Biopharmaceutical News and Research

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SAGE Therapeutics doses first patient in SAGE-547 Phase 1/2 trial for treatment of SRSE

SAGE Therapeutics, a biopharmaceutical company developing novel medicines to treat life-threatening and rare central nervous system (CNS) disorders, today announced dose initiation of the first patient in a Phase 1/2 clinical trial of SAGE-547, a neuroactive steroid, in super-refractory status epilepticus (SRSE), a critical condition in which the brain is in a state of persistent seizure.

27 Mar 2014

Alimera Sciences resubmits New Drug Application for ILUVIEN

Alimera Sciences, Inc. (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it has resubmitted its New Drug Application for ILUVIEN® to the U.S. Food and Drug Administration (FDA).

27 Mar 2014

Surveys show drug safety budgets grew between 2012 and 2013, estimated to increase in 2014

Recent surveys by Cutting Edge Information found that the majority of drug safety budgets grew between 2012 and 2013, and are projected to continue growth for 2014.

26 Mar 2014

FMCNA introduces newly branded Frenova Renal Research business

Fresenius Medical Care North America, the world's largest provider of dialysis services, today introduced its newly branded Frenova Renal Research business, the only Phase I-IV drug and device clinical development partner dedicated exclusively to renal research.

26 Mar 2014

FDA grants PMA for Pinnacle's Optiguide DCYL700 Fiber Optic Diffuser Series flexible fiber

Concordia Healthcare Corp. announced today that its subsidiary Pinnacle Biologics, Inc., a biopharmaceutical research and development company specializing in rare diseases, was granted U.S. Food and Drug Administration premarket supplemental approval (PMA) for its Optiguide DCYL700 Fiber Optic Diffuser Series flexible fiber.

26 Mar 2014

AM-Pharma reports positive results from recAP Phase I trial for Acute Kidney Injury

AM-Pharma B.V., a biopharmaceutical company focused on the development of recAP (recombinant human Alkaline Phosphatase) for inflammatory indications, announces the results of its Phase I trial with both single and multiple ascending doses, which demonstrate that recAP is safe and well tolerated at all doses.

26 Mar 2014

Precision for Medicine announces acquisition of Hobart Group Holdings

Precision for Medicine, Inc., formed in 2012 to support next generation approaches to drug development and commercialization, announces the acquisition of Hobart Group Holdings, LLC, a leading market access firm. With this addition, Precision for Medicine has established the foundation for its next phase of growth in providing integrated solutions focused on demonstrating value in the era of precision medicine.

25 Mar 2014

Transgene raises €65.5M via two-step capital increase

Transgene SA, a French biopharmaceutical company focused on discovering, developing and manufacturing targeted immunotherapies for the treatment of cancer and infectious diseases, announces that it has raised a total of €65.5 million via a two-step capital increase.

25 Mar 2014

CytRx initiates Phase 3 clinical trial to evaluate efficacy of aldoxorubicin in STS patients

CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced it has initiated a pivotal global Phase 3 clinical trial to evaluate the efficacy and safety of aldoxorubicin as a second-line treatment for patients with soft tissue sarcoma (STS) under a Special Protocol Assessment with the FDA.

25 Mar 2014

Rexahn provides updates on clinical development programs, reports full-year 2013 financial results

Rexahn Pharmaceuticals, Inc. a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, is providing an overview of its three clinical development programs and Year for the year ended December 31, 2013.

24 Mar 2014

NIH awards $28M grant to establish new center for excellence to find treatment for Ebola virus

The National Institutes of Health has awarded a five-year, $28 million grant to establish a new center for excellence to find an antibody "cocktail" to fight two types of viruses that cause severe hemorrhagic fever, including the deadly Ebola virus. The project involves researchers from 15 institutions, including Kartik Chandran, Ph.D., and Jonathan Lai, Ph.D., at Albert Einstein College of Medicine of Yeshiva University. Einstein will receive approximately $4 million of the total grant.

21 Mar 2014

Emmaus reports preliminary top-line results from Phase 3 clinical trial for treatment of sickle cell disease

Emmaus Life Sciences, Inc., a biopharmaceutical company dedicated primarily to the discovery, development and commercialization of innovative treatments and therapies for rare and orphan diseases, today announced that preliminary top-line results of its Phase 3 clinical trial evaluating the safety and efficacy of its treatment for sickle cell anemia and sickle beta-0 thalassemia met both the primary and secondary endpoints of the clinical trial.

