Regulatory
The regulator’s greenlight on Friday for Regeneron Pharmaceuticals’ monoclonal antibody Veopoz (pozelimab) makes it the first and only treatment indicated for children and adults with CHAPLE disease.
Boehringer Ingelheim will launch three Phase III studies for its obesity drug candidate; third time is a charm for Ipsen as it gets FDA approval; and Pfizer takes multiple myeloma battle to J&J.
Some experts question the value of recently issued FDA guidance that aims to address gaps in the quality of unapproved laboratory tests for cancer.
The regulator informed bluebird bio that it will not convene an advisory committee meeting to discuss the company’s application for the gene therapy being developed for sickle cell disease.
Valneva’s chikungunya vaccine candidate will have to wait three more months for a decision from the regulator, potentially giving rival Bavarian Nordic additional time to catch up.
Week in Review: Novo Nordisk Riding High, Novavax in the Black (For Now), Nektar Sues Lilly and More
Novo’s weight-loss drug Wegovy improves cardiovascular outcomes, Novavax posts surprise Q2 profit, while Nektar Therapeutics files lawsuit against Eli Lilly for misconduct in drug development deal.
The Securities and Exchange Commission has joined the mounting antitrust scrutiny of Illumina’s acquisition of the cancer diagnostics company, according to an SEC filing by the DNA sequencing giant.
The FDA has four decisions on deck this week, including ones for two rare disease treatments from Ipsen and Regeneron.
After the regulator rejected avasopasem manganese, its candidate for severe oral mucositis, Galera is implementing a restructuring initiative that involves reducing its headcount by 70%.
The vaccine maker cut 25% of staff amid post-pandemic business challenges in May, but resurgent sales and an updated COVID-19 shot may prove a turning point.
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