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MHRA Chief Executive to step down

European Pharmaceutical Review

The Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), Dame June Raine, will step down in the Autumn following five years in the role. While she is stepping down from her current role, Dame June shared that she still hopes to contribute β€œto patient safety and public health in other ways.”

Safety 111
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Gilead data lends insight into transforming HIV prevention landscape

European Pharmaceutical Review

New clinical trial findings show that twice-yearly lenacapavir for HIV pre-exposure prophylaxis (PrEP) had high efficacy and safety in a diverse group of participants. This data provides the first in-depth insight into full results of Gilead Sciences pivotal Phase III PURPOSE 2 trial.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. 6 Thus, it is critical to ensure the consistency of therapeutic effect across batches (see box).

Marketing 103
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Top-10 ways for Pharma to leverage AI according to…AI

Impetus Digital

Personalized Medicine AI can help develop precision medicine by analyzing patient data , including demographic, clinical, and genetic information, as well as information about their metabolism and microbes, environmental exposures, and lifestyle factors, to predict how different patients will respond to various therapies.

Pharma 94
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How NLP Helps Life Sciences Companies Unlock Insights from Drug Labels

PM360

Drug labels hold value for life sciences companies because they are rich, extensive documents that can be used across labeling, regulatory, safety, and medical affairs. Food and Drug Administration (FDA) or European Medicines Agency (EMA). International sources: The focus for many labeling teams is on major sources such as FDA and EMA.

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Why R&D innovation holds the key to greater patient impact

European Pharmaceutical Review

3 With greater scientific understanding of cancer, the industry has made significant progress in developing innovative medicines to help patients. However, access to these medicines is not close to meeting patient demand, creating inequalities in the health prospects of those diagnosed with cancer. 1,2 In the EU, an estimated 2.7

Patients 105
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Developing new treatment regimens for HIV

European Pharmaceutical Review

HIV treatment and prevention are at an inflection point after years of continuously improving the standard of care of once-daily oral medicines. Our industry is on the cusp of the next wave of medicines that will guide the coming decade of HIV care, making HIV a smaller part of people’s lives. 3 But that paradigm is rapidly changing.