Biosensors International Group Ltd.
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Latest From Biosensors International Group Ltd.
FDA Change In Bioequivalence Requirements Leads To Downgrade Of Accord’s Generic Tacrolimus
After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver higher concentrations, leading agency to downgrade its therapeutic equivalence rating. No problems were found with five other tacrolimus ANDAs.
Sandoz Looks To Join EU Trastuzumab Party With CHMP Thumbs Up
Sandoz looks to be in line for an EU-wide approval for its trastuzumab biosimilar during 2023, with the backing of the EMA’s Committee for Medicinal Products for Human Use.
Lebrikizumab Among Nine Drugs To Get EMA Nod; PTC Faces Disappointment For Translarna
The European Medicines Agency has OKd nine new medicines for EU-wide approval, but recommended against renewing the conditional marketing authorization of two drugs.
Enzene CEO On Biosimilar Denosumab And Cetuximab; Medicare Negotiation Impact On US Market
CEO of Enzene Biosciences weighs in on the impact of Medicare negotiations in the US on the biosimilars market even as a US filing is planned for a Prolia biosimilar. In the interview, he says Enzene “is not afraid or concerned” over ongoing litigation with Merck KGaA over an Erbitux biosimilar in India, adding that new modalities like ADCs are being “seriously” considered.
Company Information
- Industry
- Distributors
- Medical Devices
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Pharmaceuticals
- Drug Delivery
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Medical Devices
- Consumables, Central Supplies
- Diagnostic Imaging Equipment & Supplies
- Implantable Devices
- Infection Control-Sterilization
- Infusion Therapy Equipment and Supplies
- Laser
- Monitoring Equipment & Devices
- Radiofrequency Devices
- Rehabilitation Equipment and Devices
- Surgical Equipment & Devices
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Surgical Equipment & Devices
- Minimally or Less Invasive
- Other Names / Subsidiaries
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- CardioMind, Inc.
- Devax, Inc.
- JW Medical Systems
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