The warning letters identify the agency’s concerns about deviations from US current Good Manufacturing Practice (cGMP) requirements at Ranbaxy’s manufacturing facilities in Dewas and Paonta Sahib (including the
The multi-center, double-blind, randomized, placebo-controlled study evaluated doses of 3, 10, 25 or 50mg of odanacatib administered orally, once-weekly and without regard to the timing of meals or
As a result, the company will focus research activities on its muscle biology programs while advancing drug candidates in its clinical pipeline. To implement this plan, the company
The addition of LifeTrak will enable the blood center to manage thousands of donor records, including the donor eligibility requirements that blood centers are required to calculate. LifeTrak
ArKal Medical is developing a novel continuous glucose monitoring system for the management of diabetes. ArKal’s monitoring system is said to be designed to eliminate many of the
The availability of WoundStat in Canada enables military, emergency medical services, law enforcement services, rescue services, and other first responders to stop arterial bleeding within seconds and stabilize
ThyroTest is FDA cleared and has also achieved CLIA waived status, so the test can be administered in the more than 100,000 CLIA waived doctors’ offices in the
The Phase III study will involve up to 750 subjects with Type-1 diabetes mellitus. There are 74 sites in the US, Canada, Bulgaria, Poland, Romania, Russia and Ukraine
The Aegis ProTek technology has been employed to create stabilized formulations of human growth hormone (hGH), insulin, antibodies, and other protein drugs that remain unchanged even after continuous
According to the company, the Neuropath guide catheter line is designed with a flexible and visible tip that allows for ready vascular access, while maintaining stability. This design
Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.