Biologics
FDA has approved an expanded use for GSK’s Arexvy (respiratory syncytial virus (RSV) vaccine, adjuvanted) for preventing RSV lower respiratory tract disease (LRTD) in adults aged 50 through 59 years and who are at increased risk. The vaccine was previously approved for use in adults aged 60 and older.
Devices
FDA has cleared two Abbott 510(k)s for over-the-counter continuous glucose monitoring (CGM) systems Lingo and Libre Rio, which are based on the company’s FreeStyle Libre CGM technology. “The newly cleared systems have been intentionally designed to meet different needs – Lingo for consumers who want to
Drugs
FDA’s Peripheral and Central Nervous System Advisory Committee 6/10 unanimously voted (11 to 0) to recommend the approval of Eli Lilly’s donanemab-azbt to treat Alzheimer’s disease. Panel members agreed that the clinical data and biomarker data were convincing on donanemab’s effectiveness. In discussing their
FDA Policy/General
Federal Register notice: FDA is announcing the renewal of its Obstetrics, Reproductive and Urologic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 3/23/2026. To view the notice, click here.
Devices
FDA has cleared a Moon Surgical 510(k) for its Maestro surgical system. The small, adaptable device is intended to be integrated into existing clinical workflows over any laparoscopic indication, according to the company. “The system is equipped with NVIDIA Holoscan, a powerful edge computing platform that allows real-time
Drugs
FDA has approved a Geron NDA for Rytelo (imetelstat) for treating adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks. The company says the therapy is intended for patients who have not responded
FDA Policy/General
Federal Register notice: CDER is publishing a proposal to refuse the approval of a supplemental NDA submitted by Vanda Pharmaceuticals for Hetlioz (tasimelteon) capsules, 20 mg, indicated for treating insomnia characterized by difficulties with sleep initiation. The notice summarizes the grounds for not approving the supplement and offers Vanda an
FDA Policy/General
Federal Register notice: FDA is announcing a 7/25 Oncologic Drugs Advisory Committee meeting to discuss an AstraZeneca supplemental BLA for Imfinzi (durvalumab) injection. The company is seeking an indication for combination use with chemotherapy as neoadjuvant treatment, followed by Imfinzi as monotherapy after surgery, for treating adult patients with
FDA Policy/General
FDA has cleared a DePuy Synthes 510(k) for the VELYS Robotic-Assisted Solution and its use in unicompartmental knee arthroplasty (UKA). The expanded indication builds upon the device’s cleared use in total knee arthroplasty. Depuy says UKA (partial knee replacement) offers the potential for bone preservation and shortened
Devices
FDA has cleared a Genetic Signatures 510(k) for its EasyScreen Gastrointestinal Parasite Detection Kit and GS1 automated workflow. The device uses the company’s patented 3base technology to identify eight of the most common and clinically relevant gastrointestinal parasites in a single test, from a single patient sample, according
Drugs
An inspection last month at Cipla Ltd.’s Maharasthra, India active pharmaceutical ingredient and finished dosage manufacturing facility resulted in a one-item Form FDA-483 that cited its quality system. FDA investigators said the firm’s responsibilities and procedures for the quality control unit are not fully followed -- personnel
Drugs
FDA says that while there were 55 new drug shortages in CY 2023, actions by the agency, manufacturers, and other groups successfully prevented 236 potential shortages. The information is in the agency’s 11th annual report to Congress on drug shortages. It says that of the 55 new shortages, 33
Biologics
Replimune Group is planning a BLA for its RP1 therapy in combination with nivolumab for treating melanoma patients who’ve failed an anti-PD1 therapy based on just-released data from its IGNYTE clinical trial. The results showed that one-third of patients receiving RP1 plus nivolumab responded to treatment,
FDA Policy/General
Federal Register notice: FDA is issuing an order debarring Marina Sievert for 10 years from importing or offering for import any drug into the U.S. The order is based on her felony conviction for operating the Web site www.beautyforeverflorida.com where she sold a variety of foreign unapproved
Drugs
Medexus Pharmaceuticals says FDA has accepted for review its Medac licensor’s resubmitted NDA for treosulfan, indicated for combination use with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation. Medac’s resubmission provided additional information previously requested by FDA relating to the pivotal Phase 3 clinical trial
Drugs
An FDA briefing document released in advance of a 6/10 meeting of the agency’s Peripheral and Central Nervous System Advisory Committee raises some issues about the safety and effectiveness of Lilly’s donanemab-azbt to treat Alzheimer’s disease. The document says the company’s 6/12/2023
Devices
Eight external stakeholder groups interviewed by the Government Accountability Office for its information sheet on over-the-counter (OTC) hearing aids say several issues should be monitored as the market matures—marketing, children’s use of OTC hearing aids, return policies, and gain limits (the amount of amplification added to
Drugs
Reps. Donna DeGette (D-CO) and Larry Bucshon (R-IN) are asking stakeholders, interest groups, and healthcare advocates for information on what Congress can do to bring about the next generation of healthcare treatments. “Today we are beginning a new chapter in the legacy of 21st Century Cures,” DeGette and
Drugs
FDA and the Clinical Trials Transformation Initiative are hosting an 8/6 hybrid public workshop on artificial intelligence (AI) in drug and biological product development. Meeting organizers say that “AI use in drug development creates new and unique challenges that require both careful management and a risk-based regulatory framework
Devices
University of Missouri—Kansas City researchers say innovation for pediatric orthopedic devices lags substantially behind that for adult orthopedic devices. “These findings are consistent with clinical experience and the common practice of modifying adult implants for off-label use in pediatric patients,” the researchers write in the Journal of Bone
Devices
FDA has cleared a Diasorin 510(k) for its Liaison Plex Yeast Blood Culture Assay for microbiological diagnosis of bloodstream infections. The device detects 16 pathogens commonly associated with fungemia (fungal bloodstream infections). “Fungal pathogens are often seen as an emerging threat and are of great concern due to the
Drugs
FDA has placed a clinical hold on Biomea Fusion’s Phase 1-2 clinical trials of its investigational covalent menin inhibitor BMF-219 in Type 2 and Type 1 diabetes (COVALENT-111 and COVALENT-112), respectively. The agency cited deficiencies based on the level of possible drug-induced hepatotoxicity observed