Biologics
A professor of bioinorganic chemistry at England’s Keele University is petitioning FDA to assure accurately reported and consistent levels of aluminum in Adacel, Bostrix, Energix-B, Havrix, Infanrix, Infanrix hexa, Kinrix, Pediarix, Pedvax-HIB, Pentacel, Prevnar-13, Synflorix, and Vaqta. The petition submitted by Christopher Exley calls on FDA
Biologics
The CBER Office of Compliance and Biologics Quality says the Ramos Chiropractic and Wellness Center, Burlington, CO, which does business as Rejuvenate Stem Cell Center, markets through its Web sites “umbilical stem cells” from BioGenix for various diseases or conditions. A 5/4 Notice of Violation says the company’s
Biologics
Three U.S. senators have introduced S.1508 (text not yet available) to “harness real-world evidence (RWE) gathered during emergency use authorization to support future approvals for drugs, biologics, and medical devices at FDA.” The bill is sponsored by Sens. Roger Marshall (R-KS), Tina Smith (D-MN), and
Biologics
FDA has authorized Hope Biosciences Stem Cell Research Foundation to conduct a Phase 2 trial to assess the efficacy and safety of multiple intravenous infusions of autologous adipose-derived mesenchymal stem cells to improve activities of daily living and quality of life in patients with Parkinson’s disease. The company
Biologics
FDA has issued Protalix BioTherapeutics a Complete Response Letter (CRL) for its BLA seeking accelerated approval for pegunigalsidase alfa (PRX–102) for treating adult patients with Fabry disease. The letter did not cite any safety or efficacy concerns regarding the therapy, according to the company. The letter also noted that
Biologics
Enzyvant has resubmitted a BLA for RVT-802 (cultured human thymus tissue), a tissue-based regenerative therapy designed to treat pediatric congenital athymia, a rare and deadly condition associated with complete DiGeorge anomaly, Charge syndrome, and FoxN1 deficiency, according to the company. The submission addresses a 12/2019 Complete Response
Biologics
FDA has removed a clinical hold against UniQure’s hemophilia B gene therapy program after determining it satisfactorily addressed all issues identified by the agency concerning a single patient diagnosed with hepatocellular carcinoma (HCC) in the HOPE-B pivotal trial, according to the company. “Our comprehensive investigation showed that AMT-
Biologics
A CDC advisory committee 4/23 voted (10 to 4) to recommend that the U.S. resume vaccinations with Johnson & Johnson’s Covid-19 vaccine. Its use was paused earlier this month (see earlier story) to review safety data in the wake of rare blood clot reports. Panel members
Biologics
FDA has granted Lexeo Therapeutics a fast track designation for LX1001, an adeno-associated virus (AAV) mediated gene therapy for treating apolipoprotein E4- (APOE4) associated Alzheimer’s disease. The central nervous system-administered therapy is being evaluated in an ongoing Phase 1 clinical trial. “APOE is the major transporter of
Biologics
FDA has granted Allogene Therapeutics a Regenerative Medicine Advanced Therapy designation for ALLO-715 and its use in relapsed/refractory multiple myeloma. The designation was based on data demonstrating that the CAR T therapy ALLO-715 directed at B-cell maturation antigen can “achieve deep clinical responses while eliminating the
Biologics
Researchers from the Precision Vaccines Program at Boston Children’s Hospital and the University of Houston say they are using a $25 million grant from the National Institutes of Health Helping to End Addiction Long-term initiative to develop an adjuvant opioid use disorder vaccine. A University of Houston announcement
Biologics
FDA has denied a 5/20/20 Cell2in petition calling on the agency to update one or more guidance documents to identify real-time glutathione (GSH) monitoring methods as an acceptable means of measuring potency for purposes of submitting a BLA for cell-based therapies, including stem cell therapies. The
Biologics
A California Law Review article by two Yale Law School professors makes the case that FDA should “reboot” its rules to proactively disclose all safety and efficacy data for drugs and vaccines with minimal redactions, deploying data use agreements to ensure the most sensitive data is handled appropriately. The professors
Biologics
CBER director Peter Marks says there will be no further extensions to FDA’s intent to exercise enforcement discretion on IND and premarket approval requirements for certain regenerative medicine products. The enforcement discretion initially was to expire 11/2020 but was extended to 5/2021. In an online post, Marks
Biologics
A 4/20 European Medicines Agency (EMA) safety review says Johnson & Johnson’s (Janssen) Covid-19 vaccine continues to have a favorable benefit-risk profile but it should carry a warning in its product information about rare and unusual blood clots with low blood platelets. The EMA’s conclusions
Biologics
Agenus has submitted a BLA seeking accelerated approval for balstilimab, an anti-PD-1 antibody for treating patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The submission includes data from the company’s pivotal Phase 2 single-arm clinical trial, which demonstrate that balstilimab
Biologics
Emergent BioSolutions, contract Covid-29 vaccine supplier to Johnson & Johnson, has agreed to halt production at FDA’s request and quarantine existing bulk ingredient material at its troubled Baltimore Bayview facility as it submits to an agency inspection that began 4/12. The agreement will be in place pending
Biologics
CBER says it plans to issue guidances on 16 topics listed in four categories during the calendar year 2021. The categories are Blood and Blood Components (seven guidances); Tissues and Advanced Therapies (seven guidances); Vaccines (one guidance); and Other (one guidance).
Biologics
FDA and CDC are recommending a pause in using the Johnson & Johnson (Janssen) Covid-19 vaccine due to concerns about potential blood clots in those getting the vaccine. So far, almost 7 million vaccines have been administered in the U.S. and six cerebral venous sinus thrombosis cases have
Biologics
FDA has told Provention Bio that it has identified deficiencies with its BLA for diabetes therapy teplizumab that preclude labeling and post-marketing requirements/commitments discussions at this time. The agency’s notification stated the deficiencies do not reflect a final decision on the information under review, the company says.
Biologics
Georgia, North Carolina, Iowa and Colorado health officials have reported adverse reactions observed at vaccination sites after administering Johnson & Johnson’s Covid-19 vaccine. In Georgia, one individual was evaluated at a hospital and then released, and seven others were monitored and then sent home. In North Carolina, health
Biologics
FDA has granted Gilead Sciences full approval for Trodelvy (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. The approval is based on data from