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Kitov Pharmaceuticals' KIT-302 drug candidate meets primary efficacy endpoint in Phase III clinical trial

Kitov Pharmaceuticals, an innovative biopharmaceutical company focused on late-stage drug development, announced today that the Phase III, double-blind, placebo-controlled clinical trial for its leading drug candidate, KIT-302, successfully met the primary efficacy endpoint of the trial protocol as approved by the U.S. Food & Drug Administration (FDA).

15 Dec 2015

SLU researcher discovered world's first dengue vaccine

A vaccine to prevent dengue fever discovered by a Saint Louis University researcher in 1997 and now licensed worldwide by Sanofi Pasteur has been approved for use in Mexico. Dengvaxia is the world's first vaccine approved to prevent dengue fever, which is a virus spread by mosquitoes primarily in tropical and sub-tropical areas.

15 Dec 2015

Complix signs agreement with Selexis to advance production of autoimmune drug candidate CMX-02

Complix NV, a biopharmaceutical company developing a pipeline of transformative protein therapeutics, called Alphabodies, for the treatment of cancer and severe autoimmune diseases, announces that it is advancing the development of CMX-02, a potential treatment of severe autoimmune disease.

14 Dec 2015

Best Practices undertakes study to develop benchmarks for library services within biopharmaceutical industry

Biopharmaceutical and Medical Device executives are constantly looking to their corporate libraries to provide them with vital information in regards to research, development and maintenance of e-resources. Despite this, rapid advances in technology, mixed with plummeting resources have made it increasingly difficult for libraries to effectively balance their budget, resource and service levels within organizations.

14 Dec 2015

FDA grants Fast Track status to Cardiorentis' Ularitide for treatment of ADHF

Cardiorentis AG, a privately held biopharmaceutical company, today announced that the U.S. Food and Drug Administration has granted Fast Track status to Ularitide, an investigational therapy for the treatment of acute decompensated heart failure (ADHF).

11 Dec 2015

Palatin achieves patient enrollment target in pivotal phase 3 studies of bremelanotide for FSD treatment

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 it has achieved its patient enrollment target in its two pivotal phase 3 clinical studies of bremelanotide for the treatment of female sexual dysfunction (FSD).

10 Dec 2015

Ajinomoto Althea expands biological drug product manufacturing operations

Ajinomoto Althea, Inc., a leading provider of biopharmaceutical contract development and manufacturing services, recently announced it is expanding its existing biological drug product manufacturing operations to include highly active materials such as Antibody Drug Conjugates (ADCs).

10 Dec 2015

Sinovac gets approval to begin clinical trials on Sabin Inactivated Polio Vaccine candidate

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, today announced that the Company has obtained approval to begin human clinical trials on its Sabin Inactivated Polio Vaccine (or "sIPV") candidate.

10 Dec 2015

Dompé’s investigational biotech molecule receives orphan drug designation for treatment of neurotrophic keratitis

The Dompé biopharmaceutical company announced today that the Committee for Orphan Medicinal Products of the European Medicines Agency (EMA) has officially designated recombinant human Nerve Growth Factor (rhNGF) - the investigational biotech molecule developed by Dompé based on research by Nobel Laureate Rita Levi Montalcini - as an orphan drug for the treatment of neurotrophic keratitis.

8 Dec 2015

PAREXEL introduces IMPACT Express Clinical Trial Management System for biopharmaceutical companies

PAREXEL International Corporation, a leading global biopharmaceutical services provider, today introduced IMPACT Express Clinical Trial Management System (CTMS).

7 Dec 2015

Heptares announces strategic drug discovery collaboration with Pfizer

Heptares Therapeutics, the clinical-stage GPCR structure-guided drug discovery and development company and wholly-owned subsidiary of Sosei Group Corporation, announces that it has entered into a strategic drug discovery collaboration with Pfizer Inc. to research and develop potential new medicines directed at up to 10 G protein-coupled receptor (GPCR) targets across multiple therapeutic areas.

30 Nov 2015

Mallinckrodt sells CMDS business to Guerbet for $270 million

Mallinckrodt plc, a leading specialty biopharmaceutical company, announced today that it has closed the sale of its global contrast media and delivery systems (CMDS) business to Guerbet in a transaction valued at approximately $270 million.

