Biologics
An FDA advisory committee 6/5 unanimously voted (16-0) to recommend that Covid-19 vaccine makers formulate their upcoming fall shots to provide protection against the JN.1 variant, which was the most prevalent variant in February. In recent weeks, JN.1 has been less common as “descendants” KP.
Biologics
FDA commissioner Robert Califf and two agency colleagues say FDA is interested in pragmatic clinical research as a “middle path between traditional randomized clinical trials and observational evidence to inform decisions about the use of medical products after initial market approval.” Writing in a JAMA Viewpoint, the three say pragmatic
Biologics
FDA has approved a Moderna BLA for mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine for adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. Approval was based on data from the Phase 3 clinical trial ConquerRSV, a global study conducted in
Biologics
FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) in combination with chemotherapy for the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma. The agency has set a 9/25 user fee review action target date. The submission is based on
Biologics
FDA has accepted for priority review a Sanofi supplemental BLA for Sarclisa (isatuximab) in combination with bortezomib, lenalidomide and dexamethasone (VRd) for treating patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM). According to the company, if approved, Sarclisa would be the first anti-CD38 therapy in combination with standard-
Biologics
Responding to a question posed during a 5/23 hearing held by the House Energy and Commerce Committee Health Subcommittee, CDER director Patrizia Cavazzoni said FDA would benefit from having the authority to order mandatory recall of harmful drugs. “We have that authority for lettuce, but not for drugs,” she
Biologics
An FDA 9/20-9/30/2022 inspection at Akan Biosciences in Gaithersburg, MD, found the firm manufactures Ayama, an adipose-derived stromal vascular fraction cellular product for allogenic use that does not have agency approval. A just-released 4/30 Warning Letter says Ayama is regulated as both a
Biologics
GSK says two Phase 3 clinical trials (SWIFT-1 and SWIFT-2), which assessed the efficacy and safety of depemokimab versus placebo in adults and adolescents with severe asthma with Type 2 inflammation characterized by blood eosinophil count, met their primary endpoints of reducing the annualized rate of clinically significant
Biologics
FDA says it has determined that the Zika virus is no longer a relevant communicable disease agent or disease (RCDAD) that requires screening for human cell, tissue, and cellular and tissue-based products (HCT/Ps). An agency notice says that in 2016 FDA determined that the Zika virus was an
Biologics
FDA has approved two BLAs for interchangeable biosimilars to Regeneron’s Eylea (aflibercept) — Biocon Biologics’ Yesafili (aflibercept-jbvf) and Biogen’s Opuviz’s (aflibercept-yszy) — indicated for treating neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy. Aflibercept products inhibit vascular
Biologics
Biogen and Ionis Pharmaceuticals say they are terminating the development of BIIB105 (ION541), an investigational antisense oligonucleotide for amyotrophic lateral sclerosis based on topline data from Phase 1/2 ALSpire study. The therapy was designed to reduce expression of ataxin-2 (ATXN2) protein and demonstrated statistically significant cerebrospinal fluid ATXN2
Biologics
FDA has granted Juno Therapeutics accelerated approval for its BLA for Breyanzi (lisocabtagene maraleucel), a CAR T cell therapy for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. The approval was based on data from the TRANSCEND-FL (NCT04245839)
Biologics
Rep. Mark Green (R-TN) has introduced the Vaccines in Trial and Liability Act of 2024 that would ensure Americans are protected from fraudulent vaccine trial data. The bill is “essential for the oversight and transparency of vaccine companies and the trial data they use to obtain emergency use authorizations
Biologics
FDA has issued a complete response letter to Dynavax Technologies for its sBLA for a four-dose Heplisav-B vaccine (hepatitis B vaccine [recombinant] adjuvanted) regimen for adults on dialysis. A company statement says FDA said the application did not provide sufficient data to support the full evaluation of the
Biologics
FDA has told Moderna that it needs a couple more weeks to complete the review of its BLA for mRNA-1345, the company’s investigational respiratory syncytial virus vaccine, due to “administrative constraints.” The original user fee review action date was 5/12, and the agency now says it will
Biologics
FDA has accepted for review a Bristol Myers Squibb BLA for a subcutaneous formulation of Opdivo (nivolumab) across all previously approved adult solid tumor indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. The agency has set a
Biologics
FDA says Exocel Bio in San Diego, CA, is selling unapproved exosome products through a Facebook page and YouTube channel. A 5/7 CBER letter cites examples of promotional statements that demonstrate the firm intends the products for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. The
Biologics
As directed by a presidential Executive Order, FDA, EPA and the Department of Agriculture have developed a joint regulatory plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology. An FDA statement (includes a link to the plan) says the plan “incorporates processes and timelines
Biologics
CBER director Peter Marks told the American Society of Gene & Cell Therapy conference on 5/8 that if FDA is going to err in granting accelerated approval for a gene therapy product to treat a rare disease, he would rather err on the side of bringing a potentially useful
Biologics
FDA is announcing a 6/10 Peripheral and Central Nervous System Drugs Advisory Committee meeting to vote on an Eli Lilly BLA for donanemab solution for intravenous infusion, indicated for treating early symptomatic Alzheimer’s disease. In March, FDA decided to delay its review decision on the BLA by requiring
Biologics
Regeneron may be facing an approval delay on its supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The company said in a 5/2 earnings call that FDA recently requested sub-population breakdowns from the Phase
Biologics
CBER says it is recognizing as acceptable for use by manufacturers of blood and blood components the 1/2024 document entitled “United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128, version 4.0.0.” An FDA guidance, Recognition and Use of a