Drugs
FDA has postponed an 11/18 joint meeting of its Nonprescription Drugs Advisory Committee and Obstetrics, Reproductive and Urologic Drugs Advisory Committee. Panel members were scheduled to discuss a Laboratoire HRA Pharma supplemental NDA for Opill (norgestrel, 0.075 mg) and a proposed indication for a nonprescription use as a
Drugs
FDA has accepted for priority review a Seres Therapeutics BLA for its investigational oral microbiome therapeutic SER-109 for preventing recurrent C. difficile infection (rCDI). The agency has set a 4/26/2023 user fee review action target date. SER-109 comprises purified Firmicutes spores for treating rCDI, which the
Drugs
The International Council for Harmonization (ICH) has released a presentation outlining its finalized guidance entitled “A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials (E19).” The guideline provides recommendations on the use of selective safety data collection that may be applied
Drugs
AstraZeneca has reported positive high-level results from the SERENA-2 Phase 2 trial and the CAPitello-291 Phase 3 trial of new breast cancer drugs. The company says the SERENA-2 trial showed that AZ’s next-generation oral selective estrogen receptor degrader camizestrant met the primary endpoint of
Drugs
A 3/28-4/20 FDA inspection at the Nephron SC drug manufacturing facility in West Columbia, SC, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/11 Warning Letter says the firm also failed to submit an NDA Field Alert Report to the
Drugs
FDA says it is postponing a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting that was scheduled to review and vote on an Ipsen Biopharmaceuticals NDA for palovarotene capsules, indicated for preventing heterotopic ossification in adults and children with fibrodysplasia ossificans progressiva (see earlier announcement). The meeting is being
Drugs
A 4/21-4/27 FDA inspection at the Advanced Cosmetic Research Laboratories drug manufacturing facility in Chatsworth, CA, found significant violations of current good manufacturing practice (CGMP) regulations. A 9/26 Warning Letter says the agency has not received a detailed response from the firm for corrective actions to
Drugs
FDA has released the form FDA-483 issued following a 7/20-8/1 inspection at Jubilant Generics, a Uttaranchal, India, drug manufacturer. The six inspection observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of
Devices
FDA has cleared a NeuroOne Medical Technologies 510(k) to market its Evo sEEG Electrode technology for temporary (less than 30 days) use with equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain. “As opposed to cortical electrodes, sEEG electrodes provide a
Drugs
FDA has approved AstraZeneca’s Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) for treating adult patients with unresectable hepatocellular carcinoma, the most common type of liver cancer. Approval was based on data from the HIMALAYA Phase 3 trial, which showed that patients treated with the combination saw a 22% reduction
Drugs
Janssen Pharmaceutical says new data show that patients given Tremfya (guselkumab) saw a clinical response rate of about 80% in trial subjects with moderately to severely active ulcerative colitis (UC) and who had an inadequate response to previous treatments. The data were from the company’s Phase 2b QUASAR Induction
Drugs
FDA says it does not believe Jazz Pharmaceuticals’ Zepzelca (lurbinectedin) should be withdrawn from the market as requested in a 3/4/21 petition filed by law firm Foley Hoag. The agency denied all elements of the petition except the one asking FDA to explain the basis for allowing the
Drugs
FDA has given accelerated approval to teclistamab-cqyv (Tecvayli, Janssen Biotech), described as the first bispecific B-cell maturation antigen-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myelomas who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory
Drugs
In advance of a 10/26 meeting of the FDA Cardiovascular and Renal Drugs Advisory Committee meeting to consider GlaxoSmithKline’s anemia drug daprodustat, FDA medical reviewers are raising safety concerns about the drug. The company is seeking an indication to treat anemia due to chronic kidney disease in adult
Drugs
CDER Division of Hematologic Malignancies 2 division director Nicole Gormley has been named acting associate director for oncology endpoint development in FDA’s Oncology Center of Excellence. The agency says Gormley will have a dual role, continuing in her capacity as director of the hematology division. In her new role,
Devices
FDA has granted Intelligent Ultrasound a de novo marketing authorization for its artificial intelligence (AI) ScanNav Anatomy Peripheral Nerve Block. The company says the device uses the latest AI technology to assist healthcare professionals in identifying and labeling anatomy in live ultrasound images in preparation for ultrasound-guided regional anesthesia.
Drugs
For the second time in a year, FDA has inspected contract manufacturer Catalent’s Brussels, Belgium, facility, this time resulting in a nine-item Form FDA-483. The September inspection occurred simultaneously with an inspection at the firm’s Bloomington, IN facility that performs fill operations on Moderna’s Covid-
Drugs
FDA says it has determined that there are insufficient data at this time to support a proposed cefazolin susceptible minimum inhibitory concentration (MIC) breakpoint of less than or equal to 16 mg/L as a surrogate for determining breakpoints for oral cephalosporins for treating uncomplicated urinary tract infections (uUTI) due
Devices
FDA has closed out a Warning Letter issued to Innova Medical Group in 2021 that cited its SARS-CoV-2 Antigen Rapid Qualitative Test because it was being marketed without approval, clearance, or authorization from the agency. The letter was issued following two FDA inspections (see earlier story), which also
Biologics
FDA has released a final guidance entitled “Human Gene Therapy for Neurodegenerative Diseases.” The document focuses on considerations for product development, preclinical testing, and clinical trial design. The guidance says that general chemistry, manufacturing and controls for product manufacturing, testing and release of gene therapy products should address challenges associated
Drugs
FDA has accepted for a review a Bristol Myers Squibb supplemental NDA for Camzyos (mavacamten) for an expanded indication to reduce the need for septal reduction therapy (SRT). The therapy is currently approved for treating adults with symptomatic New York Heart Association Class II-III obstructive hypertrophic cardiomyopathy (HCM) to
Drugs
FDA has released three FDA draft guidances that provide general recommendations for physicochemical and structural (Q3) characterization tests, in vitro release test (IVRT) studies, and in vitro permeation test (IVPT) studies for topical generic drug products. The documents are intended to help sponsors who are submitting ANDAs for liquid-based