Biologics
FDA has accepted for a priority review a Genentech BLA for faricimab for treating wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). The company says faricimab will be the first bispecific antibody designed for the eye. It is designed to target two distinct pathways — via
Biologics
FDA has issued a draft guidance, Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis, to help sponsors develop such cocktails as an alternative to anti-rabies virus immunoglobulin as the passive immunization component of post-exposure prophylaxis for the prevention of rabies when given
Biologics
FDA has granted Apic Bio a fast track designation for APB-102, a gene therapy candidate designed to treat SOD1 amyotrophic lateral sclerosis (ALS). The company is planning a Phase 1/2 clinical trial in early 2022. Apic says the three-part study is intended to evaluate the safety, tolerability,
Biologics
FDA has asked Pfizer/BioNTech and Moderna to expand their trials of Covid vaccines to include several thousand school children before they seek final emergency use authorization for their vaccines. The Washington Post reports the changes to ongoing pediatric trials could delay the availability of the vaccines for children ages
Biologics
The CBER Office of Compliance and Biologics Quality says its review of a Web site maintained by The Regen Centers, Rancho Mirage, CA, determined that the firm markets cellular products derived from human umbilical cord blood, umbilical cord tissue, amniotic membrane, or adipose tissue, which the company refers to as
Biologics
The CBER Office of Compliance and Biologics Quality says its review of a Web site and Facebook page maintained by The Dahlia Center, Medina, OH, indicates that the company offers a cellular product derived from umbilical cord to treat Covid-19 or to prevent Covid-19 associated respiratory conditions via
Biologics
The CBER Office of Compliance and Biologics Quality says A Better Life Stem Cell Center, Las Vegas, NV, is marketing cellular products that appear to be derived from umbilical cord or umbilical cord blood that A Better Life refers to as “stem cell therapy” for numerous diseases or conditions such
Biologics
FDA has granted Pfizer/BioNTech a priority review for a BLA for their mRNA vaccine to prevent Covid-19 in individuals 16 years of age and older. The submission would move the vaccine’s regulatory status from an emergency use authorization (EUA) to full BLA approval. The agency has set
Biologics
Emergent Biosolutions says it is establishing a quality enhancement plan for its troubled Bayview manufacturing facility in Baltimore, MD. A just-released 4/30 submission to FDA was the company’s initial response to an FDA-483 that detailed nine concerns at the facility. The agency inspection followed reports of
Biologics
The CBER Office of Compliance and Biologics Quality says its review of a Web site, Facebook page, and other materials relating to Scarsdale Integrative Family Medicine (doing business as See Beyond), Scarsdale, NY, has determined that the practice markets a cellular product that appears to be derived from human umbilical
Biologics
FDA has approved a new warning on Johnson & Johnson’s Covid-19 vaccine. According to an emergency use authorization amendment posted on the agency’s Web site, the following information was added under a new subsection entitled Guillain Barré syndrome. It reads: “Guillain Barré syndrome (a neurological disorder in
Biologics
Johnson & Johnson says it is in discussions with FDA and other regulators about rare cases of Guillain-Barré syndrome which have been reported following vaccination with its Janssen Covid-19 vaccine. The discussions presumably will center around whether a Warning should be added to the product’s labeling. “The
Biologics
FDA has posted a guidance entitled Questions and Answers Regarding the End of the Compliance and Enforcement Policy for Certain Human Cells, Tissues, or Cellular- or Tissue-based Products (HCT/Ps). In answers to common questions, the agency says that beginning last month it no longer intends to exercise enforcement
Biologics
FDA has approved a Janssen Biotech BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. Approval was based on data from the 304-
Biologics
Pfizer says it is discussing its plans this week with FDA to seek authorization for a Covid-19 vaccine booster shot (see earlier story). Meanwhile on Sunday, National Institute of Allergy and Infectious Diseases director Anthony Fauci said it was too soon for the government to recommend another shot, according
Biologics
FDA has accepted for priority review a Genentech BLA for its Port Delivery System with ranibizumab (PDS) for treating wet, or neovascular, age-related macular degeneration (AMD). Wet AMD is a leading cause of blindness for people aged 60 and over and affects about 1.1 million people in the
Biologics
The House Oversight Committee and Select Subcommittee on the Coronavirus Crisis have written to top executives of AstraZeneca and Johnson & Johnson as part of an expanded investigation into manufacturing problems at the Emergent BioSolutions Bayview facility that resulted in millions of doses of Covid vaccine being destroyed or quarantined.
Biologics
FDA plans to “move rapidly” to add a Warning to fact sheets for the Pfizer and Moderna Covid-19 vaccines about the rare risk of developing inflammatory heart conditions. Politico reports that CBER vaccine division deputy director Doran Fink told a 6/23 meeting of a Centers for Disease Control
Biologics
FDA has released a final guidance entitled Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products. The document is intended to help biologic manufacturers/sponsors in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls information to an approved BLA. It describes
Biologics
FDA has sent an untitled letter to NatureWorks (Poulsbo, WA) after reviewing the Web sites www.natureworksacupuncture.com and www.stemcells-washington.com, as well as other information, about its marketing of cellular products derived from human umbilical cords. The letter objects to the products being offered for treating serious
Biologics
FDA has approved a Stratatech’s StrataGraft for treating adult patients with thermal burns containing intact dermal elements (remaining deep skin layers) for which surgical intervention is clinically indicated. StrataGraft is made from two kinds of human skin cells (keratinocytes and dermal fibroblasts) grown together to make a bi-layered
Biologics
FDA has released more information concerning Janssen’s Covid-19 contaminated vaccine substance made at Emergent BioSolutions’ troubled contract manufacturing facility in Baltimore. Earlier this year, Emergent was found to have significant GMP deviations that led to an agreement to shut down operations until corrections are implemented (see earlier story)