The Kymriah (tisagenlecleucel) treatment has received a positive appraisal from the Scottish Medicines Consortium, after EMA approval last year.
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Novartis reportedly knew of discrepancies in the Zolgensma data it had submitted to the FDA but delayed informing regulators so has announced alterations to its processes.
The voretigene neparvovec gene therapy treatment has been highlighted in draft guidance by NICE for availability on the NHS.
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.
The US District Court has decided in favour of Amgen’s Enbrel, ruling over Sandoz’s Erelzi in a patent conflict.
The pharmaceutical company failed to inform the FDA of manipulated data when the gene therapy was under review and could face a legal battle.
A report has suggested that the drug price reforms in the US will affect AstraZeneca and Novartis negatively, but Novo could benefit.
An integrated Phase I/III trial has enrolled its first patient to test a biosimilar for denosumab to treat postmenopausal osteoporosis.
The increasing complexity of formulations and active biological products raises new challenges for pre-filled syringe development. James Mellman, Device Manager at Novartis, speaks to Nikki Withers about the challenges of selecting the right primary packaging for injectable formulations and how he has learnt to expect the unexpected.
GSK and Novartis found to have misled consumers with the packaging and pricing of their osteoarthritis pain treatment.
As today’s scientists continue to identify new biopharmaceutical products with potential to treat a wide array of diseases, formulation remains the determining factor in their success. But what is involved in these increasingly complex formulation processes and how do they impact the packaging and delivery systems?
The grant will support African trials of a novel antimalarial combination comprising KAF156 (ganaplacide) and lumefantrine in a new once-daily formulation...