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Clinical / R&D

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Latest From Research & Development

Biogen’s Big Day Arrives, But Aducanumab Results Don’t Answer Key Question

Biogen presented highly anticipated data in Alzheimer’s disease at CTAD for its Phase III EMERGE and ENGAGE studies, but one major question remains unanswered: will the FDA approve the drug? 

Clinical Trials Neurology

Adaptive Clinical Trials: US FDA Offers More Advice On Bayesian Designs

Final guidance provides more details on clinical trial designs that use Bayesian adaptive features; says monitoring committee recommendations may deviate from the anticipated algorithm.

Guidance Documents Clinical Trials

Real-World Database Studies: Prepare For A Long Journey, IQVIA Advises

Rigorous planning and a multidisciplinary team including database experts and healthcare specialists with local knowledge are vital to effective real-world evidence, white paper shows.

Real-World Evidence Research & Development

EMA Heeds Ombudsman’s Advice On Avoiding Perception Of Bias In Drug Evaluations

An inquiry by the EU Ombudsman has prompted the European Medicines Agency to introduce changes to ensure that its experts, who advise companies in the premarket phase, are not appointed to evaluate marketing applications for the same drugs.

Approvals Research & Development

Biosimilar Insulins (Generally) Won't Need Comparative Clinical Immunogenicity Data, US FDA Says

In a move that will likely be welcomed by industry, the US FDA issued draft guidance stating that sponsors will generally not need to conduct comparative clinical immunogenicity studies in developing biosimilar/interchangeable products.

Biosimilars Metabolic Disorders

UK Conservatives Promise ‘Innovative Medicines Fund’ If Re-Elected

More money to pay for innovative new medicines, more cash and support for the life sciences sector, and Brexit by 31 January 2020 are among promises made in the Conservative Party’s election platform. 

United Kingdom Brexit
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