Apotex filed an IPR against Regeneron, seeking revocation of Regeneron’s method of treatment (MOT) patent US...
Health Canada Approves KEYTRUDA® (pembrolizumab) in additional melanoma indication
Merck announced that Health Canada has granted approval for KEYTRUDA® (pembrolizumab), for the adjuvant treatment of...
Health Canada approves Lupin’s Rymti® (biosimilar etanercept)
Lupin announced that Health Canada has approved Rymti® (biosimilar etanercept) for the treatment of rheumatoid...
Novartis announces USD300 million investment in early development of biotherapeutics
Novartis announced that it will invest USD300 million in the creation of a fully integrated, dedicated facility for...
Executive Order for Advancing Biotechnology and Biomanufacturing Innovation
President Biden has made an Executive Order to advance “biotechnology and biomanufacturing innovation for a...
Merck presents new Keytruda® (pembrolizumab) data at ESCO in September
Merck reported that it presented data at the European Society for Medical Oncology (ESCO) Congress in Paris on 11...
FDA approves Rolvedon™(eflapegrastim)
Spectrum Pharmaceuticals announced that the FDA has approved its novel long-acting GCSF (LA-GCSF) ROLVEDON™...
AstraZeneca publishes 5-year follow up results of bevacizumab
AstraZeneca published the results of a 5-year follow up study of Lynparza® (Olaparib) with or without bevacizumab in...
Biogen files natalizumab (Tysabri®) BPCIA case against Sandoz/Polpharma in Delaware
Biogen filed a sealed complaint against Sandoz and Polpharma for infringement of 28 Biogen patents in the District of...
Regeneron publishes results of aflibercept studies
Regeneron announced that the primary endpoints were met in two pivotal trials evaluating aflibercept 8mg with 12 and...
Organon AU releases global biosimilars roadmap
Organon announced the release of the ‘Biosimilars: A global roadmap for policy sustainability’ setting out a number of...
Lupin and DKSH sign licensing and supply agreement for the Philippines
Lupin and DKSH announced that they have signed an exclusive licensing and supply agreement to market five of...
Genentech and Samsung Bioepis settle US BPCIA bevacizumab (Avastin®) dispute
Genentech and Samsung Bioepis filed a joint stipulation of dismissal in the District Court of Delaware in the...
Celltrion’s ustekinumab biosimilar Ph III trials
Yonhap News Agency reported that Celltrion’s ustekinumab biosimilar CT-P43 Ph III trials demonstrated comparable...
TGA approves Cipla/Alvotech’s 100mg/mL adalimumab biosimilar AVT02
Australia’s TGA approved Cipla/Alvotech’s 100mg/mL adalimumab biosimilar AVT02 (Ciptunec®/Ardalicip®) for the...
Formycon publishes preliminary 2022 half year financial results
German based biosimilars focussed company Formycon published its preliminary and unaudited financial results for the...