FDA Rejects IPCI’s Painkiller, GNCA Bleeds On Herpes Vaccine News, PRQR Abuzz

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.

Read on…

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…

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