Drugs
Medical device maker Magellan Diagnostics (Billerica, MA) has agreed to pay $40 million to resolve criminal charges relating to its concealment of a device malfunction that produced inaccurately low lead test results for potentially tens of thousands of patients. “As part of the criminal resolution, Magellan will plead guilty to
Drugs
Pharmaceutical Researchers and Manufacturers of America says revision of the International Council for Harmonization E2D(R1) guidance on definitions and standards for managing and reporting individual case safety reports (ICSRs) on post-approval safety data “is an important step towards consideration of how new and emerging data sources should be
Biologics
An FDA 9/20-9/30/2022 inspection at Akan Biosciences in Gaithersburg, MD, found the firm manufactures Ayama, an adipose-derived stromal vascular fraction cellular product for allogenic use that does not have agency approval. A just-released 4/30 Warning Letter says Ayama is regulated as both a
Drugs
FDA has approved a 200 mg subcutaneous version of GSK’s Benlysta (belimumab), a B-lymphocyte stimulator (BLyS)-specific inhibiting monoclonal antibody, for patients five years of age and older with active systemic lupus erythematosus (SLE) who are receiving standard therapy. The new route of administration provides pediatric patients the
Drugs
An FDA 10/16-10/20/2023 inspection at the Seatex drug manufacturing facility in Rosenberg, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/1 Warning Letter says specific violations were: * failure to establish and follow adequate written procedures for
Drugs
FDA has revised its user fee review action date from 2/28/2025 to 12/29/2024 for a Bristol Myers Squibb BLA for a subcutaneous formulation of Opdivo (nivolumab) across all previously approved adult solid tumor indications as monotherapy. “If approved by the FDA, the subcutaneous administration of nivolumab
Drugs
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Drugs
FDA says the future of clinical research will “depend on generating evidence in simpler and more efficient ways, including incorporating innovation into routine clinical practice and expanding access to clinical trials.” In an online post observing Clinical Trials Day, FDA chief medical officer Hilary Marston says the recently established CDER
Drugs
FDA has removed a partial clinical hold on Larimar Therapeutics’ nomlabofusp (CTI-1601), which is being evaluated for treating patients with Friedreich’s Ataxia (FA). Nomlabofusp is described as a novel protein replacement therapy designed to address the root cause of FA by delivering frataxin to mitochondria. The company says
Drugs
FDA has issued Elevar Therapeutics and its Chinese partner, Jiangsu Hengrui Pharmaceuticals, a complete response letter for their combination rivoceranib and camrelizumab for treating liver cancer. The agency letter cited chemistry, manufacturing, and controls deficiencies found during a recent inspection, according to the companies. It also indicated that due to
Drugs
FDA has cleared an Implicity 510(k) for its algorithm SignalHF used in its remote monitoring for heart failure. The company says it used its access Health Data Hub, one of the largest databases of patients with heart disease in the world, to train and validate a machine learning algorithm
Drugs
Representatives Raul Ruiz (D-CA) and Larry Bucshon (R-IN) have introduced bipartisan legislation, Clinical Trial Modernization Act, to improve participation in clinical trials by underrepresented populations. The bill would address economic barriers that can prevent participation in clinical trials, and permit HHS to issue grants or enter into contractual
Drugs
FDA has cleared a Brainomix 510(k) for its Brainomix 360 e-Lung for lung imaging. The artificial intelligence-based workflow enhancement and visualization tool helps assess CT scans and thoracic datasets, providing automatic and objective quantifications of the lungs including lung segmentation, volumetric measurements, structural and coarse density evaluations,
Drugs
FDA has granted Notal Vision a de novo authorization for its patient self-operated SCANLY Home optical coherence tomography (OCT) device. The device was previously designated as a breakthrough device for patients suffering from wet, or neovascular, age-related macular degeneration. It captures spectral-domain OCT images in a 10
Drugs
FDA has published 32 new product-specific guidances (PSGs) with recommendations for developing generic drugs and generating evidence to support ANDA approvals. The new PSGs include 26 new documents, with 10 for new chemical entities, and six revised guidances. Some 25 of the new PSGs are for products with no
Drugs
The Humane Society of the United States is petitioning FDA to take specific steps to clarify agency rules on animal testing for the development and approval of drugs. The 5/15 petition specifically asks that FDA: * amend current regulations that misleadingly suggest animal tests may be required for drug approval
Drugs
Eli Lilly says that in the QWINT-2 and QWINT-4 trials, its once-weekly insulin efsitora alfa showed non-inferior A1C reduction compared to the most commonly used daily basal insulins globally in adults with Type 2 diabetes using insulin for the first time and those who require multiple
Drugs
An FDA guidance, Drug Products, Including Biological Products, that Contain Nanomaterials, focuses on identifying and managing risks that are present when nanomaterials are part of a product, according to CDER Office of Pharmaceutical Quality review chemist Andrei Ponta. Speaking on a CDER Small Business and Industry Assistance Chronicles podcast, Ponta
Drugs
Drug recall events dropped 14.5% in the first quarter of 2024 below the fourth quarter of 2023, according to the Sedgwick Recall Index for the first quarter. The index shows that failed specifications were the leading cause, affecting 23.2% of the 112 recalls. The total affected units fell
Drugs
FDA has granted Amgen accelerated approval for its BLA for Imdelltra (tarlatamab-dlle) for extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Approval was based on data from DeLLphi-301 [NCT05060016] clinical trial in 99 patients, according to an FDA release.
Drugs
An FDA 11/27-11/30/2023 inspection at Cohere Beauty’s Health Specialty drug manufacturing facility in Santa Fe Springs, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/15 Warning Letter says the specific violations were: * failure to establish
Drugs
In 2023, CDER approved 55 novel drugs either as new molecular entities through NDAs or new therapeutic biologics under BLAs. The Center’s Drug Trials Snapshot Summary Report 2023 says 36% of the novel drugs were first-in-class. Some 53% of the approvals were for the treatment of rare