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Latest From AutoImmune Inc.

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.

US FDA Performance Tracker Approvals

Idorsia’s Novel Hypertension Pill Among Eight New Drugs To Win EMA Nod

The European Medicines Agency believes Idorsia’s Jeraygo should be approved for use in the EU at two different doses rather than just the one approved by the US Food and Drug Administration last month.

Europe Approvals

Sanofi Clinches Key Phase III Immunology Win With Rilzabrutinib

Sanofi’s BTK inhibitor – one of two from its 2021 Principia buy – passed a Phase III test in immune thrombocytopenia as the company focuses on Dupixent-like blockbusters going forward.

Clinical Trials Companies

FTC Early Findings In PBM Investigation Coming By Mid-Summer, Chair Khan Says

The agency is also poised to announce another development in its scrutiny of the drug patents listed in the FDA’s Orange Book.

Reimbursement Patents
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