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Latest From Astrimmune Ltd.
Keeping Track: Two Breakthrough Oncologics, Another Antibiotic Clear US FDA Along With Pfizer’s Hemophilia B Gene Therapy
The US FDA approved Day One’s pediatric brain cancer drug Ojemda, ImmunityBio’s bladder cancer immunotherapy Anktiva, an uncomplicated UTI claim for Utility Therapeutics’ Pivya, which has a long history in Europe, and Pfizer’s hemophilia B gene therapy Beqvez.
ImmunityBio Will Aim Anktiva At Large Share Of Bladder Cancer Market
Execs Richard Adcock and Patrick Soon-Shiong told Scrip the company sees an addressable US population of about 20,000 and is aiming for ease of physician adoption.
US FDA’s April Outlook: Decisions Pending For Rare Pediatric Diseases, New Antibiotics
User fee goal dates in April include four novel agents with breakthrough therapy designations, including Pfizer’s hemophilia B gene therapy and Immunity Bio’s IL-15 superagonist complex for bladder cancer.
News We’re Watching: New Cybersecurity Standard; CMS Prodded On TCET; Olympus Scopes Recalled
This week, NIST published a new version of its international cybersecurity standard; SeaStar Medical’s kidney device got an HDE; and the FDA announced safety issues for DT MedTech LLC, operating room tables, and GE incubators.
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