Drugs
FDA has granted Neuren Pharmaceuticals a rare pediatric disease designation for its drug candidate NNZ-2591 and its use in treating Phelan-McDermid syndrome. The designation may qualify Neuren for a priority review voucher if its therapy gains approval. The designation is based on recent data from a Phase 2
Drugs
During an end-of-Phase 2 meeting with Agenus on its immunotherapy combination botensilimab (BOT) and balstilimab (BAL) to treat adults with relapsed/refractory microsatellite stable colorectal cancer with no liver metastases, FDA advised the company not to submit its trial results for accelerated approval, saying that objective response rates
Drugs
FDA has classified as “official action indicated” an April inspection of Zydus Lifesciences’ injectables manufacturing facility at Jarod, Gujarat, India. The company says it will “work closely with the agency to resolve the regulatory status of this facility expeditiously.” The inspection resulted in a 10-item Form FDA-483 that
Drugs
Aveo Oncology says its TiNivo-2 Phase 3 clinical trial in patients with advanced metastatic renal cell carcinoma whose tumors had progressed following prior immune checkpoint inhibitor treatment did not meet the primary endpoint of increasing progression-free survival when nivolumab (Bristol Myers Squibb’s Opdivo) was added to low-
Devices
FDA has cleared a Globus Medical 510(k) for its ExcelsiusFlex with total knee arthroplasty option. The new robotic navigation platform is designed to offer surgeons control, resection accuracy, and procedural flexibility in total knee arthroplasty, according to the company. Additionally, it says Actify 3D Total Knee System for use
Devices
FDA has granted Restore Medical a breakthrough device designation for its ContraBand device and its use in treating heart failure with reduced ejection fraction (HFrEF) patients who remain symptomatic despite maximally tolerated guideline-directed medical therapy and who don’t have significant pulmonary hypertension or right heart failure. ContraBand is
Drugs
FDA has approved a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) 10 mg tablets for relieving heartburn associated with non-erosive gastroesophageal reflux disease (non-erosive GERD) in adults. This is the third approval for Voquezna, having seen previous approvals for treating all severities of erosive esophagitis, and combination use with
Devices
FDA says it has issued two additional Warning Letters as part of its ongoing evaluation of plastic syringes made in China for potential medical device failures. Warning Letters were sent to Jiangsu Shenli Medical Production Co., Ltd. for quality system violations for syringe products, and to Jiangsu Caina Medical Co.
Drugs
FDA has published a guidance, Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies, with agency recommendations for such studies in investigational drugs, including (1) deciding whether and when to conduct the study, (2) designing the study, and (3) reporting results. The document’s recommendations are based, in part, on
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy.” The document addresses certain regulatory requirements for determining donor eligibility that apply to establishments that collect blood and blood components for transfusion or for further manufacturing use, including source plasma.
Drugs
FDA has released the form FDA-483 issued following a 3/20-4/5 inspection at Denver Solutions, an Englewood, CO, outsourcing facility doing business as Leiters Health. The seven inspection observations were: * failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its
Devices
FDA says that Philips Respironics is updating instructions for using its OmniLab Advanced+ ventilator due to interruptions and/or loss of therapy. An agency notice says it considers this latest Philips correction a Class 1 recall. According to the notice, Philips issued an urgent recall notice for all affected customers
Devices
FDA has cleared a Subtle Medical 510(k) for its SubtleSYNTH, which uses deep learning to generate synthetic Short Tau Inversion Recovery (STIR) images from already-acquired T1 and T2 weighted contrasts. “SubtleSYNTH creates synthetic STIR images with zero acquisition time that are interchangeable with conventionally acquired STIR images,” the
Devices
Baxter International is recalling (Class 1) certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly due to reports of the handset plug disconnecting from the nebulizer port on the blue ventilator adapter. To date, there have been no reported injuries associated with the issue.
FDA Policy/General
Federal Register notice: FDA is extending the comment period on its draft guidance entitled “Platform Technology Designation Program for Drug Development.” The document provides details about implementing the agency’s Platform Technology Designation Program, which was established by the PREVENT Pandemics Act. It outlines eligibility factors for receiving a platform
Drugs
CDER director Patrizia Cavazzoni and CBER director Peter Marks say they will co-lead a new Rare Disease Innovation Hub (the Hub) to work across rare diseases, but to especially focus on products intended for smaller populations or for diseases where the natural history is variable and not fully understood.
Biologics
FDA has published a guidance, Blood Pressure and Pulse Donor Eligibility Requirements—Compliance Policy, addressing the regulatory requirements for determining donor eligibility that apply to establishments that collect blood and blood components for transfusion or for further manufacturing use. The document says the agency has developed the guidance in response
Drugs
Endo is recalling (Class 1) one lot of clonazepam orally disintegrating tablets 0.25 mg due to mislabeling on the cartons of some packs that shows the product strength as 0.125 mg and not 0.25 mg. The blister strips inside the product pack reflect the correct strength of
Devices
FDA has cleared a Hyperfine 510(k) for the ninth generation of artificial intelligence-powered Swoop system software. The software is designed to significantly reduce scan times across multiple magnetic resonance (MR) sequences without sacrificing image quality, the company says. “These scan time reductions may enable Swoop system images to
Drugs
Based on positive results from the Phase 3 ARANOTE trial of its Nubeqa (darolutamide) in men with metastatic hormone-sensitive prostate cancer, Bayer says it will discuss with FDA a regulatory submission to expand the drug’s indication. A company statement says the trial of Nubeqa with androgen deprivation therapy
Biologics
FDA has accepted for priority review an Atara Biotherapeutics BLA for gene therapy tabelecleucel (tab-cel) indicated as monotherapy for treating adult and pediatric patients two years of age and older with Epstein-Barr virus (EBV)-positive post-transplant lymphoproliferative disease who have received at least one prior therapy. The
FDA Policy/General
The FDA “Annual Report on Inspections of Establishments in FY 2023” says the agency completed 2,953 domestic and foreign drug and medical device establishment inspections. Of that number, the report says, 2,051 inspections were in the U.S., 287 in the European Union, 155 in India, 53 in