Biologics
The CBER Office of Compliance and Biologics Quality says Sparrow Health & Performance, Hoover, AL, has been offering on a Web site and Facebook page cellular products derived from adipose tissue as “stem cell therapy” to treat many diseases or conditions. A 5/11 notice of violation says that more
Biologics
FDA has granted Moderna a fast track designation for its mRNA vaccine candidate (mRNA-1273) for Covid-19. “As we await the full set of clinical data from the [NIH]-led Phase 1 study, we are actively preparing for our Phase 2 and Phase 3 clinical studies to continue learning
Biologics
FDA has completed its review of a Moderna IND for its mRNA-1273 vaccine candidate to be used against SARS-Cov-2 and has authorized the company to start a Phase 2 study. The company says it hopes to start a pivotal Phase 3 study this summer. Moderna CEO Stéphane
Biologics
Pfizer and BioNTech have announced that the first participants have been dosed in the U.S. in a Phase 1/2 clinical trial for their BNT162 vaccine program to prevent Covid-19. As part of their global development program, the first cohort in Germany were dosed last week. The Phase
Biologics
The CBER Office of Compliance and Biologics Quality says its review of a BrioMD Web site shows that it is marketing “perivascular cells” or “perivascular cellular therapy” for treatment of respiratory conditions, immunologic and autoimmune diseases, neurologic conditions, and musculoskeletal conditions. A 4/28 Notice of Violation says the Hattiesburg,
Biologics
With the abrupt ouster of Rick Bright as director of the HHS Biomedical Advanced Research and Development Authority (BARDA), CBER director Peter Marks has been positioned as the administration’s unofficial vaccine “czar,” providing input to BARDA and other federal organizations working on a Covid-19 vaccine. Politico reports that
Biologics
The CBER Office of Compliance and Biologics Quality says Regenerative Solutions of New Jersey, Edison, NJ, is marketing exosome products from Kimera Labs for numerous diseases or conditions, including treating Covid-19. A 4/10 untitled letter says the products are administered by various routes, including intravenously. The letter quotes
Biologics
CytoDyn has submitted clinical and chemistry, manufacturing and controls portions of a BLA for leronlimab as a combination therapy with antiretroviral therapy in treatment experienced HIV patients. FDA previously granted both a fast track designation for leronlimab and a rolling review for its BLA. Leronlimab is an investigational humanized IgG4
Biologics
Some 35 members of the House of Representatives led by Reps. William Foster (D-IL) and Donna Shalala (D-FL) have written to FDA commissioner Stephen Hahn and HHS secretary Alex Azar asking them to consider conditions under which a Covid-19 vaccine might be approved and deployed more rapidly
Biologics
The CBER Office of Compliance and Biologics Quality says its review of the Web site for Kimera Labs, Miramar, FL, and other materials has found that the company markets exosome products to treat numerous diseases or conditions, including some that are serious or life-threatening. A 4/10 agency letter
Biologics
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
Biologics
Pfizer and its German partner BioNTech say they could start joint clinical trials of BioNTech’s mRNA Covid-19 vaccine program at the end of this month, assuming regulatory clearance. The trials would be held at multiple sites in the U.S. and Europe. In a statement, the companies say
Biologics
FDA says it has determined that additional safety protections are needed for any investigational use of fecal microbiota for transplantation (FMT), whether under an IND on file with the agency or FDA’s enforcement discretion policy. A 4/6 announcement about the recommended new safety steps follows a 3/12
Biologics
An FDA Office of Bioresearch Monitoring Operations 6/24-6/28/19 inspection at Steiner Biotechnology, Henderson, NV, found “objectionable conditions” related to the firm’s participation in nonclinical Good Laboratory Practice studies concerning the Skeletal Graft and Ridge Graft. A just-released 2/3 Warning Letter says specific deviations
Biologics
A 10/4-10/11/19 FDA inspection at California IVF Fertility Center, Sacramento, CA, found significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products. A just-released 2/26 Warning Letter says the specific deviations were: * failing to test a specimen from an
Biologics
In a filing with the Securities and Exchange Commission, Moderna says the Phase 1 clinical trial of its mRNA-1273 potential vaccine against the novel coronavirus SARS-CoV-2 (Covid-19) is proceeding according to protocol. The study is being led by the National Institutes of Health, the filing says,
Biologics
FDA has approved a Samsung Bioepis supplemental BLA for a 420 mg multi-dose vial of Ontruzant (trastuzumab-dttb), a biosimilar referencing Genentech’s Herceptin. Ontruzant was approved 1/2019 as a 150mg single-dose vial for use in treating HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric
Biologics
CBER director Peter Marks says that FDA and the European Medicines Agency jointly chaired a 3/18 meeting of global regulators to discuss regulatory strategies to facilitate the development of SARS-CoV-2 vaccines for use in the Covid-19 pandemic. An FDA statement says the meeting's purpose
Biologics
CBER says it is possible that convalescent plasma collected from recovered Covid-19 patients could contain antibodies to the SARS-CoV-2 virus and thus be effective against the infection. While clinical trials on such use are being pursued, the Center says in an online post that it is facilitating
Biologics
FDA has issued a safety alert telling healthcare providers and patients about the potential risk of transmitting the SARS-CoV-2 virus by using fecal microbiota for transplantation. FDA says that it has determined that additional safety protections are needed. The alert says that several recent studies have documented the
Biologics
A 3/25-4/3/19 FDA inspection at Invitrx Therapeutics, Lake Forest, CA, documented 17 issues in the firm’s processing of products for allogeneic use. A 3/16 Warning Letter lists 17 significant deviations from current good manufacturing practice (CGMP) regulations applicable to the firm’s products as
Biologics
An 8/5-8/16/19 inspection at Reproductive Technologies, Berkeley, CA, found significant deviations from regulations for human cells, tissues, and cellular and tissue-based products. A just-released 11/6/19 Warning Letter says specific deviations were: * failing to quarantine semen from anonymous donors until the required retesting;