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Bayer-new phase 3 liver cancer data

Bayer-new phase 3 liver cancer data

Bayer has announced that a Phase III trial evaluating its oncology compound Stivarga® (regorafenib) tablets for the treatment of patients with unresectable hepatocellular carcinoma (HCC) has met its primary endpoint of a statistically significant improvement in overall survival. The study, called RESORCE, evaluated the efficacy and safety of regorafenib in patients with HCC whose disease has progressed after treatment with sorafenib. The safety and tolerability were generally consistent with the known profile of regorafenib. Detailed efficacy and safety analyses from this study are expected to be presented at an upcoming scientific congress. [More]
Scientists provide overview of most promising compounds to combat prostate cancer

Scientists provide overview of most promising compounds to combat prostate cancer

Scientists from MIPT (Moscow Institute of Physics and Technology), MSU (Moscow State University), and National University of Science and Technology “MISIS” provided an overview of the most promising compounds which can be used as medications for prostate cancer. [More]
BioAgilytix announces acquisition of IPM Biotech

BioAgilytix announces acquisition of IPM Biotech

BioAgilytix, a leading provider of contract bioanalytical testing services specializing in large molecule bioanalysis, has announced the acquisition of IPM Biotech, a German-based bioanalytical contract research laboratory renowned for its expertise in large molecule bioanalysis, particularly in the area of immunogenicity. [More]
Biomarkers may provide novel approaches to monitoring immunosuppressive therapy in organ transplant patients

Biomarkers may provide novel approaches to monitoring immunosuppressive therapy in organ transplant patients

Recently discovered biomarkers may provide valuable new approaches to monitoring immunosuppressive drug therapy in organ transplant recipients--with the potential for individualized therapy to reduce organ rejection and minimize side effects, according to a special article in the April issue of Therapeutic Drug Monitoring, official journal of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology. [More]
Rutgers' new drug candidate may help fight malaria

Rutgers' new drug candidate may help fight malaria

Malaria killed about 440,000 people - mostly young children - last year, but a new drug candidate discovered at Rutgers may help fight the long-dreaded disease. [More]
Xencor begins XmAb5871 Phase 2 trials in patients with IgG4-RD and Systemic Lupus Erythematosus

Xencor begins XmAb5871 Phase 2 trials in patients with IgG4-RD and Systemic Lupus Erythematosus

Xencor, Inc., a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, today announced dosing the first patient in a Phase 2 trial of XmAb5871 in patients with IgG4-Related Disease (IgG4-RD). [More]
New drug shows promise against Huntington's disease

New drug shows promise against Huntington's disease

A drug that would be the first to target the cause of Huntington's disease (HD) is effective and safe when tested in mice and monkeys, according to data released today that will be presented at the American Academy of Neurology's 68th Annual Meeting in Vancouver, Canada, April 15 to 21, 2016. [More]
Regulus reports net loss of $7.2 million for fourth quarter 2015

Regulus reports net loss of $7.2 million for fourth quarter 2015

Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today reported financial results for the fourth quarter and full-year ended December 31, 2015 and provided a summary of recent corporate highlights. [More]
AMRI's net revenues increase $126.4M to 46% in fourth quarter 2015

AMRI's net revenues increase $126.4M to 46% in fourth quarter 2015

AMRI today reported financial and operating results for the fourth quarter and full year ended December 31, 2015 and provided an outlook for 2016. [More]
Allergan's sNDA for TEFLARO (ceftaroline fosamil) accepted by FDA

Allergan's sNDA for TEFLARO (ceftaroline fosamil) accepted by FDA

Allergan plc today announced the U.S. Food and Drug Administration has accepted for filing the company's supplemental New Drug Application (sNDA) for TEFLARO (ceftaroline fosamil). [More]
Ambrisentan avoids sildenafil drug interaction in PAH patients

Ambrisentan avoids sildenafil drug interaction in PAH patients

Sildenafil may be better given to pulmonary arterial hypertension patients in combination with ambrisentan than with bosentan, study findings suggest. [More]
Molecular imaging and radiochemistry: the importance of instrumentation. An interview with Professor Björn Wängler

Molecular imaging and radiochemistry: the importance of instrumentation. An interview with Professor Björn Wängler

I’m Björn Wängler, Professor for Molecular Imaging and Radiochemistry at the medical faculty Mannheim of Heidelberg University. I’m a radiopharmaceutical chemist by background and completed my PhD in 2004 at the University of Mainz. [More]
MabVax receives FDA authorization to initiate 89Zr-HuMab-5B1 Phase I trial in pancreatic cancer patients

MabVax receives FDA authorization to initiate 89Zr-HuMab-5B1 Phase I trial in pancreatic cancer patients

MabVax Therapeutics Holdings, Inc., a clinical-stage oncology drug-development company, announces receipt of notice from the U.S. Food and Drug Administration authorizing initiation of a Phase I clinical trial with 89Zr-HuMab-5B1 as a new generation PET scan cancer imaging agent in patients with pancreatic cancer. [More]
AbbVie doses first subject in adalimumab clinical trial using Halozyme's ENHANZE technology

AbbVie doses first subject in adalimumab clinical trial using Halozyme's ENHANZE technology

Halozyme Therapeutics, Inc. today announced that AbbVie has dosed the first subject in a clinical trial evaluating the safety and pharmacokinetics of adalimumab with Halozyme's proprietary ENHANZE technology. [More]
F-star signs agreement with AbbVie to discover, develop bispecific antibodies in immuno-oncology

F-star signs agreement with AbbVie to discover, develop bispecific antibodies in immuno-oncology

F-star today announced that it has entered into a collaboration and license agreement with AbbVie to research and develop bispecific antibodies in immuno-oncology. Financial terms were not disclosed. [More]
E-cigarettes share similar short-term safety profile as Nicorette products

E-cigarettes share similar short-term safety profile as Nicorette products

A new study, published in the Journal of Regulatory Toxicology and Pharmacology, found that e-cigarettes share a similar short-term safety profile as Nicorette products and are comparable in reducing tobacco withdrawal symptoms. [More]

DURECT reports successful completion of DUR-928 Phase 1 study for acute use indications

DURECT Corporation today announced the successful completion of a Phase 1 clinical trial with an injectable formulation of DUR-928 intended for acute use indications. DUR-928 is an endogenous, small-molecule, new chemical entity (NCE), which may have broad applicability in metabolic diseases such as nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), and in acute organ injuries such as acute kidney injury (AKI). [More]
HBI-8000 granted orphan drug designation in Japan for treatment of peripheral T-cell lymphoma

HBI-8000 granted orphan drug designation in Japan for treatment of peripheral T-cell lymphoma

HUYA Bioscience International, Founder, CEO & Executive Chair, Dr. Mireille Gillings today announced that the Ministry of Health, Labour and Welfare granted HBI-8000 orphan drug designation in Japan for peripheral T-cell lymphoma (PTCL). [More]
Alexza reports interim results from AZ-002 Phase 2a study in epilepsy patients

Alexza reports interim results from AZ-002 Phase 2a study in epilepsy patients

Alexza Pharmaceuticals, Inc. today announced interim results of its Phase 2a study of AZ-002 (Staccato alprazolam) in epilepsy patients. AZ-002 produced a dose-related decrease in mean Standardized Photosensivity Range (SPR), the primary endpoint in the study. [More]
DS Biopharma reports completion of DS102 Phase I trial for treatment of fatty liver disorders

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). [More]
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