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
Biologics
Democratic leaders of the House Committee on Oversight and Reform are calling on FDA commissioner Stephen Hahn to take steps now to ensure complete transparency in the development, review, and deployment of any Covid-19 vaccines. In a 6/18 letter, the committee leaders said the best way to bolster
Biologics
FDA commissioner Stephen Hahn and CBER director Peter Marks say it is time that unproven and unapproved regenerative medicine products be identified and recognized as uncontrolled experimental procedures that can cost patients both physically and financially. Writing in the Journal of the American Medical Association, Hahn and Marks say that
Biologics
Luciana Borio, who was FDA acting chief scientist and served on the National Security Council in the Trump administration, says FDA needs to work to regain public trust after its missteps involving the emergency use authorization for hydroxychloroquine and chloroquine and allowing unapproved serology tests into the country. Interviewed for
Biologics
FDA has approved an Ultragenyx Pharmaceutical and Kyowa Kirin supplemental BLA for Crysvita (burosumab) for treating fibroblast growth factor 23 (FGF23)-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adults and pediatric patients two years of age and
Biologics
A 9/16-9/26 FDA inspection at Fenwal International, Maricao, Puerto Rico, found deviations from current good manufacturing practice requirements for the manufacture of the firm’s blood-pack units with and without in-line leukoreduction filters, as well as InterSol, a platelet additive solution. A just-released 5/
Biologics
FDA has approved an Eli Lilly BLA for Lyumjev (insulin lispro-aabc) injection, 100 units/mL and 200 units/mL, a new rapid-acting insulin indicated to improve glycemic control in adults with Type 1 and Type 2 diabetes. The company says the novel formulation of insulin lispro was developed
Biologics
FDA has issued a Warning Letter to Eucyt Laboratories based on an inspection 11/2019 that cited the firm’s products, which are derived from human umbilical cord blood and umbilical cord, for use without agency approval. The letter said the products need approval to be promoted or used for
Biologics
FDA has approved a Viela Bio BLA for Uplizna (inebilizumab-cdon) injection for intravenous use for treating neuromyelitis optica spectrum disorder (NMOSD) in adult patients with a particular antibody (patients who are anti-aquaporin-4 or AQP4 antibody positive). The rare autoimmune disease of the central nervous system affects the
Biologics
CNN reports that vaccine experts it contacted are concerned that President Trump will exert political pressure to get a Covid-19 vaccine on the market before it has been fully studied and approved. The report says the experts are asking FDA for assurance that it will not authorize a vaccine
Biologics
Officials from CDER and CBER told a Biotechnology Innovation Organization digital conference that they anticipate a busier agency workload after the emphasis on the Covid-19 pandemic eases. An online report on the meeting posted by the Regulatory Affairs Professionals Society says that while drug companies and FDA officials are
Biologics
CBER director Peter Marks told a Biotechnology Innovation Organization virtual meeting that regulators such as FDA, the European Medicines Agency (EMA), and Health Canada are working together to reach an agreement on how clinical trials should be designed and conducted for coronavirus vaccines. “Because it’s such a bad pandemic,
Biologics
A Public Citizen analysis finds that all five of the Trump administration’s short-list picks for a Covid-19 candidate vaccine have benefited from substantial public funding. A news release from the advocacy group identifies the vaccine manufacturer candidates as AstraZeneca (with Oxford University), Moderna (with the National Institutes
Biologics
Days after CBER director Peter Marks joined the Trump administration’s Operation Warp Speed project to develop a coronavirus vaccine, he left the group to resume his full-time work at FDA. In a lengthy article based on anonymous interviews with current and former HHS and other officials, Politico says
Biologics
Two University of Pennsylvania Perelman School of Medicine professors say FDA must apply “rigorous standards” when considering whether to approve a coronavirus vaccine. Writing in a Washington Post op-ed, they note that “already the White House has been accused of pressuring government agencies to put politics before science when
Biologics
FDA has accepted for review a Y-mAbs Therapeutics BLA for Danyelza (naxitamab) for treating patients with relapsed/refractory high-risk neuroblastoma. The agency has set an 11/30 user fee review action target date, and it has told the company that an advisory committee meeting will not be required.
Biologics
Two consumer advocacy groups — Public Citizen and Lower Drug Prices Now — say that Trump administration coronavirus “vaccine czar” Moncef Slaoui should be classified as a special government employee and thus subject to the conflict of interest code and disclosure requirements. A complaint filed with the HHS Inspector General and the
Biologics
CBER says there were 563 human cell, tissue, and cellular and tissue product (HCT/P) inspections conducted in Fiscal Year 2019, the lowest in the period 2015-2019. The highest was 636 inspections in 2016, according to a chart released by the Center. Of the inspections in 2019, some 440
Biologics
In a 5/20 petition, Seoul, Korea, biotechnology company Cell2in is asking FDA to update applicable guidances to identify real-time glutathione monitoring methods as an acceptable means of measuring potency for purposes of submitting a BLA for cell-based therapies, including stem cell therapies. The petition says it is
Biologics
The CBER Office of Compliance and Biologics Quality says ValeoMD, Millburn, NJ, is using a Web site to market “stem cell therapy” derived from adipose tissue to treat many neurological, inflammatory, and degenerative diseases. A just-released 4/28 Notice of Violation says the firm’s adipose-derived cellular product
Biologics
FDA has issued a guidance, Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma, to recognize the May 2020 version 2.1 standard full-length and abbreviated donor history questionnaires and accompanying materials prepared by the Plasma Protein
Biologics
FDA commissioner Stephen Hahn says that CDER director Janet Woodcock and CBER director Peter Marks will recuse themselves “from the supervisory chain of command in matters related to product review decisions for applications related to the areas that they are advancing that have a nexus to Covid-19.” Hahn issued