By a News Reporter-Staff News Editor at Drug Week AbbVie, a global biopharmaceutical company, announced data from the SURVEYOR studies of its investigational HCV regimen, ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor, that show high rates of sustained virologic response at 12 weeks post-treatment in non-cirrhotic patients
Actinium Pharmaceuticals, Inc. issued a press release on November 25, 2015 regarding a letter that was sent to shareholders outlining recent and expected milestones. On November, 25, 2015, the Company also issued a press release regarding the filing of an Application for Orphan Drug Designation with the U.S. Food and Drug Administration for Iomab-B
AFT Pharmaceuticals Ltd., a pharmaceutical company, intends to issue 11.9 million shares at a price of NZD2.8 per share, to raise gross proceeds of NZD33.2 million in an initial public offering. The trustees of the Atkinson Family Trust, associated with founder Hartley Atkinson and wife Marree, will raise NZD3 million selling their stake down to 76
By a News Reporter-Staff News Editor at Health& Medicine Week Alliance Life Sciences, a leading global life sciences consultancy and technology provider, announces that Alan Crowther, CEO, Alliance Life Sciences, and Carina Schey, consultant health economist and researcher at the University of Groningen, will present at the 6th Annual World Orpha
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has issued a Complete Response Letter for its supplemental Biologics License Application for Opdivo as a single agent for the treatment of previously untreated patients, specifically those with BRAF V600 mutation positive unresectable or metastatic melanoma.
PETACH TIKVA, Israel, Nov. 27, 2015/ PRNewswire/ Can-Fite BioPharma Ltd., a biotechnology company with a pipeline of proprietary small molecule drugs being developed to treat inflammatory diseases, cancer and sexual dysfunction, today reported financial results for the nine months ended September 30, 2015 and updates on its drug development progr
By a News Reporter-Staff News Editor at Drug Week Flex Pharma, Inc.: Click to Tweet this News Flex Pharma, Inc., a biotechnology company developing innovative and proprietary treatments for exercise-associated muscle cramps, nocturnal leg cramps, and spasms associated with severe neuromuscular conditions, announced at its Investor Day in New York
Germany: Merck and Pfizer Receive Positive Opinion for Orphan Drug Designation for Avelumab in Merkel Cell Carcinoma from EMA Committee for Orphan Medicinal Products. Merck and Pfizer today announced that the European Medicines Agency s Committee for Orphan Medicinal Products has issued a positive opinion for Orphan Drug designation for avelumab, a
Fast Market Research announces the availability of the new GlobalData report, "Hirsutism Global Clinical Trials Review, H2, 2015", on their comprehensive research portalBoston, MA 11/27/2015 GlobalData's clinical trial report, "Hirsutism Global Clinical Trials Review, H2, 2015" provides an overview of Hirsutism clinical trials scenario.
?Subsequent to its three months ended on September 30, 2015, the Company announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration has granted orphan designation status for the use of the drug Bucillamine for the treatment of cystinuria.? Subsequent to its three months ended on September 30, 2015, the Com
Release date- 24112015- Paris and Tarrytown, New York- Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the companies have completed enrollment in the global Phase 3 ODYSSEY OUTCOMES trial, which is prospectively evaluating the potential cardiovascular benefits of Praluent Injection after an acute coronary syndrome.
Marcus& Boxerman announces that it is investigating claims of potential misrepresentations by Zafgen, Inc.. On October 16, 2015, the Company announced that the FDA had ordered a "partial clinical hold" on the Company's Beloranib clinical trials following the death of a patient. This press release may be considered Attorney Advertising in some juris
Targovax is the owner of two established technologies with promising phase I data; TG01 and ONCOS-102. With these two technologies, Targovax has established a solid platform for further development of its clinical stage immune-oncology technologies and targeted immunotherapy treatments for cancer patients. x0D;. In the first quarter 2015, Targova
The U.S. Food and Drug Administration today approved Fluad, the first seasonal influenza vaccine containing an adjuvant. Fluad provides another alternative for a safe and effective influenza vaccine in people 65 years of age and older, said Karen Midthun, M.D., director of the FDA s Center for Biologics Evaluation and Research. Fluad was evaluated
In a significant shift, the Final Guidance allows for a wide array of permissible GE- related claims, even as it confirms FDA s long-held position that such labeling is not mandatory under the Federal Food, Drug, and Cosmetic Act. On the same day, FDA also denied two Citizen Petitions demanding mandatory labeling, took the significant step of appro
Accutest Research Laboratories, a leading independent and internationally accredited Contract Research Organization, has formed a strategic partnership with Fox Chase Cancer Center- Temple Health for joint work on clinical trials. The partnership aims to offer a strategic research platform for Fox Chase Cancer Center- Temple Health and Accutest...
?Zoptrex? recently received DSMB recommendation to continue the ZoptEC Phase 3 clinical program to completion following review of the final interim efficacy and safety data? Zoptrex? met Phase 2 Primary Endpoint in men with heavily pretreated castration- and Taxane-resistant prostate cancer? First patient enrolled in the confirmatory Phas
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.
-Anavex Life Sciences Corp., a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimers disease, other central nervous system diseases, pain and various types of cancer, announces that Kristina M. Capiak, CCRP has been promoted the Companys Vice President of Regulatory Affairs. Prior to joining Anavex, Ms. Capiak was
-BioMarin Pharmaceutical Inc. announced today that NASDAQ has halted trading of the companys stock. The briefing materials and webcast information can be found on the FDA website at: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm467180. htm. The Prescription Drug User Fee Act action date for completion of FDA review of the Kyndrisa NDA is Decem
Deal Type: Venture Financing Deal Sub Type: Growth Capital/Expansion Deal Country: United States of America Deal Status: Completed Deal Value: 14.7980 USD. Exicure Inc., a biopharmaceutical company, has raised USD14.79 million in venture financing round. Index- Biotechnology Index- Drug Discovery Index- United States of America Index- Dermatologica
-Emergent BioSolutions Inc. today announced that the U.S. Food and Drug Administration approved its supplemental Biologics License Application to expand the label of BioThrax to include post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure when administered in conjunction with recommended...
Major pharmerging countries such as Brazil, Russia, India are also encouraging the clinical trial support services. The global clinical trial support services market is segmented based on phase of the clinical trial cycle such as preclinical studies, Phase I, Phase II, Phase III and Phase IV, by study design which includes observational studies and
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