Challenges to ongoing efforts to provide effective aid for hospitalized patients with COVID-19 continued April 8, with two new trial failures reported. A phase III trial testing the Olumiant (baricitinib) vs. placebo, both on top of standard of care, missed its primary endpoint of progression to non-invasive ventilation, invasive mechanical ventilation or death, said drugmakers Eli Lilly and Co. and Incyte Corp. A phase II trial testing Beigene Ltd.'s Brukinsa (zanubrutinib) vs. placebo in patients hospitalized with respiratory symptoms of COVID-19 also fell short, missing its co-primary efficacy endpoints of respiratory failure-free survival or reduction in days on oxygen. Read More
HONG KONG – Covig-19, an anti-SARS-CoV-2 hyperimmune immunoglobulin therapy that Takeda Pharmaceutical Co. Ltd. developed alongside the Covig-19 Plasma Alliance, has failed to meet its endpoints in a global phase III trial. The multicenter Inpatient Treatment with Anti-Coronavirus Immunoglobulin trial was sponsored and funded by the National Institute of Allergy and Infectious Diseases. It aimed to demonstrate the drug’s safety, tolerability and efficacy in hospitalized adults at the onset of COVID-19 progression, the companies said. Read More
Ventus Therapeutics Inc. closed a $100 million series B round less than 12 months after raising $60 million in series A funding, to continue development of several preclinical programs informed by novel insights into the structural biology of key targets associated with innate immune signal pathways implicated in a wide range of disease areas. Read More
HONG KONG – Onquality Pharmaceuticals LLC raised an additional $20 million from a series A+ financing round, bringing its amount of capital raised to $35 million. Read More
In the debate over the interpretation of the U.S. government’s patent march-in rights under the Bayh-Dole Act, those arguing for march-in as a price control cite the billions of tax dollars being invested in scientific research at universities that may lead to marketable inventions. Read More
Xenter Inc. has officially launched, positioning itself as the first startup device/data/drug med-tech company. The company is developing wireless solutions for interventional cardiology, interventional radiology and neurointerventional radiology. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Algernon, Aurinia, Beigene, BMS, Connect, Eli Lilly, Galderma, Global Blood, GT, Immunitybio, Incyte, Laurent, Merck, Ocuphire, Portage, Secura. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bio-Thera, Biogen, Context, Cytoimmune, Dicerna, DS, Hemostemix, Hyundai, Immunoprecise, Integral Molecular, Medolife, Metriopharm, Moderna, Nuvothera, Oncology, Regen, Talem, Trisalus, Vir. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Cansino, Cytodyn, Gilead, Immutep, Teva. Read More