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Latest From Mallinckrodt plc
VC funding slowed recently, but public company financings kept up a brisk pace with follow-on public offerings for Allakos and Alpine, private placements for Ventyx and Syros, and Albireo’s royalty deal. In restructuring updates, Biogen raised $592m in a real estate deal and Acerus is assessing options.
Keeping Track: Terliprez, Sotyktu Keep Up US FDA’s Novel Approvals Pace; Submissions By Pfizer, Chiesi And BioLineRx
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Office of Neuroscience Director Billy Dunn touted FDA’s ability to withdraw approval for AMX0035 if subsequent data indicate a lack of substantial evidence of effectiveness. However, this provision appears to have been infrequently used and involves a potentially time-consuming hearing.
Terlivaz is the first product approved to improve kidney function in adults with hepatorenal syndrome (HRS). The approval is a milestone in a long regulatory road for the drug.
- Medical Devices
- Generic Drugs
- Specialty Pharmaceuticals
- Other Names / Subsidiaries
- Aspect Medical Systems, Inc.
- BÂRRX Medical, Inc.
- Cadence Pharmaceuticals, Inc.
- CNS Therapeutics, Inc.
- ev3 Inc.
- Given Imaging Ltd.
- Ikaria Holdings, Inc.
- InfaCare Pharmaceutical Corporation
- INO Therapeutics, LLC
- Mallinckrodt Inc.
- Mallinckrodt Pharmaceuticals
- Micro Therapeutics, Inc.
- Nellcor Puritan Bennett, Inc.
- Ocera Therapeutics Inc. (OCRX)
- Oridion Systems Ltd.
- Questcor Pharmaceuticals, Inc.
- Somanetics Corp.
- Sonorant Inc.
- SpecGx Inc.
- Sucampo Pharmaceuticals, Inc.(SCMP)
- VNUS Medical Technologies
- Stratatech Corporation
- Tranzyme Pharma