AstraZeneca Pharmaceuticals LP
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Citing the need to improve its Risk Evaluation and Mitigation Strategy, the regulator has declined AstraZeneca’s bid to get its C5 complement inhibitor approved in neuromyelitis optica spectrum disorder.
The British drugmaker filed a lawsuit on Friday in the U.S. District Court for the District of Delaware claiming the Inflation Reduction Act conflicts with the goals of the Orphan Drug Act.
A transformational moment in the treatment of depression, GSK takes first shot in a vaccine patent war with Pfizer, a Louisiana woman sues Novo Nordisk and Lilly, and companies face a steep COVID-19 cliff.
Following the FDA’s approval last month, a Centers for Disease Control and Prevention panel has recommended AstraZeneca’s and Sanofi’s Beyfortus for immunizing infants and high-risk young children.
The settlement agreement between the companies follows three patent-infringement lawsuits filed by Bristol-Myers Squibb over the blockbuster cancer immunotherapies.
The British drugmaker’s rare disease subsidiary Alexion will take on a number of Pfizer’s preclinical gene therapy programs and technologies to advance its genomic medicines pipeline.
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.
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