- Hypertrophic Cardiomyopathy (HCM)
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All-oral Hep C drug combo expedited toward market launch
Breakthrough Therapy Designation given to daclatasvir and asunaprevir
In late February, FDA granted Bristol-Myers Squibb Company a Breakthrough Therapy Designation for its investigational DCV Dual Regimen (daclatasvir and asunaprevir) for use as a combination therapy in the treatment of genotype 1b chronic hepatitis C infection (HCV). The designation is based on data from the company’s ongoing Phase III clinical trial program evaluating the all-oral combination regimen of DCV, an investigational NS5A replication complex inhibitor, and ASV, an investigational NS3 protease inhibitor, without ribavirin.
The relatively new FDA Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions, and criteria require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.
According to experts, the designation is seen as a positive sign that FDA is ensuring that innovative drug products are brought to market even more quickly for the millions of patients with serious medical conditions. More than 3 million people are estimated to have HCV in the United States.
Express Scripts predicts that HCV drug trend will grow by 168% in 2015. The emerging therapies offer 95% or higher sustained virologic rates and are rapidly becoming standard care.
A Conversation With Greg Baker, RPh, CEO of AffirmedRx
March 31st 2024Greg Baker, CEO of AffirmedRx, describes his early career, shares some of his critical opinions about the pharmacy benefit management (PBM) industry and how, in his view, his company is offering a better alternative.
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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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Florida Gets the OK. But Will Drug Importation from Canada Actually Happen?
March 5th 2024Canadian health officials warn that maintaining a drug supply for Canadians is their priority. The staunch opposition of the U.S. pharmaceutical industry may also be an obstacle to imports from north of the border.
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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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