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Amgen to discuss data supporting Repatha BLA for high cholesterol treatment with FDA EMDAC

Amgen today announced that the Company will discuss the data supporting the Repatha (evolocumab) Biologics License Application (BLA) for the treatment of high cholesterol with the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC).

10 Jun 2015

BerGenBio begins BGB324 Phase 1b trial in combination with erlotinib in NSCLC patients

BerGenBio AS, an oncology biopharmaceutical company, today announces that its multi-centre open label Phase 1b trial (BGBC004) of BGB324, a selective inhibitor of Axl, in patients with Stage IIIb and Stage IV non-small cell lung cancer (NSCLC) in erlotinib-sensitive and refractory patients who have an activating EGFR mutation, is now underway at the University of Texas MD Anderson Cancer Center, Houston, Oncology Partners, Houston, and at UT Southwestern Medical Center, Dallas, Texas, USA.

10 Jun 2015

New study shows that estrogen receptors vanish in cervical cancer tumors

Scientists have prior evidence that the hormone estrogen is a major driver in the growth of cervical cancer, but a new study examining genetic profiles of 128 clinical cases reached a surprising conclusion: Estrogen receptors all but vanish in cervical cancer tumors.

10 Jun 2015

GSU scientists design new MRI technique for early detection of liver tumors

Scientists at Georgia State University with funding from the National Institute of Biomedical Imaging and Bioengineering have designed an imaging technique to detect early-stage liver tumors, and have proven it successful in mice.

10 Jun 2015

New study outlines framework for long-term improvements in life science research reproducibility rates

A new study published in Open Access journal PLOS Biology by the Global Biological Standards Institute (GBSI) and two leading economists estimates that, in the U.S. alone, approximately $28 billion per year is spent on preclinical research that is not reproducible.

10 Jun 2015

Massey researchers aim to develop models that can predict complications from stem cell transplantation

Researchers at VCU Massey Cancer Center's Bone Marrow Transplant Program have recently published findings from a phase 2 clinical trial that demonstrate lymphocyte recovery in related and unrelated stem cell transplant recipients generally falls into three patterns that are significantly associated with survival.

10 Jun 2015

Phase 2 study of AR101 meets primary endpoint in patients with peanut allergy

Aimmune Therapeutics, Inc., a privately held biopharmaceutical company developing desensitization treatments for food allergies, announced today that a Phase 2 study (ARC001) evaluating the company's lead investigational product, AR101 for the treatment of peanut allergy, met its primary endpoint and additional endpoint of desensitizing patients to cumulative amounts of peanut protein of 443 mg and 1,043 mg, respectively.

10 Jun 2015

Stemedica receives FDA's IND approval for itMSC Phase IIa clinical trial to treat Alzheimer's disease

Stemedica Cell Technologies, Inc. received the FDA's investigational new drug (IND) approval for a United States-based, Phase IIa clinical study using its allogeneic stem-cell therapy to treat subjects with mild to moderate dementia due to Alzheimer's disease (AD), the sixth leading cause of death in the United States.

9 Jun 2015

Clarus Ventures announces closure of Clarus Lifesciences III, L.P. and affiliated funds

Clarus Ventures, a leading life science investment firm, announced today the close of Clarus Lifesciences III, L.P. and affiliated funds, a $500 million fund, well above its initial $375 million target.

9 Jun 2015

Results from Intarcia's two phase 3 clinical trials of ITCA 650 to be presented at ADA's Scientific Session

Intarcia Therapeutics, Inc. today announced the presentation of results from its first two phase 3 clinical trials (FREEDOM-1 and FREEDOM-1 HBL) of its late-stage investigational candidate ITCA 650 (exenatide delivered continuously via a small matchstick-size subcutaneous osmotic mini-pump just once or twice yearly) at the 75th Scientific Sessions of the American Diabetes Association.

8 Jun 2015

Celtaxsys closes $40M Series D financing and receives $5M CFFT grant to conduct CTX-4430 Phase 2 trial

Celtaxsys, Inc., a clinical stage drug development company focused on developing novel therapies for inflammatory diseases, today announced the successful completion of a $40M Series D financing led by Domain Partners VIII. Additional investors in the financing include Lumira Capital, RMI Partners, Masters Capital Management and the Georgia Research Alliance Venture Fund.

8 Jun 2015

IDMC recommends continuation of Argos’ ADAPT phase 3 trial of AGS-003 in mRCC patients

Argos Therapeutics Inc., an immuno-oncology company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer based on the Arcelis technology platform, today announced an independent data monitoring committee (IDMC) has recommended the continuation of the company’s pivotal phase 3 ADAPT clinical trial of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC) following the first of three planned interim data analyses.