20 Mar 2014

New data shows curative effects of GFT505 in NASH associated with metabolic disorders

GENFIT, a biopharmaceutical company at the forefront of drug discovery and development, focusing on the early diagnosis and preventive treatment of cardiometabolic and associated disorders, today announces new data from Professor Isabelle Leclercq of Université Catholique de Louvain (Belgium) demonstrating the curative effects of GFT505 in an experimental model of NASH associated with metabolic disorders.

20 Mar 2014

PAREXEL International expands global Clinical Logistics Services capabilities

PAREXEL International Corporation, a leading global biopharmaceutical services provider, today announced the expansion of its global Clinical Logistics Services (CLS) capabilities. A new, state-of-the-art distribution center in Singapore and the recent expansion of the Company's facilities in Billerica, Mass., will help PAREXEL more effectively manage clients' global clinical trial supply requirements.

From Parexel 19 Mar 2014

Non-alcoholic steatohepatitis (NASH): an interview with Jean-François Mouney, CEO of Genfit

The progressive form of Non-Alcoholic Fatty Liver Disease (NAFLD) is Non-Alcoholic Steatohepatitis (NASH), which defines a subgroup of NAFLD where liver steatosis co-exists with cell injury (hepatocyte ballooning) and inflammation with or without fibrosis at histological examination.

18 Mar 2014

Trovagene reports net loss of $1 million for fourth quarter 2013

Trovagene, Inc., a developer of cell-free molecular diagnostics, today reported its financial results for the quarter and the year ended December 31, 2013.

18 Mar 2014

AnaptysBio announces strategic immuno-oncology collaboration with TESARO

AnaptysBio, Inc., a leader in the discovery and development of therapeutic antibodies, today announced a strategic immuno-oncology collaboration with TESARO, Inc., an oncology-focused biopharmaceutical company.

13 Mar 2014

SAGE Therapeutics announces completion of $38 million Series C financing

SAGE Therapeutics, a biopharmaceutical company developing novel medicines to treat specialty, critical and orphan central nervous system (CNS) disorders, today announced the successful completion of a $38 million Series C financing. OrbiMed Advisors, LLC, EcoR1 Capital Management, Foresite Capital Management and two undisclosed blue chip public investment funds joined existing investors Third Rock Ventures and ARCH Venture Partners.

13 Mar 2014

CRO services division of Galapagos to be acquired by Charles River Laboratories

Charles River Laboratories International, Inc. announced today that it has entered into a definitive agreement to acquire the CRO services division of Galapagos NV (Euronext: GLPG), which includes both Argenta and BioFocus.

13 Mar 2014

Protein Metrics releases Byologic software to improve analytical quality

Protein Metrics, Inc., a leading provider of software for rapid and thorough protein characterization, today announced the release of Byologic. Byologic software enables easy and convenient identification and quantification of sequence variants, protein modifications, and degradants down to trace concentrations.

12 Mar 2014

Biopharmaceutical News and Research

SAGE Therapeutics doses first patient in SAGE-547 Phase 1/2 trial for treatment of SRSE

Alimera Sciences resubmits New Drug Application for ILUVIEN

Surveys show drug safety budgets grew between 2012 and 2013, estimated to increase in 2014

FMCNA introduces newly branded Frenova Renal Research business

FDA grants PMA for Pinnacle's Optiguide DCYL700 Fiber Optic Diffuser Series flexible fiber

AM-Pharma reports positive results from recAP Phase I trial for Acute Kidney Injury

Precision for Medicine announces acquisition of Hobart Group Holdings

Transgene raises €65.5M via two-step capital increase

CytRx initiates Phase 3 clinical trial to evaluate efficacy of aldoxorubicin in STS patients

Rexahn provides updates on clinical development programs, reports full-year 2013 financial results

NIH awards $28M grant to establish new center for excellence to find treatment for Ebola virus

Emmaus reports preliminary top-line results from Phase 3 clinical trial for treatment of sickle cell disease

New data shows curative effects of GFT505 in NASH associated with metabolic disorders

PAREXEL International expands global Clinical Logistics Services capabilities

Non-alcoholic steatohepatitis (NASH): an interview with Jean-François Mouney, CEO of Genfit

Trovagene reports net loss of $1 million for fourth quarter 2013

AnaptysBio announces strategic immuno-oncology collaboration with TESARO

SAGE Therapeutics announces completion of $38 million Series C financing

CRO services division of Galapagos to be acquired by Charles River Laboratories

Protein Metrics releases Byologic software to improve analytical quality

How to optimize your cell line development eBook

Advancing Intracellular Delivery with LumiPore®

How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

The role of UV-Vis in biopharma QC

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