Drugs
FDA has given Soligenix the green light to advance a pivotal Phase 3 clinical trial evaluating SGX942 (dusquetide) for treating oral mucositis in head and neck cancer patients being treated with chemoradiation (CRT). The company plans to begin the trial in the second quarter. Based on positive Phase 2 results
Drugs
FDA has approved an investigator-initiated IND to begin a Phase 1 trial involving ZioPharm Oncology’s CD33-specific CAR-T therapy for relapsed or refractory acute myeloid leukemia (AML). The first patient is expected to be enrolled in the study in the third quarter. The CD33-specific CAR-T
Drugs
Seven patient advocacy groups — Alliance for Aging Research, American Cancer Society Action Network, Friends of Cancer Research, Leukemia and Lymphoma Society, National Organization for Rare Disorders, Parent Project Muscular Dystrophy, and St. Baldrick’s Foundation — say it is “imperative that patients seeking expanded access to unapproved therapies be treated with
Drugs
FDA has released the FDA-483 issued following a 4/10-4/18 agency inspection at Aurobindo Pharma, Hyderabad, Telangana, India. Inspection observations included: * failing to have laboratory controls include establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that components and drug products conform
Drugs
FDA has told Intra-Cellular Therapies that it has concerns with certain findings observed in nonclinical animal toxicology studies involving ITI-007 (lumateperone), an investigational therapy for schizophrenia. During a company-requested feedback meeting, the agency requested additional information to confirm that the nonclinical findings are not indicative of a
Devices
FDA has approved a Medtronic PMA for the Resolute Onyx Drug-Eluting Stent (DES) in 4.5 mm and 5.0 mm sizes to treat patients with large coronary anatomies. The company says the device is the first DES to feature core wire technology, a stent manufacturing method that involves
Drugs
Medical ethicist Arthur Caplan and two other Health Affairs bloggers warn that “right-to-try” legislation that purports to give terminally ill patients the right to try experimental drugs outside of a clinical trial “will do nothing to make companies more likely to grant patients access to their experimental drugs
Drugs
FDA has released the FDA-483 issued at the conclusion of a 4/17-4/21 inspection at Nephron Pharamceuticals, West Columbia, SC. Specific violations noted on the form include: * failing to include adequate validation of the sterilization process in procedures designed to prevent microbiological contamination of a drug product
Devices
FDA says that ReFlow Medical is recalling specified lots of its Wingman35 crossing catheters. An agency notice says the catheters have been found to exhibit tip splitting or separation, which has resulted in two adverse events. Tip splitting has the potential to lead to loss of device function, the notice
FDA Policy/General
Senate Health, Education & Pensions Committee leaders have scheduled a 5/10 mark-up of S 934 “Food and Drug Administration Reauthorization Act,” a bill to reauthorize the user fee agreements for the next five years. The measure reflects the recommendations sent by FDA to Congress in January, which were
Devices
FDA has classified as Class 1 a recall of Newport Medical Instruments’ Newport HT70 and Newport HT70 Plus ventilators due to a software issue that may cause an unexpected shutdown without alarm. The devices are used to provide breathing support for individuals who require mechanical ventilation. An FDA recall notice
Biologics
FDA has issued a guidance, Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), to provide agency recommendations for testing living donors for West Nile Virus using an FDA-
Drugs
Implementation of policies at academic medical centers that restricted pharmaceutical detailing between 2006 and 2012 was associated with modest but significant reductions in prescribing of detailed drugs across six of eight drug classes, according to research published (subscription or purchase required) online in the Journal of the American Medical Association.
Devices
FDA has cleared a Luminex Corp. 510(k) for the ARIES Bordetella Assay for detecting and identifying of Bordetella pertussis and Bordetella parapertussis nucleic acid in nasopharyngeal swab specimens obtained from individuals suspected of having a respiratory tract infection attributable to either organism. The assay works on the company’s
Drugs
A Health Affairs blog post outlines three complex challenges facing FDA commissioner nominee Scott Gottlieb and ways in which he could address them. The post says that critics and supporters who seek to judge what Gottlieb would do as commissioner are trying to discern the answer to a question that
Drugs
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Criticare Technologies North Kingstown, RI (4/21): FDA inspected the firm in March and cited it for GMP violations related to its patient vital sign monitors. For example, FDA
FDA Policy/General
Federal Register notice: FDA has reopened the comment period regarding issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established under the Drug Supply Chain Security Act (DSCSA). The information
FDA Policy/General
Federal Register notice: FDA has recently determined that a list of drug products were not withdrawn from sale for reasons of safety or effectiveness. This determination means that the agency will not begin the process to withdraw approval of ANDAs that reference the products, and it will allow the approval
Drugs
Dr. Reddy’s Laboratories tells stock analysts in India that FDA completed its inspection of the firm’s formulation manufacturing plant at Bachupally, Hyderabad, India, and issued an FDA-483 containing 11 observations. “These observations are mostly procedural in nature,” the firm says, “reflecting the need to improve people capabilities
Drugs
A 6/27-7/1/16 FDA inspection at Sal Pharma, Hyderabad, Andhra Pradesh, India, found significant deviations from current good manufacturing practices for active pharmaceutical ingredients (API), according to a 4/30 Warning Letter. Specific deviations included: * failing to transfer all quality or regulatory information received from the API
Devices
A 3/6-3/29 FDA inspection at Unetixs Vascular, North Kingstown, RI, found violations of the Quality System Regulation in the firm’s manufacturing of vascular diagnostic ultrasound systems such as the MultiLab Series 2. A 4/25 Warning Letter says that significant violations included: * failing to establish and
Drugs
The Esophageal Cancer Action Network is asking FDA to require a stronger warning about the risk of esophageal cancer for all OTC drug products labeled to relieve or prevent heartburn associated with reflux disease, acid indigestion, and sour stomach. “The warnings should note that these OTC drug products do not