FDA Policy/General

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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.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome