMA Quinazoline Program

The MDA has committed to invest funds in the FSMA Quinazoline Program at Repligen Corporation to assist in advancing the program to an IND filing with the FDA.

16 Dec 2010

Precise method to measure telomeres

Life Length, S.L. is a new biotechnology company set up to measure the length of telomeres which form caps at the end of chromosomes and that have a fundamental role in avoiding the break down and the aging of cells and organisms. The breakthroughs that Dr. Maria Blasco has made at the Spanish National Cancer Research Centre (Centro Nacional de Investigaciones Oncologicas, or CNIO) in Madrid, Spain form the founding basis of the company.

16 Dec 2010

$Phase 1b clinical trial of JX-594 in metastatic, refractory colorectal cancer commences in Korea$

Phase 1b clinical trial of JX-594 in metastatic, refractory colorectal cancer commences in Korea

Jennerex, Inc., a private clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class targeted oncolytic products for cancer, and Transgene, a bio-pharmaceutical company specialized in the development of immunotherapeutic products, today announced that enrollment and treatment of patients in a Phase 1b clinical trial has been initiated to evaluate JX-594 in patients with advanced metastatic, refractory colorectal cancer (CRC).

16 Dec 2010

NIH grants $7.5 million for researchers to develop novel compounds in treating nicotine addiction

The Scripps Research Institute and the University of California, San Diego, School of Medicine have been awarded approximately $7.5 million over five years to develop novel compounds that could eventually become drug candidates for the treatment of nicotine dependence, and possibly other drug addictions.

16 Dec 2010

Enzon in collaboration with NCI initiates EZN-2968, EZN-2208 Phase I studies for arresting tumor growth

Enzon Pharmaceuticals, today announced the initiation of Phase I clinical studies, in collaboration with the National Cancer Institute, for two of the Company's novel oncology product candidates, EZN-2968 and EZN-2208 (PEG-SN38).

16 Dec 2010

Ocera completes two studies of OCR-002 in patients with hyperammonemia, hepatic encephalopathy

Ocera Therapeutics, Inc. announced today that it has completed two studies evaluating the safety and pharmacokinetics of OCR-002 (ornithine phenylacetate) which includes healthy volunteers and patients with liver cirrhosis. OCR-002 recently received Orphan Drug status and Fast Track designation by the United States Food and Drug Administration for the treatment of hyperammonemia (excessive ammonia levels) and resultant Hepatic encephalopathy.

16 Dec 2010

MDA supports Repligen with $1.4M grant for RG3039 Spinal Muscular Atrophy development program

Repligen Corporation today announced that the Company has received $1,400,000 in research funding from the Muscular Dystrophy Association ("MDA") to support the ongoing development of RG3039 for Spinal Muscular Atrophy ("SMA"). RG3039, our lead compound, is an inhibitor of an RNA processing enzyme which targets increased production of SMN, a protein of deficient levels in patients with SMA.

15 Dec 2010

Charité begins implementation of MGN1601 clinical phase I/II study in renal cancer

The Charité - Medical University of Berlin has today begun the implementation of the clinical study phase I/II with the renal cancer medication MGN1601 (ASET Study). With this MOLOGEN AG product, an innovative cell-based gene therapy for the treatment of advanced renal cancer is entering the first important test phase.

15 Dec 2010

Positive results from Creabilis CT327 Phase IIa study in atopic dermatitis

Creabilis SA, a clinical stage European biotechnology company addressing unmet medical needs in dermatology, announced positive results in the Phase IIa study of its lead product CT327 in atopic dermatitis.

15 Dec 2010

Myotec, Hybrid merge to form PsiOxus Therapeutics

Myotec Therapeutics, Ltd. and Hybrid BioSystems, Ltd. today announced their merger to form PsiOxus Therapeutics, Ltd. (PsiOxus), a new, development stage biotechnology company using non-traditional approaches to novel therapeutics for cancer and wasting diseases. PsiOxus, which will be led by CEO Dr. John Beadle, boasts a combined pipeline of phase I and II clinical stage assets.

15 Dec 2010

NCI initiates crolibulin/cisplatin combination Phase II trial in anaplastic thyroid cancer

EpiCept Corporation today announced that the National Cancer Institute (NCI) has initiated a Phase II trial with crolibulinTM (EPC2407). The trial will assess the drug's efficacy and safety in combination with cisplatin in patients with anaplastic thyroid cancer (ATC). CrolibulinTM is a vascular disruption and apoptosis inducing agent that has demonstrated potent anti-tumor activity in both preclinical and early clinical studies.

15 Dec 2010

Amira's clinical-stage DP2 receptor antagonist program data to be presented at Pacifichem 2010

Amira Pharmaceuticals, Inc. announced today that it will present preclinical and clinical data from its DP2 receptor antagonist program on December 17, 2010, at Pacifichem 2010 in Honolulu, Hawaii. The data from Amira's clinical-stage DP2 program will be delivered by Brian Stearns, Ph.D., in a presentation titled "Discovery and optimization of a novel series of DP2 antagonists with efficacy in mouse models of COPD and asthma."

