TME Pharma announced the publication of interim data from Ph I/II clinical trials of NOX-A12 (PEGylated L-stereoisomer...
CHMP recommends Dupixent® (dupilimab) for prurigo nodularis
The CHMP recommended the approval of Dupixent® (dupilumab) for the treatment of moderate-to-severe prurigo nodularis...
Janssen publishes Ph III results of Tremfya® (guselkumab) for psoriatic arthritis
Janssen published data from Ph III trials of Tremfya® (guselkumab) for the treatment of psoriatic arthritis. Janssen...
Alvotech to present data from adalimumab IC switching studies
Alvotech announced that it will present two posters (and will be featured in an Ignite Talk) related to its switching...
First global denosumab biosimilar approved in PRC for Luye Pharma/Boan Biotech
China’s NMPA approved Luye Pharma subsidiary Boan Biotech’s Boyoubei® (denosumab biosimilar) for the treatment of...
PTAB invalidates two Regeneron aflibercept patents
PTAB issued decisions in Mylan’s IPR challenges relating to Regeneron’s 9,254,338 and 9,669,069 relating to Eylea®...
Coherus’ Cimerli™ (biosimilar ranibizumab) achieves leading biosimilar market share in the US
Coherus Biosciences provided a business update, announcing that Cimerli™ (biosimilar ranibizumab) has achieved leading...
NICE recommends Keytruda® (pembrolizumab) for triple-negative breast cancer
NICE published final draft guidance recommending Keytruda® (pembrolizumab) for the treatment of triple-negative breast...
MHRA updates 2021 biosimilars guidance
The MHRA has updated its guidance on the licensing of biosimilars to allow interchangeability between biosimilars to...
Amgen to present data on biosimilars portfolio at ACRC
Amgen announced that it will present data across its portfolio at the American College of Rheumatology Convergence on...
New dupilumab study suggests serum dupilumab levels are not associated with treatment response or adverse effects in AD patients
A new study involving 295 patients with AD published in JAMA reported that there is no association between serum...
Supreme Court grants Amgen’s petition for certiorari in patent proceedings against Sanofi/Regeneron (alirocumab)
On Friday, the US Supreme Court granted Amgen’s petition for certiorari in relation to ‘whether enablement is governed...
Accord cleans up at 2022 Global Generics and Biosimilars Awards
Accord Healthcare was the clear winner at the Global Generics and Biosimilars Awards which were presented on 2...
Bio-Thera Solutions commences Ph III trials of Novartis’ secukinumab (Cosentyx®)
Bio-Thera Solutions announced that it has commenced Ph III trials of BAT2306, biosimilar to Novartis’ secukinumab...
PBAC lifts tocilizumab shortage measures
Australia’s PBAC reversed the temporary COVID measures put in place in response to drug shortages during the COVID...
PBAC public summary documents published
The Australian Pharmaceutical Benefits Advisory Counsel (PBAC) published the public summary documents from its July...