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# Since Our Last Issue ...
- URL: https://www.fdaweb.com/since-our-last-issue-22/
- Published: 2020-06-07T12:00:00.000Z
- Updated: 2026-09-14T16:17:22.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134623

A Nevada federal court 7/10 entered a consent decree of permanent injunction against Las Vegas-based **Bio Health Solutions** and its manager/co-owner, **Mark Garrison**, for selling RenAvast, an unapproved animal drug. According to FDA’s complaint, the firm has marketed RenAvast to treat diseases, including chronic renal failure, in cats and dogs. The decree is intended to prevent Bio Health and Garrison from introducing RenAvast and any other unapproved new animal drugs into interstate commerce without first gaining FDA approval, according to a news release. A Warning Letter was sent to Bio Health in 2012 regarding RenAvast.

**Allergan** has entered into a global agreement with **AstraZeneca** to develop and commercialize ATM-AVI, an investigational fixed-dose antibiotic that combines aztreonam and avibactam to treat serious infections caused by metallo and lactamase MBL-producing Gram-negative pathogens, a difficult-to-treat sub-type of carbapenem-resistant *Enterobacteriaceae*. Allergan says it will maintain commercialization rights in the U.S. and Canada.  
  
**Merus Labs** has entered into an agreement with **UCB** to acquire rights to the nitrates Elantan, Isoket and Deponit in Europe and certain other markets. The products are used to treat both acute and chronic coronary artery disease. According to Merus, it has agreed to acquire product rights for a one-time payment of 92 million Euros or 2.7 times the last 12 months net revenue of about 34 million Euros.

**Jazz Pharmaceuticals** says data from the Phase 3 study of defibrotide were published online in *Blood*, the Journal of the American Society of Hematology, showing that its use in patients with hepatic veno-occlusive, also known as sinusoidal obstruction syndrome, with multi-organ failure post-hematopoietic stem-cell transplantation was associated with a statistically significant improvement in Day +100 survival and in rate of complete response by Day +100, compared with rigorously selected historical controls.

**Panacea Pharmaceuticals** has selected **Goodwin Biotechnology**, a biological Contract Development and Manufacturing Organization, to develop a proof-of-concept conjugation of a fully-human monoclonal antibody to a radionuclide chelator to generate an antibody-chelator conjugate. According to Panacea COO Steven Fuller, the company has developed a fully human antibody directed against the tumor-specific marker, human aspartyl (asparaginyl) ß-hydroxylase, and Goodwin was selected to optimize, scale-up, and manufacture this antibody-chelator conjugate, of one of its lead cancer products.