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Rockwell Medical announces design of Phase III development program for Soluble Ferric Pyrophosphate

Rockwell Medical, a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron-deficiency anemia, announced today the design of its Phase III development program for Soluble Ferric Pyrophosphate (SFP) as a continuous iron replacement therapeutic.

20 Oct 2010

Aradigm reports positive data from DRCFI, ARD-3150 Phase 2b bronchiectasis study

Aradigm Corporation today announced positive top line data from its recently concluded 6-month Phase 2b study (ORBIT-2) with Aradigm's once-daily dual release ciprofloxacin for inhalation (DRCFI, ARD-3150) in patients with non-cystic fibrosis bronchiectasis.

20 Oct 2010

European Commission grants Ipsen's OBI-1 orphan drug status for treatment of hemophilia

Ipsen announced today that the European Commission has granted orphan drug status for OBI-1 for the treatment of hemophilia. Expected to enter pivotal clinical trials before the end of this year, OBI-1 is designed to treat individuals with hemophilia who have developed inhibitory antibodies (inhibitors) against human Factor VIII (hFVIII).

20 Oct 2010

LANL's researcher to implement first human trial of mosaic HIV vaccine candidate

Los Alamos National Laboratory researcher Bette Korber is part of an international team of investigators working to design and implement the first human trial of a mosaic HIV vaccine candidate. The vaccine represents a novel strategy for fighting the virus that causes AIDS by attempting to address one of the most daunting challenges in HIV vaccine design: the virus's extensive genetic diversity.

20 Oct 2010

Neuralstem updates Phase I human clinical trial of spinal cord stem cells for ALS

Neuralstem, Inc. updated the progress of its ongoing Phase I human clinical trial of the company's spinal cord stem cells in the treatment of ALS (Amyotrophic Lateral Sclerosis, or Lou Gehrig's disease) at Emory University in Atlanta, Georgia.

20 Oct 2010

NIAID announces four new contracts for clinical trials to address problem of antimicrobial resistance

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, today announced four new contracts for large-scale clinical trials that address the problem of antimicrobial resistance.

20 Oct 2010

MannKind begins MKC1106-MT Phase 2 trial for advanced melanoma

MannKind Corporation today announced the first patient has been dosed in a phase 2 clinical trial of the novel, investigational cancer vaccine MKC1106-MT. As a part of MannKind's cancer immunotherapy program, this phase 2 study will evaluate the safety, tolerability, immune response and clinical response of MKC1106-MT in patients with advanced melanoma.

20 Oct 2010

Ceregene commences enrollment in CERE-120 Phase 2b study for Parkinson's disease

Ceregene, Inc., a biopharmaceutical company, announced today that enrollment has begun in a new double-blind sham surgery-controlled Phase 2b study evaluating CERE-120 in Parkinson's disease patients. CERE-120 is a gene therapy product that delivers the neurotrophic factor neurturin to degenerating or dying dopamine neurons. Data from the first Phase 2 clinical trial of CERE-120 are being published later this year in Lancet Neurology (to appear online October 21, 2010).

20 Oct 2010

BioMarin announces BMN-111 program for treatment of achondroplasia

BioMarin Pharmaceutical Inc. today announced its program for BMN-111, a peptide therapeutic for the treatment of achondroplasia. BioMarin plans to file an IND in the fourth quarter of 2011 and to initiate a Phase 1 clinical trial by the first quarter of 2012.

19 Oct 2010

Rexahn announces publication of 3-aryl-1-isoquinolinamines preclinical data

Rexahn Pharmaceuticals, Inc. a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced the publication of new preclinical data on the development of 3-aryl-1-isoquinolinamines in the European Journal & Medicinal Chemistry.

19 Oct 2010

Acorda announces data of GGF2 preclinical studies for focal ischemic stroke

Acorda Therapeutics, Inc, today announced that data from preclinical studies show that Glial Growth Factor 2 (GGF2) promoted functional recovery following a permanent focal ischemic stroke.

19 Oct 2010

Adolor initiates ADL5945 Phase 2 proof-of-concept study for patients with OIC

Adolor Corporation today announced the initiation of a Phase 2 proof-of-concept (PoC) study of ADL5945 in patients suffering from opioid-induced constipation (OIC).

19 Oct 2010

Cytheris initiates ORVACS Phase II clinical trial to study HIV infection

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced the initiation of Phase II clinical trial of the company's investigative immunomodulatory agent, CYT107 (rhIL-7), in combination with two potent antiretroviral drugs represented by the integrase inhibitor raltegravir (ISENTRESS- Merck & Co.) and the CCR5 inhibitor, maraviroc (SELZENTRY- ViiV Healthcare).

