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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.

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Acer's bank reserves have dwindled down to next to nothing following the failure of its menopause drug, osanetant, in a Phase II trial some six months ago. Enter Zevra, which is getting hold of the company and its just-launched urea cycle disorder drug, Olpruva, in what looks like a bargain.

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Finance Watch: Ferring Shutters San Diego R&D Site As Even Money-Making Firms Cut Costs

Restructuring Edition: After reporting record revenue, but lower profits due to rising costs, Ferring has decided to consolidate R&D in Europe. Also, Codiak has filed for Chapter 11 bankruptcy and will sell off its assets, while Exicure, Applied Molecular Transport, Gamida Cell and others revealed new job cuts.

Restructuring Business Strategies

Dispute Resolution: Ardelyx Eyes Tenapanor Resubmission Following Successful Appeal To FDA

Office of New Drugs grants company’s appeal of complete response letter for tenapanor in dialysis patients, marking a rare sponsor victory through the agency’s formal dispute resolution process; new drug application resubmission is targeted for first half of 2023.

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