Biologics
FDA has approved a Galderma BLA for Nemluvio (nemolizumab), a pre-filled pen for subcutaneous injection for adults with prurigo nodularis. The underdiagnosed neuroimmune skin disease is characterized by several debilitating symptoms, including chronic itch, skin nodules covering large body areas, and poor sleep quality, the company says. Galderma says
Biologics
A 3/15-5/19/2023 FDA Bioresearch Monitoring Program inspection of a clinical study led by Konrad Rejdak in Lublin, Poland, found objectionable conditions. A just-released 5/29 Warning Letter says the agency has determined that Rejdak violated regulations governing the proper conduct of clinical studies involving investigational
Drugs
An FDA review of records submitted by Nowrez & Ismail Shukri Company in Amman, Jordan, identified significant violations of current good manufacturing practice (CGMP) regulations in its production of over-the-counter finished drugs. A just-released 7/11 Warning Letter says specific violations were: * failure to have for each
Devices
A 2/15-3/7 FDA inspection at Globus Medical, Inc., in Audubon, PA, found Quality System (QS) and Medical Device Reporting (MDR) violations associated with the firm’s manufacturing of the Class 2 Excelsius GPS surgical robot and associated interbody spine and cranial modules. A just-released 7/15
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP), Procedures for Handling Requests for Proprietary Name Review, with procedures to be used by the CDER Office of Surveillance and Epidemiology (OSE), the Office of New Drugs (OND), the Office of Generic Drugs (OGD), and the Office of Prescription Drug
Drugs
Tandem Diabetes Care has issued an update on its March recall of its Apple iOS t:connect mobile app in the U.S. due to an issue that can cause rapid depletion of a user’s t:slim X2 insulin pump battery. “This battery depletion can result in the pump
Drugs
A bipartisan group of senators has introduced the Creating Hope Reauthorization Act to encourage the development of drugs to treat rare diseases affecting children. The sponsors include Sens. Susan Collins (R-ME), Bob Casey (D-PA), Markwayne Mullin (R-OK), and Sherrod Brown (D-OH). A statement from Sen. Collins
Drugs
The University of Illinois Chicago College of Pharmacy is petitioning FDA to revoke the agency order stopping the U.S. Pharmacopeia (USP) from creating modified monographs of biological drugs. The petition says FDA could reduce the cost of developing biosimilars without compromising their safety and efficacy by removing the side-
FDA Policy/General
As a follow-up to an FDA 6/13 public listening session on the agency’s use of and procedures for advisory committees, 3D Communications surveyed more than 400 current and former advisory committee members so their voices could be part of the conversation. The firm said the listening session
Devices
FDA has cleared a Surgical Planning Associates 510(k) for its new HipInsight 2.0 mixed-reality guidance system for hip arthroplasty. The device is updated with “enhanced features to support the essential steps of both primary and complex revision arthroplasty,” the company says, adding that it provides surgeons with
Drugs
FDA has removed a partial clinical hold on Stoke Therapeutics’ zorevunersen (STK-001) and its use in children and adolescents with Dravet syndrome. The therapy was under a modified partial hold since 3/2023 that allowed the administration of a single dose of STK-001 (70 mg) in its ongoing
Drugs
FDA has given BioVie approval to begin its Phase 2 SUNRISE-PD trial in Parkinson’s disease patients. The company says the agency reviewed its clinical trial and provided a single, actionable comment recommending the inclusion of the Part II score from the Movement Disorder Society’s Unified Parkinson’s
Devices
Abiomed is recalling (Class 1) certain Impella CP with SmartAssist heart pumps after nine devices in a single lot failed inspection but were inadvertently released to customers. “Using affected pumps may lead to unexpected pump stops or release of potentially harmful particulates,” a recall notice says. “Serious adverse health consequences
Drugs
FDA has granted Kyverna Therapeutics a regenerative medicine advanced therapy designation for the company’s autologous CD19 chimeric antigen receptor (CAR) T-cell product candidate, KYV-101, and its use to treat patients suffering from progressive myasthenia gravis. The autoimmune disorder is associated with muscle weakness in tissues throughout the
FDA Policy/General
Federal Register notice: FDA is announcing a 9/13 Gastrointestinal Drugs Advisory Committee meeting to discuss an Intercept Pharmaceuticals supplemental NDA for Ocaliva (obeticholic acid) that was filed to fulfill its 2016 accelerated approval postmarketing requirements. The submission includes data describing and verifying clinical benefit for treating adult patients with
FDA Policy/General
Federal Register notice: FDA is announcing a 10/16 public meeting entitled “Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub.” The meeting is intended to outline the new hub, which it says will enhance collaboration and cooperation among CBER, CDER, and other offices to advance rare disease
FDA Policy/General
Federal Register notice: FDA is withdrawing an 8/2 notice that sought comments on a proposed information collection entitled “Risk/Safety Considerations and Motivations for Purchase and Use of Kratom and Psychedelics Alone and in Combination With Other Substances.” At the time, the agency said the collection was intended to
Drugs
Lykos Therapeutics says it will pursue FDA’s dispute resolution process after the agency issued an 8/9 complete response letter on its NDA for midomafetamine (MDMA) capsules for a proposed indication of treating post-traumatic stress disorder (PTSD). The agency’s Psychopharmacologic Drugs Advisory Committee (PDAC) voted in June
Drugs
FDA has approved an Ascendis Pharma NDA for Yorvipath (palopegteriparatide) for treating hypoparathyroidism in adults. The rare endocrine disease is caused by insufficient levels of parathyroid hormone that can impact multiple organs. Approval was based on data from the global Phase 2 PaTH Forward and Phase 3 PaTHway trials, according
Biologics
FDA has told Humacyte it needs more time to complete the review of the company's BLA for the acellular tissue-engineered vessel (ATEV), indicated for treating vascular trauma. “During the course of the BLA review, the FDA has conducted inspections of our manufacturing facilities and clinical sites and
Drugs
FDA has approved an ARS Pharmaceuticals NDA for neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including anaphylaxis, in adult and pediatric patients. “Today's approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection,” CDER Division
Drugs
Braun Medical has recalled (Class 1) two lots of 0.9% sodium chloride for injection USP 1,000 mL due to the potential for particulate matter in the drug container and fluid leakage. “The affected batches were inadvertently released to the market prior to the completion of the required acceptance