Drugs
A 1/15-1/24 inspection by the FDA Office of Bioresearch Monitoring Inspectorate Foreign Inspection Cadre at Jiangsu Kerbio Medical Technology Group Co. in Jiangsu Sheng, China, found serious violations of good laboratory practice for nonclinical laboratory studies regulations. A just-released 7/11 Warning Letter says the specific
Drugs
FDA has expanded the approved use of Amgen’s cholesterol-lowering drug Repatha (evolocumab) to include adults at increased risk of major adverse cardiovascular events due to uncontrolled low-density lipoprotein cholesterol (LDL-C), even if they have not been diagnosed with cardiovascular disease. The change removes a key limitation
Drugs
CBER has suspended Valneva Austria’s BLA for Ixchiq (chikungunya vaccine, live) due to serious safety concerns related to the vaccine, which appears to be causing chikungunya-like illness in vaccine recipients. The vaccine was granted accelerated approval in 2023 for the preventing disease caused by the chikungunya virus (CHIKV)
Drugs
Vanda Pharmaceuticals has requested FDA commissioner Marty Makary to reconsider a recent agency decision upholding approvals of two generic versions of Hetlioz (tasimelteon), the company’s drug for non-24-hour sleep-wake disorder. The request follows a July ruling by recently retired CDER director Jacqueline Corrigan-Curay, who sided
Drugs
Boston Scientific is recalling (Class 1) its Carotid Wallstent Monorail Endoprosthesis due to a manufacturing defect that created an inner lumen smaller than specifications, which causes resistance when withdrawing the stent delivery system. “Using the affected stent systems could cause serious harm, such as injury to the blood vessel, damage
Drugs
Regeneron’s FDA delays in getting two regulatory submissions approved for Eylea HD (aflibercept) injection 8 mg are shedding light on the extent of problems being uncovered in agency inspections at the plant that manufactures the product. Earlier this week, the company announced the delay in reviewing these because information
Drugs
FDA says it will now publish drug safety data on a daily basis, a shift the agency says will give the public faster access to information about adverse events tied to prescription drugs and biologics. The move marks a major change to FDA’s Adverse Event Reporting System (FAERS), which
Drugs
FDA has accepted for review a Stealth BioTherapeutics NDA resubmission for elamipretide for treating Barth syndrome. The agency is considering the submission a Class 2 response with a six-month user fee goal date of 2/15/2026, but it has told Stealth that a decision will be made by
Drugs
Nicox says it will submit an NDA early next year after new data from its DENALI Phase 3 study of glaucoma therapy NCX 470 showed promising results. The study, which enrolled 696 patients with open-angle glaucoma or ocular hypertension across 90 sites in the U.S. and China, showed
Drugs
FDA has approved an Ionis Pharmaceuticals NDA for Dawnzera (donidalorsen) as the first RNA-targeted prophylactic treatment for hereditary angioedema (HAE) in patients 12 years and older. The drug is designed to block plasma prekallikrein, a protein that drives the inflammatory force behind HAE attacks, according to the company. The
Drugs
AbbVie is reporting that its JAK inhibitor Rinvoq (upadacitinib) met primary and secondary endpoints in a pivotal Phase 3 study testing the drug in patients with severe alopecia areata (AA). The company says that its Study 1 of the UP-AA program saw 45.2% of patients receiving a 15
Drugs
Officials in 14 states (13 attorneys general and one governor) say they are joining four other states in their petition to FDA, asking the agency to eliminate the mifepristone REMS program that controls access to the drug that is the most common means of abortion in the U.S. In
Drugs
FDA has granted Keros Therapeutics an orphan drug designation for its investigational therapy KER-065 and its use in treating Duchenne muscular dystrophy. The company says it is preparing to launch a Phase 2 trial of the therapy. Keros describes KER-065 as a ligand trap designed to block signaling
Drugs
FDA has published a draft guidance, Approaches to Assessment of Overall Survival in Oncology Clinical Trials, with recommendations for sponsors on assessing overall survival in randomized oncology clinical trials conducted to support marketing approval of drugs and biological products, with an emphasis on the analysis of overall survival as a
Drugs
Contract development and manufacturing organization Nucleus RadioPharma has appointed former FDA commissioner Stephen Hahn (Trump Administration 2019-2021) as its chief executive officer. Hahn joins Nucleus after serving as CEO-partner of Flagship Pioneering and CEO of Harbinger Health since 2021. Before joining FDA, he was the chief medical executive
Drugs
Writing on behalf of an unnamed client, Wiley Rein is petitioning FDA to take “specific and necessary actions to address the significant and escalating public health risks associated with the large-scale production and distribution of compounded drug preparations purporting to contain semaglutide.” The petition asks for these specific FDA
Drugs
B. Braun Medical has recalled (Class 1) one lot each of its Lactated Ringers Injection USP 1,000 mL and 0.9% sodium chloride injection USP 1,000 mL due to the presence of particulate matter inside the containers. B. Braun has received several complaints and identified the potential for
Drugs
A 2/24-2/28 FDA inspection at the Anhui Hanbon Daily Chemical Co., Ltd., drug manufacturing facility in Huainan Shi, Anhui Sheng, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/11 Warning Letter says the specific violations were: * failure to test
Drugs
FDA has issued PTC Therapeutics a complete response letter (CRL) on its NDA for vatiquinone and its use for treating Friedreich’s ataxia, calling for additional evidence of the drug’s effectiveness. The CRL said PTC’s submission did not demonstrate “substantial evidence of efficacy” and that another well-controlled
Drugs
FDA has placed a clinical hold on a BiomX Phase 2b trial of BX004, an investigational phage therapy for cystic fibrosis (CF). The agency action does not relate to the BX004 drug itself, but instead concerns a third-party nebulizer device used to deliver the treatment, the company says. BiomX
Drugs
FDA has denied a 12/4/2022 petition submitted by Ferring Pharmaceuticals asking the agency to reconsider its denial of a 2/10/2022 petition asking that FDA require ANDA sponsors citing Ferring’s Firmagon (degarelix) as the reference-listed drug to conduct in vivo bioequivalence studies and update the
Drugs
FDA has published a guidance, Emerging Scientific and Technical Information on Leachable NDBA and Other Small-Molecule Nitrosamines in Infusion Bags, asking manufacturers and applicants to obtain better data and applicants to report data in their applications so the agency can better understand the emerging issue of the detection of