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Latest From Sanwa Kagaku Kenkyusho Co., 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.

US FDA Performance Tracker Approvals

Amneal Launches Ready-To-Use Pemetrexed And OTC Naloxone

Amneal launched two highly anticipated products, a ready-to-use pemetrexed injectable Pemrydi and over-the-counter naloxone spray, strengthening the firm’s focus on injectables and inhalation.

United States Launches

Parkinson’s Results Further Sweeten AbbVie’s Acquisition of Cerevel

Cerevel, which AbbVie is spending $8.7bn to acquire, unveiled topline results from the TEMPO-3 study of tavapadon, which an analyst said represents potentially a $1bn opportunity.

Clinical Trials Neurology

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.

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