Release date- 25112015- NEW YORK, NY- Anavex Life Sciences Corp., a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer's disease, other central nervous system diseases, pain and various types of cancer, announces that Kristina M. Capiak, CCRP has been promoted the Company's Vice President of Regulatory Affairs.
Dublin- Research and Markets has announced the addition of the "Hyperandrogenism Global Clinical Trials Review, H2, 2015" report to their offering. This new report provides an overview of Hyperandrogenism clinical trials scenario. It includes an overview of trial numbers and their average enrollment in top countries conducted across the globe.
GlobalData's clinical trial report, "Hypogonadotropic Hypogonadism Global Clinical Trials Review, H2, 2015" provides an overview of Hypogonadotropic Hypogonadism clinical trials scenario. This report provides top line data relating to the clinical trials on Hypogonadotropic Hypogonadism. Report includes an overview of trial numbers and their averag
Patent Application Titled "Dual- Target Antibody Targeting Vegfr-2 and Dll4, and Pharmaceutical Composition Including Same" Published Online. By a News Reporter-Staff News Editor at Women's Health Weekly According to news reporting originating from Washington, D.C., by NewsRx journalists, a patent application by the inventors Kim, Joong Kyu; Yoo,
Medidata, the leading global provider of cloud-based solutions for clinical research in life sciences, today announced that Infinity Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the discovery, development and delivery of medicines for difficult-to-treat diseases, has expanded its use of the Medidata Clinical Cloud .
Actinium Pharmaceuticals, Inc., is a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. We look forward to 2016 and beyond with confidence, "said Kaushik J. Dave, Ph.D., MBA, Chief Executive Officer of Actinium Pharmaceuticals. Actinium Pharmaceuticals, Inc. is a New York- base
INDIANAPOLIS- Shares of Aduro BioTech Inc. were down 16% on Tuesday as investors were worried about a serious adverse event that was reported in the company's phase 2 a clinical trial of CRS-207 and GVAX Pancreas in patients with metastatic pancreatic cancer. The FDA panel, which reviewed BioMarin Pharmaceutical Inc.' s New Drug Application for Kyn
Alnylam Pharmaceuticals and The Medicines Company Announce that New ALN-PCSsc Results from Late-Breaking Presentation at American Heart Association Meeting Confirm Potential for Bi-Annual Hypercholesterolemia Dose Regimen. By a News Reporter-Staff News Editor at Biotech Week Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company,...
Amgen today announced the submission of a Biologics License Application with the United States Food and Drug Administration for ABP 501, a biosimilar candidate to Humira . Amgen believes this submission is the first adalimumab biosimilar application submitted to the FDA and represents Amgen's first BLA submission using the 351 biosimilar pathwa
Anavex Life Sciences Corp., a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer s disease, other central nervous system diseases, pain and various types of cancer, announces that Kristina M. Capiak, CCRP has been promoted the Company s Vice President of Regulatory Affairs. Ms. Capiak has more than 10 yea
Deal Type: Venture Financing Deal Sub Type: Growth Capital/Expansion Deal Country: United States of America Deal Status: Completed Deal Value: 3.0000 USD. Aridis Pharmaceutical, LLC., a biotechnology company, has raised USD3 million of its planned USD3.5 million financing round. Index- Contract Manufacturers Index- Drug Discovery Index- Infectious
Aurinia Pharmaceuticals Announces Outcome from Data and Safety Monitoring Board for Its Phase 2 b Study in Lupus Nephritis Study to Continue as Planned. The AURA-LV DSMB has been established according to the FDA Guidance for Clinical Trial Sponsors and is guided by its charter. Aurinia remains blinded to the actual safety and efficacy results.
By a News Reporter-Staff News Editor at Immunotherapy Weekly AXON Neuroscience presented encouraging Phase 1 study results of the company's active tau vaccine AADvac1 at the opening session of the 8th International Conference on Clinical Trials in Alzheimer's Disease. At the CTAD 2015 presentation, AXON's Medical Director, Matej Ondrus, showed th
By a News Reporter-Staff News Editor at Biotech Week BioTime, Inc., a clinical-stage regenerative medicine company, and Hepregen Corporation, a privately held company engaged in the development and marketing of proprietary drug screening products, announced the formation of Ascendance Biotechnology, Inc.. Ascendance combines Hepregen's...
This determination will allow FDA to approve abbreviated new drug applications for TYLENOL WITH CODEINE oral tablets, 325 mg/7. 5 mg, 325 mg/15 mg, 325 mg/30 mg, and 325 mg/60 mg, if all other legal and regulatory requirements are met. The 1984 amendments include what is now section 505 of the Federal Food, Drug, and Cosmetic Act, which requires FD
By a News Reporter-Staff News Editor at Biotech Week Dyax Corp. announced that two oral presentations describing clinical data from its DX-2930 Phase 1 b study were presented at the American College of Allergy, Asthma, and Immunology Annual Meeting taking place in San Antonio, Texas. "We are pleased to have our Phase 1 b DX-2930 data selected fo
EDDA Technology, a global leading provider in advanced imaging-guided precision treatment solutions, announced today that the company has received FDA clearance on IQQA - Guide, a system that supports intra-operative precision 3 D navigation for surgical procedures of thoracic, abdominal, and pelvic soft-organs. "With the latest FDA clearance,
BioMarin Pharmaceutical Inc. announced today that the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration met to discuss the data submitted to support the New Drug Application for KyndrisaTM for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping. The committee reviewed the..
Federal health officials have approved a first-of-a-kind flu vaccine that contains a booster to help protect seniors vulnerable to the virus. The Food and Drug Administration says Fluad is the first seasonal vaccine that contains an adjuvant, a substance that boosts the body's immune response. The vaccine was first approved in Italy in 1997 and
Toronto, Ontario- Theralase Technologies Inc., a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that the Food and Drug Administration has granted 510 approval for Theralase s next generation therapeutic laser, the TLC -2000 Therapeutic Medical Laser System.
Cellceutix Corporation, a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that the U.S. Food and Drug Administration has granted Fast Track Designation for Brilacidin-OM, an oral rinse formulation of the Company's novel...
INDIANAPOLIS- Eli Lilly and Co. announced that the U.S. Food and Drug Administration has approved Portrazza, in combination with gemcitabine and cisplatin, as the first biologic for the first-line treatment of people with metastatic squamous non-small cell lung cancer or NSCLC. Portrazza has been granted Orphan Drug Designation by the FDA.
By a News Reporter-Staff News Editor at Biotech Week FORUM Pharmaceuticals Inc., a biopharmaceutical company singularly focused on the development and delivery of transformative medicines to treat serious brain diseases, announced that the U.S. Food and Drug Administration has removed a partial clinical hold on the Phase 3 encenicline program for
-GW Pharmaceuticals plc, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced that Justin Gover, GW's Chief Executive Officer, will present at the Piper Jaffray 27th Annual Healthcare Conference to be held at the Lotte New York Palace