16 October 2023
16 October 2023
The approval is based on findings from the Phase III CheckMate-76K clinical trial of Opdivo.
The EMA gave a negative approval decision for Amylyx’s Albrioza due to concerns surrounding Phase II results.
The positive opinion has been adopted based on data from the pivotal ReSTORE Phase III clinical study.
Keytruda was recommended by the EU CHMP based on results from KEYNOTE-859 study and is also under review in the US.
The approval was based on data from the ELEVATE UC Phase III registrational programme, including ELEVATE UC 52 and ELEVATE UC 12.
The dose-selection Phase I trials for evaluating PepGen’s peptide-conjugated antisense oligonucleotide have been cleared to begin in the US.
The Phase IIb study will enrol 265 patients and has an estimated completion date in Q2 2024.
MediLink will receive $70m upfront and up to $1bn in additional milestone-based payments from BioNTech.
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With only a few approved drugs currently available to treat DN by means other than regulation of blood pressure, innovator products that can treat by targeting other factors such as treatment of dyslipidemia, hypertension, or angiotensin inhibition, among others, is a key area of R&D in the DN space and is likely to pave the way for novel therapies in the near future. However, the treatment landscape is expected to remain unchanged due to limited availability of products in the late-stage pipeline currently.
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