Merck announced that the FDA has approved Keytruda® (pembrolizumab) in combination with chemoradiotherapy to treat...
WuXi Biologics and BioNTech Ink $20M Deal for Two Monoclonal Antibodies
WuXi Biologics announced that it has signed a research service agreement with BioNTech under which Wuxi will receive a...
Scientific Advisory Group to Discuss Eisai/Biogen’s MAA for Leqembi® (lecanemab)
Eisai announced that the Scientific Advisory Group (SAG) will meet to discuss Eisai’s marketing authorisation...
Celltrion Applies to FDA for Interchangeable Status for Yuflyma® Biosimilar to AbbVie’s Humira® (adalimumab)
Celltrion announced in a corporate filing that it applied to the FDA seeking interchangeable status for CT-P17...
Regeneron Sues Amgen over ABP938 Biosimilar to Eylea®
Regeneron filed a Compliant in the US District Court for the Central District of California against Amgen asserting...
First Biosimilar Alert: EC Approves Alvotech/STADA’s Uzpruvo® (AVT04) Biosimilar to Janssen’s Stelara® (ustekinumab)
Alvotech and STADA announced the European Commission (EC) has granted centralised marketing authorisation (MA) for...
Celltrion Presents Strategic Vision & Growth Plan at JP Morgan Conference
Celltrion announced the next phase of its strategic transformation to focus on new drug development at the JP Morgan...
PTAB Finds Two Regeneron Eylea® (aflibercept) Patents Invalid
The Patent Trial and Appeal Board (PTAB) in found that Regeneron’s patents 10,130,681 and 10,888,601 relating to...
Study Demonstrates Switching from AbbVie’s Humira® (adalimumab) to Samsung Bioepis’ Biosimilar, Adalloce®, is Safe and Efficacious in NIU
A study published in Ocular Immunology and Inflammation found that switching patients with non-infectious uveitis...
Approval Alert: Biogen/Eisai’s Leqembi® (lecanemab) Approved by NMPA to Treat Alzheimer’s Disease
Biogen and Eisai announced that Leqembi® (lecanemab) has been approved by the National Medical Products Administration...
GSK Acquires Aiolos Bio for $1B Including mAb AIO-001 in Phase II Studies
GSK and Aiolos Bio announced they have entered into an agreement for GSK to acquire Aiolos, a clinical-stage...
EC Grants MA to Bayer’s Eylea® 8mg (aflibercept) for nAMD and DMO
Bayer announced that the European Commission (EC) granted marketing authorisation (MA) for Eylea® 8mg (aflibercept) to...
Celltrion’s Remsima SC®, Biobetter to Remsima®, Biosimilar to Janssen’s Remicade® (infliximab), Sales Jump 48%
The Korea Biomedical Review has reported that Celltrion confirmed it has increased Australian sales of Remsima SC®,...
AGC Biologics to Build New Biologics and ATMP Manufacturing Site in Yokohama
AGC Biologics announced that it will construct a new manufacturing facility for biologics and advanced therapy...
Accord’s BLA for its Ustekinumab (Stelara®) Biosimilar Accepted by FDA; Settlement with Janssen Permits Launch by 15 May 2025
Accord BioPharma, a wholly-owned subsidiary of Intas Pharmaceuticals, announced that the US Food and Drug...
Samsung Bioepis, Celltrion and Formycon File Opposition to Regeneron Motion for Alternative Service in Eylea® (aflibercept) Proceedings
Samsung Bioepis, Celltrion and Formycon have filed responses to Regeneron’s Motion for Alternative Service in each of...