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severe hypertriglyceridemia

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EMA to evaluate Roche arthritis drug RoActemra for severe COVID-19

FDA approval has already been granted following positive phase 3 trials

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FDA opens door to COVID-19 booster jabs

FDA approves third shot of mRNA vaccine for the immunocompromised but EMA says there’s “not yet enough data”

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Price hike for Pfizer/BioNTech COVID-19 vaccine as UK orders boosters for 2022

The UK will pay £22 a shot, up from £18 previously, as confirmation of the UK's COVID-19 booster campaign for this winter is awaited, while the EU and the US...

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FDA grants orphan drug status to Allogene’s BCMA-targeted treatment for multiple myeloma

The decision follows the RMAT designation granted by the FDA in April

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Valneva’s COVID-19 vaccine to be tested in older people

The trial for VLA2001 will involve people over the age of 56 in New Zealand and aims to generate additional safety and immunogenicity data in older people

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South Korean company SK bioscience moves into phase 3 trials for its COVID-19 vaccine

Part of the Wave 2 vaccine programme, GBP510 will bolster South Korea’s domestic supply if successful

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FDA requests further safety trials for AZ, FibroGen’s roxadustat

The response follows concerns over serious thrombotic events and seizures

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Gene therapy company bluebird bio quits Europe

The decision comes after a trial in a rare neurological disease is halted over safety concerns and the FDA has placed the eli-cel programme on clinical hold

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AZ publishes new real-world safety data for COVID-19 vaccine Vaxzevria

Real-world data shows similar safety profile for Vaxzevria and mRNA-based jabs

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AZ raises full-year guidance after completing Alexion acquisition in Q2

Total revenue was up by 31% to $8.2bn and also increased by 24% to $15.2bn for the half year

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AZ’s PNH therapy Ultomiris wins EU backing to expand use for children

The positive recommendation is based on interim results from a phase 3 trial

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Roche engaged in talks with FDA for Alzheimer’s drug candidate

CEO Severin Schwan told reporters Roche will complete a phase 3 trial of gantenerumab in the second half of 2022

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