Biologics
FDA’s Vaccine and Related Biological Products Advisory Committee 10/15 unanimously (19-0) voted to recommend Johnson & Johnson’s Covid-19 booster vaccine in all adults two months after receiving their initial J&J dose. To date, about 15 million people have received their first J&
Biologics
FDA is reportedly delaying its decision on expanding a Moderna emergency use authorization for its Covid-19 vaccine in adolescents while it further investigates myocarditis risks. According to several news reports, the agency has been assessing the risk among younger men vaccinated with the Moderna vaccine after several Nordic countries
Biologics
Although not taking a position on whether FDA should approve a booster shot for the Johnson & Johnson Covid-19 vaccine, agency reviewers are raising questions about the company’s evidence for such boosters. In a briefing document released in advance of a 10/15 meeting of the Vaccine and
Biologics
The FDA Vaccines and Related Biological Products Advisory Committee meets 10/14 to consider Moderna’s request for an emergency use authorization (EUA) for a booster dose of its mRNA Covid-19 vaccine. An agency briefing document released in advance of the meeting contains effectiveness and safety data on the
Biologics
FDA has approved Enzyvant Therapeutics’ thymus tissue-based product Rethymic for treating pediatric patients with congenital athymia, a rare immune disorder in which a child is born without a thymus – an organ that helps the body learn to fight infections. “Children impacted by this disease typically die within the first
Biologics
FDA has granted Y-mAbs Therapeutics a rare pediatric disease designation for the company’s lutetium-labeled omburtamab antibody program for treating medulloblastoma. The therapy is currently in a multicenter Phase 1 clinical trial in pediatric patients with refractory medulloblastoma, and in a multicenter Phase 1 clinical trial targeting B7-
Biologics
Pfizer and BioNTech say they have formally submitted an emergency use authorization request to permit use of their mRNA Covid-19 vaccine in children aged 5 to under 12 years of age. Last week, the companies submitted FDA Phase 2/3 clinical trial data that they said demonstrated a favorable
Biologics
Johnson & Johnson has submitted data to support an emergency use authorization for its Covid-19 booster shot in those 18 years of age and older. The filing, according to the company, includes data from the Phase 3 ENSEMBLE 2 study that found a booster given 56 days after the
Biologics
FDA has announced a 10/14-15 Vaccines and Related Biological Products Advisory Committee meeting to discuss booster doses for both Moderna and Janssen Covid-19 vaccines. Panel members are also scheduled to discuss available data on the use of a booster of a different vaccine than the one used
Biologics
FDA has published two guidances relating to gene therapy products. The first, Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations, gives the agency’s current thinking on determining the sameness of these products for orphan drug designation and exclusivity. It is intended to assist stakeholders in developing
Biologics
While FDA has invested some resources in trying to regulate private clinics marketing stem cell products, “they’re just outmatched and overwhelmed,” according to University of California Irvine bioethicist Leigh Turner. Speaking to the Associated Press, Turner said the 2017 decision to give stem cell clinics three years to demonstrate
Biologics
In the wake of two senior FDA vaccine officials leaving the agency (see earlier story) during the next month, CBER director Peter Marks has announced he will immediately serve as Office of Vaccines Research and Review (OVRR) acting director. Marks is replacing OVRR director Marion Gruber, who is retiring 10/
Biologics
Pfizer and BioNTech say they have submitted Phase 2/3 clinical trial data on their mRNA Covid-19 vaccine in children aged 5 to under 12 to FDA and will seek an emergency use authorization for that group in the coming weeks. The companies announced 9/20 positive topline results
Biologics
Eisai has initiated a rolling BLA submission for lecanemab (BAN2401), the company’s investigational anti-amyloid beta (AB) protofibril antibody for treating early Alzheimer’s disease. The BLA, which is seeking accelerated approval, is based on clinical, biomarker and safety data from the Phase 2b clinical trial (Study 201) in
Biologics
FDA has approved an Amgen supplemental BLA for Repatha (evolocumab) injection as an add-on treatment to diet alone or together with certain other therapies for patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH). Repatha works by recto reducing low-density lipoprotein
Biologics
(Update 9/24): Less than 24 hours after FDA amended the emergency use authorization (EUA) for Pfizer-BioNTech’s Covid-19 vaccine to allow a booster dose for certain adults, the Centers for Disease Control and Prevention (CDC) 9/23 narrowed the recommended shots to exclude front-line and other
Biologics
The CBER Office of Compliance and Biologics Quality says its review of a Web site, social media pages, and other online sources for Genesis Medical Center, Irvine, CA, determined that the firm markets what it describes as a “stem cell therapy” or “biological therapy” product derived from adipose tissue to
Biologics
FDA has told Reykjavik, Iceland-based Alvotech that it is deferring action on its BLA for AVT02, the company’s proposed biosimilar of AbbVie’s Humira (adalimumab) Humira, until manufacturing facility inspections/assessments can be completed. “The FDA can defer action when no deficiencies have been identified and the application
Biologics
AbbVie has submitted a BLA supplement for Skyrizi (risankizumab-rzaa) (600 mg intravenous (IV) induction and 360 mg subcutaneous (SC) maintenance therapy) for treating patients 16 years and older with moderate to severe Crohn’s disease. The submission is based on data from three Phase 3 studies — ADVANCE, MOTIVATE and
Biologics
Pfizer and BioNTech 9/20 announced results from a Phase 2/3 trial showing a “favorable safety profile and robust neutralizing antibody responses” for a lower-dose Covid-19 vaccine for children five to 11 years of age. The antibody responses in children were comparable to those recorded in a
Biologics
FDA’s Vaccines and Related Biological Products Advisory Committee 9/17 voted unanimously (18 to 0) to recommend Pfizer-BioNTech’s Comirnaty Covid-19 booster vaccine, under an emergency use authorization, in individuals 65 years of age and older and those at high risk of severe covid-19 (e.g.
Biologics
Moderna says data from studies conducted with Kaiser Permanente and the Centers for Disease Control demonstrate that the company’s mRNA-1273 Covid-19 vaccine is “highly effective against circulating variants of concern.” A company statement also says a new analysis of the incidence of breakthrough Covid-19 cases among