Devices
FDA has issued an alert on all Baxter Novum IQ Large Volume Pumps and Novum IQ Syringe Pumps after becoming aware of a company notification to users that the devices’ software should be corrected before continued use. The issue is related to software anomalies that may result in a blank
Biologics
A resubmitted Omeros BLA for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) has been hit with a three-month extension after the company provided additional information pursuant to an FDA request. The new user fee review action target date is 12/26. In communicating the extension,
Drugs
FDA has approved a Precigen BLA for Papzimeos (zopapogene imadenovec-drba), which the agency describes as a “first-of-its-kind non-replicating adenoviral vector-based immunotherapy for the treatment of adult patients with recurrent respiratory papillomatosis (RRP).” The rare chronic disease is caused by persistent human papillomavirus (HPV) 6
Devices
FDA has issued an alert after becoming aware that Medtronic recently sent a letter to customers recommending that certain DLP Left Heart Vent Catheters be removed from where they are used or sold. Reports have been received about affected products resisting shape retention when being bent, according to the alert,
Drugs
Pfizer says a Phase 3 study of its investigational sickle cell disease drug inclacumab failed to meet the primary endpoint. THRIVE-131 is evaluating inclacumab, a P-selectin inhibitor, in 241 patients aged 16 and older with sickle cell disease who experienced between two and 10 vaso-occlusive crises (VOCs)
Biologics
FDA has granted Beam Therapeutics a Regenerative Medicine Advanced Therapy designation for BEAM-101, an investigational gene-edited cell treatment for sickle cell disease. The designation follows the agency’s orphan drug status awarded in June for the therapy. Updated clinical data from the BEACON Phase 1/2 clinical trial
Drugs
In an 8/14 open letter to HHS secretary Robert F. Kennedy, Jr. and FDA commissioner Martin Makary, the Multidisciplinary Association for Psychedelic Studies (MAPS) is calling for approval for MDMA-assisted therapy for those living with treatment-resistant trauma. The letter notes that one year ago, FDA issued a
Drugs
President Donald Trump has issued an Executive Order calling for actions to replenish the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) that was created during his first term and then, he says, was depleted by the Biden administration’s lack of effort to ensure domestic sources for essential medicines. The order
Drugs
Schrödinger has discontinued the clinical development program for SGR-2921, its CDC7 inhibitor being evaluated in a Phase 1 dose-escalation study in patients with relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndromes. “Despite early evidence of monotherapy activity observed in the Phase 1 study, based on the
Drugs
FDA has granted Halda Therapeutics a Fast Track designation for HLD-0915, which the company describes as a drug candidate for treating metastatic castration-resistant prostate cancer (mCRPC). In preclinical prostate cancer models, the therapy showed tumor shrinkage, prostate-specific antigen declines, and activity in drug-resistant disease, it says.
Drugs
An 8/12 petition submitted by Foley & Lardner on behalf of a client asks FDA to not approve any ANDA submission for a generic version of Nova Nordisk’s Ozempic (semaglutide injection) unless specified conditions are met. The petition says FDA should ensure that: * the generic drug-device product
Drugs
FDA has published a CDER Manual of Policies and Procedures, Equal Voice Collaboration and Regulatory and Policy Decision-Making in CDER, describing the principles behind the Center’s Equal Voice and how the process is used for collaborative review and regulatory and policy decision-making. The MAPP says CDER uses
Biologics
HHS has revived a task force on safer childhood vaccines, a federal panel created by Congress to improve child vaccine safety, quality, and oversight. The original task force was disbanded in 1998. The new task force is led by NIH director Jay Bhattacharya, and includes representation by senior FDA and
Devices
Thoratec has recalled (Class 1) its HeartMate Mobile Power Unit AC power cords due to unintended power disruptions. According to a just-posted recall notice, a misaligned V-Lock feature on the cords may cause an unintended disconnect. Customer advisory letters were recently sent stating that affected cords will be
Drugs
Texas attorney general Ken Paxton has filed suit against Eli Lilly, charging that the company bribed and illegally induced healthcare providers to prescribe 14 of its most profitable drugs, including the GLP-1 medications Mounjaro and Zepbound (both tirzepatide). A statement (contains a link to the suit) from Paxton’s
Drugs
The Justice Department says two men have been charged as part of its investigation into illegal importation and distribution of misbranded sildenafil, an active ingredient in FDA-approved erectile dysfunction drugs. A department statement says that Jitender Behl of East Greenwich, RI, imported hundreds of thousands of pills from India
Drugs
Ocular Therapeutix says that it has received a written agreement from FDA regarding its registrational trial design under a Special Protocol Assessment for evaluating Axpaxli in the treatment of non-proliferative diabetic retinopathy (NPDR). “This formal agreement ensures direct FDA alignment with our proposed approach for NPDR and provides us
Drugs
FDA is announcing a 12/5 Public Workshop on “Pediatric Drug Development Safety and New Approach Methodologies” to discuss new approach methods that can address pediatric developmental safety during drug development. FDA says the meeting comes at a critical time for pediatric drug development. “An accumulation of knowledge from pediatric
Devices
FDA has granted de novo authorization for the ArteraAI Prostate test, the only artificial intelligence (AI)-powered software authorized to prognosticate long-term outcomes for patients with non-metastatic prostate cancer. A company statement says the authorization establishes a new product code category for future AI-powered digital pathology risk-
Drugs
HHS officials say the agency is investing in On Demand Pharmaceuticals’ Pharmacy on Demand modular manufacturing unit to make the U.S. the most competitive nation in the world for drug manufacturing. An agency statement describes an 8/13 visit made by HHS to On Demand Pharmaceuticals’ new centralized production
Devices
DeepSight Technology says it has received 510(k) clearance for its NeedleVue LC1 Ultrasound System, a device designed to deliver high-precision imaging for image-guided medical procedures. The device works by “leveraging” the company’s proprietary NeedleVue and OnPoint Imaging technologies to provide “real-time, highly accurate, ultrasound-based
Drugs
FDA has issued a Manual of Policies and Procedures (MAPP) detailing how the CDER Office of Pharmaceutical Quality (OPQ) will facilitate and expedite the development, time to submission, assessment, and marketing approval of NDAs and BLAs for products that address unmet medical needs. The document helps fulfill agency commitments on