5 Jun 2015

Pivotal Therapeutics enrolls first patient in POMEGA Phase IIa clinical trial of PVT-100

Pivotal Therapeutics Inc., a specialty pharmaceutical company with a focus on Omega-3 therapies for cardiovascular disease (CVD) and overall health, announced today the enrollment of the first patient in Pivotal's POMEGA Phase IIa clinical trial with PVT-100.

4 Jun 2015

Cytokinetics, The ALS Association expand partnership to fight against ALS

Cytokinetics, Incorporated and The ALS Association announced an expanded partnership in which the company will provide Gold Level Sponsorship of the National Walks to Defeat ALS as well as Platinum Level Sponsorship for ALS Association Golden West Chapter initiatives.

4 Jun 2015

Rhythm announces initiation of two setmelanotide Phase 2 trials for treatment of PWS, POMC-null obesity

Rhythm announced today the initiation of two Phase 2 clinical trials focused on evaluating the safety and effectiveness of setmelanotide (RM-493), the company's novel melanocortin 4 receptor (MC4R) agonist, for the treatment of Prader-Willi Syndrome (PWS) and POMC-null obesity.

4 Jun 2015

Regulus Therapeutics begins RG-012 Phase I clinical study for treatment of Alport syndrome

Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that dosing has begun in a first-in-human Phase I clinical study of RG-012, a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21 ("miR-21").

4 Jun 2015

CASI files application with CFDA to conduct ENMD-2076 Phase 2 trial in fibrolamellar carcinoma patients

CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, announced today that it has filed an application with China's Food and Drug Administration to conduct a Phase 2 clinical trial in fibrolamellar carcinoma (FLC) patients in China for its proprietary drug candidate, ENMD-2076.

4 Jun 2015

University of Chicago scientists develop new technique to accurately measure epigenetic changes

One of the most widely used tools in epigenetics research - the study of how DNA packaging affects gene expression - is chromatin immunoprecipitation (ChIP), a technique that allows researchers to examine interactions between specific proteins and genomic regions. However, ChIP is a relative measurement, and has significant limitations that can lead to errors, poor reproducibility and an inability to be compared between experiments.

4 Jun 2015

Novel strategy shows aptamer-based modular delivery of microRNA in endothelial, breast cancer cells

Researchers have shown that a novel delivery strategy can efficiently introduce a functional microRNA that has anti-cancer and angiogenic activities into two different types of cells--breast cancer cells to inhibit tumor growth and metastasis, and cells that line blood vessels to protect against atherosclerosis.

4 Jun 2015

AbbVie selects Halozyme's ENHANZE platform to augment their development pipeline

Halozyme Therapeutics, Inc. today announced a global collaboration and license agreement with AbbVie to develop and commercialize products combining proprietary AbbVie compounds with Halozyme's ENHANZE platform.

3 Jun 2015

Therapeutics News and Research

Amgen to discuss data supporting Repatha BLA for high cholesterol treatment with FDA EMDAC

BerGenBio begins BGB324 Phase 1b trial in combination with erlotinib in NSCLC patients

New study shows that estrogen receptors vanish in cervical cancer tumors

GSU scientists design new MRI technique for early detection of liver tumors

New study outlines framework for long-term improvements in life science research reproducibility rates

Massey researchers aim to develop models that can predict complications from stem cell transplantation

Phase 2 study of AR101 meets primary endpoint in patients with peanut allergy

Stemedica receives FDA's IND approval for itMSC Phase IIa clinical trial to treat Alzheimer's disease

Clarus Ventures announces closure of Clarus Lifesciences III, L.P. and affiliated funds

Results from Intarcia's two phase 3 clinical trials of ITCA 650 to be presented at ADA's Scientific Session

Celtaxsys closes $40M Series D financing and receives $5M CFFT grant to conduct CTX-4430 Phase 2 trial

IDMC recommends continuation of Argos’ ADAPT phase 3 trial of AGS-003 in mRCC patients

Pivotal Therapeutics enrolls first patient in POMEGA Phase IIa clinical trial of PVT-100

Cytokinetics, The ALS Association expand partnership to fight against ALS

Rhythm announces initiation of two setmelanotide Phase 2 trials for treatment of PWS, POMC-null obesity

Regulus Therapeutics begins RG-012 Phase I clinical study for treatment of Alport syndrome

CASI files application with CFDA to conduct ENMD-2076 Phase 2 trial in fibrolamellar carcinoma patients

University of Chicago scientists develop new technique to accurately measure epigenetic changes

Novel strategy shows aptamer-based modular delivery of microRNA in endothelial, breast cancer cells

AbbVie selects Halozyme's ENHANZE platform to augment their development pipeline

Industry Focus eBook - Cell biology (5th 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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