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October FDA Pipeline
FDA actions and new molecular entities
Cymbalta
Duloxetine
Lilly
New indications
Topamax
Topiramate
Ortho-McNeil
Epilepsy therapy approved for migraine prophylaxis
FDA Actions in brief FDA approved mixed salts of a single-entity amphetamine (Adderall XR, Shire Pharmaceuticals) as a once-daily treatment for attention deficit hyperactivity disorder (ADHD) in adults.
A liquid formulation of palivizumab (Synagis, MedImmune) was approved to prevent serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk for RSV disease.
FDA approved atorvastatin (Lipitor, Pfizer) for the prevention of cardiovascular disease by reducing heart attack risk in people with normal to mildly elevated levels of cholesterol but with other risk factors for heart disease.
Acamprosate (Campral, Lipha Pharmaceuticals) was approved for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation.
FDA granted accelerated approval to pemetrexed (Alimta, Lilly) for the treatment of locally advanced or metastatic non-small-cell lung cancer in previously treated patients.
What Payers Need to Know As Retail Pharmacies Move Into Primary Care
September 6th 2023Healthcare beyond the doors of the doctor’s office has the potential to offer more care to more people. But payers need to think about how to ensure that care is consistent. Regardless of the setting, care decisions must be based on evidence-based content and supported with strong patient education.
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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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Addressing the Barriers of Medication Adherence Through Digital Health
July 9th 2023Tony Little, ND, VP of Solutions Architecture at Prescryptive Health, shares how the organization is tackling one of the biggest barriers to prescription adherence — cost — through a digital app, among the other barriers patients face.
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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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