15 Dec 2010

Abbott initiates ABT-806 Phase 1 trial in EGFR expressing tumors

Life Science Pharmaceuticals (LSP) announced today a milestone related to monoclonal-antibody (mAb) 806 licensed to Abbott. A Phase 1 trial with ABT-806, a humanized version of mAb 806 that selectively targets the epidermal growth factor receptor (EGFR), has been initiated by Abbott in the U.S. The trial will assess the safety and pharmacokinetics of ABT-806 in patients with advanced solid tumors likely or known to express EGFR.

15 Dec 2010

Tolerx commences TRX518 Phase 1 trial in malignant melanoma

Tolerx, Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by modulating T cell activity, today announced that it has initiated a Phase 1 clinical trial to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of TRX518, a monoclonal antibody designed to enhance the immune system by enabling T cells to more effectively attack cancer cells.

14 Dec 2010

DARPA awards Pulmatrix $5.7 million grant to advance iCALM therapies

Pulmatrix, a clinical stage biotechnology company discovering and developing a new class of therapies for the prevention, treatment and control of respiratory diseases, today announced that it has been awarded a grant for $5.7 million from the Defense Advanced Research Projects Agency (DARPA), a component of the Department of Defense (DOD), focused on identifying and advancing novel technologies to support defense of our nation's soldiers and civilian population.

14 Dec 2010

Preliminary results from Phase 1b/2a trial of MediciNova's ibudilast in opioid addicts announced

Drug addiction investigators with joint appointments at Columbia University Medical Center and the New York State Psychiatric Institute along with MediciNova Inc, a biopharmaceutical company publicly traded on the Nasdaq Global Market and the Jasdaq Market of the Osaka Securities Exchange, today reported preliminary results of the company's neurological drug candidate, ibudilast (MN-166/AV411), in a Phase 1b/2a trial in opioid addicts. The study was largely funded by the National Institute on Drug Abuse (NIDA) with MediciNova supplementation.

14 Dec 2010

Lack of 'systematic reviews' in stroke research lead to waste of time, resources

Research being conducted into stroke needs to slow down and take stock if a therapeutic breakthrough is ever likely to happen, says a leading stroke expert.

14 Dec 2010

Chimerix reports positive results from CMX157 Phase 1 clinical trial for HIV

Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, today announced first-in-human Phase 1 clinical trial results for CMX157 demonstrating a favorable safety, tolerability and drug distribution profile.

14 Dec 2010

Intercell to stop further development of Travelers' Diarrhea Vaccine Patch

Intercell AG announced today preliminary clinical results on its investigational Travelers' Diarrhea (TD) Vaccine Patch program and the decision not to pursue further the development of this vaccine candidate. The decision was made following the receipt of results of its randomized and placebo-controlled Phase III study (ELT301) with 2036 travelers from Europe to Mexico and Guatemala as well as the pilot efficacy Phase II trial (ELT209) with 723 travelers from Europe to India.

13 Dec 2010

Preclinical News and Research

FDA clears Novavax's Phase I clinical trial to evaluate new RSV vaccine candidate

MDA commits to invest funds in FSMA Quinazoline Program

Precise method to measure telomeres

Phase 1b clinical trial of JX-594 in metastatic, refractory colorectal cancer commences in Korea

NIH grants $7.5 million for researchers to develop novel compounds in treating nicotine addiction

Enzon in collaboration with NCI initiates EZN-2968, EZN-2208 Phase I studies for arresting tumor growth

Ocera completes two studies of OCR-002 in patients with hyperammonemia, hepatic encephalopathy

MDA supports Repligen with $1.4M grant for RG3039 Spinal Muscular Atrophy development program

Charité begins implementation of MGN1601 clinical phase I/II study in renal cancer

Positive results from Creabilis CT327 Phase IIa study in atopic dermatitis

Myotec, Hybrid merge to form PsiOxus Therapeutics

NCI initiates crolibulin/cisplatin combination Phase II trial in anaplastic thyroid cancer

Amira's clinical-stage DP2 receptor antagonist program data to be presented at Pacifichem 2010

Abbott initiates ABT-806 Phase 1 trial in EGFR expressing tumors

Tolerx commences TRX518 Phase 1 trial in malignant melanoma

DARPA awards Pulmatrix $5.7 million grant to advance iCALM therapies

Preliminary results from Phase 1b/2a trial of MediciNova's ibudilast in opioid addicts announced

Lack of 'systematic reviews' in stroke research lead to waste of time, resources

Chimerix reports positive results from CMX157 Phase 1 clinical trial for HIV

Intercell to stop further development of Travelers' Diarrhea Vaccine Patch

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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