Biopharmaceutical News and Research

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AbbVie begins six global Phase 3 clinical studies to evaluate efficacy of investigational HCV regimen

AbbVie, a global biopharmaceutical company, today announced the initiation of six global Phase 3 clinical studies evaluating the safety and efficacy of its all-oral, once-daily, ribavirin-free investigational hepatitis C virus (HCV) regimen, ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor, in patients with genotypes 1-6 (GT1-6) chronic HCV infection.

12 Jan 2016

Sorrento, Karolinska Institutet partner to develop new NK cell-based therapies

Sorrento Therapeutics, Inc., an antibody-centric, clinical-stage biopharmaceutical company developing new treatments for cancer and other unmet medical needs, announced today that it has formed an exclusive partnership with the world-renowned Karolinska Institutet in Stockholm, Sweden, to perform cutting-edge immuno-oncology research and to develop new natural killer (NK) cell-based therapies.

11 Jan 2016

Rani Therapeutics, MedImmune collaborate to evaluate novel oral drug delivery platform

Rani Therapeutics announced today that it has entered into a collaboration with MedImmune, the global biologics research and development arm of AstraZeneca, to evaluate Rani's novel oral drug delivery platform. The companies have agreed to conduct feasibility studies over the next two years, in which Rani will test select biologic molecules in the area of metabolic disease to evaluate the oral delivery of these molecules.

6 Jan 2016

Purified cannabinoid reduces seizures in children and young adults with treatment-resistant epilepsy

Children and young adults with severe forms of epilepsy that does not respond to standard antiepileptic drugs have fewer seizures when treated with purified cannabinoid, according to a multi-center study led by researchers from UCSF Benioff Children's Hospital San Francisco.

6 Jan 2016

Millendo signs license agreement, secures funding to test new drugs for treatment of endocrine disorders

Millendo Therapeutics, a University of Michigan startup company, announced an exclusive license agreement with AstraZeneca for the worldwide development and commercialization rights to test a new compound, MLE4901, for the treatment of polycystic ovary syndrome.

6 Jan 2016

FDA permits Sound Pharmaceuticals to start SPI-1005 clinical trial for treatment of Meniere's Disease

Sound Pharmaceuticals is pleased to announce that it began enrolling a clinical trial to test SPI-1005 in the treatment of Meniere's Disease (MD). MD or idiopathic endolymphatic hydrops is an inner ear disease that involves episodic vertigo, sensorineural hearing loss, and tinnitus.

5 Jan 2016

Ardelyx announces positive results from RDX022 clinical study for treatment of hyperkalemia

Ardelyx, Inc., a clinical-stage biopharmaceutical company focused on gastrointestinal and cardio-renal diseases, today announced positive results of an open label clinical study evaluating the pharmacodynamic (PD) activity of RDX022 in healthy adult volunteers.

5 Jan 2016

CFDA issues new drug certificate and production license for Sinovac's EV71 vaccine

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, today announced that the China Food and Drug Administration issued the new drug certificate and production license for its Enterovirus 71 ("EV71") vaccine.

4 Jan 2016

Araim Pharmaceuticals forms new strategic collaboration with Vault Bioventures to market novel peptides

Araim Pharmaceuticals has formed a long-term strategic partnership with Vault Bioventures to facilitate the advancement to market of its novel peptide library which targets devastating injuries and chronic diseases underserved by current therapies.

4 Jan 2016

Novel antibody improves glucose regulation and reduces fatty liver in obese mice

A new study by researchers from Harvard T.H. Chan School of Public Health and colleagues describes the pre-clinical development of a therapeutic that could potentially be used to treat type 2 diabetes, fatty liver disease, and other metabolic diseases.

24 Dec 2015

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

Biopharmaceutical News and Research

AbbVie begins six global Phase 3 clinical studies to evaluate efficacy of investigational HCV regimen

Sorrento, Karolinska Institutet partner to develop new NK cell-based therapies

Rani Therapeutics, MedImmune collaborate to evaluate novel oral drug delivery platform

Purified cannabinoid reduces seizures in children and young adults with treatment-resistant epilepsy

Millendo signs license agreement, secures funding to test new drugs for treatment of endocrine disorders

FDA permits Sound Pharmaceuticals to start SPI-1005 clinical trial for treatment of Meniere's Disease

Ardelyx announces positive results from RDX022 clinical study for treatment of hyperkalemia

CFDA issues new drug certificate and production license for Sinovac's EV71 vaccine

Araim Pharmaceuticals forms new strategic collaboration with Vault Bioventures to market novel peptides

Novel antibody improves glucose regulation and reduces fatty liver in obese mice

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

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