Drugs
FDA has approved a Shorla Oncology NDA for Tepylute (thiotepa), a ready-to-dilute formulation for treating breast and ovarian cancer. “This approval fulfills an unmet need by addressing the shortcomings and handling complexities of the current lyophilized powder formulation,” the company says. “We have taken a vital oncology drug
Drugs
Johnson & Johnson says its Phase 3 Vivacity-MG3 study of nipocalimab in patients with generalized myasthenia gravis (gMG) demonstrated positive results. “Patients treated with nipocalimab plus standard of care (SOC) achieved superiority over placebo plus SOC as measured by the primary endpoint of improvement in the MG-ADL score
Drugs
Two stakeholders are praising a revised FDA draft guidance on promotional labeling and advertising considerations for prescription biological reference products, biosimilar products, and interchangeable biosimilar products. The Biosimilars Council, a division of the Association for Accessible Medicines, says it applauds FDA’s continued commitment to combatting misinformation about biosimilars. “Misinformation
FDA Policy/General
FDA has published a guidance, Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs, with recommendations for the evaluation of the effectiveness of drugs indicated to prevent heartworm disease caused by Dirofilaria immitis in dogs. The document says the recommendations should be read
Drugs
FDA has released the form FDA-483 issued following a 6/10-6/21 inspection at the Cipla drug manufacturing facility in Goa, India. The observations were: * failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods; * aseptic processing areas are deficient regarding the system for
FDA Policy/General
FDA is opening an office in the U.S. embassy in Kigali, Rwanda, to provide direct support to the African Medicines Agency (AMA). Announcement of the office was made by FDA associate commissioner for global policy and strategy Mark Abdoo on 6/26 in a presentation at the 2024 Global
Drugs
FDA says it has determined that the Risk Evaluation and Mitigation Strategies (REMS) for autologous chimeric antigen receptor (CAR) T cell immunotherapies must be modified to minimize the burden on the healthcare delivery system. An online post says currently, the risks for CAR T cell immunotherapies can be conveyed adequately
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” The document describes the format and content of Diversity Action Plans, including the timing and process for submitting such plans by application or notification type.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Priority Zoonotic Animal Drug Designation and Review Process.” The document is intended to assist sponsors seeking a Priority Zoonotic Animal Drug (PZAD) designation for a new animal drug. It also provides the eligibility criteria for PZAD designation, the process
Drugs
FDA has issued Daiichi Sankyo and Merck a complete response letter on their BLA for patritumab deruxtecan (HER3-DXd) for treating adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies. The letter cited findings from an
Drugs
Rep. Jan Schakowky (D-IL) has introduced the Affordable and Safe Prescription Drug Importation Act that would amend the Federal Food, Drug, and Cosmetic Act to allow American wholesalers, pharmacies, and individuals to import “affordable and safe drugs from Canada, the United Kingdom, the European Union, and Switzerland.” In a
Drugs
CDER director Patrizia Cavazzoni says the Support for clinical Trials Advancing Rare disease Therapeutics (START) pilot program started by CDER and CBER is helping to accelerate the development of novel drugs and biologics. In an online post, Cavazzoni says the two Centers created START “with hopes that the insight gained
Drugs
FDA has released the form FDA-483 issued following a 6/3-6/12 inspection at the Torrent Pharmaceuticals finished product and non-sterile active pharmaceutical ingredient manufacturing facility in Indrad, Gujarat, India. The inspection observations were: * failure to have a testing program to assess the stability characteristics of drug
Devices
FDA has granted a de novo marketing authorization to Cepheid for its Xpert HCV test and GeneXpert Xpress System, which the agency says is the first hepatitis C virus (HCV) test that can be used to bring diagnosis to appropriately certified point-of-care settings for individuals at risk for
FDA Policy/General
FDA has published a guidance, Priority Zoonotic Animal Drug Designation and Review Process, to assist sponsors pursuing Priority Zoonotic Animal Drug (PZAD) designation of a new animal drug. The document is intended to provide: * the definition of a PZAD; * eligibility criteria for PZAD designation; * the process for PZAD designation requests;
Drugs
FDA has published a draft guidance, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies, to assist sponsors conducting certain clinical studies involving drugs, biological products, and medical devices to meet the requirements for the submission of diversity action plans under the Federal Food, Drug,
Drugs
FDA has approved a Verona Pharma NDA for Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is described as the “first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years.” Approval
Drugs
BrainStorm Cell Therapeutics says it has reached “alignment” with FDA on chemistry, manufacturing, and controls (CMC) aspects of the company’s upcoming Phase 3b clinical trial for NurOwn, its investigational therapy for treating amyotrophic lateral sclerosis (ALS). A recent Type C meeting between the company and FDA helped the company
Devices
FDA says CDRH is partnering with the Bill and Melinda Gates Foundation to create new analytical methods to help develop breath-based diagnostic devices for disease detection in underserved populations. In an online post, CDRH director Jeffrey Shuren and Office of Science and Engineering Laboratories director Ed Margerrison say the
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a proposed information collection entitled “Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot.” The pilot was agreed upon as part of the medical device user fee commitments for fiscal year (FY) 2023 through FY 2027. The agency says the program
FDA Policy/General
Federal Register notice: FDA is requesting comments on its “Information Technology (IT) Strategy” and ‘”Customer Experience (CX) Strategy.” Under the agency’s user fee program commitments, it must annually update and publish its IT Strategy by 9/30. The initial strategy was published 9/2023 and it outlined the future
Devices
FDA has cleared a Tempus AI 510(k) for its Tempus ECG-AF device that uses artificial intelligence to help identify patients at increased risk of atrial fibrillation/flutter (AF). The company says this is the first FDA clearance for an AF indication in the category known as “cardiovascular machine