Biologics
AbbVie has submitted a supplemental BLA for Skyrizi (risankizumab) 1,200 mg intravenous (IV) (induction dose) and 180 mg and 360 mg subcutaneous (maintenance doses) for treating adults with moderately to severely active ulcerative colitis. Currently, the drug is approved for treating plaque psoriasis, psoriatic arthritis and Crohn’s disease.
Drugs
Novocure says its Phase 3 ENGOT-ov50/GOG-3029/INNOVATE-3 clinical trial of Tumor Treating Fields (TTFields) together with paclitaxel in patients with platinum-resistant ovarian cancer did not meet its primary endpoint of overall survival (OS) at the final analysis. “Patients randomized to receive TTFields therapy plus paclitaxel
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies.” The document describes FDA’s compliance policies regarding enforcement of requirements for the interoperable, electronic, package-level product tracing
Drugs
FDA has released a new guidance entitled “Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies” that spells out the agency’s intention to not take enforcement actions pursuant to the security requirements until after 11/27/2024. The
FDA Policy/General
Inmar Supply Chain Solutions is recalling FDA-regulated products (over-the-counter (OTC) human or animal drugs, OTC medical devices, dietary supplements, food, etc.) contained in pallets stored at the firm’s Arlington, TX facility between 5/1/2022 and 6/30/2023. Affected products were stored at the facility
Drugs
CDER is seeking comments on its proposal to withdraw Oncopeptides’ accelerated-approved multiple myeloma drug Pepaxto (melphalan flufenamide). The proposal came after a confirmatory trial (OCEAN) demonstrated a worse overall survival and failed to verify clinical benefit. Pepaxto was originally approved 2/2021, and at FDA’s request, Oncopeptides ceased
Devices
CDRH is announcing the qualification of a new tool through the agency’s voluntary Medical Device Development Tools program: Accelerated Testing to Prove Long-Term Material Biostability. The new tool is described as a non-clinical assessment model intended to assess long-term hydrolytic biostability of thermoplastic polyurethane materials being
Devices
FDA has cleared a Fresenius Medical Care 510(k) for VersiHD with GuideMe Software, a self-guided interface for the company’s VersiHD chronic home hemodialysis (HHD) system. The device provides “graphical walk-through guidance that aims to enhance ease of use and confidence for both patients and nurses,” the
Drugs
FDA has granted Redx an orphan drug designation for zelasudil (RXC007), an oral, selective Rho-associated coiled-coil containing protein kinase 2 (ROCK2) inhibitor for treating idiopathic pulmonary fibrosis (IPF). Zelasudil is currently in a Phase 2a trial in IPF patients, with topline data expected early next year. Zelasudil works
Devices
FDA says it agrees with an 8/23 Medtronic Urgent Medical Device Communication and updated patient management recommendations for its HeartWare Ventricular Assist Device (HVAD) systems. The communication describes a newly identified subgroup of HVAD pumps defined by serial numbers (subgroup 3) that have a higher risk of failure to
Drugs
Merck and Eisai have terminated the Phase 3 LEAP-010 trial evaluating Merck’s Keytruda (pembrolizumab), an anti-PD-1 therapy, plus Eisai’s Lenvima (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor (TKI), as a first-line treatment for patients with recurrent or metastatic head and neck squamous
Drugs
FDA has approved a Gilead sNDA for the use of Veklury (remdesivir) with no dose adjustments to treat Covid-19 in people with mild, moderate, and severe hepatic impairment. A company statement says the approval supports Veklury’s position as the only approved antiviral Covid-19 treatment that can be
Drugs
Akebia Therapeutics says it expects to resubmit an NDA to FDA in the third quarter for its vadadustat to treat anemia due to chronic kidney disease in patients on dialysis. The company says the resubmission follows its receipt of minutes summarizing an End of Dispute Type A meeting with FDA
Drugs
FDA has granted Nectero Medical a fast track designation for its Endovascular Aneurysm Stabilization Treatment (EAST) combination product to treat patients with infrarenal abdominal aortic aneurysms (AAAs) with a maximum diameter of 3.5 – 5.0 cm. According to the company, EAST is a single-use endovascular product comprising a
Devices
FDA has cleared a Paragonix Technologies 510(k) for its next-generation donor lung preservation system, BAROguard. Paragonix says the device combines its existing advanced hypothermic preservation technology with automated continuous and active airway pressure control that is intended to provide an optimal temperature range and a clinically recommended inflation
Drugs
Two Oregon State University (OSU) studies indicate that FDA is approving more novel pharmaceutical drugs on single clinical trials and with less public disclosure about those trials than was the norm a few years ago. A university statement says researchers agree it is important to minimize delays in making treatments
FDA Policy/General
Federal Register notice: FDA is announcing a 10/5 Vaccines and Related Biological Products Advisory Committee meeting to discuss the strain selection for the influenza virus vaccines for the 2024 southern hemisphere influenza season. To view the notice, click here.
Drugs
FDA has granted Taysha Gene Therapies a fast track designation for TSHA-102, an intrathecally delivered AAV9 gene transfer therapy for treating Rett syndrome. The therapy uses the company’s miRNA-Responsive Auto-Regulatory Element (miRARE) technology, which is designed to mediate levels of the MECP2 gene in the central
Biologics
FDA has approved a Sandoz BLA for Tyruko (natalizumab-sztn), the first biosimilar to Biogen’s Tysabri (natalizumab) injection for treating adults with relapsing forms of multiple sclerosis. “Tyruko, like Tysabri, is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active
Drugs
Three Ropes & Gray attorneys say an FDA 8/15 final guidance on informed consent “illustrates a continuing trend toward modernization of clinical research through adoption of risk-based positions that attempt to reduce administrative burden while maintaining protections for human subjects.” Their online Alert also says FDA gives increased
Drugs
FDA says its 9/1-9/29/22 inspection at a clinical trial site maintained by Angela Stupi in Cranberry Twp., PA, found objectionable conditions for two trials of investigational drugs. The inspection was part of the agency’s Bioresearch Monitoring Program and found that Stupi did not comply with
Drugs
FDA says its Endocrinologic and Metabolic Drugs Advisory Committee will meet 9/21 to review and vote on an Intarcia Therapeutics NDA for ITCA 650 (exenatide in Duros device), a drug/device combination product that was rejected by CDER in 2021 as an adjunct to diet and exercise to improve