Biopharmaceutical News and Research

RSS

Baxalta announces initial results from ADYNOVATE Phase 3 trial for treatment of hemophilia patients

Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, today announced initial results from a Phase 3 clinical trial of ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)].

22 Dec 2015

New drug approved by FDA for treatment of von Willebrand disease

"VONVENDI [von Willebrand factor (Recombinant)]", the new drug from Baxalta Incorporated, a global biopharmaceutical company recently spun off from Baxter International, has just been approved by the United States Food and Drug Administration.

22 Dec 2015

Samsung BioLogics celebrates groundbreaking of new biopharmaceutical manufacturing plant in Korea

Samsung BioLogics today celebrated the groundbreaking of its third plant in Incheon Free Economic Zone, Songdo, Korea. Joining the event were Samsung Electronics Vice Chairman Jay Y. Lee, Samsung BioLogics President & CEO Dr. TH Kim and over 500 attendees.

21 Dec 2015

Regulus begins RG-125(AZD4076) Phase I study for treatment of NASH in patients with type 2 diabetes/pre-diabetes

Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that dosing has begun in a first-in-human Phase I clinical study of RG-125(AZD4076), by its collaboration partner AstraZeneca.

21 Dec 2015

Turing Pharmaceuticals emphasizes continued availability of Daraprim

Turing Pharmaceuticals AG, a privately-held biopharmaceutical company focused on developing and commercializing innovative treatments for serious diseases and conditions, today emphasizes the continued availability of Daraprim and cautions healthcare providers of proposed alternatives to Daraprim.

20 Dec 2015

DS Biopharma reports completion of DS102 Phase I trial for treatment of fatty liver disorders

DS Biopharma, a privately held biopharmaceutical company, today announced the successful completion of a Phase I trial with an oral formulation of the active pharmaceutical ingredient DS102 (15-HEPE) which is being explored for the treatment of fatty liver disorders, such as non-alcoholic steatohepatitis (NASH) and pulmonary disorders, such as idiopathic pulmonary fibrosis (IPF).

18 Dec 2015

Kitov announces more data from Phase III trial on the favorable blood pressure effects of KIT-302

Kitov Pharmaceuticals, an innovative biopharmaceutical company focused on late-stage drug development, today announced more data from its successfully concluded Phase III trial for its lead drug candidate, KIT-302. Data showed the favorable blood pressure effects of KIT-302 were present in all blood pressure variables measured in the study.

18 Dec 2015

MPP signs licensing agreement with AbbVie to address future demands for HIV treatment in Africa

The Medicines Patent Pool today announced a new licensing agreement with AbbVie, a global biopharmaceutical company, that seeks to address future demands for HIV treatment Lopinavir/Ritonavir (LPV/r) in South Africa and across Africa. The agreement has been reached in particular to help ensure sustainability of long-term supply of LPV/r, the most widely used second-line HIV treatment in South Africa and across Africa.

18 Dec 2015

Soligenix reports positive results from SGX942 Phase 2 trial in patients with head and neck cancer

Soligenix, Inc., a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today positive results in its Phase 2 clinical trial, in which SGX942, a first-in-class Innate Defense Regulator (IDR), at a dose of 1.5 mg/kg, successfully reduced the median duration of severe oral mucositis by 50% in all patients and by 67% in patients receiving the most aggressive chemoradiation therapy (CRT) for treatment of their head and neck cancer.

16 Dec 2015

WuXi forms strategic alliance with MedImmune to accelerate development of biologics portfolio in China

WuXi AppTec, a leading open-access R&D capability and technology platform company serving the global pharmaceutical, biotechnology, and medical device industries, announced today that it has formed a strategic alliance with MedImmune, the global biologics research and development arm of AstraZeneca.

16 Dec 2015

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

Biopharmaceutical News and Research

Baxalta announces initial results from ADYNOVATE Phase 3 trial for treatment of hemophilia patients

New drug approved by FDA for treatment of von Willebrand disease

Samsung BioLogics celebrates groundbreaking of new biopharmaceutical manufacturing plant in Korea

Regulus begins RG-125(AZD4076) Phase I study for treatment of NASH in patients with type 2 diabetes/pre-diabetes

Turing Pharmaceuticals emphasizes continued availability of Daraprim

DS Biopharma reports completion of DS102 Phase I trial for treatment of fatty liver disorders

Kitov announces more data from Phase III trial on the favorable blood pressure effects of KIT-302

MPP signs licensing agreement with AbbVie to address future demands for HIV treatment in Africa

Soligenix reports positive results from SGX942 Phase 2 trial in patients with head and neck cancer

WuXi forms strategic alliance with MedImmune to accelerate development of biologics portfolio in China

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

Event guide: 3rd EHS for Biopharma Summit 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

Latest News