Drugs
FDA has published a draft guidance, Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products, with recommendations for applicants for NDAs and ANDAs for nonprescription drug products on documenting minor labeling changes in the next annual report. The document also gives examples of such minor labeling changes.
Drugs
Pfizer says it plans to discuss with FDA data from its Phase 3 study of the antibody-drug conjugate Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab for treating patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The data showed a “statistically significant and clinically meaningful improvement
Drugs
Lexicon Pharmaceuticals says that after receiving recent FDA feedback it plans to resubmit its NDA for sotagliflozin oral tablets, 200 milligrams (mg) and 400 mg, as an adjunct to insulin therapy in patients with Type 1 diabetes and chronic kidney disease. In 2021, CDER issued a Federal Register notice proposing
Drugs
Acadia Pharmaceuticals says it is scrapping pimavanserin for treating negative symptoms of schizophrenia after announcing “disappointing” top-line results from the Phase 3 ADVANCE-2 trial. “Pimavanserin did not demonstrate a statistically significant improvement over placebo on the study’s primary endpoint, the change from baseline to week 26 on
Drugs
FDA has issued Viatris/Mapi Pharma a complete response letter on their NDA for GA Depot 40 mg, a long-acting glatiramer acetate being investigated as a once-monthly injection to treat relapsing forms of multiple sclerosis. The companies say they are reviewing the letter’s content and will be
Drugs
FDA has released a draft guidance entitled “Early Alzheimer’s Disease: Developing Drugs for Treatment.” The document addresses drug clinical development for treating stages of sporadic Alzheimer’s disease (AD) that occur before the onset of overt dementia (Stages 1 through 3, which are also referred to as early AD)
Drugs
Johnson & Johnson has filed a supplemental BLA for Tremfya (guselkumab) for treating adults with moderately to severely active ulcerative colitis (UC). The submission is based on data from the Phase 3 QUASAR program in patients who had an inadequate response or intolerance to conventional therapy, prior biologics or JAK
Drugs
FDA has approved a new indication for Novo Nordisk’s weight loss drug Wegovy (semaglutide) injection — reducing the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and being either obese or overweight. “Wegovy is now the first weight loss medication to also be approved to
Drugs
FDA is continuing to slow roll its review decision on Eli Lilly’s experimental Alzheimer’s drug donanemab by requiring the agency’s Peripheral and Central Nervous System Drugs Advisory Committee to discuss the company’s Phase 3 TRAILBLAZER-ALZ 2 trial, which evaluated the efficacy and safety of donanemab
Drugs
Faced with disappointing data from the Phase 3 PHOENIX clinical trial of Amylyx Pharmaceuticals’ amyotrophic lateral sclerosis (ALS) drug Relyvrio (sodium phenylbutyrate and taurursodiol), the company says it is considering voluntarily withdrawing the drug. “Amylyx will continue to engage with regulatory authorities and the broader ALS community, including ALS specialists
Drugs
KVK Research, Inc., a generic drug manufacturer in Bucks County, PA, has pleaded guilty to criminal charges that it introduced adulterated drugs into interstate commerce and consequently it has agreed to pay a $1.5 million penalty on those charges and $2 million to resolve civil liability under the False
Drugs
Novo Nordisk says a Phase 1 trial of a pill version of its experimental weight-loss drug amycretin found that trial participants lost 13.1% of their weight after 12 weeks. Reuters reports that the result compares to a 6% loss after 12 weeks and 15% after 68 weeks in
Drugs
FDA has granted accelerated approval to BeiGene USA’s Brukinsa (zanubrutinib) with obintuzumab (Genentech’s Gazyva) for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. An agency notice says the regimen was evaluated in a trial of 217 patients. Efficacy was based on the overall
Drugs
The Alliance for Regenerative Medicine (ARM) says it is concerned that an FDA draft guidance, Advanced Manufacturing Technologies Designation Program, “fails to provide a clear framework for the adoption of advanced manufacturing technologies (AMT) across the cell and gene therapy industry.” In its comment letter, ARM questions the agency’s
Drugs
FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) for combination use with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC) (bladder cancer). The approval is based on data from the Phase 3 CheckMate-901 trial which evaluated Opdivo in combination
Biologics
Six House members from California and Arizona, five Republicans and one Democrat, are asking FDA commissioner Robert Califf to “reconsider expediently the addition of coccidioidomycosis, also known as Valley Fever, to the current list of tropical diseases that qualify for a priority review voucher as directed in House Report 117-
Drugs
FDA has published the International Council for Harmonization (ICH) guidance, Q14 Analytical Procedure Development, describing science and risk-based approaches for developing and maintaining analytical procedures suitable for evaluating the quality of drug substances and drug products. The document says that the systematic approach suggested in other ICH guidances can
Drugs
FDA commissioner Robert Califf says he is concerned that the main use of artificial intelligence (AI) algorithms in healthcare will be “decisions that optimize the bottom line rather than optimizing the longevity and well-being of patients.” Speaking 3/5 to the Coalition for Health AI, of which FDA is
Drugs
FDA has published an International Council for Harmonization (ICH) guidance, Q2(R2) Validation of Analytical Procedures, with elements for consideration during the validation of analytical procedures included as part of registration applications. The document includes a collection of terms and their definitions that are meant to bridge the differences that
Drugs
FDA has approved Pfizer’s Besponsa (inotuzumab ozogamicin) for an expanded indication — treating pediatric patients aged one year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). The drug was originally approved in 2017 for the same indication in adults. The expanded use was
Drugs
Four CDER Office of Translational Services researchers say a successful Model-Informed Drug Development (MIDD) pilot program started under PDUFA 6 is leading to an integration of MIDD as part of PDUFA 7. Writing in Clinical Pharmacology & Therapeutics, the researchers say the pilot enabled discussions on the use of
Drugs
FDA has approved a Lantheus Holdings supplemental NDA for an expanded use for ultrasound enhancing agent Definity (perflutren lipid microsphere) in pediatric patients with suboptimal echocardiograms. The approval offers a “valuable tool to opacify the left ventricular chamber and better identify the left ventricular endocardial border,” the company says. The