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Debiopharm receives FDA Fast Track designation for anti-infectious agent Debio 1450

Debiopharm Group, a Swiss-based global biopharmaceutical company, today announced that the US Food and Drug Administration granted Fast Track designation to its anti-infectious agent Debio 1450, a highly potent antibiotic specifically active against all Staphylococcus species.

8 Jan 2015

Soligenix's SGX301 receives FDA 'Fast Track' designation for CTCL treatment

Soligenix, Inc., a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today that its SGX301 (synthetic hypericin) development program for the first-line treatment of cutaneous T-cell lymphoma (CTCL) has received "Fast Track" designation from the US Food and Drug Administration.

7 Jan 2015

ContraVir granted Type B meeting with FDA to discuss proposal for FV-100 Phase 3 trial

ContraVir Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that it has been granted a Type B meeting with the U.S. Food and Drug Administration (FDA) to discuss its proposal for the design of a Phase 3 trial of ContraVir's lead antiviral candidate, FV-100.

7 Jan 2015

EnGeneIC closes oversubscribed Series B financing

EnGeneIC, Ltd., an emerging biopharmaceutical company focused on developing its proprietary EDV™ nanocell platform for the targeted delivery of cancer therapeutics, announced it has completed an oversubscribed $10 million Series B financing.

6 Jan 2015

CytRx reports positive interim results from aldoxorubicin Phase 2 trial for treatment of GBM

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced positive interim results from its ongoing Phase 2 clinical trial with aldoxorubicin for the treatment of unresectable glioblastoma multiforme (GBM), a deadly form of brain cancer.

6 Jan 2015

Sirnaomics submits STP705 IND Application to CFDA for skin scar treatment

Sirnaomics, Inc. and its affiliate Suzhou Sirnaomics Pharmaceutics, Co. Ltd., together with its partner Guangzhou Xiangxue Pharmaceutical, Co. Ltd., (SZSE: 300147), have formally submitted an Investigational New Drug (IND) Application to the China Food and Drug Administration for STP705, an anti-fibrosis RNA interference (RNAi) therapeutic for prevention and treatment of human skin hypertrophic scars.

5 Jan 2015

Palatin begins bremelanotide phase 3 study for treatment of female sexual dysfunction

Palatin Technologies, Inc., a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs and commercial potential, today announced that it has started its bremelanotide pivotal registration program.

29 Dec 2014

Tianyin Pharmaceutical releases unaudited preliminary financial results for Q1 FY 2015

Tianyin Pharmaceutical Inc., a pharmaceutical company that specializes in the patented biopharmaceutical, modernized traditional Chinese medicine (mTCM), branded generics and active pharmaceutical ingredients (API) released unaudited preliminary financial results for the first quarter of fiscal year 2015.

25 Dec 2014

Soligenix closes previously announced registered public offering

Soligenix, Inc., a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today that on December 24, 2014 it closed its previously announced registered public offering.

25 Dec 2014

PlasmaTech Biopharmaceuticals closes underwritten public offering of common stock

PlasmaTech Biopharmaceuticals, Inc., a biopharmaceutical company advancing patient care in critical areas, announced the closing of an underwritten public offering of 3,500,000 shares of common stock, and warrants to purchase up to an aggregate 3,500,000 shares of common stock, at an offering price of $4.00 per share and $.01 per warrant.

25 Dec 2014

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

Biopharmaceutical News and Research

Debiopharm receives FDA Fast Track designation for anti-infectious agent Debio 1450

Soligenix's SGX301 receives FDA 'Fast Track' designation for CTCL treatment

ContraVir granted Type B meeting with FDA to discuss proposal for FV-100 Phase 3 trial

EnGeneIC closes oversubscribed Series B financing

CytRx reports positive interim results from aldoxorubicin Phase 2 trial for treatment of GBM

Sirnaomics submits STP705 IND Application to CFDA for skin scar treatment

Palatin begins bremelanotide phase 3 study for treatment of female sexual dysfunction

Tianyin Pharmaceutical releases unaudited preliminary financial results for Q1 FY 2015

Soligenix closes previously announced registered public offering

PlasmaTech Biopharmaceuticals closes underwritten public offering of common stock

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

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