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Otsuka Pharmaceutical

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Bristol Myers Squibb’s acute myeloid leukaemia oral maintenance therapy recommended by NICE

Phase 3 trial results show Onureg offers significantly longer overall and relapse-free survival

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EMA accepts Otsuka and Astex’s marketing authorisation application for acute myeloid leukaemia treatment 

The application is supported by results from a phase 3 trial demonstrating an exposure equivalence to the current standard of care for AML

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EMA accepts Mundipharma’s application for invasive candidiasis treatment rezafungin

Despite currently available treatments, the mortality rate for patients with invasive candidiasis remains high at up to 40%

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AbbVie submits migraine prevention drug to EMA for marketing authorisation

If approved, atogepant would be the first daily oral CGRP receptor antagonist migraine treatment for adults in Europe

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EMA grants Bavarian Nordic access to PRIME scheme for RSV vaccine candidate

It is estimated that infections caused by this respiratory virus lead to over 175,000 hospitalisations and 14,0000 deaths in older people in the US each year

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AstraZeneca’s COVID-19 vaccine receives EMA approval for use as third-dose booster

Vaxzevria is a ‘viral vector’ vaccine, a technology that is also used to create vaccines for other infectious diseases like flu, HIV and Ebola

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Positive CHMP opinion issued for PTC Therapeutics’ Upstaza

The treatment for AADC will be the first marketed gene therapy to be administered directly into the brain

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EMA accepts Valneva’s marketing authorisation application for COVID-19 vaccine

The vaccine is currently the only inactivated, whole virus adjuvanted candidate in clinical trials in Europe

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Biogen retracts EMA application for Alzheimer’s drug Aduhelm

The application was pulled after the CHMP said the data provided was not enough to support a marketing authorisation

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FDA lifts hold on Gilead’s clinical trials for leukaemia

Following a review of the safety data, enrolment can be resumed for the MDS and AML clinical trials

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EMA and ECDC publish advice on fourth doses of mRNA COVID-19 vaccines

The regulators have concluded that there is not enough supporting evidence for an immediate fourth dose

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EMA establishes DARWIN EU Coordination Centre

The new centre will give the EMA and other EU member states access to reliable, real-world evidence for EU medicine assessments

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