Phase III
Alnylam announced another delay, this one caused by a much more sinister reason – the invasion of Ukraine, now heading into its third month and causing disruption on a multi-faceted and global scale.
Moderna has made the official request to the FDA to approve its COVID-19 for use in children ages 6 months to 5 years. Moderna also announced the location of its first non-U.S. mRNA manufacturing facility.
Pfizer says it will open the first U.S. sites in its Phase III study evaluating its investigational mini-dystrophin gene therapy in ambulatory patients with Duchenne muscular dystrophy (DMD).
Alexion shared the news that Ultomiris (ravulizumab-cwvz) has been approved by the FDA for commercialization, adding another indication for the precedent-setting drug.
The Q1 results for Voxzogo gave BioMarin the confidence to raise its 2022 full-year guidance to between $100 million to $125 million (net product revenue) for the drug.
BeiGene’s candidate drug tislelizumab for cancer succeeded in meeting the primary endpoint of overall survival in a global Phase III trial. Learn more about it here.
The war has shattered plans for a variety of clinical trials, but Roche is particularly concerned about fenebrutinib, a drug it is developing for multiple sclerosis (MS).
Protagonist Therapeutics’ Phase II study of an ulcerative colitis treatment failed to meet its primary endpoint at a higher dosage amount. Even so, the company remains optimistic about the drug’s future.
Nektar Therapeutics outlined a strategic reorganization plan that includes cutting 70% of its workforce. This comes only weeks after BMS abandoned its clinical collaboration program with Nektar.
The FDA has now approved the first treatment for COVID-19 in young children, expanding its approval for Gilead’s Veklury to children who are at least 28 days old and weigh at least three kilograms.
PRESS RELEASES