Natesto (testosterone), from Toronto's Acerus Pharmaceuticals Corp., will continue to be unavailable in Canada until sometime in the first half of 2021. In August, four commercial lots of the nasal gel formulation of testosterone released in Canada and South Korea were found to be nonconforming during long-term stability studies. The lots, according to Acerus, are not harmful to patients but may result in difficulties in dispensing. While the company has since produced a revised batch of Natesto, Health Canada is requiring Acerus to submit a supplemental new drug submission. The company expects the submission's review will go into the first three months of next year and it has yet to determine if and when the new batch can be released in Korea.
Bristol-Myers Squibb Co., of New York, has extended the expiration date of its offer to exchange Summit, N.J.-based Celgene Corp. notes for up to $19.85 billion the aggregate principal amount of new notes to be issued by BMS. BMS is in the process of acquiring Celgene for $74 billion. The new expiration date is 5 pm Eastern time on Nov. 6.
New data from Genisphere LLC, of Hatfield, Pa., show its 3DNA nanocarrier carrying a peptide drug through the body to target microglia cells in the brain. Using a model of premature infant brain injury, the 3DNA-based therapeutic targeted microglia and modified their cellular biology, which protected white matter tissue in the brain and improved animal behavior and memory. 3DNA is Genisphere's nanoscale, multivalent scaffold made from synthetic DNA. The data, the result of a study of targeting nanotherapeutics for neurological disease, were recently published in Brain.
An evidence report from The Institute for Clinical and Economic Review (ICER) found Bagsvaerd, Denmark-based Novo Nordisk A/S's Rybelsus (semaglutide), an oral GLP-1 receptor agonist for treating type 2 diabetes mellitus, to be less cost effective, at an estimated net price, than SGLT-2 competitor Jardiance (empagliflozin) from Boehringer Ingelheim GmbH, of Ingelheim, Germany, as an add-on therapy for type 2 diabetes. For the analysis, semaglutide was compared to background therapy with metformin alone and to three competitors for add-on therapy: liraglutide (Victoza, Novo Nordisk), sitagliptin (Januvia, Merck & Co. Inc.) and empagliflozin. "Patients seeking to use a GLP-1 agonist but wishing to avoid injection have had no oral options until oral semaglutide, which appears to have efficacy similar to the injectable GLP-1s," said David Rind, ICER's chief medical officer. "However, judging from the list price of oral semaglutide, its net price is likely to be much higher than that of competitor oral treatments, including the SGLT-2 inhibitors like empagliflozin that appear to have similar benefits with fewer common side effects."
Research from Regen Biopharma Inc., of San Diego, showed that suppressing immune checkpoint NR2F6 with the company's compounds resulted in selective inhibition of new blood vessels under conditions associated with cancer and wet macular degeneration. The data, obtained using human umbilical vein endothelial cells, indicate that NR2F6 may have a larger biological role than originally suspected. Regen has been using NR2F6 as a target for immune modulation and cancer stem cells. This is the first indication that NR2F6 is involved in the formation of new blood vessels, according to Regen.