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CEO of Novartis pledges to speed data integrity disclosures
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.
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NICE recommends voretigene neparvovec for use on NHS
The voretigene neparvovec gene therapy treatment has been highlighted in draft guidance by NICE for availability on the NHS.
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China’s drug bulk-buy programme has been expanded
China has expanded a pilot drug bulk-buying programme to almost the entire country which is adding pressure on pharma companies.
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FDA announces expansion of generic impurity investigation
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.
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Amgen wins court patent ruling over Sandoz biosimilar
The US District Court has decided in favour of Amgen’s Enbrel, ruling over Sandoz’s Erelzi in a patent conflict.
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Novartis could face legal action over Zolgensma application
The pharmaceutical company failed to inform the FDA of manipulated data when the gene therapy was under review and could face a legal battle.
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AstraZeneca and Novartis set to lose out from US drug prices reforms
A report has suggested that the drug price reforms in the US will affect AstraZeneca and Novartis negatively, but Novo could benefit.
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First patient enrolled on clinical study for denosumab biosimilar
An integrated Phase I/III trial has enrolled its first patient to test a biosimilar for denosumab to treat postmenopausal osteoporosis.
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Sickle cell drug wins Priority Review by the FDA
The US Food and Drug Administration (FDA) has given an investigational sickle cell medicine, crizanlizumab (SEG101), Priority Review.
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Top five generic drug makers
The global generic drugs market continues to grow. With increasing demand for more accessible medication, pharmaceutical companies are harnessing the benefits offered by generic drugs. Here are the top five generic drugs makers by revenue.
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Expecting the unexpected in drug formulations
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.
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GSK and Novartis ‘misled’ consumers, says Federal Court of Australia
GSK and Novartis found to have misled consumers with the packaging and pricing of their osteoarthritis pain treatment.
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Formulation In-Depth Focus 2019
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?
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Europe-Africa partnership spearheads development of next-generation antimalarial drug
The grant will support African trials of a novel antimalarial combination comprising KAF156 (ganaplacide) and lumefantrine in a new once-daily formulation...
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Top novel drug approvals: February 2019
Cablivi and Egaten were the two top novel drugs approved last month, with a focus on parasitic infestation and the rare disorder, aTTP...
