Division of Novartis AG
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The Quality Lowdown: Novartis/Sandoz Child-Resistant Packaging; Solvent Testing; Quality Metrics; Cell And Gene Therapy
Why did Novartis/Sandoz’s hospital blister packs have to be child-resistant? Why did two warning letters to Chinese firms follow promises of more, better testing? And should firms should consider volunteering for new FDA quality metrics programs (or not) and a pre-competitive industry collaboration on cell and gene therapies?
Interchangeability Comments From Biosimilar Sponsors Highlight Need For Flexibility, Challenges Of Postmarket Data Collection
Biosimilar Substitution: US State Laws Require Physician Communication And, In Some Cases, Lower Prices
Bills allowing pharmacies to substitute biosimilars for reference biologics have been enacted in all but six states. Interactive map notes state-by-state provisions.
The advisory committee route for approving a first biosimilar to a reference product is no longer necessarily the norm, going by FDA's recent approval of Mylan/Biocon's pegfilgrastim-jmdb, which references Amgen’s Neulasta; agency’s view that a meeting was not needed should encourage other biosimilar aspirants.
- Generic Drugs
- Therapeutic Areas
- North America
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- Novartis AG
- Senior Management
Greg Nulty, CFO, VP & CFO, NA
Peter Goldschmidt, Pres.
Patrick Genestin, VP, Bus. Dev. & Licensing
Carlos Sattler, MD, VP, Clin. Dev. & Medical Affairs
Scott Smith, VP, Commercial Operations, US
Anthony Maffia, III, VP, Regulatory Affairs
- Contact Info
Phone: (609) 627-8500
100 College Rd. West
Princeton, NJ 08540
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