OR WAIT null SECS
Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.
September 01, 2014
A surge in generic drug applications is testing FDA?s ability to reduce the backlog of ANDAs.
August 17, 2014
The development of new treatments and preventives to combat the lethal Ebola virus has been slow, marked by caution at public health agencies to approve testing of high-risk compounds, and reluctance of biopharmaceutical companies to invest in a field with limited market potential. All that has changed now, as thousands of people have been sickened by the virus, and the death rate has escalated.
August 02, 2014
FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.
July 23, 2014
After months of speculation about prospects for biosimilar development in the United States, Novartis announced on July 24 that FDA has accepted Sandoz’ biologics license application (BLA) for a similar version of Amgen’s Neupogen (filgrastim).
July 16, 2014
A potential treatment for sickle cell disease has come through the “valley of death” of early-stage development due to support from a collaborative partnership established by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH).
July 02, 2014
Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.