Devices
Bausch+Lomb’s Synergetics unit is recalling (Class 1) its I-PACK Injection Kit with Drape, which is used for the administration of an intravitreal (back of the eye) injection, because sterilization certificates could not be validated by the supplier. The company sent an “Urgent Medical Device Voluntary Recall” notice
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of a Takeda NDA for Exkivity (mobocertinib succinate) capsules after the company requested the action in response to a confirmatory study failing to demonstrate the therapy’s clinical benefit. The drug was granted accelerated approval 9/2021 for treating adult patients with locally
Biologics
FDA has granted Bayer-owned Asklepios BioPharmaceutical (AskBio) a fast track designation for AB-1005, a gene therapy candidate for treating moderate Parkinson’s disease. The investigational adeno-associated virus 2 glial cell line-derived neurotrophic factor (AAV2-GDNF) neurorestorative gene therapy is designed for stable and continuous expression of
FDA Policy/General
Federal Register notice: FDA is making available two draft guidances entitled “Dental Composite Resin Devices — Premarket Notification (510(k)) Submissions” and “Dental Curing Lights — Premarket Notification (510(k)) Submissions.” The documents provide recommendations for device description, performance testing, and labeling to include in 510(k) submissions for dental composite resin
Devices
FDA has cleared an Oticon Medical 510(k) for its active transcutaneous bone conduction hearing system, the Sentio System. The device includes the Sentio 1 Mini, an external sound processor, and Sentio Ti Implant, which is placed under the skin. Its design and slim profile make it 26% lighter than
Drugs
AbbVie has filed a supplemental NDA for Rinvoq and its use in treating adult patients with giant cell arteritis (GCA), an autoimmune disease involving medium and large arteries that can cause headache, jaw pain, and changes in vision, including sudden and permanent loss of vision. The submission is based on
Devices
FDA has published draft guidances on dental composite resins and curing lights. The first, Dental Composite Resin Devices—Premarket Notification (510(k)) Submissions, has draft recommendations for dental composite resin 510(k)s. The document says the device is intended to fill and restore defects or carious lesions in teeth.
Devices
Hamilton Medical is recalling (Class 1) its software for the Hamilton-C6 Medical Ventilator because the ventilator may fail to restart ventilation if it enters sensor fail mode after open suction is performed and the patient is reconnected. The agency says the recall is a device correction and not a
Devices
FDA says Baxter is recalling its Life 2000 Ventilators with a specific product code due to potential battery charger dongle damage. An agency online post says the company has received reports that the devices are not properly charging when there is damage to the battery charger dongle. “Baxter has received
FDA Policy/General
Federal Register notice: FDA is providing notice that a patent infringement lawsuit has been filed against Amgen over its BLA submission for a biosimilar copy of Regeneron’s Eylea (aflibercept), indicated for treating wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. The complaint is titled Regeneron Pharmaceuticals,
FDA Policy/General
Federal Register notice: FDA is making available final guidance entitled “Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder (OUD).” The document provides recommendations on pivotal clinical study designs for such devices. To view the notice, click here.
Drugs
FDA has released the form FDA-483 issued following a 5/29-6/12 inspection at the Hikma Pharmaceuticals USA outsourcing facility in Cherry Hill, NJ. The three inspection observations were: * failure to establish and follow procedures designed to prevent objectionable microorganisms in drug products not required to be sterile;
Drugs
The Duke-Margolis Institute for Health Policy has released its summary of a 3/19-3/20 public meeting held with FDA on enhancing the adoption of innovative clinical trial approaches. The workshop discussion aimed to better understand shared opportunities for communication and cooperation to enhance the development and adoption
Drugs
Pfizer says it has selected its preferred once-daily modified-release formulation for danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist it is developing for treating obesity. The company plans to conduct dose optimization studies later this year that will assess multiple doses of the selected modified-
Biologics
FDA has issued Novo Nordisk a complete response letter (CRL) on its BLA for once-weekly basal insulin icodec, indicated for treating diabetes mellitus. In the letter, the agency requested more information about the manufacturing process and the Type 1 diabetes indication before the application’s review can be completed,
FDA Policy/General
The Senate Appropriations Committee 7/11 unanimously (27 to 0) marked up and approved FDA’s fiscal year (FY) 2025 budget, which provides $6.87 billion in total funding for the agency, which is about a $170 million (2.5%) boost over the FY 2024 spending measure. It includes $3.
Drugs
Researchers from FDA and the University of Pennsylvania say payers can be crucial allies in improving evidence generation to inform clinical practice because better data would better inform coverage decisions. Writing in JAMA, the researchers say increasing payer involvement in evidence generation “can benefit all participants in the medical innovation
Drugs
FDA has approved an Arcutis Biotherapeutics supplemental NDA for Zoryve (roflumilast) cream, 0.15%, for treating mild to moderate atopic dermatitis in adult and pediatric patients six years of age and older. The once-daily, steroid-free cream is designed to provide rapid disease clearance and significant reduction in itch,
Drugs
FDA has granted Longeveron a Regenerative Medicine Advanced Therapy (RMAT) designation for Lomecel-B and its use for treating mild Alzheimer’s Disease. The allogeneic cellular investigational therapy is currently being evaluated across multiple indications, including Alzheimer’s (Phase 2a completed), aging-related frailty (Phase 2b completed) and hypoplastic left
Devices
FDA has published a guidance, Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder, with recommendations for the design of pivotal studies for devices intended to treat opioid use disorder (OUD) and used to support marketing submissions. The document says the recommendations apply to the design and
Drugs
Kazia Therapeutics says a Phase 2/3 trial evaluating its paxalisib versus standard of care for patients with glioblastoma demonstrated the drug’s effectiveness in extending overall survival. A company statement says the trial showed a 3.8-month improvement in overall survival for newly diagnosed unmethylated patients with glioblastoma
FDA Policy/General
Federal Register notice: FDA is announcing an 8/6 public workshop entitled “Artificial Intelligence (AI) in Drug & Biological Product Development” to bring drug developers and AI experts together to discuss guiding principles for the responsible use of AI in developing drugs and biological products. Topics for discussion include: * Optimizing