Bionovo receives CMC approval for Menerba
EMERYVILLE, Calif. The Food and Drug Administration has approved a manufacturing plan for a drug to treat hot flashes in menopausal women.
Bionovo said Thursday that the FDA had accepted its chemistry, manufacturing and controls plan for the drug Menerba. The decisions and agreements are considered binding on the company and the FDA.
“This CMC approval represents a revolutionary set of ‘firsts,’” Bionovo chairman and CEO Isaac Cohen said. “This is the first time that the FDA’s botanical drug development CMC guidance has been applied to an oral drug in a major indication.”
ScriptPro becomes pharmacy automation systems provider for NIH
MISSION, Kan. The National Institutes of Health has retained ScriptPro as a provider of pharmacy automation systems, ScriptPro said.
The NIH, based in Bethesda, Md., will use ScriptPro’s robotic dispensing, pharmacy management and drug information systems to assist in the internal control and identification of drugs and to enhance the safety and efficiency of medication dispensing and use by patients.
ScriptPro already provides pharmacy automation systems to the Veterans Health Administration, the Food and Drug Administration, the Department of Defense, federal prisons and public health services, the company said.
New Health Reform Report website provides ‘real facts, trusted analysis’ about healthcare law
WASHINGTON Newt Gingrich, former House speaker and founder of the Center for Health Transformation, unveiled a new website on Wednesday — HealthReformReport.com — dedicated to providing “real facts, trusted analysis” with news about how the new federal healthcare law impacts individuals, doctors, businesses, hospitals, insurers and others.
“If you want to know what this means for you, this is the site where you can cut through red tape to get the answers,” Gingrich said. “No government jargon. No painful, twisted bureaucratic explanations. Just the facts. Pure and simple.”
HealthReformReport.com will be a compilation of news stories and pieces written by contributors from public policy analysts, think tanks, the medical profession and others who analyze the upcoming policy ramifications of the healthcare law and what it means to individuals, employers, physicians, hospitals and more.
"I imagine anyone who goes to this website will have their eyes wide open,” stated Nancy Desmond, CEO of the Center for Health Transformation, a sponsor of the site. “It should become a trusted source for anyone trying to learn about the healthcare law, just as political junkies go to Politico.com or sports fans go to ESPN’s website.”
Gingrich said there is no single source for information about the new healthcare law. The Health Reform Report will provide a simple timeline of implementation changes for those who want to anticipate a certain tax or policy requirement, for example. To learn more, visit HealthReformReport.com.