Moderna has announced that it commenced proceedings against Pfizer and BioNTech in both the U.S. District Court for...
Merck proposed acquisition of Seagen
Merck & Co is reportedly in negotiations to acquire Seagen Inc (previously known as Seattle Genetics, Inc), with...
EC approves Formycon’s Ranivisio® (biosimilar ranibizumab)
Formycon announced that the European Commission has approved Ranivisio®, biosimilar to Lucentis®/ranibizumab developed...
Alvotech commences confirmatory study for denosumab biosimilar
Alvotech announced that it has commenced a confirmatory patient study for AVT03 (biosimilar to Prolia® and Xgeva®,...
Novartis announced that it will spin off Sandoz
Novartis announced that it will spin off Sandoz into a new publicly traded standalone company. The new company will...
STADA publishes half year financial results
STADA published its first half 2022 financial results, reporting a 15% increase in adjusted group sales. Adjusted for...
Lupin and I’rom sign licence for denosumab in Japan
Lupin announced that it has entered into an exclusive licensing agreement with I’rom Group for biosimilar denosumab in...
TGA approves Samsung Bioepis’ Byooviz® (biosimilar ranibizumab)
Samsung Bioepis’ Byooviz® (biosimilar ranibizumab) was approved in Australia for the treatment of neovascular (wet)...
Amgen announces the results of Ph III eculizumab trials
Amgen announced the results of a Ph III study evaluating the efficacy and safety of ABP959 (proposed eculizumab...
Novartis’ Beovu® granted additional indication for diabetic macular oedema
Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety has approved an expanded indication for...
TGA approves Cipla’s FILPEGLA® (biosimilar pegfilgrastim)
AU’s TGA approved Cipla’s FILPEGLA® (biosimilar pegfilgrastim) for the treatment of cancer patients following...
Fresenius Kabi submits tocilizumab MAA to EMA
Fresenius Kabi announced that the EMA has accepted its MAA for MSB11456 (biosimilar tocilizumab). The application...
European Commission approves Vegzelma™ (biosimilar bevacizumab)
Celltrion announced that the EC approved Vegzelma™ (biosimilar bevacizumab) for the treatment of metastatic breast...
Samsung and Organon announce FDA approval of high concentration adalimumab biosimilar (HADLIMA)
Samsung Bioepis and Organon announced that the FDA has approved the citrate-free, high-concentration (100mg/mL)...
Formycon reports on ustekinumab biosimilar Ph III trials
Formycon has reported that its ustekinumab biosimilar candidate FYB202 showed comparable efficacy and safety to...
Merck and Orna Therapeutics enter into collaboration agreement
Merck and Orna Therapeutics announced that they have entered into a collaboration agreement to discover, develop and...