Clinical Trials Phase News - Biotech, Pharma and Life Science Channel
Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV are 'post-approval' studies.
Before pharmaceutical companies start clinical trials on a drug, they conduct extensive pre-clinical studies.
Source: Wikipedia
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News Articles
YORK, Pa., May 20, 2013 /PRNewswire-USNewswire/ -- At the headquarters city for the #2 U.S. amalgam manufacturer, a broad-based coalition of community, faith-based, and environmental groups call on De...
Clinical Trials Sites in Need of Clinical Research Associates
New research finds a steady rise in CRA staffing from an average of 3.3 in Phase 1 to 12.5 in Phase 3 The range of CRA staffing widens considerably from Phase 1 to Phase 3...
Acetylon Pharmaceuticals to Present at UBS Global Healthcare Conference
Acetylon Pharmaceuticals Inc., the leader in targeted epigenetic drug discovery and development for enhanced therapeutic outcomes, today announced that Walter C. Ogier, President...
CytRx Issues Letter to Stockholders Providing Business Update
- Provides Detailed Roadmap for Oncology Drug Development Programs - CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development company specializing...
Aduro BioTech, Inc. announces two poster presentations at the upcoming American Society of Clinical Oncology (ASCO) annual meeting in Chicago. Dr. Raffit Hassan, Head of the Solid...
New Study Identifies the Optimal Dose of Intravenous Vitamin C for Future Anticancer Clinical Trials
SCHAUMBURG, Ill., May 20, 2013 /PRNewswire-USNewswire/ -- The use of vitamin C to treat cancer patients first became popular in the 1970s as a result of the work of Nobel Laureate Linus Pauling. ...
CHAPEL HILL, N.C., May 20, 2013 /PRNewswire/ -- Cempra, Inc. (Nasdaq: CEMP), a clinical-stage pharmaceutical company focused on developing differentiated antibiotics to meet critical medical needs in...
Elcelyx Therapeutics Enrolling Phase 2b Trial of NewMet for Type 2 Diabetes
SAN DIEGO, May 20, 2013 /PRNewswire/ -- Enrollment of patients with Type 2 diabetes is underway in Elcelyx Therapeutics' Phase 2b dose-finding clinical trial of product candidate NewMet™, a dela...
Flexion Therapeutics Names Frederick Driscoll Chief Financial Officer
WOBURN, Mass., May 20, 2013 /PRNewswire/ -- Flexion Therapeutics, Inc. today announced the addition of Frederick W. Driscoll to its management team as chief financial officer. Mr. Driscoll has mo...
SAN DIEGO, May 20, 2013 /PRNewswire/ -- TRACON Pharmaceuticals, a biopharmaceutical company that develops targeted therapies for oncology and ophthalmology, today announced multiple clinical inve...
Events
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Companies
Loma Linda University Medical Center
Loma Linda University Medical Center (LLUMC), a Seventh-Day Adventist institution, is among the largest private medical educational centers in the United States and the only one in inland Southern...
OncoMed Pharmaceuticals is a clinical-stage company that discovers and develops novel therapeutics targeting cancer stem cells, the cells believed to be capable of driving tumor growth, recurrence and...
Certara is dedicated to improving human health through a broad spectrum of software products and services, from molecular discovery through clinical development, with special focu...
Alvine Pharmaceuticals, Inc. is a private, clinical-stage, specialty biopharmaceutical company located in San Carlos, CA, focused on the development of biologics targeting autoimm...
Forest Laboratories, Inc. & Ironwood Pharmaceuticals, Inc.
Ironwood Pharmaceuticals (NASDAQ: IRWD) is an entrepreneurial pharmaceutical company dedicated to the art and science of great drugmaking. Linaclotide, Ironwood's GC-C agon...
Provectus Pharmaceuticals, Inc.
Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its lead oncology agent, PV-10, is designed to selectively target and destroy cancer cells...
InSite Vision is an ophthalmic products company currently focused on ocular infection, glaucoma, and retinal disease. The Company specializes in three platform technologies: topical drug delivery (Dur...
Founded in 1995, Pharos Innovations assists healthcare providers and payers in achieving next generation clinical and financial performance improvement. An innovative, device-free platform, Tel-Assura...
Retrophin is a biotechnology company focused on discovering and developing treatments for rare and life-threatening diseases. Retrophin is currently developing treatments for foca...
Valence Health was founded in March 1996 with a vision of providing management support to providers and provider initiatives such as IPAS, PHOs and integrated delivery systems. To...
Clinical Trials
The primary objective is to demonstrate that early intervention with Teriflunomide in patients presenting with their first clinical episode consistent with MS prevents or delays conversio...
Nephrotic Syndrome Study Network
Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and Membranous nephropathy (MN), generate an enormous individual and societal financial burden, accounting for appr...
We would like to see if aspirin could block niacin-induced flushing by analyzing blood and urine after taking aspirin. Phase I: 5 days of 81 mg aspirin/placebo followed by 600 mg Niacin,...
