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Newron Pharmaceuticals submits safinamide NDA to FDA

Newron Pharmaceuticals S.p.A. ("Newron"), a research and development company focused on novel CNS and pain therapies, and its partner Zambon S.p.A., an international pharmaceutical company strongly committed to the CNS therapeutic area with a long experience in respiratory disease therapies, woman care and primary care, announce that the New Drug Application (NDA) for safinamide was submitted today to the US Food and Drug Administration (FDA).

30 May 2014

Genzyme: FDA accepts resubmission of Lemtrada sBLA

Genzyme, a Sanofi company, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company's resubmission of its supplemental Biologics License Application (sBLA) seeking approval of LemtradaTM (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis.

30 May 2014

ALOXI injection receives FDA approval for prevention of nausea, vomiting associated with cancer chemotherapy

Eisai Inc. and Helsinn Group today announced the Food and Drug Administration (FDA) approval of ALOXI (palonosetron HCl) injection for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy, in children aged 1 month to less than 17 years.

29 May 2014

Patrys reports positive results from PAT-SM6 clinical trial in patients with multiple myeloma

Patrys Limited, a clinical stage biotechnology company, is pleased to announce the clinical results from a patient treated with PAT-SM6 in combination with other marketed multiple myeloma drugs.

28 May 2014

CytRx announces Phase 2b clinical trial results of aldoxorubicin in subjects with metastatic STS

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced updated results from its ongoing multicenter, randomized, open-label global Phase 2b clinical trial investigating the efficacy and safety of aldoxorubicin compared with doxorubicin as first-line therapy in subjects with metastatic, locally advanced or unresectable soft tissue sarcomas.

28 May 2014

Inovio announces positive results on DNA-based monoclonal antibody therapy targeting CHIKV

Inovio Pharmaceuticals, Inc. announced today that its novel DNA-based therapeutic monoclonal antibody targeting Chikungunya virus (CHIKV) completely protected mice from a lethal CHIKV challenge.

27 May 2014

Micell Technologies presents DESSOLVE I and II trial data at EuroPCR conference

Micell Technologies, Inc. today announced that long-term clinical outcomes from its DESSOLVE I and II clinical trials were presented at the EuroPCR conference in Paris, France this week.

23 May 2014

BIOTRONIK ProMRI ICD trial expansion achieves FDA approval

BIOTRONIK, a leading manufacturer of cardiovascular medical devices, announced today that the Food and Drug Administration (FDA) has approved a significant expansion of its ongoing ProMRI® trial.

23 May 2014

NCCN receives $2M grant to evaluate effectiveness of volasertib in treatment of hematologic malignancies

The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) has been awarded a $2-million grant from Boehringer Ingelheim Pharmaceuticals, Inc.

23 May 2014

Agios Pharmaceuticals to present AG-221 Phase 1 study results at EHA meeting

Agios Pharmaceuticals, Inc., a leader in the fields of cancer metabolism and inborn errors of metabolism (IEMs), today announced that new clinical data from the Phase 1 study of AG-221, an orally available, selective, potent inhibitor of the mutated IDH2 protein, will be highlighted in an oral presentation at the 19th Congress of the European Hematology Association (EHA) taking place June 12 -15, 2014 in Milan, Italy.

22 May 2014

SinoVeda announces positive clinical results for EffectiCal in post-menopausal women

SinoVeda Canada Inc. today announces positive clinical results for EffectiCal® from its 24-week double-blind, randomized comparative clinical trial in post-menopausal women.

22 May 2014

Phase 3 data of VIVACITO study evaluating effect of T+O FDC in COPD presented at ATS conference

Boehringer Ingelheim today presented results of the VIVACITO® (NCT01559116) study, the first Phase 3 data to be reported from the TOviTO® clinical trial program, evaluating the effect of the fixed-dose combination of tiotropium and olodaterol (T+O FDC) delivered via the Respimat® inhaler on lung function in people with chronic obstructive pulmonary disease (COPD).

22 May 2014

Genprex initiates Phase II clinical trial of Oncoprex for late-stage lung cancer patients

Genprex, Inc. announced today that it has enrolled the first patient in a clinical trial evaluating its lead product candidate Oncoprex in combination with erlotinib (Tarceva) for late-stage lung cancer patients.

