Adherex Technologies Inc., today announced that it has received feedback from the FDA at an End-of-Phase 2 meeting held yesterday. During the FDA meeting, Adherex reviewed the opportunity that eniluracil offers to Metastatic Breast Cancer patients who had rapid disease progression on capecitabine. Adherex proposed a small pivotal single arm clinica
TOKYO& SAN FRANCISCO Astellas Pharma Inc. and Medivation, Inc. today announced that Astellas has submitted an application for marketing approval of enzalutamide to the Ministry of Health, Labour and Welfare in Japan for the treatment of prostate cancer. This filing application is based mainly on results obtained from the global Phase 3 trial* a
Biodesix, Inc. announced that final results of the first completed biomarker-stratified, validation study in oncology will be presented at the 2013 American Society of Clinical Oncology Annual Meeting, May 31- June 4. The study's Principal Investigator Vanesa Gregorc, M.D., of the Department of Oncology at the Scientific Institute of the University
The Clinical Research Treatment Unit, which officially opened yesterday at Cardiff's Velindre Hospital, will give people with cancer the chance to take part in level one trials, where a new drug is tested in patients for the first time. Health Minister Mark Drakeford said: "The Clinical Research Treatment Unit at Velindre Cancer Centre will ensure
By a News Reporter-Staff News Editor at Health& Medicine Week Masimo announced that its rainbow Acoustic Monitoring? sensor, RAS-125c Acoustic Respiration Cloth Sensor has received U.S. FDA 510 clearance for continuous, noninvasive monitoring of acoustic respiration rate in pediatric patients. Masimo rainbow Acoustic Monitoring noninvasively an
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 23, 2013.{ nfg} Omeros Corporation announced its Investigational New Drug Application to evaluate OMS824 in Huntington's disease has been cleared by the U.S. Omeros plans to advance OMS824 into Phase 2 clinical trials for Huntington's disease next
On May 17, 2013, the registrant announced that "Oramed Receives FDA Clearance to Initiate Oral Insulin Trials in the U.S." ,indicating that the U.S. Food and Drug Administration cleared an Investigational New Drug application for ORMD-0801, its oral insulin. The described IND relates to a sub-study/Phase 2 a trial that will be a one-week, in-patien
Perosphere Inc. said that it has received U.S. Food and Drug Administration Investigational New Drug clearance to initiate clinical investigations of the safety and efficacy of PER977 to reverse the anticoagulant activity of unfractionated heparin, low molecular weight heparins, fondaparinux, and factor Xa- and IIa-inhibitors. Daiichi Sankyo Compan
Protalex, Inc., a clinical-stage biopharmaceutical company, announced that following a planned interim safety review by its independent Data Safety Monitoring Committee, the Company is continuing enrollment and increasing the dose for subjects in its multicenter Phase 1 b randomized, multiple-dose, dose-escalation study of PRTX-100 in combination..
Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced that Sinovac Beijing, the main operating subsidiary company of Sinovac, obtained the Certificate of Good Manufacturing Practices for Pharmaceutical Products from the China State and Food Administration for its proprietary vaccines, its Haidian district bulk..
Spectral Diagnostics Inc. today announced that Mr. Anthony Bihl has been appointed as the Chairman of the board. FDA approval for its lead theranostics product for the treatment of septic shock.
Sunovion Pharmaceuticals Inc. has announced results from a post- hoc study analysis showing that adult patients with schizophrenia who were treated with Latuda were more likely to achieve sustained remission over 12 months of treatment compared to patients taking Seroquel XR. The analysis utilized remission criteria that were established by the...
Release date- 23052013- AMBRIDGE, Mass.,- Takeda Pharmaceutical Company Limited today announced the initiation of an international phase 3 clinical trial evaluating once a week MLN9708 in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma who are not candidates for transplant. The multi-center study wi
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products. SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled "Guidance on Meetings With Industry and...
RICHMOND, Va., May 23, 2013 AIBioTech is pleased to announce receipt of a firm fixed price subcontract from DynPort Vaccine Company LLC, a CSC company, valued at nearly $3 million for laboratory studies to support development of a biologic intended for use prior to an exposure to nerve agents. DVC issued this subcontract under its prime contract
BioElectronics Corporation, the maker of very effective, safe consumer medical devices, comments on the FDA panel meeting for non-thermal shortwave diathermy:. The FDA' s Public Advisory Panel Reclassification Pulsed Shortwave Therapy Meeting was held on May 21, 2013 in Gaithersburg, MD, USA. The focus of the meeting was very narrow, in that the
Biogen Idec announced that it has submitted a Biologics License Application to the U.S. Food and Drug Administration for approval of PLEGRIDY, the company's pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis. "This filing demonstrates our dedication to the treatment of MS, both through the discovery of new medica
Celerion has announced the appointment of Dr. Bruce Morimoto as Executive Director of Applied Translational Medicine. Prior to joining Celerion, he was Vice President of Drug Development at Allon Therapeutics, where his focus was to manage their neurodegeneration and dementia therapeutic programs including preclinical, manufacturing and clinical...
Celgene International Srl, a subsidiary of Celgene Corporation today announced that the U.S. Food and Drug Administration has assigned a Priority Review designation to the supplemental New Drug Application for the use of ABRAXANE^ in combination with gemcitabine for the first line treatment of patients with advanced pancreatic cancer.
BOUDRY, Switzerland Celgene International Srl, a subsidiary of Celgene Corporation today announced that the U.S. Food and Drug Administration has assigned a Priority Review designation to the supplemental New Drug Application for the use of ABRAXANE in combination with gemcitabine for the first line treatment of patients with advanced p
The University of Michigan's Comprehensive Cancer Center issued the following news release:. This gene fusion, believed to be the triggering event of prostate cancer, was initially discovered in 2005 by U-M researchers led by Arul Chinnaiyan, M.D., Ph.D.going to a new website. By better understanding the evolving biology of prostate cancer, we will
Cynapsus Therapeutics Inc., developing the only non-injectable delivery of the only approved drug to be used as a rescue therapy for "off" motor symptoms of Parkinson's disease, today announced its results for the three months ended March 31, 2013. As previously announced, in March 2013 the Company successfully raised $7.3 million, converted $4 mil
CytRx Corp., a biopharmaceutical research and development company specializing in oncology, has announced initial data from a Phase 1 b clinical trial evaluating the pharmacokinetics and safety of aldoxorubicin, its novel conjugate of the widely used chemotherapeutic agent doxorubicin, in patients with metastatic solid tumors who have either relaps
EL PASO, Texas and IRVINE, Calif., May 23, 2013/ PRNewswire/ Masimo today announced that El Paso Children's Hospital, the newest and most expansive dedicated children's hospital in west Texas, has upgraded to Masimo SET pulse oximetry and sensor technologies, the standard-of-care at leading health organizations worldwide. El Paso Children's al
WASHINGTON The Food and Drug Administration said Thursday it approved a new blood test from Roche to help doctors diagnose diabetes. The FDA said Roche's test is the first to be approved to diagnose the disease. "Providing health care professionals with another tool to identify undiagnosed cases of diabetes should help them provide patients appr
