Zion Pharma announced that Roche has acquired the global rights to ZN-A-1041, an orally administered selective tyrosine kinase inhibitor targeting the Human Epidermal Growth Factor Receptor 2 (HER2). ZN-A-1041 has the potential to treat or prevent the onset of brain metast...
AbbVie announced that Health Canada has approved its Rinvoq® (upadacitinib, 15mg), an oral once-daily selective and reversible JAK inhibitor for the treatment of Active Non-Radiographic Axial Spondyloarthritis (nr-axSpA) in adult patients with objective signs of inflammatio...
Sandoz announced that it has partnered with Just-Evotec Biologics (subsidiary of Evotec SE) to develop and manufacture multiple biosimilar medicines (with an option for expansion). The deal will utilise Just-Evotec Biologics’ AI driven drug substance development platform a...
Roche announced that the FDA has accepted its sBLA for Vabysmo® (faricimab) to treat macular edema following retinal vein occlusion. The sBLA is based on results from the phase III BALATON and COMINO studies which met primary endpoint of non-inferior visual acuity gains at...
Innovent Biologics and Eli Lilly announced that the Chinese NMPA has approved the sNDA for TYVYT® (sintilimab injection) in combination with bevacizumab and chemotherapy (pemetrexed and cisplatin) in patients with epidermal growth factor receptor (EGFR)-mutated non-squamous...
AstraZeneca announced Koselugo® (selumetinib) has been approved in by the Chinese NMPA for the treatment of symptomatic, inoperable plexiform neurofibromas in patients with neurofibromatosis type 1 aged three years and above. The NMPA relied on results of the SPRINT Stratu...
The Korea Times has reported Celltrion has reported a Q1 2023 net profit of ₩167.1B (US$126.4 million). Celltrion said in a regulatory filing that operating profit for Q1 rose 41.1% on-year to ₩182.4B, and revenue increased 12.4% to ₩597.5B.
Amgen announced new data from a real-world study of nearly half of a million postmenopausal women with osteoporosis in the US showing Prolia® (denosumab) injection reduced fracture risk in patients versus oral alendronate, a frequently prescribed bisphosphonate treatment. T...
Innovent Biologics announced that the first patient with thyroid eye disease (TED) has been dosed in the phase III study (RESTORE) for IBI311. IBI311 is a recombinant anti-insulin-like growth factor-1 receptor monoclonal antibody. The study (CTR20223393) will evaluate th...
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