An FDA expert committee has recommend approval of Zarizio, the first US biosimilar application from Sandoz, setting a milestone for generic biologic drugs and setting the stage for future approvals.
FDA set several milestones in approving more new, important drugs and biologics in 2014. Breakthrough drug designations went through through the roof, speeding more new therapies for cancer and critical conditions to patients.
FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.
A global framework of standards enabling collaboration among industry stakeholders is needed to battle the increasing threat of counterfeit medicines.
Patient access to critical experimental medicines continues to grab public attention as states enact “Right-to-Try” laws and Congress eyes establishing a national policy to provide not-yet-approved therapies to terminally ill patients.
The development and approval of new vaccines and antivirals to contain and treat the Ebola virus outbreak has become a top priority for the federal government and Congress, as seen in new policies to spur R&D and added funding for these efforts.
The author looks at how life-science research has evolved in Europe and the United Kingdom, and discusses the current funding opportunities for SMEs.
Sponsor response to FDA's breakthrough program has exceeded FDA expectations, but puts pressure on manufacturers to address formulation, stability and quality production issues very early in development.
The 2014 mid-term elections handed over control of the Senate to Republicans and boosted the GOP majority in the House, a clear blow to Obama administration policies, including the president’s landmark health reform initiative.
Most new injectable drugs and biologics are being designed as combination therapies, presenting difficult regulatory and production issues for manufacturers.