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AMARANTH

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AstraZeneca and Medera’s Novoheart develop first human models of heart failure

The ‘heart-in-a-jar’ model will be used to effectively test drug candidates for HFpEF patient

- PMLiVE

EMA grants AZ’s Vaxzevria COVID-19 vaccine full marketing authorisation

Vaxzevria has been shown to be effective against all forms of COVID-19

- PMLiVE

FDA receives Santhera and ReveraGen’s application for Duchenne muscular dystrophy treatment

The submission includes positive data from the pivotal phase 2b and four open-label studies

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GSK’s anaemia drug gets FDA advisory committee support for patients on dialysis

A final decision for daprodustat by the FDA is expected by 1 February 2023

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Eli Lilly and Purdue sign $92.5m deal for pharma manufacturing scholarships

Participating students with be able to compete for a role at the company following graduation

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Janssen’s Tecvayli granted FDA approval for multiple myeloma

A phase 2 study demonstrated an overall response rate of 61.8% in Tecvayli-treated patients

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Alexion’s Ultomiris shows promise in neuromyelitis optica spectrum disorder phase 3 trial

Ultomiris-treated patients showed zero relapses with a median treatment duration of 73 weeks

- PMLiVE

AstraZeneca’s two advanced breast cancer trials meet primary endpoints

Both trials showed significant improvement in progression-free survival

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AstraZeneca’s Imjudo/Imfinzi combination approved by FDA for unresectable liver cancer

Phase 3 trial results demonstrated a 22% reduction in risk of death versus sorafenib

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Novavax’s COVID-19 vaccine candidate approved for emergency use by FDA as a booster

The authorisation is for those unable to receive an FDA-authorised mRNA bivalent booster

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FDA awards over $38m for advancement of rare disease treatments

Grants will support clinical trials, natural history studies and regulatory science tools

Biomarin

BioMarin’s application for haemophilia A gene therapy accepted by FDA

If approved, the treatment would be the first gene therapy in the US for this indication

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