BioCentury
ARTICLE | Product Development

Nov. 23 Quick Takes: NIH panel says bamlanivimab should not be considered COVID-19 SOC; plus Eiger, Shionogi-Roche, Kiniksa, Schrödinger, Halozyme-Horizon and Immunicum-DCPrime

NIH panel says bamlanivimab should not be considered standard-of-care for COVID-19
NIH’s COVID-19 Treatment Guidelines Panel said there is not enough data to recommend either for or against use of bamlanivimab from Eli Lilly and Co. (NYSE:LLY) to treat outpatients with mild to moderate COVID-19, due to the  small number of participants and hospitalizations or ER visits in the interim analysis of the Phase II BLAZE-1 trial that formed the basis for FDA’s Nov. 9 emergency use authorization (EUA) of the mAb against SARS-CoV-2 spike protein. Distribution of bamlanivimab is expected to begin on Tuesday; the monotherapy could soon be superseded by Lilly’s two-mAb combo.

Eiger sells voucher obtained via progeria approval
Eiger Biopharmaceuticals Inc. (NASDAQ:EIGR) sold to AbbVie Inc. (NYSE:ABBV) for $95 million the Priority Review voucher it received upon FDA approval Friday of Zokinvy lonafarnib, the first therapy approved to treat ultra-rare premature aging disorders Hutchinson-Gilford progeria syndrome and progeroid laminopathies, which collectively affect about 20 known patients in the U.S. The company will split the proceeds equally with the Progeria Research Foundation, which funded clinical studies showing that the farnesyl transfer inhibitor led to a survival benefit...