Drugs

NIH, FDA Move on International Research Response

NIH, FDA, CDC and the European Medicines Agency are looking to develop an international strategy for a coordinated research response to the Covid-19 pandemic. The planned “Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV)” partnership will develop a collaborative framework for prioritizing vaccine and drug candidates, streamlining clinical trials, coordinating regulatory processes and/or leveraging assets among all partners to rapidly respond to the COVID-19 and future pandemics, according to a release. The effort aims to provide infrastructure, subject matter expertise and funding to identify, prioritize and facilitate the entry of some of the most promising candidates into clinical trials.

“Industry partners also will make available certain prioritized compounds, some of which have already cleared various phases of development, and associated data to support research related to Covid-19,” NIH says. The partnership is being developed with input from a steering committee which includes leaders from NIH, FDA and the research and development organizations of the companies. The program outlines the following four fast track focus areas:

Standardize and share preclinical evaluation methods in an open forum that allows for comparison and validation
Prioritize and accelerate clinical evaluation of therapeutic candidates with near-term potential
Maximize clinical trial capacity and effectiveness
Advance vaccine development

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