Biologics

Recovered Covid Patients Should Donate Plasma: Hahn

FDA commissioner Stephen Hahn says individuals who have recovered from Covid-19 could help others by donating blood plasma to be used to manufacture hyperimmune globulin that can treat other Covid-19 patients. In a statement, Hahn says that people who have fully recovered from Covid-19 for at least two weeks can contact their local blood or plasma collection center to schedule an appointment.

The notice says that so-called convalescent plasma “is an antibody-rich product made from blood donated by people who have recovered from the disease caused by the virus. Prior experience with respiratory viruses and limited data that have emerged from China suggest that convalescent plasma has the potential to lessen the severity or shorten the length of illness caused by Covid-19. It is important that we evaluate this potential therapy in the context of clinical trials, through expanded access, as well as facilitate emergency access for individual patients, as appropriate.”

Hahn says the response to the agency’s national effort to facilitate the development of and access to convalescent plasma has “been tremendous” with more than 1,040 sites and 950 physician-investigators nationwide participating in a Mayo Clinic-led expanded access protocol. He says there are also clinical trials taking place to evaluate the safety and efficacy of convalescent plasma and FDA has granted numerous single-patient emergency IND applications.

FDA has launched a Web page to guide recovered patients to local blood or plasma collection centers to discuss their eligibility and potentially make an appointment to donate. The page also has information for those interested in participating in the expanded access protocol, conducting clinical trials, or submitting emergency IND applications.

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