Biologics
There are several decisions facing new FDA commissioner Robert Califf over the next few months that will give insight into his thinking, according to a Barron’s article (subscription required). The article identifies and describes these issues: * Amylyx Pharmaceuticals’ experimental ALS therapy AMX0035 could put the agency into another Biogen
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FDA has published a draft guidance, Human Gene Therapy Products Incorporating Human Genome Editing, with recommendations for sponsors developing human gene therapy products incorporating genome editing of human somatic cells. Specifically, the document provides recommendations about the information that should be provided in an IND application to assess the safety
Biologics
FDA has issued AstraZeneca a complete response letter on its supplemental BLA for Fasenra (benralizumab) for patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). The agency letter is requesting additional clinical data, according to the company. It notes the submission “included data from the OSTRO Phase 3 trial,
Biologics
A California federal judge has approved a $3.65 million settlement with 1,063 former clients of StemGenex, a La Jolla, CA, stem cell clinic, and its former chief medical officer. The clients’ class-action suit filed in 2016 alleged that they were misled by StemGenex advertising and promotional materials
Biologics
FDA has declined to grant Ocugen an emergency use authorization for Covaxin for active immunization to prevent Covid-19 in individuals aged two to 18 years of age. Ocugen says it plans to work with FDA to evaluate the regulatory pathway for the pediatric vaccine. Last year, Ocugen teamed with
Biologics
Sanofi has petitioned FDA requesting that it mandate a labeling change to Seqirus’ influenza vaccine products Fluad and Fluad Quadrivalent to reflect that a confirmatory study failed to verify clinical benefit. The request is presumably intended to give Sanofi a competitive edge for its Fluzone Quadrivalent influenza vaccine. Sanofi’s
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FDA has granted Pfizer a breakthrough therapy designation for its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, and its use in preventing RSV-associated lower respiratory tract illness in infants from birth up to six months of age through active immunization of pregnant women. The designation is
Biologics
FDA has extended by three months its review of an AbbVie supplemental BLA for Skyrizi (risankizumab-rzaa) for treating moderate to severe Crohn’s disease in patients 16 years and older. The extension gives the agency additional time to review additional data submitted by AbbVie, including information about the on-
Biologics
FDA has accepted for review a Pfizer supplemental BLA for Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Abbott’s Humira. An interchangeability designation would allow pharmacists to substitute Humira for Abrilada without approval from physicians. The citrate-free biosimilar received FDA approval in 2019 for treating certain patients with
Biologics
FDA has issued Boise, ID-based Smart Surgical, dba Burst Biologics, a Warning Letter after an inspection last year determined it is marketing unapproved products derived from human umbilical cord blood (BioBurst Fluid and BioBurst Rejuv) for allogeneic use. The inspection also cited significant GMP deviations and current good tissue
Biologics
Sanofi and GlaxoSmithKline say they will submit data to FDA supporting their request for regulatory authorization for a Covid-19 vaccine. The companies say that in a Phase 3 trial, two doses of the vaccine demonstrated 100% efficacy against severe Covid-19 disease and hospitalizations, 75% efficacy against moderate or
Biologics
An independent review of FDA’s user fee program for biosimilars found that first-cycle approval rates were higher (67%, 14 of 21) during the first four years of the current five-year program than during the program’s 2013-2017 baseline first five years (39%, 9 of 23). The
Biologics
CBER says it has “substantially increased” its international efforts in addressing the Covid-19 pandemic, including regulatory and research collaborations on Covid-19 vaccine and convalescent plasma products. An online overview report says that by “providing scientific and regulatory strategies to facilitate the development, authorization, and availability of Covid-19
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FDA has granted Bavarian Nordic A/S a breakthrough therapy designation for vaccine candidate MVA-BN RSV for preventing lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults aged 60 years or older. The designation was made based on preliminary clinical evidence showing that the vaccine candidate
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FDA has granted a Regenerative Medicine Advanced Therapy designation to a gene therapy developed by University of California San Francisco researchers to treat Artemis-SCID. The designation means the research is considered promising and will be expedited for development and review. The university says Artemis-SCID is a severe form
Biologics
Y-mAbs Therapeutics is planning to re-submit a BLA on omburtamab for treating patients with CNS/leptomeningeal metastases from neuroblastoma after what it characterizes as a positive pre-BLA meeting with FDA reviewers. In 10/2020, FDA issued a refuse-to-file letter on the therapy due to deficiencies
Biologics
Gamida Cell has begun a rolling BLA submission for omidubicel, indicated for patients with blood cancers in need of stem cell transplant. The company says the submission should be completed before 6/30. The BLA is based on data from a Phase 3 study showing that omidubicel achieved a statistically
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Pfizer/BioNTech reportedly have started submitting data to FDA to support an emergency use authorization for their Covid-19 vaccine for use in children aged six months to four years old. Bloomberg News reports it learned of the rolling submission of data from sources familiar with the situation. The news
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FDA 1/31 has granted full approval to Moderna’s Covid-19 vaccine under the name Spikevax for use in individuals 18 years of age and older. The previous vaccine, which was previosly available under an emergency use authorization (EUA), joins the Pfizer-BioNTech Covid-19 vaccine Comirnaty as the
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Novavax has submitted an emergency use authorization request for NVX-CoV2373, its protein-based Covid-19 vaccine candidate for individuals 18 year of age and older. The request is based on data from two pivotal clinical trials involving 45,000 patients that demonstrated an overall efficacy of about 90% in
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FDA would have many responsibilities in the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act) released 1/25 by Sens. Patty Murray (D-WA) and Richard Burr (R-NC), the chair and ranking member of the Senate HELP Committee. Murray and Burr
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FDA has approved an Immunocore BLA for Kimmtrak (tebentafusp-tebn) for treating certain adult patients with unresectable or metastatic uveal melanoma (mUM). Approval was based on data from the company’s Phase 3 IMCgp100-202 clinical trial, which evaluated overall survival (OS) of Kimmtrak compared to investigator’s choice (either