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IMARC Research, a CRO based in Strongsville, Ohio, recently expanded its footprint in the medical device market by opening a new office in the Minneapolis area. The new office, located at 12800 Whitewater Drive, Suite 100, in Minnetonka, Minnesota, underscores IMARC’s continued growth and commitment to ensuring compliance for medical device research. “Minneapolis is a […]
The NIH has announced awards to add four regional medical center groups to the national network of healthcare provider organizations (HPOs) that will implement the Precision Medicine Initiative (PMI) Cohort Program. Combined, the new HPOs will receive initial funds of $5.5 million to begin recruitment and build infrastructure. As efforts advance, the centers may receive first-year funds up […]
The post NIH funds additional medical centers for precision medicine research program appeared first on CenterWatch News Online.
To meet the growing demand for preemptive pharmacogenomic risk factor screening that may one day aid drug prescription practices, Thermo Fisher Scientific has introduced PharmacoScan Solution, a new microarray-based research tool that contains pharmacogenomic content with relevant markers involved in absorption, distribution, metabolism and excretion (ADME) pathways of commonly prescribed medicines. Pharmacogenomics (PGx) research is aimed at […]
The post Thermo Fisher Scientific launches new Pharmacoscan solution appeared first on CenterWatch News Online.
True North Therapeutics, a clinical stage biotechnology company developing novel product candidates that selectively inhibit the Complement system to treat certain rare diseases, has announced that the FDA has granted Orphan Drug Designation for the company’s lead product candidate TNT009, for the treatment of autoimmune hemolytic anemia, including Cold Agglutinin Disease (CAD), a form of […]
The post True North Therapeutics receives FDA Orphan Designation for TNT009 appeared first on CenterWatch News Online.
ICON, a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, has announced senior appointments to its clinical research, medical imaging and commercialization and outcomes services. Dr. Andrew Garrett has been appointed executive vice president, Scientific Operations, Dr. Paul McCracken has joined ICON as vice president, Medical Imaging […]
Healthcare is one of the most personal services you can encounter. As a patient, consider how the healthcare experience compares to other personal service offerings. In other service offerings, the importance of the overall experience, the personal touch and the perceived value of the service is what determines repeat business. As a patient in a […]
LEO Science & Tech Hub launches in Boston LEO Pharma, headquartered in Ballerup, Denmark, has opened the LEO Science & Tech Hub in Cambridge, Massachusetts. The hub will be the first center in the Boston area to focus exclusively on dermatology. Michael Sierra, vice president of the new LEO Science & Tech Hub, said, “The […]
TG Therapeutics has filed with the FDA an amended protocol for the GENUINE phase III trial. Prior to the amendments, the GENUINE study consisted of two parts. Part I was intended to evaluate the effect of the addition of TG-1101 to ibrutinib on overall response rate (ORR) in approximately the first 200 patients enrolled, to support a […]
The post TG Therapeutics amends the GENUINE phase III Clinical Trial appeared first on CenterWatch News Online.
The list has been updated through September 2016.
The FDA and CluePoints have signed a cooperative research and development agreement (CRADA) to explore a data-driven approach to quality oversight in clinical trials. FDA and its stakeholders have an interest in assuring the integrity of clinical trial data and the protection of participants during the conduct of clinical research. Misconduct in clinical research, including, but […]
The post FDA, CluePoints sign CRADA to explore a data-driven approach to oversight appeared first on CenterWatch News Online.
Adverum Biotechnologies has provided an update on its development program for ADVM-043 (formerly ANN-001), a novel gene therapy for Alpha-1 Antitrypsin (A1AT) Deficiency, a rare genetic disorder that may result in serious respiratory and liver disease. Adverum has decided to upgrade the ADVM-043 manufacturing process by implementing its proprietary baculovirus-based production system and plans to transfer […]
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its October meeting. The CHMP recommended granting a conditional marketing authorization for Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (also known as primary bile cirrhosis). Ocaliva is an orphan-designated medicine. The Committee recommended granting a conditional marketing authorization for Venclyxto (venetoclax) for the […]
The post EMA’s CHMP approves recommends eight products for approval appeared first on CenterWatch News Online.
Merck, known as MSD outside the U.S. and Canada, has launched Biosimilars Clarified, a new educational website for patients, caregivers and the healthcare community, designed to provide clear, concise and straightforward information about biosimilar medicines. Biosimilars are a type of biological product that are approved by the FDA because they are highly similar to an already […]
TxCell, a biotechnology company developing innovative, personalized cellular immunotherapies using regulatory T cells (Treg) to treat severe chronic inflammatory and autoimmune diseases, has appointed Li Zhou, Ph.D., vice president, Cell Engineering. Dr. Zhou brings extensive pharmaceutical experience in antibody engineering and T-cell engineering to strengthen and accelerate the development of TxCell’s ENTrIA CAR-Treg platform. In his […]
Quanterix, a company digitizing biomarker analysis to accurately measure change for precision health, has announced it is making a strategic investment in ImmunArray, a molecular diagnostics company advancing the development of novel, multi-marker tests for complex diseases with compelling levels of accuracy. As part of the deal, ImmunArray gains access to Quanterix Simoa technology. Both […]
The post Quanterix, ImmunArray partner on neurodegenerative disease appeared first on CenterWatch News Online.
A Single Site, Randomized, Double-blind, Placebo Controlled Trial of NIC5-15 in Subjects With Alzheimer's Disease
Status: Completed, Condition Summary: Alzheimer's Disease; Dementia
Certara, a provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, has announced that Peking Union Medical College (PUMC) Hospital in Beijing, China, and Keio University in Tokyo, Japan have become Phoenix Centers of Excellence. Phoenix is the most advanced, intuitive, and widely-used software for pharmacokinetic (PK), pharmacodynamic […]
The post Certara establishes Phoenix PK/PD Centers of Excellence in China and Japan appeared first on CenterWatch News Online.
Crescendo Biologics, the drug discovery and developer of Humabody-based therapeutics, and Takeda Pharmaceutical has announced a global, strategic, multi-target collaboration and license agreement for the discovery, development and commercialization of Humabody-based therapeutics for cancer indications with a high unmet medical need. Crescendo will use its proprietary transgenic platform and engineering expertise to discover and optimally configure Humabody […]
The post Crescendo Biologics, Takeda collaborate for Humabody-based Therapeutics appeared first on CenterWatch News Online.
Sunovion Pharmaceuticals has announced that the FDA has accepted for review the New Drug Application (NDA) for SUN-101 (glycopyrrolate), a nebulized long-acting muscarinic antagonist (LAMA), delivered via PARI’s innovative investigational eFlow closed system nebulizer, for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). The expected action date by […]
The post Sunovion receives NDA Acceptance for COPD treatment SUN-101/eFlow appeared first on CenterWatch News Online.