Commercial Strategy

Nicole Dale

Clinical Trial Changes and Protocol Amendments

Pharmatica image of a clinical development office with clinical trial protocol amendment files, study documentation, and trial data monitors against a city skyline with an approaching storm.

Protocol amendments can rescue studies or weaken evidence. Learn how sponsors can distinguish justified adaptation from costly drift in clinical development.

Nicole Dale

Night of the Living Drug: The Mortuary of Molecules Has Come Alive!

Pharmatica image of a pharmaceutical research vial on a laboratory bench, representing drug repurposing and the revival of abandoned drug candidates.

Drug repurposing can revive abandoned compounds. Discover the science of exploring the drug cemetery and the resurrection strategies helping drug discovery.

Nicole Dale

Camizestrant Approval: First ctDNA-Guided Cancer Care

Pharmatica image of a gloved hand holding a blood sample tube in a bright laboratory with red and pink tones and the Pink Breast Cancer Awareness ribbon.

The camizestrant FDA approval is the first for a ctDNA-guided cancer treatment. Find out why the FDA overruled its own advisers and what sponsors must plan next.

Nicole Dale

Continuous Manufacturing of Biologics Is Ready to Scale

Pharmatica image of a stainless-steel bioreactor and connected equipment in a bright biopharmaceutical manufacturing facility, illustrating continuous biologics production.

Continuous manufacturing of biologics could cut facility costs by up to 50%. Learn what ICH Q13 and the latest evidence mean for pharma teams.

Nicole Dale

The FDA Rare Disease Framework Initiative Explained

Pharmatica image of six red visual elements converging into a unified framework, illustrating the FDA’s six commitments to improving rare-disease regulatory review.

The FDA Rare Disease Framework Initiative aims to make rare disease drug review more consistent. Explore the six commitments and what sponsors should do now.

Nicole Dale

An Overview of EuroQol EQ-5D: Quality-of-Life Assessment

Pharmatica visual of an abstract blue five-bar health scale glowing on a bright background, representing EuroQol EQ-5D quality of life measurement.

EuroQol EQ-5D explained: How it measures quality of life, supports QALYs and HTA decisions, and what new EuroQol tools mean for clinical trial strategy.

Nicole Dale

CMS Finalises Medicare GLOBE to Rewrite Drug Pricing

Pharmatica image showing a pharmaceutical medicines vial and abstract international pricing benchmark concept representing the Medicare GLOBE drug payment model.

The Medicare GLOBE drug payment uses international drug prices to reshape selected Medicare Part B rebates. Here is what the final CMS rule means for pharma.