19 Oct 2010

Amgen to review study results of ESA in chronic renal failure patients with FDA and CRDAC

Amgen will review the results from TREAT (the Trial to Reduce Cardiovascular Events with Aranesp® Therapy) and will discuss how these results inform the appropriate use of erythropoiesis-stimulating agents (ESAs) for chronic renal failure (CRF) patients at today's meeting of the Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC).

19 Oct 2010

Positive results from Diamyd Medical's NP2 Enkephalin Phase I trial for chronic pain

Substantial and sustained reduction in pain scores were reported in the middle and high dose cohorts of Diamyd Medical's Phase I, open-label, dose escalation trial investigating NP2 Enkephalin as a potential therapy for chronic pain. No treatment related Serious Adverse Events have been observed in the study to date.

19 Oct 2010

Novartis announces six-year data of Reclast injection for postmenopausal women with osteoporosis

Novartis announced today that new six-year data reinforce the long-term efficacy and safety profile of once-yearly Reclast (zoledronic acid) injection in postmenopausal women with osteoporosis.The study of more than 1,200 women was presented this weekend at the annual meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, ON, Canada.

19 Oct 2010

Study investigates effectiveness of potential treatment for Non-alcoholic steatohepatitis

Estimates of the prevalence of liver disease suggest that one‐third of the United States population has non‐alcoholic fatty liver disease (NAFLD). NAFLD is now the most common cause for elevated liver function tests in the United States, a trend related to the obesity epidemic in this country. Non-alcoholic steatohepatitis (NASH), the progressive form of NAFLD, can lead to cirrhosis and all its complications.

19 Oct 2010

New research coalition to design first human trial of mosaic HIV vaccine candidate

Duke University Medical Center vaccine experts have assembled an international team of investigators to design and implement the first human trial of a mosaic HIV vaccine candidate, a novel strategy that attempts to counter one of the most daunting challenges in HIV vaccine design: the virus's extensive genetic diversity

19 Oct 2010

Transcept announces Intermezzo tablet preliminary data for insomnia

Transcept Pharmaceuticals, Inc. today announced its preliminary analysis of data from the recently completed Intermezzo 3.5 mg (zolpidem tartrate sublingual tablet) highway driving study.

19 Oct 2010

Salix presents two Phase 3 pivotal clinical trials data for non-C IBS at ACG Meeting

Salix Pharmaceuticals, Ltd. today announced the presentation of two analyses of data from its Phase 3 pivotal clinical trials, TARGET 1 and 2, demonstrating a 14-day course of XIFAXAN 550 mg (rifaximin) taken three times daily achieved adequate relief of symptoms of non-constipation irritable bowel syndrome (non-C IBS) in a significantly greater proportion of patients compared with placebo.

19 Oct 2010

Drug Trial News

Rockwell Medical announces design of Phase III development program for Soluble Ferric Pyrophosphate

Aradigm reports positive data from DRCFI, ARD-3150 Phase 2b bronchiectasis study

European Commission grants Ipsen's OBI-1 orphan drug status for treatment of hemophilia

LANL's researcher to implement first human trial of mosaic HIV vaccine candidate

Neuralstem updates Phase I human clinical trial of spinal cord stem cells for ALS

NIAID announces four new contracts for clinical trials to address problem of antimicrobial resistance

MannKind begins MKC1106-MT Phase 2 trial for advanced melanoma

Ceregene commences enrollment in CERE-120 Phase 2b study for Parkinson's disease

BioMarin announces BMN-111 program for treatment of achondroplasia

Rexahn announces publication of 3-aryl-1-isoquinolinamines preclinical data

Acorda announces data of GGF2 preclinical studies for focal ischemic stroke

Adolor initiates ADL5945 Phase 2 proof-of-concept study for patients with OIC

Cytheris initiates ORVACS Phase II clinical trial to study HIV infection

Amgen to review study results of ESA in chronic renal failure patients with FDA and CRDAC

Positive results from Diamyd Medical's NP2 Enkephalin Phase I trial for chronic pain

Novartis announces six-year data of Reclast injection for postmenopausal women with osteoporosis

Study investigates effectiveness of potential treatment for Non-alcoholic steatohepatitis

New research coalition to design first human trial of mosaic HIV vaccine candidate

Transcept announces Intermezzo tablet preliminary data for insomnia

Salix presents two Phase 3 pivotal clinical trials data for non-C IBS at ACG Meeting

How agentic AI is reshaping laboratory workflows

Fourier 80: bringing benchtop NMR systems to the laboratory

How industrial hygiene flow calibration supports defensible exposure data

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