Biologics
Enlivex Therapeutics says there were mixed results from its Phase 2 study of Allocetra in patients with sepsis, in which 120 patients enrolled. The company says it is developing Allocetra as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. “Diseases such as solid
Drugs
FDA has granted PureTech Health a fast-track designation for LYT-200 in combination with anti-PD1 therapy for treating recurrent/metastatic head and neck squamous cell carcinomas. LYT-200 is described as an antibody against galectin-9, a potent cancer driver. It is being evaluated in two ongoing clinical
Devices
FDA has granted 16 Bit Inc. a de novo marketing authorization for Rho, an AI-enabled software device aimed at improving osteoporosis screening. The device was given a breakthrough device designation in 2021 as the first FDA-recognized radiology software for opportunistic evaluation of low bone mineral density (BMD), according
Drugs
As FDA continues to evaluate the risk of suicidal thoughts or actions in patients taking glucagon-like peptide-1 receptor agonists (GLP-1 RAs) such as Novo Nordisk’s Ozempic and Wegovy and Lilly’s Mounjaro and Zepbound, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) 4/
Drugs
FDA has approved new safety labeling for Veloxis Pharmaceuticals’ Envarsus XR (tacrolimus), indicated for use with other medicines to help prevent organ rejection in people who have had a kidney transplant. The labeling now reflects an updated contraindication in patients with known hypersensitivity to tacrolimus or to any of the
Drugs
CDER Office of Pharmaceutical Quality acting deputy director of science Susan Rosencrance says the agency has chosen nine applicants for a new Quality Management Maturity (QMM) evaluation program. Speaking at the agency’s Generic Drugs Forum, Rosencrance said the QMM program encourages manufacturers to implement quality management practices that go
FDA Policy/General
Federal Register notice: FDA has determined that UCB’s Kemstro (baclofen) orally disintegrating tablets, 10 mg and 20 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are
FDA Policy/General
Federal Register notice: FDA has determined that Pfizer’s Vistaril (hydroxyzine pamoate) oral suspension, 25 mg/5 mL, was not withdrawn from sale for reasons of safety or effectiveness. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met.
Drugs
Oncolytics Biotech is asking for a 2nd quarter Type C meeting with FDA to discuss its planned registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer. A company statement says its leadership is “optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with
Drugs
FDA has released the form FDA-483 issued following a 3/28-4/4 inspection at the Cipla Limited facility in Raigad, Maharashtra, India, that manufactures human and animal active pharmaceutical ingredients (API) and human drug products. The six inspection observations were: * failure to clean and maintain equipment and utensils
Devices
FDA has given a breakthrough device designation to Roche’s Elecsys pTau217 plasma biomarker test that it is developing with Lilly to aid healthcare providers in identifying amyloid pathology, a feature of Alzheimer’s disease. A Roche statement describes pTau217 as a phosphorylated fragment of the protein tau that is
Drugs
FDA has approved an AstraZeneca supplemental BLA for Fasenra (benralizumab) as an add-on maintenance treatment for patients with severe asthma aged 6 to 11 years with an eosinophilic phenotype. The drug was first approved in 2017 as an add-on maintenance for the treatment of severe eosinophilic asthma in
Devices
FDA has cleared a Neurovalens 510(k) for the Modius Stress and its use to treat generalized anxiety disorder (GAD). The prescription device is designed to treat anxiety by delivering a small electrical pulse to the head for 30 minutes before bed, during which users can do other activities, such
Drugs
The American Society of Health-System Pharmacists (ASHP) says the current 323 ongoing and active drug shortages are the highest number since the society began tracking shortages in 2001. In an online summary with graphs, ASHP says basic and life-saving products are in short supply including oxytocin, Rho(D)
Drugs
U.S. Representative Ro Khanna (D-CA) took FDA commissioner Robert Califf to task during a House Oversight Committee hearing 4/11 on the agency’s Orange Book and frivolous patents that are listed there to prevent cheaper generics from coming to market. The lawmaker said Americans are frustrated because
Drugs
The Court of Appeals for the Federal Circuit has affirmed the 5/17/2023 decision of the Delaware federal court to deny Norwich Pharmaceutical’s petition to modify the court’s final order preventing FDA from approving Norwich’s ANDA for a generic form of Salix’ Xifaxan (rifaximin) 550 mg
Drugs
FDA has authorized Seattle Children’s to launch the first chimeric antigen receptor (CAR) T-cell clinical trial in the U.S. for children under age 18 with the most common form of lupus. “Despite recent advances in lupus management, many patients have lupus that is resistant to current treatment
Devices
FDA has cleared a U.S. Army Biotechnology High Performance Computing Software Applications Institute 510(k) for an artificial intelligence-powered smartphone application (APPRAISE-HRI) that uses vital-sign data from trauma patients to assess their risk of hemorrhage. The clearance will permit the Army’s Medical Research and Development
Drugs
FDA has granted Lisata Therapeutics an orphan drug designation for LSTA1 and its use in treating osteosarcoma, a rare cancer that can develop in children, adolescents and young adults. The investigational drug is designed to activate a “novel uptake pathway that allows co-administered or tethered (i.e., covalently bound)
FDA Policy/General
Federal Register notice: FDA is announcing that it has issued a priority review voucher to Italfarmaco SpA for being the sponsor of a rare pediatric disease product application. FDA has determined that the company’s 3/21-approved Duvyzat (givinostat), indicated for treating Duchenne muscular dystrophy in patients six years
Drugs
Par Pharmaceutical is asking the DC federal court to grant a temporary restraining order to block FDA’s grant of final approval to a BPI Labs NDA supplement for an epinephrine product that cites Par’s Adrenalin (epinephrine) as the reference-listed drug. Par says there is a 30-month
Drugs
The Oncologic Drugs Advisory Committee meets on 4/12 to discuss using minimal residual disease (MRD) as an endpoint in multiple myeloma (MM) clinical trials. An agency briefing document developed in conjunction with two applicants, the University of Miami and 12TEAMM, and distributed in advance of the meeting, says that