Brand, Generic Companies Excluding Side Deals In Reverse Settlements
Executive Summary
Brand name and generic drug manufacturers are no longer routinely attaching side deals to their patent infringement settlement agreements, the Federal Trade Commission reports in its annual summary of these deals
You may also be interested in...
FTC Sues Cephalon For Anticompetitive Side Deals In Reverse Settlements
The Federal Trade Commission is once again challenging reverse settlements between a brand name company and its would-be generic competitors. This time around, the agency is focusing on side deals tacked onto the settlements, contending they constitute unfair competition
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.
Current Pathways For Rare Disease Drugs Are Not Optimal, US FDA’s Califf Says
Anticipating a ‘tsunami of therapies’ for rare diseases, commissioner says the agency will have to think of creative approaches and employ regulatory flexibility for them. FDA considers copying the oncology center’s Project Facilitate for expanded access to other diseases.