Shares of Amgen, Inc. (NASDAQ:AMGN) ended Friday session in green amid volatile trading. The shares closed up +0.32 points or 0.19% at $172.96 with 4.03 million shares getting traded. Post opening the session at $172.59, the shares hit an intraday low of $171.05 and an intraday high of $173.39 and the price vacillated in this range throughout the day. The company has a market cap of $129.68 billion and the numbers of outstanding shares have been calculated to be 748.36 million shares.
Amgen, Inc. (AMGN) on Sept. 16, 2016 announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of Parsabiv™ (etelcalcetide), recommending approval for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. If approved, Parsabiv will be the first calcimimetic agent that can be administered intravenously by a healthcare provider three times a week at the end of a hemodialysis session.
“We are pleased to receive a positive CHMP opinion for Parsabiv, which has demonstrated strong efficacy in clinical trials and could help fill an unmet need in the delivery of this important therapy,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Secondary hyperparathyroidism is a disease that affects many patients with advanced chronic kidney disease, and we look forward to continuing to work with regulatory authorities to provide these patients with a novel therapy and advance the management of this complex disease.”
The Marketing Authorization Application (MAA) submission for Parsabiv included data from three Phase 3 studies, all of which met their primary endpoints, including two pooled placebo-controlled trials in more than 1,000 patients and a head-to-head study evaluating Parsabiv compared with cinacalcet.
The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, a centralized marketing authorization with unified labeling will be granted in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the EC.
Shares of HCA Holdings Inc (NYSE:HCA) ended Friday session in red amid volatile trading. The shares closed down -0.10 points or -0.13% at $75.29 with 3,955,021 shares getting traded. Post opening the session at $75.25, the shares hit an intraday low of $74.87 and an intraday high of $76.00 and the price vacillated in this range throughout the day. The company has a market cap of $28.47 billion and the numbers of outstanding shares have been calculated to be 378.65 million shares.
HCA Holdings Inc (HCA) on September 7, 2016 announced the signing of an agreement to purchase Mobile Heartbeat, a leading developer of applications for smartphones to improve clinical workflow and team communications. Mobile Heartbeat technology solutions consolidate clinical communications, including alarms and notifications, patient information and lab data, secure texting, voice and photography.
HCA recently completed a successful pilot of Mobile Heartbeat’s CURE™ (Clinical Urgent Response) technology for its iMobile Project, an initiative to implement smartphone-based critical care team communications. HCA is launching Mobile Heartbeat’s CURE technology in 21 hospitals across the country with plans to implement the technology enterprise-wide.
“Mobile Heartbeat is an innovator that is keenly focused on meeting the mobile technology needs of clinicians,” said Dr. Jonathan Perlin, HCA’s chief medical officer and president of the Clinical Services Group. “This acquisition will enhance our ability to work closely with Mobile Heartbeat as we continue to create and refine technology solutions to improve clinical workflows and provide secure communications that foster better patient care.”
Following the completion of the transaction, Mobile Heartbeat’s current chief executive officer Ron Remy will serve as CEO of the organization which will operate as an indirect, wholly owned subsidiary of HCA. Mobile Heartbeat’s team will continue to serve the company’s clients and market its products to leading healthcare organizations from the company’s location in Massachusetts.
“We’ve worked closely with HCA for several years to better understand the challenges clinicians face and to enhance our applications to meet their needs,” said Remy. “Joining HCA will help us serve our current and future customers through a closer collaboration with one of the leading healthcare providers in the world. HCA’s leadership will be instrumental as we continue to develop improved solutions for secure clinical communications.”