Drugs

2 Guides Address Product Development and Covid Variants

FDA has issued a new guidance and revised another to assist vaccine, diagnostic and therapeutic product developers to address the emergence and potential future emergence of Covid-19 variants. The new guidance is entitled Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency. FDA says it is aware that some monoclonal antibodies that have been authorized are less active against some of the Covid-19 variants that have emerged. The guidance provides recommendations on efficient approaches to the generation of non-clinical, clinical, and chemistry, manufacturing and controls data that could potentially support an emergency use authorization for monoclonal antibody products that may be effective against variants.

The revised guidance, COVID-19: Developing Drugs and Biological Products for Treatment or Prevention, was updated to address the “evolving landscape” of Covid-19 drug development, including the emergence of the variants and the availability of authorized vaccines, FDA says. “With these guidances, the FDA is encouraging developers of drugs or biological products targeting SARS-CoV-2 to continuously monitor genomic databases for emerging SARS-CoV-2 variants and evaluate phenotypically any specific variants in the product target that are becoming prevalent or could potentially impact its activity,” it says.

The document also describes the agency’s current recommendations on Phase 2 and Phase 3 trials for such drugs. It focuses on the population, trial design, efficacy endpoints, safety considerations, and statistical considerations for such clinical trials. The guidance also addresses considerations for treating or preventing acute Covid-19. It does not address drug development programs targeting the treatment of persistent or late symptoms after recovery from acute illness, according to the agency.

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