Momenta Pharmaceuticals, Inc.
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Latest From Momenta Pharmaceuticals, 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’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.
As 2024 Begins, US FDA’s Novel Agent Prospects Look A Lot Like 2023
Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.
J&J In Immunology: 'We Plan To Lead The Orals Market'
Johnson & Johnson’s historical strength in immunology will form the foundation of a renewed push in the field, with novel candidates for indications such as psoriasis, arthritis and inflammatory bowel disease.
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Biotechnology
- Drug Discovery Technologies
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Large Molecule
- Antibodies
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- Mimeon, Inc.
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