Drugs

Allergan, AstraZeneca Partner on Antibiotic Combo

Allergan and AstraZeneca have entered into a global agreement to develop and commercialize ATM-AVI, an investigational, fixed-dose antibiotic containing aztreonam and avibactam. Under the pact, the companies say they will evaluate the combination to treat serious infections caused by metallo βlactamase MBL-producing Gram-negative pathogens, a difficult-to-treat sub-type of carbapenem-resistant Enterobacteriaceae, which currently have limited treatment options. The agreement calls for Allergan maintaining commercialization rights in the U.S. andCanadaandAstraZenecamaintaining the commercialization rights in all other countries.

ATM-AVI is the first drug candidate to be developed under a public-private partnership agreement betweenAstraZenecaand theBiomedical Advanced Research and Development Authority(BARDA), a part of theU.S. Department of HealthandHuman Services' Office of the Assistant Secretary for Preparedness and Response(ASPR). The goal of this strategic alliance is to develop a portfolio of drug candidates over the next five years with dual uses in treating illnesses caused by bioterrorism agents and antibiotic-resistant infections.

Aztreonam is not inactivated by MBLs — as a single agent it has limited utility because the vast majority of MBL-producing pathogens also express serine-β-lactamases that can inactivate it, Allergan says. “With avibactam’s ability to inhibit many serine-β-lactamase enzymes, aztreonam’s activity is restored against pathogens that co-produce MBLs and serine enzymes, thus presenting a new treatment option for patients.”

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