On Nov. 5, 2018, Amgen and Provention Bio, a clinical-stage biopharmaceutical company focused on immune-mediated diseases, announced a licensing and co-development agreement for AMG 714, a novel anti-IL-15 monoclonal antibody, for the treatment of gluten-free diet non-responsive celiac disease. Under the terms of the agreement, Provention will cond
Ascelia Pharma AB today announced that the company has successfully concluded discussions with the US Food and Drug Administration regarding the study design for the single pivotal Phase 3 trial for Mangoral as a contrast agent in patients with focal liver lesions and severe renal impairment. Ascelia Pharma will now complete the preparatory work
ASIT biotech, a Belgian biopharmaceutical company specialized in the research and development of innovative allergy immunotherapy products, today announced that it hosted the investigator meeting in Prague on November 16-17, 2018 ahead of the launch of its confirmatory Phase III clinical study with gp-ASIT+? in grass pollen rhinitis prevention.
Axsome Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system disorders, today announced that Herriot Tabuteau, MD, Axsome s Chief Executive Officer, will conduct investor meetings at the upcoming 2018 Global Mizuho Investor Conference on December 3, 2018.
BiondVax Pharmaceuticals Ltd., a Phase 3 clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, today issued a clarification regarding information published on November 13, 2018 in connection with the third quarter financial results. As correctly indicated in the financial tabl
Brigham and Women's Hospital issued the following news release:. Results of the Dapagliflozin Effect on CardiovascuLAR Events- Thrombolysis in Myocardial Infarction 58 trial, sponsored by AstraZeneca, were presented by Stephen Wiviott, MD, a senior investigator in the TIMI Study Group and a cardiovascular medicine specialist at Brigham and Women's.
-Acquired U.S. FDA- approved abbreviated new drug application from Laurus Labs Limited. ROCKVILLE, Md.- CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world, today r
ContraFect Corporation, a clinical-stage biotechnology company focused on the discovery and development of protein and antibody therapeutics for life-threatening, drug-resistant infectious diseases, today announced that Steven C. Gilman, Ph.D., the Company's Chairman and Chief Executive Officer, will participate in a fireside chat at the Piper Ja
CStone Pharmaceuticals today announced that a first patient has been enrolled and dosed in a Phase I clinical trial in China for the recombinant humanized anti-programmed death-1 monoclonal antibody CS1003. Frank Jiang, Chairman and CEO of CStone, "We are happy to see Phase I trial get under way in China. We plan to carry out global development f
Dublin, Ireland- November 19, 2018- Cosmo Pharmaceuticals N.V. announced that the U.S. Food and Drug Administration has approved AEMCOLO?, containing 194 mg of Rifamycin as delayed-release tablets, a new minimally-absorbed antibiotic that is delivered to the colon, for treatment of Travelers' Diarrhea caused by non-invasive strains of Escherichia
"Travelers` diarrhea affects millions of people each year and having treatment options for this condition can help reduce symptoms of the condition," said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA`s Center for Drug Evaluation and Research. The highest-risk destinations are in most of Asia as well as the M
"Travelers` diarrhea affects millions of people each year and having treatment options for this condition can help reduce symptoms of the condition," said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDAs Center for Drug Evaluation and Research. The highest-risk destinations are in most of Asia as well as the Middle
The US Food and Drug Administration has approved first-line treatment for newly diagnosed peripheral T-cell lymphoma using a new review program...
The post FDA approves treatment for peripheral T-cell lymphoma appeared first on European Pharmaceutical Review.
These initiatives are all part of efforts to become a full-fledged integrated pharmaceutical company, says Dr Cheng Chen- yu, chairman and president of Formosa Lab. Through its biopharmaceutical subsidiary Formosa Pharmaceuticals, Formosa Lab ventured into new drug development, and is centred on the indications of ophthalmology, oncology,...
A husband-and-wife pair of researchers at the University of Virginia Cancer Center have been awarded funding for work to improve radiation therapy and breast surgery for patients with early-stage breast cancer. According to a release, radiation oncologist Timothy Showalter, MD, and breast cancer surgeon Shayna L. Showalter, MD, will use the $1.8 mi
FOSTER CITY- Gilead Sciences, Inc. announced that the China National Medical Products Administration has approved Vemlidy 25 mg, for chronic hepatitis B Virus Infection in adults and adolescents. Jinlin Hou, Nanfang Hospital of Southern Medical University. Vemlidy received marketing approval from the U.S. Food and Drug Administration and the Japane
Report Forecasting Regional and Global Analysis on Clinical Chemistry Analyzer Market By Product type (Consumables and Accessories (Reagents, Assay Kits, Microplates, Accessories), Instruments (Spectrophotometers, Flow Cytometers, Hematology Analyzers, Cell Counters), By End-User (Hospitals, Diagnostic Centers, Research Institutions, Pharmaceutical
In another strike against tremelimumab, AstraZeneca plc said the anti-CTLA-4 mAb in combination with PD-L1 inhibitor Imfinzi durvalumab missed the co-primary endpoint of improving overall survival in the Phase III MYSTIC trial to treat previously untreated non-small cell lung cancer. FDA has approved rival anti-PD-1 mAb Keytruda pembrolizumab from.
OXFORD, UK/ ACCESSWIRE/ November 19, 2018/ IntraBio Inc., a late-stage biopharmaceutical company developing novel therapies for rare and common neurodegenerative diseases, announced that the European Commission has granted Orphan Medicinal Drug Designation for its lead compound series for the treatment of GM2 Gangliosidosis, a rare lysosomal storag
According to report published by Grand View Research, The global liquid handling technology market is expected to reach USD 5.54 billion by 2025. Major pharmaceutical and biopharmaceutical companies are rapidly integrating robotic solutions including automated liquid handling workstations to enhance their workflows, which in turn, is expected to...
LMI070, a candidate oral therapy under development by Novartis, is being tested in a Phase 1/ 2 clinical trial for infants with spinal muscular atrophy type 1.. A recent study describes how the compound was discovered from a large screen for SMN2 modulators in a nerve cell model, followed by several rounds of chemical optimization to increase poten
Amid the growing opioid crisis, the U.S. Food and Drug Administration has attracted criticism for approving a new kind of opioid that's five to 10 times more powerful than fentanyl, the deadliest drug in Virginia. Under the FDA' s approval guidelines, the drug, known as Dsuvia, can be distributed only by a health care professional in a certified me
Amid the growing opioid crisis, the U.S. Food and Drug Administration has attracted criticism for approving a new kind of opioid that's five to 10 times more powerful than fentanyl, the deadliest drug in Virginia. Under the FDA's approval guidelines, the drug, known as Dsuvia, can be distributed only by a health care professional in a certified med
The European Medicines Agency on Friday approved use of fexinidazole shown to be effective in treating all stages of sleeping sickness. This approval is a result of clinical trials led by the Drugs for Neglected Diseases Initiative, a non-profit research and development organisation, and an application submitted by Sanofi, a global biopharmaceutica
Rocket Pharmaceuticals, Inc., a leading U.S.- based multi-platform gene therapy company, today announces the clearance of the Company s Investigational New Drug application by the U.S. Food and Drug Administration for RP-L201. We are excited to achieve this important milestone ahead of schedule, and look forward to working with the medical and p