The U.S. Food and Drug Administration is in agreement with Repros Therapeutics Inc. (Nasdaq:RPRX) on how to move forward in approaching the development of a new testosterone production therapy, according to a release from the company on Tuesday. The therapy, Androxal, produces testosterone levels in the normal range for men while helping them maintain sperm count. Repros Therapeutics President and CEO Joseph Podolski said products currently on the market that treat testosterone deficiencies typically decrease sperm count...

Apple Inc. is reportedly planning to release its iTV product in 32- and 37-inch versions as early as this summer, according to a story on Tuesday from DigiTimes referencing supply chain sources. Cupertino-based Apple (NASDAQ:AAPL) co-founder Steve Jobs told his biographer before he died that he had made a breakthrough on a long quest to improve the television. The sets are expected to come out in the second or third quarters of 2012. South Korea's Samsung Electronics Co. Ltd. is reportedly producing the chips for televisions, while Japanese multinational corporation Sharp Corp...

Southpointe-based Mylan Inc. has received the go-ahead from the U.S. Food and Drug Administration to market a generic Keppra XR extended release tablet to treat epileptic seizures. The FDA approval to Mylan Pharmaceuticals, a unit of Mylan Inc. (Nasdaq: MYL), is under the abbreviated new-drug application/first-to-file program. The product name is Levetiracetam Extended-Release (ER) Tablets, 500 mg and 750 mg, the generic of UCB's Keppra XR. There were sales of $162.8 million for the year ended Sept...

(Reuters) - Two U.S. food makers have voluntarily recalled snacks contaminated by peanuts, while another firm increased its recall of alfalfa products due to salmonella contamination, the Food and Drug Administration said on Sunday.

Marken announced recently that Steve Roese is named Vice President of Marken's Global Quality Assurance organization, which will support Marken's continued investment in their expanding network of pharmaceutical service depots around the world.

Product Brief | Comprehend Systems has added new features and functionalities to its clinical data visualization and analytics software, Comprehend Clinical, offering clinical developers unparalleled access to research data within individual trials and across multiple studies in a category or pipeline.

News Brief | Lehigh Valley Health Network selected StudyManager’s Reveal software to manage its clinical trials. As a premier health network that includes three hospital facilities, nine health centers and numerous primary and specialty care physician practices located throughout the state of Pennsylvania, Lehigh Valley Health Network sought a solution to centralize activity across multiple facilities and departments. Billing and protocol compliance, financial accountability, patient tracking, and high-level reporting for management oversight were all important criteria in selecting a CTMS system. Following an in-depth review process, Lehigh Valley selected StudyManager Reveal.

News Brief | Perceptive Informatics announced that its DataLabs Electronic Data Capture (EDC) solution ranked highest among EDC solutions for overall satisfaction in ISR's 2011 The State of The EDC Market Report, an independent study conducted by Industry Standard Research (ISR). The DataLabs EDC solution enables clinical trial sponsors to more efficiently manage the clinical development process from study design to collection and reporting of study data.

Bio-IT World | Separate industry surveys by information technology research and advisory firm Gartner and global software company ClearTrial make a strong case for clinical resource management tools in the cost-cutting arsenal of biopharmaceutical and medical device companies.

Bio-IT World | Mark Goldberg, PAREXEL’s chief operating officer, recently sat down with Bio•IT World chief editor Kevin Davies to discuss the importance of convergence in Perceptive Informatics’ suite of eClinical offerings, and to share his insights on the future opportunities, trends, and challenges facing the industry.

November 3, 2011 | It is fair to say that Nancy Kelley, the executive director of the New York Genome Center (NYGC), did not expect to be leading such an ambitious effort 12 months ago. But convinced of the potential

Examination of eClinical shows that it is more than just bold claims, there is substance.

Product Brief | Cmed Technology has announced the launch of Timaeus Guided Trial Builder (GTB), a new product that introduces an entirely different approach to reduce the time and effort required to start up electronic trials. GTB enables study teams to speed up and simplify Study Setup—without sacrificing flexibility, quality or adherence to best practices.

Merge Healthcare, a provider of enterprise imaging and interoperability software, recently announced its Merge RIS v7.0 product has received the federal government’s “Meaningful Use” stamp of approval, thus becoming one of the industry’s first radiology information system (RIS) with complete electronic health record ambulatory certification.

Product Brief | PDF | BBK Worldwide announces the debut of DocManager v2 – a technological initiative developed in direct response to industry demand for secure, web-based systems solely devoted to managing timely and cost-efficient translation, regulatory approvals, and distribution of patient recruitment and retention materials around the world.