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- PMLiVE

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EMA addresses considerations for single-arm trials as pivotal evidence in regulatory filings

The reflection paper offers suggestions on trial design and strategies for minimising bias

- PMLiVE

EU outlines measures to mitigate antibiotic shortage across Europe

An unseasonably early upsurge in respiratory infections has led to the increase in demand

- PMLiVE

EU to revise pharmaceuticals law amid antibiotic shortages

The early upsurge in respiratory infections has led to a sudden increase in demand for antibiotics

- PMLiVE

bluebird bio sells second FDA priority review voucher for $95m

The company sold its first voucher to Dutch biotech Argenx for $102m

- PMLiVE

Jasper Therapeutics’ briquilimab given orphan drug designation in EU

The drug will be used for transplant patients with SCID, AML and MDS

- PMLiVE

FDA lifts partial clinical hold on bluebird bio’s sickle cell gene therapy studies

The company can now resume the enrolment and treatment of patients aged two to 17 years

- PMLiVE

EMA’s emergency task force backs bivalent COVID-19 vaccines for primary vaccination

National authorities may decide to use the vaccines in their primary vaccination campaigns

- PMLiVE

bluebird bio sells Rare Pediatric Disease Priority Review Voucher

The company was granted two PRVs upon the FDA approvals of Zynteglo and Skysona

- PMLiVE

BeiGene’s Brukinsa receives EC approval for marginal zone lymphoma

The BTK inhibitor was also granted an additional year of marketing protection

- PMLiVE

EMA issues new guidance to limit use of JAK inhibitors for chronic inflammatory disorders

The guidance aim to minimise the risk of serious side effects associated with these medicines

- PMLiVE

GSK’s application for its RSV vaccine accepted by EMA under accelerated assessment

The vaccine demonstrated overall efficacy of 82.5% in adults aged 60 years and older

- PMLiVE

AbbVie submits application for lymphoma therapy epcoritamab to EMA

Phase 2 trial showed an overall response rate of 63% and a complete response rate of 39%

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