21 May 2014

Isis Pharmaceuticals starts Phase 1 clinical study of ISIS-PKKRx to treat patients with HAE

Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that it initiated a Phase 1 clinical study of ISIS-PKKRx. ISIS-PKKRx is an antisense drug in development to treat patients with hereditary angioedemia (HAE).

21 May 2014

Recruiting more Hispanics to cancer clinical trials crucial to reducing health disparities

Hispanics are the fastest-growing demographic group in the United States, and they suffer from major health disparities, including higher rates of cancers of the cervix, stomach and liver.

20 May 2014

Sanofi presents Phase II trial results for investigational vaccine for prevention of CDI

Sanofi Pasteur, the vaccines division of Sanofi, presented Phase II (H-030-012) trial results for an investigational vaccine for the prevention of Clostridium difficile infection at the 114th General Meeting of the American Society for Microbiology.

20 May 2014

Juventas presents positive trial results of JVS-100 drug delivered by Biocardia’s Helix transendocardial system

BioCardia®, Inc., a leader in cardiovascular regenerative medicine, today announced the presentation by Juventas Therapeutics of their positive four-month results for their STOP-HF Trial.

20 May 2014

GSK reports positive results from Incruse Ellipta and Advair Diskus combination therapy in COPD patients

GlaxoSmithKline plc today presented data at the American Thoracic Society (ATS) from a late-stage clinical study.

20 May 2014

Elotuzumab granted Breakthrough Therapy Designation for treatment of multiple myeloma

Bristol-Myers Squibb Company and AbbVie today announced that the U.S. Food and Drug Administration (FDA) has granted elotuzumab, an investigational humanized monoclonal antibody, Breakthrough Therapy Designation for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior therapies.

20 May 2014

Researchers identify drugs to slow progression of idiopathic pulmonary fibrosis

Researchers in separate clinical trials found two drugs slow the progression of idiopathic pulmonary fibrosis, a fatal lung disease with no effective treatment or cure, and for which there is currently no therapy approved by the Food and Drug Administration.

19 May 2014

Drug Trial News

Newron Pharmaceuticals submits safinamide NDA to FDA

Genzyme: FDA accepts resubmission of Lemtrada sBLA

ALOXI injection receives FDA approval for prevention of nausea, vomiting associated with cancer chemotherapy

Patrys reports positive results from PAT-SM6 clinical trial in patients with multiple myeloma

CytRx announces Phase 2b clinical trial results of aldoxorubicin in subjects with metastatic STS

Inovio announces positive results on DNA-based monoclonal antibody therapy targeting CHIKV

Micell Technologies presents DESSOLVE I and II trial data at EuroPCR conference

BIOTRONIK ProMRI ICD trial expansion achieves FDA approval

NCCN receives $2M grant to evaluate effectiveness of volasertib in treatment of hematologic malignancies

Agios Pharmaceuticals to present AG-221 Phase 1 study results at EHA meeting

SinoVeda announces positive clinical results for EffectiCal in post-menopausal women

Phase 3 data of VIVACITO study evaluating effect of T+O FDC in COPD presented at ATS conference

Genprex initiates Phase II clinical trial of Oncoprex for late-stage lung cancer patients

Isis Pharmaceuticals starts Phase 1 clinical study of ISIS-PKKRx to treat patients with HAE

Recruiting more Hispanics to cancer clinical trials crucial to reducing health disparities

Sanofi presents Phase II trial results for investigational vaccine for prevention of CDI

Juventas presents positive trial results of JVS-100 drug delivered by Biocardia’s Helix transendocardial system

GSK reports positive results from Incruse Ellipta and Advair Diskus combination therapy in COPD patients

Elotuzumab granted Breakthrough Therapy Designation for treatment of multiple myeloma

Researchers identify drugs to slow progression of idiopathic pulmonary fibrosis

Transforming Lab Workflows with Cell Culture Automation

Building Bridges to Scalable Allogeneic Cell Therapy

Edoardo Fabini

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