Biologics

BlueWillow to Test Intranasal Anthrax Vaccine

FDA has given the green light to BlueWillow Biologics to conduct a Phase 1 study of its next-generation intranasal anthrax vaccine candidate BW-1010. The study is being funded by NIHֺ’s National Institute of Allergy and Infectious Diseases. Product development is ongoing through BlueWillow’s partnership with Porton Biopharma. The vaccine combines BlueWillow’s novel intranasal NanoVax system with recombinant protective antigen for anthrax from Porton Bio,” BlueWillow says. “The NanoVax platform employs a proprietary oil-in-water nanoemulsion adjuvant that elicits both systemic and mucosal immunity, uniquely enabling protection against challenging respiratory infections such as anthrax,” it says.

The new vaccine addresses the government’s interest in protecting the nation against the potential risk of an anthrax attack. HHS currently stores tens of millions of injectable anthrax vaccine doses in the U.S. Strategic National Stockpile. “Evidence indicates the current vaccine may cause acute side effects, as well as the risk of potential fetal harm if administered to pregnant women,” BlueWillow says. “The BlueWillow/PBL anthrax vaccine has the potential to provide significant advantages over the current injectable vaccine.”

Additionally, BlueWillow says its animal studies have demonstrated its vaccine is safe and elicits protection against anthrax after one or two vaccinations. And it says informal stability studies have shown that it has a shelf life of over five years, compared to three years for the current injectable vaccine.

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