Devices
Eitan Medical has recalled its Sapphire MT Infusion Pump, Sapphire Epidural Infusion Pump, and Sapphire Plus Infusion Pump due to software issues that may fail to detect air in the line when running on battery power. “In some cases, the pump may not sound an alarm when there is air
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Orphan Drugs — 21 CFR Part 316.” The collection supports FDA regulations covering such products, such as recommendations on studies required for a product’s approval. It also supports the conditions under which a sponsor of an approved
Drugs
Pfizer says it will not advance its twice-daily weight-loss drug danuglipron into Phase 3 studies due to high discontinuation rates in a just-reported Phase 2b clinical trial. Instead, the company plans to advance a once-daily formulation of the oral Glucagon-like peptide-1 receptor agonist (GLP-
Drugs
FDA has granted Genmab a breakthrough therapy designation for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously for treating adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Epcoritamab, under the brand name Epkinly, is currently FDA-approved for certain
Devices
Becton Dickinson’ Carefusion unit is recalling (Class 1) its Alaris Infusion Pumps due to compatibility issues with Cardinal Health Monoject syringes. “The Alaris pumps are validated for use with ‘Monoject’ syringes and list ‘Monoject’ as one of the options when the user is selecting a syringe type within the Alaris
Drugs
CDER appears to be clearing its deck of unresolved citizen petitions that have lingered for more than five years at the agency without producing formal responses. In a letter to petition holder BakerHostetler, the Center it has been reviewing unresolved petitions assisgvpned to for action. “One goal of this review
Devices
FDA says it is evaluating the potential for device failures such as leaks, breakage, and other problems involving plastic syringes made in China. An agency safety communication says FDA is collecting and analyzing data to evaluate plastic syringes made in China for injecting fluids into or withdrawing fluids from the
FDA Policy/General
FDA chief scientist Namandjé Bumpus has been selected to replace principal deputy commissioner Janet Woodcock when she retires early next year. In an online “X” announcement, FDA commissioner Robert Califf called Bumpus a “powerhouse scientist and leader, who will continue to advance the agency’s critical public health initiatives using
Drugs
Novo Nordisk says it is pursuing legal proceedings against two compounding pharmacies for selling adulterated and misbranded drugs claiming to contain semaglutide, the active ingredient in the firm’s Ozempic, Rybelsus, and Wegovy. A company statement identifies the pharmacies as Wells Pharmacy, a nationwide compounding pharmacy network, and Brooksville Pharmaceuticals
Drugs
AbbVie says it will engage with FDA about filing for accelerated approval of telisotuzumab-vedotin (Teliso-V) in patients with c-Met protein overexpression, epidermal growth factor receptor wild type, advanced/metastatic nonsquamous non-small cell lung cancer (NSCLC). The decision to seek accelerated approval is based on just-announced
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Product Jurisdiction and Combination Products — 21 CFR Parts 3 and 4.” The collection supports FDA’s authority to assign combination products to the appropriate agency component for regulation. To view the notice, click here.
Drugs
Global biopharm UCB associates itself with comments submitted by Pharmaceutical Research and Manufacturers of America on an FDA workshop on optimizing the use of post-approval pregnancy studies and the development of a framework. It asks the agency to further consider these points: * routine pharmacovigilance is currently considered out of
Devices
FDA has given 510(k) clearance to GE Healthcare’s Critical Care Suite 2.1 featuring a pneumothorax (PTX) algorithm for the detection, notification, triage, and diagnosis of PTX. The company says the updated PTX algorithm expands the suite’s on-device triage capabilities by providing immediate notification of the
Drugs
FDA has granted Arcturus Therapeutics an orphan drug designation for ARCT-032 and its use to treat cystic fibrosis (CF). The company says the first CF patient in its Phase 1b study “successfully” completed two administrations of ARCT-032, adding that interim data will be reported in the first half
FDA Policy/General
Federal Register notice: FDA is proposing to classify into Class 3 certain types of wound dressings and liquid wound washes containing antimicrobials or other chemicals as solid wound dressings, and wound dressings formulated as a gel, cream, or ointment. The agency currently regulates the unclassified devices as those devices requiring
Drugs
FDA has granted fast-track designation to eFFECTOR Therapeutics for its zotatifin in combination with fulvestrant and abemaciclib (ZFA triplet) to treat ER+/HER2- advanced metastatic breast cancer. The company says the designation covers the use of ZFA triplet for second- or third-line treatment of adult patients with disease
Devices
AdvaMed says it appreciates FDA efforts to develop a draft guidance to help support a process for electronic submissions with a De Novo electronic template. The association’s comment letter raises these concerns for the agency to consider as it develops a final guidance: * ensure the De Novo eSTAR guidance
Drugs
The Association for Accessible Medicines (AAM) says that while it recognizes FDA’s significant efforts and investments to design a quality management maturity (QMM) program, it and its members have questions and concerns about the design and planned implementation of the program. In its comment letter, AAM raises these issues:
FDA Policy/General
Sens. Dick Durbin (D-IL) and Charles Grassley (R-IA) asked the Senate on 11/28 for unanimous consent to pass their bipartisan Drug-price Transparency for Consumers (DTC) Act that would require list price disclosures in ads for prescription drugs. A statement from Durbin says Sen. Mike Crapo (R-
Drugs
FDA says the CDER Next Gen Portal now includes a Drug Supply Chain Security Act (DSCSA) portal that enables the agency and trading partners to communicate when FDA requests information about investigations of suspect or illegitimate products or during a recall. An online notice says the DSCSA portal is used
Drugs
FDA has denied a 10/3/2017 petition submitted by Axinn, Veltrop & Harkrider requesting permission to submit an ANDA for apixaban tablets 10 mg, with a reference-listed drug of Bristol-Myers Squibb’s Eliquis in 2.5 mg and 5 mg doses. The denial letter says the proposed
Drugs
FDA has released a 10-item Form FDA-483 related to an inspection last month at SCA Pharmaceuticals’ Windsor, CT outsourcing facility that cited significant GMP deficiencies. For example, the agency took issue with the firm’s lack of quality control efforts because it does not require identification of particulates