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EMA backs SV95C as digital primary endpoint for DMD trials

The EMA has endorsed a digital measurement using wearables developed by Sysnav Healthcare as a primary endpoint for use in trials involving patients with Duchenne muscular

News

EMA probes suicide risk with Novo Nordisk obesity drugs

The European Medicines Agency (EMA) has started a review of two Novo Nordisk drugs used to treat obesity and those overweight, following reports of suicidal thoughts or se

News

When can single-arm trials support drug filings?

The EMA has launched a consultation on the circumstances in which single-arm trials (SATs) – those without a control group – can be used to support marketing applications

Market Access

What happened to all the antibiotics?

Across the world, there are reports of shortages of common antibiotics.

News

After FDA nod, Eisai and Biogen file lecanemab in EU

Eisai and Biogen have moved swiftly ahead with regulatory filings for their new Alzheimer's therapy lecanemab in the EU, after getting a green light for the anti-amyloid beta antibody in th

News

Janssen J&J Johnson and Johnson pharmaceutical companies

Janssen makes EMA marketing application for talquetamab for ...

The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), seeking approval of talqueta

EMA backs SV95C as digital primary endpoint for DMD trials

EMA probes suicide risk with Novo Nordisk obesity drugs

When can single-arm trials support drug filings?

What happened to all the antibiotics?

After FDA nod, Eisai and Biogen file lecanemab in EU

Janssen makes EMA marketing application for talquetamab for ...

Ben Sidders on integrating causality in AI for R&D success

The value of a partner, globally and locally

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