FDA Actions in Brief May 2012
Recent FDA Approvals (through May 2012) related to (Meda, Novo Nordisk, Janssen, Vivus, Clinigen, GlaxoSmithKline, Stride Arcolab)
Azelastine and fluticasone (Dymista, Meda) was approved for the treatment of seasonal allergic rhinitis.
Insulin detemir [rDNA origin] injection (Levemir, Novo Nordisk) has expanded its pediatric indication and was approved for use for children aged 2 to 5 years old with type 1 diabetes. It is the first and only basal insulin analog approved for use in patients as young as age 2 years.
Levofloxacin (Levaquin, Janssen) was approved to treat plague, a rare and potentially deadly bacterial infection. Levaquin also was approved to reduce the risk of getting plague after exposure to Yersinia pestis, the bacterium that causes the disease.
Foscarnet sodium (Foscavir, Clinigen) was approved for the treatment of HIV/AIDS-related cytomegalovirus infections and herpes.
Tazarotene (Fabior Foam 0.1%, GlaxoSmithKline) was approved for the treatment of acne vulgaris in patients 12 years of age and older.
Acetazolamide for injection USP (Strides Arcolab), 500-mg vial (preservative-free) in lyophilized format was approved for the adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure.
Briana Contreras, editor of Managed Healthcare Executive, spoke with Nancy Lurker, CEO and president of EyePoint Pharmaceuticals. Nancy shared a bit about EyePoint and how the organization’s innovative therapies are addressing patient needs through eye care, and most importantly, she addressed C-Suite positions like the CEO role. Nancy shared advice for those seeking to reach the CEO level, especially toward women in healthcare and other roles, and what it takes to run a biopharma company.
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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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