This prospective, multi-center, non-interventional study will evaluate the efficacy and safety of Herceptin (trastuzumab) in routine clinical practice in Chinese patients with gastric or g...
The purpose of this investigation is to collect following data in patients given Nexium capsule (Nexium) for long term in usual-post-marketing therapy to prevention of recurrence of gastri...
The purpose of this study is to assess the effectiveness and safety of pegylated liposomal doxorubicin hydrochloride injection in Japanese patients with Mullerian carcinoma. This clinical...
Bipolar Disorder Research Study for Ages 12 and Older
The Bipolar Disorder Center for Pennsylvanians aims to reduce significant differences in treatment results among Pennsylvanians with bipolar disorder, especially among youth, the elderly,...
IRX-2 is designed to activate your own body's immune system so that it can better fight the invasion of head and neck cancer. Researchers hope that IRX-2 will help your immune system to m...
Influenza Vaccine in Lung Transplant Patients
Research Question: How do antibody and T cell responses following influenza vaccine compare among lung transplant patients, patients waiting for lung transplantation and healthy individua...
Acute Myeloid Leukemia T Cell Depletion to Improve Transplants in Adults With Acute Myeloid Leukemia
This study is a single arm Phase II, multicenter trial. It is designed to determine whether the anticipated endpoints for a T cell depleted transplant arm of a planned prospective randomi...
PubMed Articles
The aim of the study is to evaluate the efficacy and safety of a three-drug chemotherapy regimen including gemcitabine, carboplatin, and paclitaxel as induction therapy in clinical stage III non-small...
Recently, novel molecular targeted agents markedly changed the treatment of renal cell carcinoma (RCC), with promising results. However, there is little understanding of how these agents affect immune...
Prostate cancer (PCa) is one of the most commonly diagnosed malignancies in men and the second leading cause of male cancer mortality. MAZ (Myc-associated zinc-finger protein) is a transcription facto...
Crystal phase engineered quantum wells in ZnO nanowires.
We report the fabrication of quantum wells in ZnO nanowires (NWs) by a crystal phase engineering approach. Basal plane stacking faults (BSFs) in the wurtzite structure can be considered as a minimal s...
We investigate the structural stability and magnetic properties of the cubic, tetragonal and hexagonal phases of Mn3Z (Z=Ga, Sn and Ge) Heusler compounds using first-principles density-functional theo...
Phase composition of epitaxial/textured LiNbO3 films on sapphire substrates, grown by pulsed laser deposition, atmospheric pressure metal organic chemical vapor deposition and pulsed injection metal o...
Phase-change materials are the alloys at the heart of an emerging class of next-generation, non-volatile digital memory technologies. However, the widely studied Ge-Sb-Te system possesses several unde...
Supercurrent modulated by magnetization in a composite topological superconductor junction.
We report a theoretical study of the supercurrent flowing in a composite topological superconductor (TS) junction, where a magnetized quantum dot is considered in between the two TS leads. Based on th...
Block copolymer stabilized nonaqueous biocompatible sub-micron emulsions for topical applications.
Polyethylene glycol (PEG) 400/Miglyol 812 non-aqueous sub-micron emulsions were developed due to the fact that they are of interest for the design of drug-loaded biocompatible topical formulations. Th...
Videos
Designing Clinical Trials
Presented by Dr. Brent Logan, PhD, Professor in the Division of Biostatistics, Medical College of Wisconsin. This lecture will provide an overview of study d...
Medical and Biotech [MESH] Definitions
Ethics Consultation
Services provided by an individual ethicist (ETHICISTS) or an ethics team or committee (ETHICS COMMITTEES, CLINICAL) to address the ethical issues involved in a specific clinical case. The central purpose is to improve the process and outcomes of patients' care by helping to identify, analyze, and resolve ethical problems.
Nontherapeutic Human Experimentation
Human experimentation that is not intended to benefit the subjects on whom it is performed. Phase I drug studies (CLINICAL TRIALS, PHASE I AS TOPIC) and research involving healthy volunteers are examples of nontherapeutic human experimentation.
Computers, Handheld
MICROCOMPUTERS, sometimes called PDA, that are very small and portable, fitting in a hand, and that have much more function than a calculator. They are convenient to use in clinical and other field situations for quick data management. They usually require docking with MICROCOMPUTERS for updates.
Mastocytosis, Systemic
A group of disorders caused by the abnormal proliferation of MAST CELLS in a variety of extracutaneous tissues including bone marrow, liver, spleen, lymph nodes, and gastrointestinal tract. Systemic mastocytosis is commonly seen in adults. These diseases are categorized on the basis of clinical features, pathologic findings, and prognosis.
Factor For Inversion Stimulation Protein
A highly abundant DNA binding protein whose expression is strongly correlated with the growth phase of bacteria. The protein plays a role in regulating DNA topology and activation of RIBOSOMAL RNA transcription. It was originally identified as a factor required for inversion stimulation by the Hin recombinase of SALMONELLA and Gin site-specific recombinase of BACTERIOPHAGE MU.
