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Francesca Bruce

Senior Writer

Francesca writes about a broad range of policy and regulatory topics, including intellectual property rights. However, her main areas of expertise are pricing and reimbursement and how medicines may or may not make it to patients. She writes about developments in Europe and is also expanding coverage in emerging markets, including Latin America and the Middle East. Francesca writes for Pink Sheet, Scrip and In Vivo.

Latest From Francesca Bruce

Brazilian Regulator Extends COVID-19 Measures

Brazil’s medicines regulator is extending COVID-19 era resolutions designed to speed up its evaluation of clinical research in Brazil.

South America Brazil

Canada Publishes Real World Evidence Guidance For HTA And Regulatory Decision Making

The new guidance was drawn up through extensive engagement with national and international experts in RWD and RWE, as well as stakeholders in Canada.

North America Canada

EU Pharma Revision Of Hospital Exemptions For ATMPs 'Is Unsatisfactory'

The EU legislative overhaul falls short on dealing with the issue of hospital exemptions for advanced therapies, says the Alliance For Regenerative Medicine.

Europe Compliance

European Countries Flag Four Medicines For Joint HTA Evaluation

Drugs for treating Duchenne muscular dystrophy and amyotrophic lateral sclerosis are among the products that the European cross-country coalition BeNeLuxA thinks would be suitable for a joint health technology evaluation.

Europe Austria

Mexico, Colombia and Cuba Formalize Talks On New Latin American Regulator

Medicines regulators from Mexico, Colombia and Cuba have pledged to create a new agency for medicines and medical devices of Latin America and the Caribbean.

South America North America

Oncopeptides’ Melflufen: Same Data, Different Conclusions From EMA, US FDA

The two regulators were an OCEAN apart on their interpretation of the overall survival and progression-fee survival data from the Phase III confirmatory trial. European regulators saw fit to recommend Pepaxti’s approval, even after the drug was voluntarily discontinued in the US market due to FDA concerns.

Approvals Regional Comparisons
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