Markets & regulation

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FDA lifts partial clinical hold on phase 3 low blood sugar treatment

By Larissa Worneck-Silvestrin

Rare disease biotech Rezolute recently announced that the FDA has lifted the partial clinical hold on RZ358 (ersodetug), a novel therapy in development for the treatment of low blood sugar (hypoglycemia) resulting from congenital hyperinsulinism.

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FDA grants expanded approval for Emergent Bio’s mpox vaccine

By Larissa Warneck-Silvestrin

The U.S. company Emergent BioSolutions recently announced the FDA approval of its application to expand the indication for ACAM2000 – previously approved for smallpox – to include the prevention of mpox in high-risk individuals.

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EU approves Regeneron’s bispecific antibody following US rejection

By Jonathan Smith

Just months after facing a rejection in the US, the bispecific antibody odronextamab (Ordspono) has been approved by the European Commission for the treatment of two types of blood cancer in patients that have failed to respond to previous treatments.

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Adcendo and Multitude target cancer resistance to ADCs in $1BN deal

By Jonathan Smith

As antibody-drug conjugates (ADCs) continue to heat up in the industry, Adcendo of Denmark has gained the global rights from Multitude Therapeutics to develop the Chinese company’s ADC for the treatment of cancer outside of the Greater China region.

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Scientists engineer brain parasite as novel drug delivery system

By Liza Laws

A team of scientists from the universities of Glasgow and Tel Aviv has developed a groundbreaking method to transform the brain parasite Toxoplasma gondii into a potential vehicle for delivering therapeutic treatments directly to brain cells.