FDA Actions in Brief April 2011 (Benlysta, Yervoy, Zostavax, Banzel Oral Suspension, Intuniv, Promacta, Gadavist)
Recent FDA Approvals (through March 2011) related to Benlysta, Yervoy, Zostavax, Banzel Oral Suspension, Intuniv, Promacta, Gadavist
Belimumab (Benlysta, Human Genome Sciences and GlaxoSmithKline) was approved to treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs. It is the first inhibitor designed to target B-lymphocyte stimulator protein, which may reduce the number of abnormal B cells thought to be a problem in lupus.
Ipilimumab (Yervoy, Bristol-Myers Squibb) was approved to treat patients with late-stage (metastatic) melanoma.
An expanded age indication for Zoster Vaccine Live (Zostavax, Merck) was approved for the prevention of herpes zoster in adults aged 50 to 59 years.
Guanfacine (Intuniv, Shire) once-daily extended-release tablets were approved as adjunctive therapy to stimulants for the treatment of attention deficit hyperactivity disorder in children and adolescents aged 6 to 17 years as part of a total treatment program.
Eltrombopag (Promacta, GlaxoSmithKline) oral tablet was approved for the treatment in patients with chronic immune (idiopathic) thrombocytopenic purpura who have had an insufficient response to cortiocosteriods, immunoglobulins, or splenectomy.
Gadobutrol (Gadavist, Bayer Pharmaceuticals), a gadolinium-based agent, was approved for use in patients undergoing magnetic resonance imaging of the central nervous system.
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.
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