AstraZeneca Pharmaceuticals LP
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On the heels of a European Union investigation, the UK’s health agency is reviewing safety data for GLP-1 receptor agonists after reports of self-harm and suicidal thoughts.
The U.S. regulator Monday approved the Beyfortus single-dose monoclonal antibody, developed jointly by the two companies, for the pediatric prevention of respiratory syncytial virus.
Topline results for its Daiichi Sankyo-partnered antibody-drug conjugate showed statistically significant improvement. However, AstraZeneca shares dropped around 6% in early Monday trading.
After a series of milestone approvals in the first half of 2023, the FDA is slated to decide on four more firsts before the year’s end.
Despite a challenging economic climate and gloomy forecast, 2023 has still notched some mega-deals for biopharmas. BioSpace highlights the biggest deals in the industry this year.
Pieris Pharmaceuticals announced partner AstraZeneca’s decision to discontinue clinical studies of elarekibep, an inhaled IL-4 receptor alpha inhibitor, based on a non-clinical toxicology study.
As geopolitical tensions rise in the region, AstraZeneca is looking at potentially spinning off its China unit into its own independent business.
The company paid $85 million upfront to Quell Therapeutics to develop Treg therapies for Type 1 diabetes and inflammatory bowel disorder, with the deal potentially worth more than $2 billion.
The FDA’s Antimicrobial Drugs Advisory Committee voted 21–0 that the companies’ respiratory syncytial virus antibody, nirsevimab, has a favorable benefit-risk profile in infants and young children.
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