Market Access
Biotech funding has returned. The bar has moved with it.
For biotech sponsors, the question worth asking is not whether the rebound is real, but what it is actually rewarding.
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ViiV wins US approval for HIV treatment in newborn babies
The US FDA has green lit ViiV Healthcare’s Tivicay PD (dolutegravir) for the treatment of HIV-1 in children weighing at least 2 kg.
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Expanded US Imaavy approval first ever for wAIHA
The FDA has approved Johnson & Johnson's Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune haemolytic anaemia (wAIHA).
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EC greenlights Acadia’s DAYBU for Rett Syndrome in Europe
Acadia Pharmaceuticals has secured EC approval for DAYBU (trofinetide) for the neurobehavioural symptoms of Rett syndrome in the EU.
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Japan first approval for GSK’s bepirovirsen for CHB
Japan has approved GSK's antisense oligonucleoide Hibsago (bepirovirsen) as a functional cure in chronic hepatitis B virus infection in adult patients
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