September FDA Pipeline
New combinations
New combinationsVytorin
Ezetimibe and simvastatin
MERCK/SCHERING-PLOUGH
Cost. The ezetimibe/simvastatin combination tablet will be priced at $2.34 per dose for all doses, according to the manufacturer.
New indicationsAldara
Imiquimod cream, 5%
3M PHARMACEUTICALS
IMMUNE RESPONSE MODIFIER APPROVED FOR SUPERFICIAL BASAL CELL CARCINOMA
Atazanavir (Reyataz, Bristol-Myers Squibb) was approved for use with low-dose ritonavir (Norvir, Abbott) in treatment-experienced HIV-infected patients.
FDA approved levofloxacin tablets/injection and levofloxacin in 5% dextrose injection (Levaquin, Johnson & Johnson) to treat multi-drug resistant strains of Streptococcus pneumoniae in community-acquired pneumonia (CAP).
FDA approved lansoprazole (Prevacid, TAP Pharmaceutical Products) for the short-term treatment of symptomatic gastroesophageal reflux disease (GERD) and erosive esophagitis in adolescent patients aged 12 to 17 years. Also approved was a delayed-release, orally disintegrating tablet formulation of lansoprazole (Prevacid SoluTab, TAP Pharmaceutical Products), which can be administered via an oral syringe or nasogastric tube.
Intradermal botulinum toxin type A (Botox, Allergan) was approved for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.
FDA approved additional efficacy labeling for quetiapine (Seroquel, AstraZeneca). The data demonstrated that after 12 weeks, approximately two-thirds of patients receiving quetiapine as monotherapy achieved remission. The new label includes safety and efficacy data for mania associated with bipolar disorder extending up to Week 12.
David Calabrese of OptumRx Talks New Role, Market Insulin Prices and Other Topics 'On His Mind'
April 13th 2023In this month’s episode of the "What's On Your Mind podcast," Peter Wehrwein, managing editor of MHE connects with the now Chief Clinical Officer of OptumRx Integrated Pharmacies, David Calabrese. In this conversation, David touches on his transition in January as OptumRx’s former chief pharmacy officer and market president of health plans and PBMs to his new role as Chief Clinical Officer where he now focuses more on things such as specialty pharmacy to home delivery — with an overall goal of creating whole-patient care. Throughout the conversation, Calabrese also touched on the market’s hot topic of insulin prices and behavioral health services within the OptumRx community, among other topics.
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Phase 3 Trials of Oral Povorcitinib Show Positive Results in Hidradenitis Suppurativa
March 24th 2025A new drug application for povorcitinib is expected to be filed in late 2025 to early 2026 to treat adult patients with moderate to severe hidradenitis suppurativa, a chronic and painful inflammatory skin condition.
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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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Opzelura Topical Cream Drives Incyte's Record Growth in 2024 with 50% Revenue Surge
February 18th 2025Opzelura is a treatment for nonsegmental vitiligo in patients 12 and older, making it the first and only cream in the U.S. that helps restore skin color for this condition. It’s also approved to treat mild to moderate atopic dermatitis in patients 12 and older who are not immunocompromised.
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