Today’s Daily Dose brings you news about FDA approval of Amphastar’s generic Bloxiverz; Arbutus’ positive Cohort 4 results from phase II study of ARB-1467 in chronic HBV patients; the upcoming catalyst of Catalyst Biosciences; Genocea’s decision to cease development of genital herpes drug candidate GEN-003 and Intellipharmaceutics’ Complete response Letter for investigational opioid painkiller Rexista.
The FDA has approved Amphastar Pharmaceuticals Inc.’s (AMPH) abbreviated new drug application for Neostigmine Methylsulfate Injection, USP, 1mg/mL, 10mL, and 0.5mg/mL, 10mL vial.
The approved product is therapeutically equivalent to Bloxiverz sold in the United States by Avadel, which is used for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.
According to IMS Health data, the U.S. brand and generic sales of Neostigmine Methylsulfate Injection, USP, 1mg/mL, 10mL, and 0.5mg/mL, 10 mL were about $185 million for the 12 months ended June 30, 2017.
Amphastar anticipates launching its product in the fourth quarter of 2017.
AMPH closed Monday’s trading at $16.27, up 1.06%. In after-hours, the stock was up 6.33% to $17.30.
Arbutus Biopharma Corp.’s (ABUS) topline results of bi-weekly dosing segment of Cohort 4 of its phase II study of ARB-1467 in chronic HBV patients on stable nucleotide therapy have demonstrated greater reduction in serum HBsAg levels with a favorable safety profile.
According to the trial results, all twelve patients in Cohort 4 experienced reductions in serum HBsAg levels, whose average reduction in serum HBsAg was greater than that observed with monthly dosing in Cohorts 1 through 3.
The Company is planning to initiate a new study of ARB-1467 next quarter to evaluate longer dosing of ARB-1467 combined with interferon.
ABUS closed Monday’s trading at $6.75, up 3.05%.
Catalyst Biosciences Inc.’s (CBIO) collaborator ISU Abxis has completed dosing of the first subcutaneous cohort in an ongoing phase 1/2 proof-of-concept clinical trial of CB 2679d/ISU304 in individuals with severe hemophilia B. This cohort represents the second of up to five patient cohorts.
The companies plan to have interim top-line data from the trial by the end of 2017.
The positive results from Cohort 1 of the trial were reported earlier this month.
CBIO closed Monday’s trading at $5.09, up 5.60%.
Shares of Genocea Biosciences Inc. (GNCA) plunged nearly 52% in extended trading on Monday after the Company announced that it is…