Category Archives: FDA

Breakthrough Drug Initiative Success Creates Manufacturing Challenges

The breakthrough drug initiative has accelerated the development and approval of highly effective therapies, enabling important new medicines to reach patients sooner, according to Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER). Twelve breakthrough drugs have been approved over the past two years for several critical conditions in addition to cancer, […]
Also posted in Manufacturing | Tagged , , , , , | Leave a comment

Breakthrough Therapy Program Exceeds FDA’s Expectations

The two-year-old initiative to accelerate the development and approval of highly effective drugs and biologics has enabled a number of important new medicines to reach patients sooner,  according to Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER). Twelve breakthrough drugs have been approved over the past two years, for several critical […]
Also posted in Op-Ed, Regulatory, Safety | Tagged , , , , | Leave a comment

CytRx Faces Partial Clinical Hold after Death in Compassionate Use Program

CytRx announced on Tuesday that FDA gave notice of a partial clinical hold for trials for its oncology candidate aldoxorubicin. The hold results from a reported death of a late-stage cancer patient “who did not qualify to participate in any of the ongoing aldoxorubicin clinical trials, but had received aldoxorubicin under the Company’s expanded access […]
Also posted in Safety, Strategy | Tagged , | Leave a comment

CMS Struggles to Fix Sunshine System

The feds have “a long way to go” to get the Open Payments system operating effectively and user friendly, according to officials in charge of the financial disclosure program. “Sunshine” went live September 30, 2014, as scheduled, but incomplete and contradictory data listings made it necessary to withhold nearly one-third of financial transaction reports from […]
Also posted in Op-Ed, Regulatory | Tagged , , , , , | Leave a comment

Amgen and Sandoz in Legal Battle Over Biosimilar Application

By Randi Hernandez In a landmark lawsuit over the first biosimilar application, Amgen is suing Sandoz for unlawfully refusing to follow the patent resolution protocol laid out by the rules of the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
Also posted in Biotech, Legal | Tagged , , , , | Leave a comment
  • Categories

  • Meta