Drugs
Dozens of patient advocacy groups have signed a letter urging congressional leaders to pass before the end of the 118th Congress the Creating Hope Reauthorization Act (H.R. 7384/S. 4583), which would reauthorize the Rare Pediatric Disease Priority Review Voucher (PRV) program for at least five years. Noting that
Biologics
A Texas federal court 12/6 ruled against FDA in an ongoing Freedom of Information Act (FOIA) lawsuit by Public Health and Medical Professionals for Transparency (PHMPT) looking for data and information on the Pfizer/BioNTech Covid-19 vaccine. The group sued FDA in 2021 and the agency was ordered
Devices
Responding to concerns raised by Rep. Earl Blumenauer (D-OR), who has focused on animal welfare in medical product trials, FDA has advised Congress that in a 6/2023 inspection, the agency found “objectionable conditions” at an animal testing laboratory at Elon Musk’s Neuralink company. Reuters reports that the
Drugs
FDA has published a draft guidance, Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics, with information on the agency’s policies and procedures for accelerated approval as well as threshold criteria generally applicable to concluding that a drug is a candidate for accelerated approval. The document also
Biologics
FDA has accepted for review a Genentech supplemental BLA for Columvi (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for treating patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of therapy and are not candidates for
FDA Policy/General
Federal Register notice: FDA has determined that 29 drug products listed in the notice were not withdrawn from sale for reasons of safety or effectiveness. The determination allows the agency to continue to approve ANDAs that reference the products as long as they meet relevant legal and regulatory requirements. To
Drugs
FDA has approved AstraZeneca’s Imfinzi (durvalumab) to treat adults with limited-stage small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. A company statement says Imfinzi is the only approved immunotherapy regimen for that cancer diagnosis. The approval was based on
Drugs
Rayner Surgical is petitioning FDA to apply specified restrictions on any ANDA referencing or relying on Omidria (phenylephrine and ketorolac injection) 1%/3%. The 11/27 petition specifically asks that the agency: * decline to accept or approve any ANDA referencing Omidria for a proposed generic product that lacks a buffer;
Drugs
Protara Therapeutics is reporting encouraging data from the Phase 2 open-label ADVANCED-2 trial of its cell-based TARA-002 in high-risk non-muscle invasive bladder cancer patients with carcinoma in situ who are Bacillus Calmette-Guérin (BCG)-unresponsive or BCG-naïve. “The complete response (CR) rate across
Drugs
FDA has granted EpicentRx a fast-track designation for its AdAPT-001 and its combination use with checkpoint inhibitors nivolumab or atezolizumab in treating recurrent or refractory advanced or metastatic soft tissue sarcoma (STS) with disease progression after at least one prior line of therapy. The designation was based on
Devices
FDA has granted Field Medical a breakthrough device designation its FieldForce Ablation System for treating sustained monomorphic scar-related ventricular tachycardia (VT). The device was also accepted into the agency’s Total Product Life Cycle Advisory Program (TAP), according to the company. Field Medical says the device is the first
Devices
FDA has added empty intravenous containers to the CDRH medical device shortages list and says the shortage is expected to last through 3/2025. An agency notice says after receiving alerts from healthcare providers and group purchasing organizations about potential shortages of empty IV bag containers, which are primarily used
Devices
FDA has cleared the Zimmer Biomet Persona SoluTion Porous Plasma Spray Femur, a total knee implant component that is an alternative for patients with sensitivities to bone cement and/or metal. A company statement says the Persona features a porous coating for cementless fixation and leverages a proprietary surface treatment
Drugs
FDA has granted Merus accelerated approval for Bizengri (zenocutuzumab-zbco) for adults with advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) and pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. Last month, FDA extended by three months its
Drugs
Researchers at FDA’s National Center for Toxicological Research (NCTR) have found that drug interactions with UDP-glucuronosyltransferase (UGT) enzymes are a strong predictor of drug-induced liver injury (DILI) across different drug types. An agency statement says NCTR conducted the study with scientists from Elsevier’s Life Sciences. “This
Drugs
DifGen Pharmaceuticals is petitioning FDA to not approve an ANDA for prednisolone ophthalmic solution 1% without the inclusion of long-term stability studies conducted under refrigerated conditions. The 11/26 petition specifically asks the agency to: * require generic applicants to conduct long-term stability studies that specifically demonstrate the product’
Drugs
A 4/1-4/5 FDA Bioresearch Monitoring Program inspection at a clinical trial site operated by neurologist Han Phan in Atlanta, GA, found that she did not adhere to applicable laws and regulations governing the conduct of clinical investigations. A 12/3 Warning Letter says Phan failed to ensure
FDA Policy/General
Federal Register notice: FDA is making available a draft revised guidance entitled “Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis.” The document provides recommendations and considerations for bovine mastitis drug products with antibacterial activity that are administered by intramammary infusion. To view the notice,
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence (AI)-Enabled Device Software Functions.” The document provides recommendations on the information to include in a Predetermined Change Control Plan in a marketing submission for a device
Drugs
Eli Lilly’s weight-loss drug Zepbound (tirzepatide) demonstrated superiority over Novo Nordisk’s Wegovy (semaglutide) in the head-to-head SURMOUNT-5 phase 3b clinical trial, according to the company. Over 72 weeks, participants taking Zepbound saw an average weight loss of 20.2%, outperforming the 13.7% weight
Drugs
FDA has granted Stoke Therapeutics a breakthrough therapy designation for zorevunersen and its use in treating Dravet syndrome with a confirmed mutation in the SCN1A gene. The designation is based on clinical data from the Phase 1/2a and open-label extension studies, which demonstrated zorevunersen’s “substantial and sustained
Drugs
An FDA review of records submitted by Zhejiang Uniquality Nursing Products Technology Co., Ltd., doing business as Zhejiang YouQuan Care Products in Zhejiang Sheng, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 11/12 Warning Letter says specific violations were: * failure