Biopharmaceutical News and Research

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Auxilium Pharmaceuticals' XIAFLEX gets FDA approval for treatment of Peyronie's disease

Auxilium Pharmaceuticals, Inc., a fully integrated specialty biopharmaceutical company, announced today that the U.S. Food and Drug Administration has approved XIAFLEX (collagenase clostridium histolyticum, or CCH), an in-office, biologic for the treatment of Peyronie's disease. XIAFLEX is the first and only FDA-approved treatment proven effective for PD in men with a palpable plaque and a curvature deformity of 30 degrees or greater at the start of therapy.

6 Dec 2013

Eli Lilly reports edivoxetine Phase III program did not meet primary endpoint for major depressive disorder

Eli Lilly and Company (NYSE: LLY) announced today that results from three studies of edivoxetine did not meet the primary study objective of superior efficacy in depression after eight weeks of treatment.

6 Dec 2013

Soligenix initiates SGX942 Phase 2 study for treatment of oral mucositis

Soligenix, Inc., a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics, announced today that it has initiated a Phase 2, randomized, double-blind, placebo-controlled study evaluating SGX942, a first-in-class innate defense regulator, as a treatment for oral mucositis in patients undergoing chemoradiation therapy for head and neck cancer.

5 Dec 2013

Alvotech to invests $250M in the development of biosimilar monoclonal antibodies

Alvotech, a powerful new player in the field of biopharmaceuticals, today announced plans to invest $250 million in the development and manufacturing of a portfolio of biosimilar monoclonal antibodies.

5 Dec 2013

Enrollment opens for IMO-8400 Phase 1/2 trial in patients with Waldenström's macroglobulinemia

Idera Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing a novel therapeutic approach for the treatment of autoimmune diseases and genetically defined forms of B-cell lymphoma, today announced that enrollment is open for a Phase 1/2 clinical trial of IMO-8400 in patients with Waldenström's macroglobulinemia, following acceptance of its Investigational New Drug application by the U.S. Food and Drug Administration.

5 Dec 2013

FDA accepts ARCA biopharma's Gencaro IND application for atrial fibrillation

ARCA biopharma, Inc., a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that the Company's Gencaro Investigational New Drug application for atrial fibrillation has been accepted by the U.S. Food and Drug Administration and is now active.

4 Dec 2013

EMD Serono's TocopheRx to focus on development of oral FSH agonists for infertility treatment

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, announced today the creation of TocopheRx, a Boston-based spin-off company resulting from the Entrepreneur Partnership Program launched by Merck Serono, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, in April 2012.

3 Dec 2013

Soligenix initiates orBec Phase 2 study for GI manifestations of chronic GVHD

Soligenix, Inc., a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics, announced today that it has initiated a Phase 2, randomized, double-blind, placebo-controlled study evaluating orBec (oral beclomethasone 17,21-dipropionate or BDP) as a treatment for the gastrointestinal manifestations of chronic Graft-versus-Host disease.

2 Dec 2013

JHL Biotech installs GE Healthcare's FlexFactory biomanufacturing platform at Hsinchu plant in Taiwan

GE Healthcare Life Sciences and JHL Biotech today announced that GE Healthcare has completed installation of its FlexFactory biomanufacturing platform at JHL Biotech's Research Center and manufacturing plant in Hsinchu, Taiwan.

2 Dec 2013

Visterra gets $8.1M in proceeds from upsized and final closing of Series A financing round

Visterra, Inc., a developer of novel therapeutics to prevent and treat major infectious diseases, today announced that it has received $8.1 million in proceeds from an upsized and final closing of its Series A financing round. The company also announced that it has deepened its executive management team by appointing two industry veterans to newly created roles, which follows the recent appointment of Brian Pereira, M.D. as President and Chief Executive Officer of Visterra this past summer.

2 Dec 2013

Genetics and cardiovascular drugs: an interview with Nancy Lurker, CEO of PDI and Paul Kinnon, CEO of Transgenomic, Inc.

People inherit different versions of any particular gene, and some genes affect how patients process and metabolize medicines. This especially holds true for people with cardiovascular (CV) disease. They may be fast, slow or non-metabolizers and might also react badly (with serious adverse events) to certain drug therapies or not at all.

27 Nov 2013

UMass Medical School licenses "anti-gal" technology to Agalimmune

The University of Massachusetts Medical School has licensed "anti-gal" technology developed by Professor of Surgery and Medicine Uri Galili, PhD, to newly formed biopharmaceutical company Agalimmune Ltd. for the purpose of developing innovative immunotherapies for the treatment of solid tumor cancers. Agalimmune is supported by an investment group comprising Loxbridge Research LLP and Animatrix Capital LLP and is based in London and California.

27 Nov 2013

Agalimmune established to develop innovative immunotherapeutics for treatment of cancer

Agalimmune Ltd, a biopharmaceutical company, has been created to develop innovative immunotherapeutics for the treatment of cancer, with a focus on solid tumours.

