Latest Clinical research Stories
Researchers at the University of Cincinnati (UC) have found that the race and sex of study personnel can influence a patient’s decision on whether or not to participate in clinical research. The study, presented today at the Society for Academic Emergency Medicine’s annual meeting in Atlanta, that there is an interaction of the race and sex of the study assistant and the race of the patient. Lead author Kimberly Hart says that her team found that black patients, both male and...
Committee to Review Respiratory Safety Data Comparing MOXDUO with Components SYDNEY and BEDMINSTER, N.J., May 17, 2013 /PRNewswire/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today the US Food and Drug Administration (FDA) has set 17 July 2013 as the date of the Advisory Committee meeting to consider the Company's resubmitted MOXDUO( )New Drug Application (NDA). "The timing is within the expected date range of late June to late July," said Dr. John Holaday,...
The Study Data Reviewer’s Guide Template, a creation of the FDA/PhUSE Working Group collaboration is now available. The Study Data Reviewer’s Guide documents, in a human-readable way, data life-cycle decisions to aid the FDA review of licensing applications. Silver Spring, MD (PRWEB) May 16, 2013 PhUSE announces the availability of the Study Data Reviewer’s Guide (SDRG) Template. The FDA is currently reviewing the implementation/utility of this document and encourages sponsors to...
The personal injury law firm of d’Oliveira & Associates shares new infographic detailing the suspected link between Zithromax use and potential cardiovascular events. (PRWEB) May 16, 2013 Zithromax (azithromycin), commonly known as Z-Pak, is one of the world’s best-selling antibiotics used to treat and prevent certain bacterial infections including bronchitis, ear infections, pneumonia, and strep throat. The World Intellectual Property Organization (WIPO) reported in June 2003...
MuGard Gross Revenues Up 118% Quarter-on-Quarter and Over 20% from Q4 2012 DALLAS and NEW YORK, May 16, 2013 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biopharmaceutical company, released its first quarter ended March 31, 2013 financial results. The company indicated it will host a conference call at a later date to review financial results and ongoing commercial MuGard progress made within the quarter. MuGard, Access' lead product, is a novel;...
TAIPEI, Taiwan, May 16, 2013 /PRNewswire/ -- TaiGen Biotechnology Company, Limited ("TaiGen") today announced that they have submitted New Drug Application (NDA) for the oral formulation of nemonoxacin with the Taiwan Food and Drug Administration (TFDA) and China Food and Drug Administration (CFDA). Approval is expected in the first half of 2014. Nemonoxacin is the first pharmaceutical product to fall under the Cross-Strait Cooperation Agreement on Medicine and Public Health Affairs...
CLEVELAND, May 15, 2013 /PRNewswire/ -- Researchers from University Hospitals Case Medical Center's (UHCMC) Seidman Cancer Center will present findings from two studies evaluating new technologies designed to address common barriers to patient enrollment in clinical trials. Results from a large-scale, randomized trial demonstrated that the use of tailored, web-based videos delivering educational information to patients before an oncologist visit can significantly improve knowledge and...
Revises funding announcements, guidelines, and review criteria to improve application process WASHINGTON, May 15, 2013 /PRNewswire-USNewswire/ -- The Patient-Centered Outcomes Research Institute (PCORI) today opened its second year of funding of patient-centered comparative clinical effectiveness research (CER), revising its broad funding announcements to clarify key review criteria and application definitions. PCORI plans to award up to $81 million in this newly announced round of PCORI...
PITTSBURGH, May 15, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Zolmitriptan Tablets, 2.5 mg and 5 mg. This product is the generic version of IPR Pharmaceuticals Inc.'s Zomig(® )Tablets and is indicated for the acute treatment of migraine with or without aura in adults. Zolmitriptan...
Edgemont enhances its position as the leading M&A advisor to clinical research site companies NEW YORK, May 15, 2013 /PRNewswire/ -- Edgemont Capital Partners ("Edgemont"), a specialty investment bank focused on the merger and acquisition advisory needs of healthcare companies, has acted as exclusive financial advisor to Vince and Associates Clinical Research ("Vince and Associates") in its sale to Altasciences Group. Vince and Associates manages complex early development clinical...
