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FDA’s OPDP Issues Second Regulatory Action Letter of 2023

Eye on FDA

In what has been a long period of relative low activity, FDA’s OPDP has taken the opportunity to remind us that low enforcement does not mean no enforcement when it comes to promotional speech by pharmaceutical companies. This month FDA posted another letter , this one a Warning Letter involving a Sales Aid.

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Women in STEM with Gilda Ascione

Drug Target Review

Since I was a child, I always wanted to be a doctor. From a human point of view, I have always considered doctors’ work as a sort of mission for the good of others. Being a doctor means giving courage and hope day in, day out to those experiencing illness.

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Four Ideas for Pharma to Maximize the Influence of Digital Opinion Leaders in Medicine

H1 Blog

Insights for Thought Leading Stakeholder Engagement to Decrease Medication Non-Adherence Pharmaceutical companies have long recognized the importance of engaging key opinion leaders (KOLs) to gain insight and support for clinical research, drug development, and medical education.

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Beyond the pill | Moving towards value-added services

Altus Drug Development

While this strategy is widely adopted by modern pharmaceutical companies, in recent years, its effectiveness has begun to wane. This novel approach promises to create great advantages for the pharmaceutical companies who adopt it and might become the future of medicine.

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Targeted protein degradation: turning undruggable targets into druggable targets

Drug Target Review

Dr Yoshitsugu Shitaka is the Chief Scientific Officer (CScO) at Japan-based pharmaceutical company, Astellas Pharma Inc. Yoshi serves as CScO, where he oversees all internal and external collaborations involving company functions essential to creating innovative medicines to advance Astellas’ Focus Area approach.

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What type of R&D efforts are needed to develop value added medicines?

Altus Drug Development

Ensuring access to safe and effective treatments is the main challenge faced by pharmaceutical companies big and small. Value-added medicines offer an efficient method to meet the needs of patients while stimulating innovation in the pharmaceutical industry. What is a value-added medicine?

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Compliant Science: The Critical Role of Compliance for Medical Affairs

H1 Blog

Since KOLs play such a critical role, engaging with the right KOLs is a key strategy for pharmaceutical companies to stay ahead of the game. Compliance ensures that interactions between pharmaceutical companies and KOLs are transparent, fair, and free from any undue influence.