26 Nov 2013

Researchers identify new form of treatment for brain tumor

Glioblastoma is one of the most ominous brain tumors. Despite aggressive surgery, radiation and chemotherapy the outcome of this disease is almost always fatal.

26 Nov 2013

Arrowhead seeks approval to start ARC-520 phase 2a trial for chronic hepatitis B infection

Arrowhead Research Corporation, a biopharmaceutical company developing targeted RNAi therapeutics, today announced that it recently filed an application for approval to begin a phase 2a clinical trial of its RNAi-based therapeutic candidate, ARC-520, for the potential treatment of chronic hepatitis B virus infection.

25 Nov 2013

Vect-Horus, AAA form scientific collaboration to open new avenues in treatment of brain diseases

Vect-Horus, a French company specialized in the development of vector molecules for the central nervous system, announces today it has signed a scientific collaboration agreement with Advanced Accelerator Applications, a fast growing international player in Molecular Nuclear Medicine. The financial terms of the deal have not been disclosed.

20 Nov 2013

NeutroPhase irrigation therapy and NPWT help treat severe flesh eating and wound infections

NovaBay Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing topical non-antibiotic antimicrobial products, today announced the publication of a scientific paper by Dr. John R. Crew of Seton Medical Center, Daly City, California, describing the first use of adjunctive NeutroPhase irrigation therapy in conjunction with Negative Pressure Wound Therapy to successfully manage the severely-infected wound in the arm of a patient with life-threatening 'flesh-eating' disease.

20 Nov 2013

Atopix recruits first patient in OC459 Phase 2 trial for treatment of atopic dermatitis

Atopix Therapeutics Ltd, a biopharmaceutical company developing innovative CRTH2 antagonists for allergic disease, announced the recruitment of the first patient in a six month Phase 2 clinical trial of its lead compound OC459 in moderate-to-severe atopic dermatitis (eczema).

19 Nov 2013

Kiadis reports successful Phase II enrollment for CR-AIR-007 ATIR blood cancer treatment study

Kiadis Pharma B.V., a clinical stage biopharmaceutical company developing treatments for blood cancers, today announces the successful Phase II enrollment of approximately ten patients of whom the majority have already been transplanted and received ATIR™. Kiadis Pharma's lead program, ATIR™, is a cell-based product designed to enable stem cell transplantations from partially mismatched (haploidentical) family donors for blood cancer patients who do not have a standard of care stem cell donor available. Topline data from the trial (CR-AIR-007) is expected in the first half of 2014.

18 Nov 2013

New report addresses many changes that transform Medical Education landscape

Medical Education groups are often being transformed by regulatory and budget pressures, making it increasingly difficult to effectively educate healthcare practitioners on the safe and effective use of products. With the pressure to reduce budgets increasing within the pharmaceutical and medical device industries, it is absolutely critical for Medical Education groups to find practical and economical methods of reaching healthcare professionals.

16 Nov 2013

Biopharmaceutical News and Research

Auxilium Pharmaceuticals' XIAFLEX gets FDA approval for treatment of Peyronie's disease

Eli Lilly reports edivoxetine Phase III program did not meet primary endpoint for major depressive disorder

Soligenix initiates SGX942 Phase 2 study for treatment of oral mucositis

Alvotech to invests $250M in the development of biosimilar monoclonal antibodies

Enrollment opens for IMO-8400 Phase 1/2 trial in patients with Waldenström's macroglobulinemia

FDA accepts ARCA biopharma's Gencaro IND application for atrial fibrillation

EMD Serono's TocopheRx to focus on development of oral FSH agonists for infertility treatment

Soligenix initiates orBec Phase 2 study for GI manifestations of chronic GVHD

JHL Biotech installs GE Healthcare's FlexFactory biomanufacturing platform at Hsinchu plant in Taiwan

Visterra gets $8.1M in proceeds from upsized and final closing of Series A financing round

Genetics and cardiovascular drugs: an interview with Nancy Lurker, CEO of PDI and Paul Kinnon, CEO of Transgenomic, Inc.

UMass Medical School licenses "anti-gal" technology to Agalimmune

Agalimmune established to develop innovative immunotherapeutics for treatment of cancer

Researchers identify new form of treatment for brain tumor

Arrowhead seeks approval to start ARC-520 phase 2a trial for chronic hepatitis B infection

Vect-Horus, AAA form scientific collaboration to open new avenues in treatment of brain diseases

NeutroPhase irrigation therapy and NPWT help treat severe flesh eating and wound infections

Atopix recruits first patient in OC459 Phase 2 trial for treatment of atopic dermatitis

Kiadis reports successful Phase II enrollment for CR-AIR-007 ATIR blood cancer treatment study

New report addresses many changes that transform Medical Education landscape

How to optimize your cell line development eBook

Advancing Neuroscience Research Through Collaboration and Patient-Centered Innovation

The impact of vibration on microscopy

How Omics Technologies Are Transforming Biological Research and Drug Discovery

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