Under threat of emerging variants, the EU is taking to heart lessons learned so far in the global COVID-19 pandemic to accelerate the review of vaccines, improve data sharing from clinical trials and address the difficulties inherent in the mass production of vaccines that may contain up to 400 components.
HONG KONG – Ono Pharmaceutical Co. Ltd. has agreed to pay Ribon Therapeutics Inc. as much as ¥15.4 billion (US$147.3 million) for exclusive rights to develop and commercialize the company’s phase I PARP7 inhibitor RBN-2397 for the treatment of solid tumors in Japan, South Korea, Taiwan and ASEAN countries.
Preventive medicine hasn’t always had the backing of hard data, but research into genomics at the U.S. National Institutes of Health may soon change that.
Another monoclonal antibody therapy has entered the pandemic fray with the FDA granting emergency use authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg and etesevimab (JS016 or LY-CoV016) 1,400 mg as a cocktail for treating mild to moderate COVID-19 in patients aged 12 and up at high risk for progressing to severe COVID-19 and/or hospitalization.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Adaptive Phage, AIM Immunetech, Astrazeneca, Biontech, Eli Lilly, I-Mab, Merck, Panbela, Pfizer, RDIF, Regeneron, Sanifit, Sanofi, Takeda, Vico.
Among the low-hanging fruit for pruning back U.S. drug prices is the development of generics referencing complex drugs, a category that includes drug-device combination products and nonbiologic drugs with a complex molecular base, route of administration or formulation, such as abuse-deterrent opioids.
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