A discussion of drugs under consideration/review for FDA approval
Approvable designations
• Recombinant human growth hormone (Accretropin, Cangene) for the treatment of growth failure in children with growth hormone deficiency and short stature associated with Turner syndrome
• Vildagliptin (Galvus, Novartis) for the oral treatment of patients with type 2 diabetes
Recommendation for approval
• H5N1 bird flu vaccine (Sanofi Pasteur) for the prevention of H5N1 bird flu
Priority review
• Ambrisentan (Gilead) for the treatment of pulmonary arterial hypertension
• Maraviroc (Pfizer) for the treatment of HIV/AIDS
Orphan drug designations
• Cethromycin (Advanced Life Sciences) for the prophylactic treatment of patients exposed to inhalation anthrax
• I-040302 (Kuros Biosurgery) for the treatment of solitary bone cysts
• Recombinant human platelet derived growth factor (BioMimetic Therapeutics) for the treatment of osteonecrosis of the jaw
• Lintuzumab (SGN-33, Seattle Genetics) for the treatment of acute myeloid leukemia
• SGN-35 (Seattle Genetics) for the treatment of Hodgkin's disease
• Maribavir (ViroPharma) for the prevention of cytomegalovirus viremia and disease in at-risk populations
• Tissue repair cells (Aastrom Biosciences) for the treatment of dilated cardiomyopathy
• 17 alpha-hydroxyprogesterone (Gestiva, Adeza) for the prevention of preterm birth in women with a history of preterm delivery
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
Listen