Release date- 20112014- Quebec City, Canada,- Aeterna Zentaris Inc. today announced the opening of a new clinical site at the Hollings Cancer Center of the Medical University of South Carolina in Charleston, South Carolina, for the Company's ongoing multinational, pivotal ZoptEC Phase 3 trial in women with advanced, recurrent or metastatic endometr
Avaxia Biologics, Inc., a clinical-stage biopharmaceutical company developing gut-targeted antibody therapeutics for gastrointestinal diseases, announced today that the US Food and Drug Administration granted Orphan Drug Designation to AVX-470 for the treatment of pediatric ulcerative colitis. AVX-470 is a gut-targeted anti-TNF antibody, which...
This report provides elemental information and data relating to the clinical trials on Bacterial Pneumonia& Sepsis.Dallas, TX 11/21/2014 The clinical trial report, Bacterial Pneumonia Global Clinical Trials Review, H2, 2014 "provides data on the Bacterial Pneumonia clinical trial scenario. The report Bacterial Pneumonia Global Clinical
Basel, Switzerland, November 21, 2014- Basilea Pharmaceutica Ltd. reports today that the U.S. Food and Drug Administration announced a public meeting of the Anti-Infective Drugs Advisory Committee to discuss the New Drug Application for the investigational antifungal isavuconazole, which was submitted by a subsidiary of Basilea's licensing partne
BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX in the U.S. and XIAPEX in the EU, today announced new data on XIAFLEX for the treatment of Peyronie's disease from the Phase 2 and the pivotal Phase 3 IMPRESS trials, presented by BioSpecifics' licensee, Auxi
Immunovaccine Inc., a clinical stage vaccine and immunotherapy company, today announced that it has received clearance from Health Canada to conduct a Phase II clinical study of DPX-Survivac in patients with diffuse large B cell lymphoma. The Company-sponsored trial will evaluate DPX-Survivac, Immunovaccine s lead cancer vaccine candidate, in...
BOUDRY, Switzerland Celgene International Srl, a wholly-owned subsidiary of Celgene Corporation, today announced that the European Medicines Agency s Committee for Medicinal Products for Human Use has adopted a positive opinion for OTEZLA , the Company s oral selective inhibitor of phosphodiesterase 4, in two therapeutic indications:
SUMMARY: The Food and Drug Administration is announcing the availability of a document entitled "Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Guidance for Industry" dated December 2014. The guidance announced in this notice finalizes the draft guidance
The European Committee for Medicinal Products for Human Use of the European Medicines Agency has granted positive opinions for AbbVie's investigational, all-oral, interferon-free treatment of VIEKIRAX?+ EXVIERA? with or without ribavirin for patients with genotype 1 and genotype 4 chronic hepatitis C virus infection. "The CHMP positive opini
Clementia Pharmaceuticals, Inc. announced today that the European Medicines Agency has granted Orphan Medicinal Product Designation for palovarotene, the company's lead product candidate, for the treatment of fibrodysplasia ossificans progressiva. Palovarotene, an investigational retinoic acid receptor gamma agonist, is currently in a Phase 2...
The Oslo University Hospital has an agreement with Medigene for use of Medigene's new generation DC vaccines for their ongoing academic clinical studies. Furthermore, Medigene informs that an abstract on an investigator initiated phase II clinical trial with Medigene's DC vaccines for the treatment of prostate cancer currently being conducted by th
Cytori Therapeutics, Inc. today reported positive results from a clinical study of Cytori Cell Therapy? in anterior cruciate ligament reconstruction of patients with ACL tears. Ramon Cugat, co-director of the Orthopedic Institute, Hospital Quiron Barcelona and the lead investigator of the study, performed autologous bone-patellar tendon-bone...
Mr. Oczachowski continued, "In the U.S., we recently reached an important milestone in our ongoing regulatory efforts with the receipt of a letter from the FDA. This comprehensive guidance reflects the extensive discussions we have had with the FDA since our Advisory Panel meeting. In addition, we remain steadfastly committed to advancing the FDA a
EDDA Technology, a global leading provider in advanced real-time interactive quantitative imaging solutions, announced today that the company has received FDA clearance on IQQA - BodyImaging. The new product will be introduced as the latest addition to the IQQA Platform and Product Suite for imaging-guided cancer treatment at the 100 th Scie
Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs primarily in the infectious disease field, today announced that the European Committee for Medicinal Products for Human Use of the European Medicines Agency has granted positive opinions for AbbVie s investigational,.
Genzyme, a Sanofi company, announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of Cerdelga capsules, an oral treatment for certain adults living with Gaucher disease type 1.. The European Commission is expected to make a final decision on gr
Gender Distribution in Device Clinical Trials: The FDA's Increasing Emphasis on Sex-Specific Data** FDAnews Webinar** Dec. 4, 2014 1:30 p.m. 3:00 p.m. EST http://www.fdanews.com/GenderDistributionDeviceCT. Despite FDA prodding, recent device clinical trials include only 22% women. In August, the FDA issued its long-awaited draft guidance, "Eva
Findings from Henry Ford Hospital Broaden Understanding of Sleep Research. According to news reporting from Detroit, Michigan, by NewsRx journalists, research stated, "Suvorexant, an orexin receptor antagonist, improves sleep in healthy subjects and patients with insomnia. The news correspondents obtained a quote from the research from Henry Ford H
Basel, Switzerland, November 21, 2014- Basilea Pharmaceutica Ltd. reports today that the U.S. Food and Drug Administration announced a public meeting of the Anti-Infective Drugs Advisory Committee to discuss the New Drug Application for the investigational antifungal isavuconazole, which was submitted by a subsidiary of Basilea's licensing partner.
Nov. 21 Karen Jackson almost made it to the five-year mark, the momentous milestone when she could be considered cancer-free. But just months before that, she developed a dry cough. Her doctor sent the King George County woman for an X-ray, which showed a mass in her chest.
Immunomedics, Inc., today announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration has granted orphan status for the use of veltuzumab, the Company's humanized anti-CD20 antibody, for the treatment of pemphigus. "We are pleased to receive the Orphan Drug designation for veltuzumab in pemphigus from the FD
Emory University Woodruff Health Sciences Center issued the following news release:. That's a key lesson emerging from a clinical trial that was reported Nov. 17 at the American Heart Association meeting in Chicago. The study was sponsored by NeoStem, Inc. "This was an enormous undertaking, one that broke new ground in terms of assessing cell thera
Intra-Cellular Therapies, Inc., a biopharmaceutical company focused on the development of therapeutics for central nervous system disorders, today presented additional results from ITI-007-200, a Phase I/II clinical trial designed to evaluate the safety, tolerability and pharmacokinetics of low doses of its lead drug candidate, ITI-007, in health
InVivo Therapeutics Holdings Corp. today announced that the Oregon Health& Science University in Portland, OR is the fifth clinical site in the company s ongoing IDE pilot study of its Neuro-Spinal Scaffold in patients with acute spinal cord injury. On October 15, InVivo announced enrollment of its first patient at Barrow Neurological Institute
Release date- 19112014- TITUSVILLE, NJ,- Janssen Research& Development, LLC today announced the submission of a New Drug Application for three-month atypical antipsychotic paliperidone palmitate to the U.S. Food and Drug Administration. 'This innovative three-month formulation has the potential to positively affect the care of many people with...