Drugs

FDA Agrees to 2 Special Protocols for Basilea Antibiotic

FDA and Basilea Pharmaceutica have reached agreement on Special Protocol Assessments (SPAs) for two planned Phase 3 clinical studies evaluating the company’s antibiotic ceftobiprole. for treating Staphylococcus aureus bacteremia (bloodstream infections) and acute bacterial skin and skin structure infections. If successful, the company believes studies would be cross-supportive for a U.S. registration in both indications and could separately support label extensions in other parts of the world.

Both studies will be multi-center, double-blind, randomized non-inferiority studies. One study will compare ceftobiprole with daptomycin in treating adult patients with Staphylococcus aureus bacteremia, including infective endocarditis. The FDA-agreed primary endpoint is overall success at a post-treatment visit 70 days after randomization. The other study will compare ceftobiprole with vancomycin and aztreonam in treating adult patients with acute bacterial skin and skin structure infections. The FDA-agreed primary endpoint in this study is early clinical response at 48-72 hours after beginning treatment.

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

Read more

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