Archives for News - Page 11
Sandoz receives positive CHMP opinion for proposed biosimilar infliximab
Custom Synthesis, The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for marketing authorization...
Alcon AcrySof IQ PanOptix trifocal intraocular lens shows superior visual performance
Custom Synthesis, Novartis’s eye care division Alcon unveils new data showing significantly improved near and intermediate distance vision with the AcrySof IQ PanOptix intraocular lens...
Novo Nordisk shows oral semaglutide more effective in lowering glucose
Custom Synthesis, Novo Nordisk on Wednesday said that it has completed headline results of the phase 3a trials PIONEER 4 comparing oral semaglutide as a...
Idorsia enrolls first patient into Precision phase 3 study of aprocitentan
Custom Synthesis,Idorsia has enrolled the first patient into its Phase 3 study called Precision to investigate the efficacy and safety of aprocitentan for resistant...
Pharm Exec’s Top 50 Companies 2018
Custom Synthesis, Pharm Exec’s annual listing of the top biopharma players shows that most are holding their ground as they weigh a more challenging...
Keytruda becomes first anti-PD-1 therapy for patients with advanced cervical cancer
Custom Synthesis, The US Food and Drug Administration approved Merck’s Keytruda (pembrolizumab) for patients with recurrent or metastatic cervical cancer with disease progression on or...
Santhera Pharmaceuticals submits NDA in South Korea
Custom Synthesis, Santhera Pharmaceuticals said on Tuesday that the Korean Ministry of Food and Drug Safety (MFDS) has accepted its new drug application (NDA) for...
4D pharma cleared to study Blautix
Custom Synthesis, 4D pharma has been cleared by the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Health Products Regulatory Authority (HPRA) to kick...
TiGenix’s CEO leaves as operations integrate into Takeda
Custom Synthesis, TiGenix NV’s Chief Executive Officer, Eduardo Bravo will depart the board of directors and his role as CEO of TiGenix effective as...
First Japanese company joins CARB-X partnership
Custom Synthesis, CARB-X is partnering with Shionogi of Osaka, Japan, to support the development of a novel β-lactam antibiotic with potent activity against the dreaded...