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The FDA has four target action dates this week for three supplemental approvals and one New Drug Approval.
The combination therapy was added to standard chemotherapy and lowered the risk of progression or death by 37% in newly diagnosed patients with advanced ovarian cancer without BRCA mutations.
The company’s aztreonam-avibactam matched the cure rate of a meropenem-based regimen in patients with drug-resistant infections.
Abrysvo’s approval in adults aged 60 years and above comes ahead of an expected August decision in the pediatric setting.
DUO-E trial data show AstraZeneca’s Imfinzi, either alone or in combination with Lynparza, boosts progression-free survival in endometrial cancer.
Ex-FDA Neuroscience Director Billy Dunn was appointed to Prothena’s board of directors last week. Industry representatives and regulatory experts weigh in on the potential ethical implications.
The U.S. Supreme Court’s denial of Teva Pharmaceuticals’ appeal could have broad ramifications for the wider generics industry, for which “skinny labeling” is a common and accepted practice.
Preliminary trial results show the GSK five-in-one meningitis vaccine is immunologically effective against the most common strains, as the FDA decision date for Pfizer’s candidate looms.
Nirsevimab lowered hospitalizations due to RSV-related lower respiratory tract disease by 83.21%. Friday’s data drop comes ahead of next week’s advisory committee meeting for Pfizer’s RSV hopeful.
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