Biologics

Pandemic Delays FDA Action on Mallinckrodt BLA

FDA continues to struggle to inspect firms within its user fee application review timelines. The latest company impacted is Mallinckrodt, advised by the agency that action on one of its BLAs is being deferred pending a manufacturing site inspection that can’t be conducted due to Covid-19-related travel restrictions. The BLA is for StrataGraft, an investigational allogeneic cellularized scaffold product for treating adult patients with deep partial-thickness burns.

StrataGraft is an investigational treatment being developed to reduce autograft in patients with severe thermal burns. “An engineered, bilayer construct, StrataGraft is designed to mimic natural human skin with both inner dermis-like and outer epidermis-like layers,” the company says. StrataGraft can be sutured, stapled or secured with an adhesive, and it is “cryopreserved” in order to deliver viable cells upon application, it says.

Mallinckrodt is currently conducting a StrataGraft continued access clinical trial (StrataCAT, NCT04123548) under an expanded access program. The company is also planning to evaluate the product for treating adults with full-thickness burns (third-degree burns), and for its use in pediatric populations.

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