Biologics
FDA says Web sites and social media posts for Predictive Biotech, Salt Lake City, UT, promote sales of CoreCyte, an umbilical cord-derived product, to mitigate, prevent, treat, diagnose, or cure Covid-19. An 8/17 Warning Letter says CoteCyte is a human cell, tissue, or cellular or tissue-based
Biologics
CBER’s Office of Compliance and Biologics Quality has sent East West Health Solutions (Lake City, UT) an untitled letter based on a review of the company’s Web site, www.acueastwest.com, and other online sources. The review determined that the company was marketing unapproved cellular products derived from
Biologics
FDA’s Oncologic Drugs Advisory Committee has voted nine to one in favor of approving a Mesoblast BLA for Ryoncil (remestemcell-L) as a treatment for steroid-refractory acute Graft Versus Host Disease in pediatric patients. The positive vote followed briefing documents released by FDA in advance of the meeting
Biologics
FDA has accepted for priority review a Biogen and Eisai BLA for aducanumab, an investigational treatment for Alzheimer’s disease. The agency has set a user fee review action date of 3/7/2021. If approved, aducanumab would be the first therapy for reducing Alzheimer’s “clinical decline,” according to
Biologics
FDA commissioner Stephen Hahn has written a Washington Post opinion column to reassure Americans that “all FDA decisions (on Covid-19 vaccines) have been, and will continue to be, based solely on good science and data. The public can count on that commitment.” In the column, Hahn says that while
Biologics
More than 250 experts in virology, epidemiology, vaccinology, infectious disease, clinical care, and public health have signed a letter to FDA commissioner Stephen Hahn urging that no Covid-19 vaccine be made widely available until FDA has been able to evaluate safety and efficacy data from completed Phase 3 clinical
Biologics
AbbVie has terminated its Alzheimer’s and Parkinson’s disease therapy development agreements with Voyager Therapeutics. In a Securities and Exchange Commission filing, Voyager says it was informed 7/28 that its agreements with AbbVie that were reached in 2018 and 2019 would end on 8/3. “In each case,
Biologics
FDA commissioner Stephen Hahn and deputy commissioner for medical and scientific affairs Anand Shah say the agency has sought to encourage and facilitate the adoption of “advanced manufacturing,” which they say refers to new and emerging approaches for producing medical technologies. Writing in an FDA Voices post, Hahn and Shah
Biologics
Bristol Myers Squibb and Bluebird Bio have re-filed their BLA for idecabtagene vicleucel, indicated for treating patients with heavily pre-treated relapsed and refractory multiple myeloma. In May, FDA sent a refusal to file letter, telling the company that the BLA’s chemistry, manufacturing and control (CMC) module requires
Biologics
FDA has accepted from Merck two supplemental BLAs for Keytruda (pembrolizumab). One submission seeks accelerated approval for Keytruda in combination with chemotherapy for treating patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1. The user fee review action target date is 11/
Biologics
CBER director Peter Marks told an online Disease Control and Prevention Summit that FDA could issue an emergency use authorization (EUA) for a Covid-19 vaccine in a matter of weeks once the vaccine’s efficacy requirements are met. CNN reports that Marks told the summit the increased attention FDA
Biologics
Israeli researchers who looked at 57 vaccines approved by FDA between 1/1/1996 and 12/31/2015 report that the vaccines were found to be “remarkably safe” over the period. “A large proportion of safety issues were identified through existing postmarketing surveillance programs and were of limited clinical significance,
Biologics
CBER says that American Medical Aesthetics and Regenerative Medicine, Inc., Irvine, CA, markets an unlicensed “stem cell therapy” product that is derived from umbilical cord and may be administered by injection into joints or muscle or infused by IV into blood. A 7/22 Notice of Violation says the company
Biologics
Moderna says it has begun dosing participants in a Phase 3 study of its mRNA vaccine candidate (mRNA-1273) for Covid-19. The COVE (Coronavirus Efficacy) study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority under
Biologics
The four leading Democrats on the House Energy and Commerce Committee are asking FDA for information on its response to fraudulent Covid-19 antibody test scams occurring in the marketplace. In a 7/22 letter, the lawmakers say that last month the FBI warned that scammers are marketing fraudulent and/
Biologics
Executives from five drug companies told a House Energy and Commerce subcommittee that FDA is not easing regulatory standards for Covid-19 vaccines despite the pressure to get one or more approved quickly. The Hill reports that testifying were executives from Moderna, Janssen, Merck, AstraZeneca, and Pfizer. “We do believe
Biologics
FDA has issued a guidance, Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use, outlining the agency’s current thinking on the regulatory criteria for minimal manipulation and homologous use. The document supersedes one that was issued 11/2017 and corrected 12/
Biologics
FDA has placed a clinical hold on a Cellectis multiple myeloma trial (MELANI-01 study) after a study patient died. MELANI-01 is a Phase 1 dose escalation clinical study evaluating a gene-edited T-cell product candidate (UCARTCS1A) for treating patients with relapsed or refractory multiple myeloma, according to
Biologics
FDA has issued an immediately-in-effect guidance, Development and Licensure of Vaccines to Prevent Covid-19, to assist sponsors in developing coronavirus vaccines and to reassure the public that the agency will use high standards in considering any vaccine for approval. The document will remain in effect for the
Biologics
Three academic researchers say the best response to concerns raised about the Trump administration’s Operation Warp Speed approach to developing a Covid-19 vaccine “is a transparent and rigorous approach to vaccine development and regulation, including for licensure or any pre-licensure use permitted by FDA. For this effort
Biologics
Public Citizen says the U.S. government may jointly own Moderna’s mRNA-1273, a leading Covid-19 vaccine candidate, and should use that ownership to make the vaccine affordable to all in plentiful supply if it is demonstrated to be safe and effective. A report issued by the advocacy
Biologics
The Informed Consent Action Network is petitioning FDA to require placebo controls in all Phase 2 and 3 trials of vaccines against Covid-19. The group’s petition says the placebo should be a saline injection with nothing added. It calls for the placebo control group to be of at