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EMA validates Synageva's sebelipase alfa MAA for LAL Deficiency

Synageva BioPharma Corp., a biopharmaceutical company developing therapeutic products for rare disorders, today announced validation by the European Medicines Agency of the Marketing Authorization Application for sebelipase alfa for LAL Deficiency.

23 Dec 2014

Shandong Taibang Biological Products earns GMP certification for new production facility

China Biologic Products, Inc., a leading fully integrated plasma-based biopharmaceutical company in China, today announced that its majority-owned subsidiary, Shandong Taibang Biological Products Co. Ltd., has received Good Manufacturing Practices ("GMP") certification from the China Food and Drug Administration (the "CFDA") for its new coagulation factor production facility.

23 Dec 2014

FDA approves Myriad’s BRACAnalysis CDx for use with ovarian cancer drug

Myriad Genetics, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for BRACAnalysis CDx to be used as the only companion diagnostic in conjunction with AstraZeneca’s drug Lynparza™ (olaparib).

22 Dec 2014

Chimerix, ContraVir collaborate to develop and commercialize antiviral drug candidate CMX157

Chimerix, Inc., a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, and ContraVir Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that the companies have entered into a strategic collaboration for the further clinical development and commercialization of CMX157.

18 Dec 2014

Study provides new evidence for anti-cirrhotic effects of GENFIT's GFT505

GENFIT, a biopharmaceutical company at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal system, today announces that a recent study provides new evidence for anti-cirrhotic effects of GFT505 in the context of NASH.

17 Dec 2014

Anavex Life Sciences qualifies to trade on OTCQX

OTC Markets Group Inc., operator of Open, Transparent and Connected financial marketplaces, today announced that Anavex Life Sciences Corp., a clinical-stage biopharmaceutical company developing novel drug candidates to treat Alzheimer's disease, other diseases of the central nervous system (CNS), and various types of cancer, has qualified to trade on OTCQX, the best marketplace for established, global and growth companies.

14 Dec 2014

OPTIMISE project to collect data that provides in-depth picture of MS experiences

Researchers will track the lives of people with multiple sclerosis (MS) in unprecedented detail in a project to improve the evaluation of treatments.

11 Dec 2014

Epizyme's PRMT5 inhibitor shows efficacy in pre-clinical models of mantle cell lymphoma

Epizyme, Inc., a clinical stage biopharmaceutical company creating innovative personalized therapeutics for patients with genetically defined cancers, announced today the results from a preclinical study showing in vitro and in vivo activity of its first-in-class PRMT5 inhibitor EPZ015666 in mantle cell lymphoma (MCL), an aggressive form of non-Hodgkin lymphoma (NHL).

10 Dec 2014

Epizyme presents EPZ-5676 Phase 1 trial results for acute leukemia at ASH 2014

Epizyme, Inc., a clinical stage biopharmaceutical company creating innovative personalized therapeutics for patients with genetically defined cancers, announced today the presentation of results from the company’s Phase 1 trial of EPZ-5676, a potent and selective inhibitor of the DOT1L histone methyltransferase (HMT).

10 Dec 2014

ContraVir begins pharmacokinetic study of FV-100 for treating shingles

ContraVir Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that it has initiated a pharmacokinetic (PK) study of FV-100, the Company's clinical-stage antiviral for treating shingles.

9 Dec 2014

Kiadis Pharma reports positive interim data from ATIR Phase II clinical study

Kiadis Pharma B.V., a clinical stage biopharmaceutical company developing T-cell immunotherapy treatments for blood cancers, today announces positive interim data from the ongoing Phase II clinical study with its lead product ATIR.

9 Dec 2014

BeyondSpring Pharmaceuticals plans to initiate Plinabulin Phase 3 pivotal trial in NSCLC patients

BeyondSpring Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on the development of innovative cancer therapies, today announced that it plans to initiate a Phase 3 pivotal trial of lead product candidate, Plinabulin, in patients with non-small cell lung cancer (NSCLC) in the first quarter of 2015.

4 Dec 2014

CytRx's clinical trials for aldoxorubicin placed on partial clinical hold

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced that the Company has received written notice from the United States Food and Drug Administration that its clinical trials for aldoxorubicin have been placed on partial clinical hold.

3 Dec 2014

InnaVirVax receives DSMB recommendation to pursue VAC-3S Phase 2 study in HIV

InnaVirVax, a biopharmaceutical company specialized in research and development on therapeutic and diagnostic solutions for diseases linked to immune dysregulation, today announces the recommendation of its independent Data Safety and Monitoring Board (DSMB) to pursue the Phase 2 study (IPROTECT1) of VAC-3S according to the planned protocol.

2 Dec 2014

Immune Pharmaceuticals closes underwriter's exercise of partial over-allotment option of 459,697 units

Immune Pharmaceuticals Inc., a clinical stage biopharmaceutical company that engages in the development and commercialization of targeted therapeutics for the treatment of inflammatory diseases and cancer, today completed the underwriter's exercise of partial over-allotment option of 459,697 units, at a price of $2.50 per unit, for gross proceeds of approximately $1.06 million, bringing the aggregate gross proceeds of the Company's previously announced underwritten public offering to $9.685 million.

27 Nov 2014

Promethera Biosciences completes €25.33 million ($31.4 million) Series C fundraising

Promethera Biosciences, a Belgian biotechnology company developing Promethera HepaStem, a cell-based therapy for the treatment of in-born errors of metabolism and acquired liver diseases, today announces the completion of its Series C fundraising round. The company has raised €25.33 million ($31.4 million), including €20.33 million in capital.

26 Nov 2014

Auxilium Pharmaceuticals presents STENDRA clinical data for ED treatment at SMSNA Scientific Meeting

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced that data were presented regarding the use of STENDRA® (avanafil) tablets for the treatment of erectile dysfunction (ED) at the 20th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America (SMSNA) held in Miami from November 20-23, 2014.

20 Nov 2014

Biopharmaceutical News and Research

EMA validates Synageva's sebelipase alfa MAA for LAL Deficiency

Shandong Taibang Biological Products earns GMP certification for new production facility

FDA approves Myriad’s BRACAnalysis CDx for use with ovarian cancer drug

Chimerix, ContraVir collaborate to develop and commercialize antiviral drug candidate CMX157

Study provides new evidence for anti-cirrhotic effects of GENFIT's GFT505

Anavex Life Sciences qualifies to trade on OTCQX

OPTIMISE project to collect data that provides in-depth picture of MS experiences

Epizyme's PRMT5 inhibitor shows efficacy in pre-clinical models of mantle cell lymphoma

Epizyme presents EPZ-5676 Phase 1 trial results for acute leukemia at ASH 2014

ContraVir begins pharmacokinetic study of FV-100 for treating shingles

Kiadis Pharma reports positive interim data from ATIR Phase II clinical study

BeyondSpring Pharmaceuticals plans to initiate Plinabulin Phase 3 pivotal trial in NSCLC patients

CytRx's clinical trials for aldoxorubicin placed on partial clinical hold

InnaVirVax receives DSMB recommendation to pursue VAC-3S Phase 2 study in HIV

Immune Pharmaceuticals closes underwriter's exercise of partial over-allotment option of 459,697 units

Promethera Biosciences completes €25.33 million ($31.4 million) Series C fundraising

Auxilium Pharmaceuticals presents STENDRA clinical data for ED treatment at SMSNA Scientific Meeting

Qosina launches new Swabbable Pre-Slit Transfer Valve

BerGenBio's BGB324 gets orphan-drug designation from FDA for AML treatment

TSRI scientists reveal how ZMapp antibodies target Ebola virus

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