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Project Orbis
This page shows the latest Project Orbis news and features for those working in and with pharma, biotech and healthcare.
Bayer’s Nubeqa receives MHRA approval to treat metastatic prostate cancer
Nubeqa, which is already available on the NHS for patients with localised prostate cancer, was reviewed and approved through Project Orbis, an international programme to speed up the approval process of
Latest news
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Takeda’s Exkivity receives NICE recommendation for rare form of lung cancer
The treatment was licensed through by Project Orbis, an international programme to review and approve promising cancer drugs helping patients access treatments faster.
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NICE recommends Amgen’s Lumykras for non-small-cell lung cancer
Regulatory Agency (MHRA) for use across England, Scotland and Wales under Project Orbis. ... to gain access to the treatment following its CMA by MHRA through Project Orbis.
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AstraZeneca's Enhertu receives FDA grant for priority review
The sBLA is currently under review by two FDA programmes, the Real-Time Oncology Review (RTOR) and Project Orbis, which are designed to provide effective cancer treatments to patients as early ... Project Orbis is so important because it speaks to the
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FDA approves first drug to prevent graft-versus-host disease
The FDA’s review of Orencia was part of Project Orbis, which “enabled concurrent and/or shared FDA review with the health authorities in Canada, Switzerland and as a pilot in
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Green light for Amgen’s KRAS inhibitor in the UK
The approval is the second drug licensed in the UK through Project Orbis, the international partnership between medicines regulators in the UK, US, Australia and others, to speed up the approval
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Are smart deals a clever solution to UK market access?
The Innovative Licensing and Access Pathway (ILAP) was introduced to accelerate time to market for innovative medicines, and Project Orbis provides a framework for concurrent submission and review of oncology products
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