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Regulating therapies for rare diseases – recent approvals
This article summarises some of the recent notable drug approvals in the EU and US, including a gene therapy and an enzyme replacement therapy.
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From biologics to small molecules – the shift in biopharma’s revenue growth
Biopharma companies that experienced strong revenue growth due to COVID-19 drug sales have been overtaken by companies that developed obesity drugs in 2023, GlobalData suggests.
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Continuous manufacturing: an evolving technology for drug substance manufacturing
Continuous chemical manufacturing technology has been in use for more than 100 years producing high-volume commodity chemicals. However, it was not until the early 2000s that the technology caught the attention of the pharmaceutical industry in a significant way.
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NICE recommends Novartis precision brain cancer treatment
An “innovative, life-extending treatment” for BRAF V600E mutation-positive glioma has been recommended for certain young people on the NHS.
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Novartis releases new data for innovative rare kidney disease treatment
Data from the pre-specified interim analysis of Fabhalta® (iptacopan) indicate a statistically significant reduction in proteinuria reduction.
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Combination treatment could minimise cancer relapse risk
Data suggests that ribociclib plus endocrine therapy could provide a new treatment option more patients with HR-positive, HER2-negative early breast cancer.
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Novartis acquisition to address inflammation-driven diseases
Novartis’ new acquisition aims to advance first-in-class STING treatments for inflammation-driven diseases.
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New data revealed for Novartis SMA gene therapy
Novartis has revealed new data for its one-time gene therapy for spinal muscular atrophy (SMA) in older children.
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Expanded Pluvicto production gets FDA go-ahead
Novartis has obtained US manufacturing authorisation for radioligand therapy PluvictoTM at its largest, state-of-the-art radioligand therapy facility.
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Novartis secures first-of-a-kind haematology approval
A novel Factor B inhibitor of the immune system's complement pathway has been approved for paroxysmal nocturnal haemoglobinuria (PNH).
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Pharma unites to secure renewable energy in key manufacturing markets
The new industry collaboration aims to help decarbonise the global supply chain by focusing on the energy-intensive pharmaceutical manufacturing that takes place in China and India.
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Novartis completes Sandoz spin-off
As a newly independent company, Sandoz will concentrate on developing generic and biosimilar medicines, while its former parent company Novartis plans to drive its business forward with a strategic focus on innovative medicines.
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CPHI Barcelona 2023 – Event preview
CPHI Barcelona takes place in October 2023, covering a wide range of topics from next generation biomanufacturing and formulation to sustainability.
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Radioligand therapy demonstrates novel first line benefit
Novartis’ radioligand therapy (RLT) is the first to demonstrate clinically meaningful benefit in a first line setting.
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Anti-PD-1 antibody gains EU approval for oesophageal cancer
Approval of BeiGene’s TEVIMBRA® (tislelizumab) in EU follows an agreement with Novartis to regain global rights of the antibody treatment.
