Biologics
FDA has renewed its funding for the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) under a new five-year $50 million cooperative agreement. A university statement says M-CERSI is a partnership between two University of Maryland campuses and is the oldest of the
Drugs
FDA has cleared an Aion Biosystems 510 (k) for its iTempShield device and software system for continuous measurement of body temperature. The quarter-sized, skin-wearable device is supported by cloud-based software and proprietary algorithms to measure body temperatures for several clinical applications, such as oncology sepsis monitoring, post-
Biologics
Abeona Therapeutics says it will file a BLA for EB-101, a cell therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB), after completing a pre-BLA meeting with FDA. The meeting resulted in an “alignment” with the agency that EB-101’s clinical efficacy and safety data appear adequate
Devices
FDA has granted Quest Diagnostics a breakthrough device designation for its AAVrh74 ELISA assay, an enzyme-linked immunosorbent in vitro diagnostic for the semi-quantitative detection of antibodies (IgG) to AAVrh74 capsid in human serum. The test is intended to be used as an aid to identify patients eligible for
Drugs
A Reagan-Udall Foundation project, the Real-World Accelerator to Improve the Standard of collection and curation of race and Ethnicity data in healthcare (RAISE) is working to find ways to ensure that race and ethnicity data are included in the real-world data being used to support clinical trials.
Drugs
A 1/18-1/27 and 2/10-2/13 FDA inspection at K.C. Pharmaceuticals in Pomona, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 8/3 Warning Letter says specific violations were: * failing to establish and follow appropriate written
Drugs
A 2/13-2/17 FDA inspection at Gadal Laboratories in Miami, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/15 Warning Letter says specific violations were: * failing to validate and establish the reliability of a component supplier’s test analyses at
Devices
A 3/20-3/23 FDA inspection at Tesla BioHealing in Milford, DE, found that the company manufactures the Tesla MedBed Generator and Tesla BioHealer medical devices. An 8/10 Warning Letter says the devices are marketed with indications that they activate cellular self-repair mechanisms to treat a wide
Drugs
Janssen Pharmaceutical has submitted a supplemental NDA that is seeking to convert Balversa’s (erdafitinib) 2019 accelerated approval to full approval. The drug is indicated for treating adult patients with locally advanced or metastatic urothelial carcinoma that has susceptible fibroblast growth factor receptor genetic alterations, and progressed after receiving a
Drugs
FDA has approved a Bristol Myers Squibb BLA supplement for Reblozyl (luspatercept-aamt) for treating anemia in patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who have not been previously treated with an erythropoiesis stimulating agent (ESA-naïve) and who may require regular red blood cell (RBC) transfusions.
Drugs
Attorneys Dominic DiSabatino and Cortney Inman (SheppardMullin) say an 8/11 Warning Letter issued by the CDER Office of Prescription Drug Promotion (OPDP) to Exeltis USA over its Facebook post for Slynd (drospirenone) oral progestin tablets, demonstrates that OPDP is “closely monitoring social media drug promotion and will respond to
Drugs
Nine bipartisan members of Congress from Georgia, led by Sen. Raphael Warnock (D-GA) and Rep. Earl Carter (R-GA), are asking FDA for information on the agency’s response to the continuing shortage of chemotherapy drugs and what it is doing to ensure the safety of imported replacement drugs.
Drugs
Six FDA researchers say alternative trial designs and analytical methods with an iterative process that leverages nonclinical data and clinical observations beyond short-term safety data are needed to identify optimized dosages for newer oncology drugs, given that targeted therapies and immunotherapies often do not demonstrate traditional dose-limiting toxicities
Drugs
Texas has approved legislation creating a Wholesale Prescription Drug Importation Program that would contract with Canadian drug wholesalers and suppliers to bring cheaper prescription drugs into the state. The plan would require HHS approval to be implemented. The Texas Tribune reports the program will not be fully designed until next
Drugs
Senator Elizabeth Warren (D-MA) and Rep. Pramila Jayapal (D-WA) have written FDA commissioner Robert Califf urging him to restrict patents that are listed in the Orange Book to curb loopholes in the patent system that drug companies have “exploited to rake in billions in profits.” The lawmakers complain
Devices
FDA has cleared an ICU Medical 510(k) for the Plum Duo infusion pump with LifeShield infusion safety software. The device features a touch screen with a “highly intuitive user interface” and two channels capable of delivering up to four compatible intravenous medications, the company says. Its cloud-based software
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Customer/Partner Service Satisfaction Surveys.” The collection supports FDA regulations that authorize it to survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services. To view the
Drugs
FDA has approved 15 ANDAs representing the first generics of Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets, Takeda’s attention-deficit/hyperactivity disorder drug. Vyvanse is also approved for treating moderate to severe binge-eating disorder in adults. Companies receiving approval were: Teva Pharmaceuticals, Sun Pharmaceutical, Ascent Pharmaceuticals, Specgx, Rhodes
Drugs
Janssen Pharmaceutical has submitted a supplemental BLA seeking an expanded approval for Rybrevant (amivantamab-vmjw) — combination use with chemotherapy (carboplatin-pemetrexed) as a first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The
Devices
Boston Scientific says it has achieved “positive 12-month results” from its pivotal ADVENT clinical trial of the FaraPulse Pulsed Field Ablation (PFA) System, a nonthermal treatment using electric fields to selectively ablate heart tissue in patients with atrial fibrillation. The study directly compared the device to standard-of-care
Drugs
A Flag Pharma citizen petition is asking FDA to revisit the therapeutic equivalence ratings for generic drugs that relied on bioequivalence studies performed by Maharashtra, India-based Synapse Labs between 2009 and 2023 after Spanish regulatory authorities inspected the facility and documented data integrity and pharmacokinetic anomalies. “Such findings raise
Devices
FDA has cleared a BioProtect 510(k) for its BioProtect Balloon Implant System, a next-generation spacer designed to provide protection to the rectum during prostate cancer radiation therapy. “We believe that our balloon has the potential to revolutionize rectal protection from toxicity during prostate cancer radiation therapy,” the company