28 Nov 2015

Green Cross' GCFlu Quadrivalent approved to protect against four influenza strains in South Korea

Green Cross Corporation, a South Korean biopharmaceutical company, announced today that South Korea's Ministry of Food and Drug Safety has approved GCFLU QUADRIVALENT (Influenza Virus Vaccine) for immunisation of adults to help prevent disease caused by seasonal influenza (flu) virus subtype A and B. GCFlu Quadrivalent is the first locally-manufactured vaccine to cover against four influenza strains.

26 Nov 2015

Green Cross' Biologics License Application for IVIG-SN submitted to FDA

Green Cross Corporation, a South Korean biopharmaceutical company, today announced that it has submitted its Biologics License Application for IVIG-SN (human normal immunoglobulin G for intravenous administration) to the United States Food and Drug Administration.

24 Nov 2015

Viking submits IND application to FDA to conduct VK2809 Phase 2 study in patients with LDL-C and fatty liver disease

Viking Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders, today announced that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration to conduct a Phase 2 study of VK2809 in patients with hypercholesterolemia and fatty liver disease.

17 Nov 2015

Positive data from AbbVie's HCV clinical development program presented at The Liver Meeting of AASLD

AbbVie, a global biopharmaceutical company, today announced data from the SURVEYOR studies of its investigational HCV regimen, ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor, that show high rates of sustained virologic response at 12 weeks post-treatment (SVR 12) in non-cirrhotic patients with chronic hepatitis C virus (HCV) infection.

17 Nov 2015

CASI reports net loss of $1.6 million for third quarter 2015

CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, today reported financial results for the three and nine months ended September 30, 2015.

13 Nov 2015

Mallinckrodt Study Shows Acthar® Reduces Disease Activity in Patients with Persistently Active Systemic Lupus Erythematosus

Data presented yesterday by researchers for Mallinckrodt plc, a leading specialty biopharmaceutical company, suggest that H.P. Acthar® Gel (repository corticotropin injection) reduces certain measures of disease activity in patients with persistently active Systemic Lupus Erythematosus (SLE) who are receiving corticosteroid therapy.

10 Nov 2015

Idera begins enrollment in IMO-8400 Phase 2 clinical trial for treatment of dermatomyositis

Idera Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing Toll-like receptor (TLR) and RNA therapeutics for patients with cancer and rare diseases, today announced that the company has commenced enrollment in a Phase 2 clinical trial of IMO-8400, an investigational TLR 7, 8 and 9 antagonist, in patients with dermatomyositis. Dermatomyositis is a rare and debilitating inflammatory muscle and skin disease associated with significant morbidity, decreased quality of life and an increased risk of premature death.

10 Nov 2015

PAREXEL expands market access and clinical evidence services

PAREXEL International Corporation, a leading global biopharmaceutical services provider, today announced expanded evidence-based services for biopharmaceutical products.

10 Nov 2015

Biopharmaceutical News and Research

Kitov Pharmaceuticals' KIT-302 drug candidate meets primary efficacy endpoint in Phase III clinical trial

SLU researcher discovered world's first dengue vaccine

Complix signs agreement with Selexis to advance production of autoimmune drug candidate CMX-02

Best Practices undertakes study to develop benchmarks for library services within biopharmaceutical industry

FDA grants Fast Track status to Cardiorentis' Ularitide for treatment of ADHF

Palatin achieves patient enrollment target in pivotal phase 3 studies of bremelanotide for FSD treatment

Ajinomoto Althea expands biological drug product manufacturing operations

Sinovac gets approval to begin clinical trials on Sabin Inactivated Polio Vaccine candidate

Dompé’s investigational biotech molecule receives orphan drug designation for treatment of neurotrophic keratitis

PAREXEL introduces IMPACT Express Clinical Trial Management System for biopharmaceutical companies

Heptares announces strategic drug discovery collaboration with Pfizer

Mallinckrodt sells CMDS business to Guerbet for $270 million

Green Cross' GCFlu Quadrivalent approved to protect against four influenza strains in South Korea

Green Cross' Biologics License Application for IVIG-SN submitted to FDA

Viking submits IND application to FDA to conduct VK2809 Phase 2 study in patients with LDL-C and fatty liver disease

Positive data from AbbVie's HCV clinical development program presented at The Liver Meeting of AASLD

CASI reports net loss of $1.6 million for third quarter 2015

Mallinckrodt Study Shows Acthar® Reduces Disease Activity in Patients with Persistently Active Systemic Lupus Erythematosus

Idera begins enrollment in IMO-8400 Phase 2 clinical trial for treatment of dermatomyositis

PAREXEL expands market access and clinical evidence services

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