Biologics
FDA has placed a partial clinical hold on an Inovio planned Phase 2/3 trial of its Covid-19 vaccine candidate INO-4800, including its Cellectra 2000 delivery device to be used in the trial. The partial hold is not due to the occurrence of any adverse events related to
Biologics
FDA Vaccines and Related Biological Products Advisory Committee chair Hana El Sahly has recused herself from reviewing any upcoming pandemic vaccines because of her role overseeing a Moderna clinical trial for its vaccine candidate. Sahly (see curriculum vitae) is an associate professor of virology and microbiology at Baylor College of
Biologics
Just hours after FDA commissioner Stephen Hahn reassured Congress that FDA’s review and approval/authorization of a Covid-19 vaccine will be based on data and science without any political interference, president Trump said new stricter guidance proposed by the agency on the timing of when a vaccine application
Biologics
FDA is expected to issue a guidance later this week laying out tougher new standards for emergency authorization of a Covid-19 vaccine. The Washington Post says the new standards “will make it exceedingly difficult for any vaccine to be cleared before Election Day.” The Post article says the new
Biologics
Former FDA associate commissioner for public health strategy and analysis Peter Lurie says industry data showing that only 10% to 14% of compounds entering human testing in the last several decades were ultimately approved should be used to caution the public not to expect that all Covid-19 vaccines will
Biologics
CBER has updated its calendar year 2020 guidance agenda listing 29 guidances the Center plans to publish this year. The agenda lists 14 planned guidances under Blood and Blood Components, 10 under Tissues and Advanced Therapies, two under Vaccines, and three under Other.
Biologics
As Phase 3 clinical trials for Covid-19 are underway, FDA says it will soon issue a guidance for sponsors to request an Emergency Use Authorization (EUA) for their vaccines, which will also include recommendations on the data and information needed to support an EUA. A joint Web posting by
Biologics
CBER has issued an untitled letter to Laguna Beach Aesthetics, Cosmetic Dermatology and Laser Center (Laguna Beach, CA) over its unapproved cellular product derived from adipose tissue that is marketed to treat various diseases or conditions, such as cancer, chronic pain, cerebral palsy, cystic fibrosis, diabetes, epilepsy, fibromyalgia, heart disease,
Biologics
The latest Kaiser Family Foundation (KFF) health tracking poll finds that 62% of Americans worry that Trump administration political pressure will lead FDA to rush to approve a coronavirus vaccine without being sure that it is safe and effective. A KFF statement says those respondents fearing pressure include 85% of
Biologics
Janssen Pharmaceutical Companies has submitted a supplemental BLA for Darzalex FasPro (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, for treating patients with light chain amyloidosis, a life-threatening disorder that occurs when plasma cells in bone marrow produce abnormal light chains that form amyloid deposits, which build up
Biologics
As part of FDA’s ongoing effort to reaffirm its independence and integrity in the face of Covid-19 political pressures, the eight career agency executives who oversee the work of the Centers have signed a statement saying they are “following the science to protect public health” in the pandemic.
Biologics
National Institute of Allergy and Infectious Diseases director Anthony Fauci has dismissed any notion that a reported serious adverse reaction associated with an AstraZeneca Covid-19 vaccine trial (see earlier story) could delay development of this or any other vaccine. Speaking to Fox News 9/9, Fauci confirmed that the
Biologics
Nine companies developing Covid-19 vaccines have pledged to uphold scientific, regulatory and ethical rigor as they conduct clinical trials and prepare regulatory submissions. The pledge, jointly made by the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi, is intended to reassure the public
Biologics
As public confidence wanes on potential Covid-19 vaccines, an AstraZeneca and University of Oxford Phase 3 vaccine study has been put on clinical hold due to a serious adverse reaction in a trial participant in the United Kingdom. It is not determined whether FDA or another regulatory agency ordered
Biologics
FDA has accepted an Ascendis Pharma BLA for its TransCon hGH (lonapegsomatropin), an investigational long-acting prodrug of somatropin (human growth hormone) for treating pediatric growth hormone deficiency. The submission is supported by data from eight clinical trials evaluating safety and efficacy in more than 400 subjects, Ascendis says. The
Biologics
In a lengthy, detailed report, the Washington Post looks at the debate that has erupted around a nervous FDA over whether the agency should grant an emergency use authorization (EUA) to one or more coronavirus vaccines before clinical trials have been completed and analyzed. Proponents of an EUA say the
Biologics
Three law professors from different U.S. universities are joining the chorus of those expressing concern that FDA is under too much political pressure to make positive decisions on products to help resolve the Covid-19 pandemic. In a piece distributed online to be used as an op-ed, the
Biologics
Former FDA commissioner Margaret Hamburg and her principal deputy commissioner Joshua Sharfstein are using a Washington Post op-ed to urge the agency to take a firm stance for science and against political pressure and stage managing of agency decisions. The two say President Trump’s 8/23 announcement of
Biologics
CBER has issued an update to its guidance agenda for calendar year 2020. The updated agenda shows guidances the Center plans to issue under four categories: Blood and Blood Components (14 guidances); Tissues and Advanced Therapies (10 guidances); Vaccines (one guidance); and Other (three guidances).
Biologics
The three Democratic leaders of the House Energy and Commerce Committee have written to FDA commissioner Stephen Hahn seeking assurance that science and the protection of public health will drive agency decisions to authorize or approve a Covid-19 vaccine, and not political expedience. The 8/24 letter was sent
Biologics
A 9/9-9/18/19 FDA inspection at Banco Vida Corp and Laboratorio Banco Vida, San Juan, Puerto Rico, determined that the firm manufactures human umbilical cord blood for allogenic use and that it recovers umbilical cord blood and processes an umbilical cord blood product in its facility. An
Biologics
Interviewed on WILX in Lansing, MI, FDA commissioner Stephen Hahn continued his efforts to reassure the public that there has been no political pressure on FDA to speed a vaccine approval and that only scientific data will be used to make such a decision. He reiterated that the speed in