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Post-approval R&D key in advancing oncology treatments

European Pharmaceutical Review

A new report from the Pharmaceutical Research and Manufacturers of America (PhRMA) has highlighted the importance of post-approval R&D in advancing oncology treatment options and delivering unprecedented progress over the past ten years. This therefore broadens the population of patients who may benefit.

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Pharma, patient advocates clash over Inflation Reduction Act

Pharmaceutical Technology

The Inflation Reduction Act, which became US law in August 2022, has invited its fair share of critics and supporters over its drug pricing provisions. At the core of the debate was a new provision allowing the US Centers for Medicare & Medicaid Services (CMS) to negotiate prices with pharmaceutical companies for a select number of drugs.

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Strategies for Streamlining Small Molecule Formulation Development When Bridging from Candidate Selection to First-in-Human Clinical Testing

Pharmaceutical Technology

However, there is a high level of attrition during the pharmaceutical research and development process, which is an indicator of the vast number of potential drug substances considered for progression. Therefore, it is vital to choose molecules for pharmaceutical development very carefully.

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Paving the way for anti-Abeta active immunotherapy

European Pharmaceutical Review

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

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Primate models in pharma: What the future holds

Pharmaceutical Technology

Pharmaceutical research has long relied on non-human primate models for early-stage discoveries, but their use continues to cause controversy. However, according to the US Food and Drug Administration (FDA), non-human primates are still the most scientifically relevant large model to test biologic drugs for safety.

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