Drugs
DA has granted a fast track designation to Myosin Therapeutics and its investigational drug MT-125 for treating glioblastoma (GBM), one of the most aggressive and treatment-resistant brain cancers. “This fast track designation validates our conviction that MT-125 has the potential to offer an entirely novel treatment approach
Drugs
Alector’s efforts to advance a therapy for a rare genetic form of frontotemporal dementia (FTD) to market has ended in disappointment. The company reports that latozinemab (AL001) failed to meet its primary endpoint in a Phase 3 study, prompting the biotech to wind down the development program. The INFRONT-
Drugs
FDA says its review of records submitted by over-the-counter drug product manufacturer Foshan Yiying Hygiene Products Co., in Lishui Town, Guangdong, China, in response to an agency request, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/10 Warning Letter says the
Drugs
The Senate Special Committee on Aging has released a report, “Protecting Seniors’ Access to Essential Medications: Securing the Foreign Generic Pharmaceutical Supply Chain,” focused on what it calls America’s dangerous overreliance on foreign-made generic drugs, which are largely imported from China and India. A committee statement (includes a
Drugs
FDA commissioner Marty Makary recently addressed the agency’s significant shift in enforcement policy directed at direct-to-consumer (DTC) pharmaceutical advertising. During a wide-ranging FDA podcast 10/16, Makary criticized certain drug ads for relying on distracting visuals such as “singing and dancing … marching in some fake town”
Drugs
After receiving several Warning Letters from FDA. Nephron Pharmaceuticals in Columbia, SC, still does not have the needed systems in place to ensure its products are made in a sterile environment. In a news story posted on Yahoo! News, The State, a newspaper in Columbia, says Nephron’s most recent
Drugs
FDA has published the third of a planned four-guidance series on patient-focused drug development. The latest document, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments, covers approaches to selecting, developing, modifying, and evaluating clinical outcome assessments (COAs) to measure outcomes of importance
Drugs
FDA has posted hiring data showing steep declines in staffing at its two key centers, CDER and CBER, responsible for drug and biologics regulation. The figures come amid a sweeping reorganization earlier this year at HHS and mounting concerns that the agency may be losing capacity to keep up with
Drugs
A 3/10-3/26 FDA inspection at the BRS Analytical Services drug manufacturing facility and contract testing laboratory in St. Louis, MO, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 9/17 Warning Letter says the specific violations were: * failure to
Drugs
GSK and Spero Therapeutics are announcing positive Phase 3 results for tebipenem HBr, an investigational oral antibiotic for complicated urinary tract infections (cUTIs), including pyelonephritis. The findings are from the pivotal PIVOT-PO trial, which was stopped early for efficacy following a recommendation from an independent data monitoring committee. The
Drugs
FDA says it is requiring labeling changes to tranexamic acid injection products to strengthen the Warning that it should only be administered intravenously and is not indicated for intrathecal or epidural use. An agency statement says the labeling changes follow FDA’s identification and evaluation of medication error cases of
Drugs
FDA has approved an additional contract with the Institute for Safe Medication Practices (ISMP) to provide expert analysis and data-driven insights to strengthen the agency’s ability to identify and reduce the risk of medication errors. ISMP says it will collaborate with CDER to advance postmarket surveillance, identify potential
Drugs
A 3/17-3/21 FDA inspection at the Guangxi Yulin Pharmaceutical Group drug manufacturing facility in Yulin, Guangxi, China, found repeated significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/30 Warning Letter says the specific violations were: * failure to have, for each batch
Drugs
FDA has granted Quoin Pharmaceuticals an orphan drug designation for QRX003 and its use in treating Netherton syndrome, a rare and severe genetic skin disorder. Quoin is conducting two pivotal, late-stage clinical trials evaluating QRX003 lotion (4%) in patients with Netherton syndrome. Enrollment in both studies is expected to
Drugs
FDA has approved Genentech’s Gazyva (obinutuzumab) for treating adult patients with active lupus nephritis who are receiving standard therapy. The approval makes Gazyva the first anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in a Phase 3 trial of lupus nephritis patients, according to the company.
Drugs
FDA has accepted for review a Replimune BLA resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for treating advanced melanoma in patients whose disease has progressed on an anti–PD-1-based regimen. The agency set a user fee review action target date of 4/10. The company says
Drugs
Roche says new data from the Phase 3 evERA Breast Cancer study show its investigational oral therapy giredestrant, used in combination with everolimus, significantly improved progression-free survival (PFS) in patients with estrogen receptor-positive, HER2-negative advanced breast cancer. According to the data, the combination reduced the risk of
Drugs
Summit Therapeutics is reporting that its investigational bispecific antibody ivonescimab, when combined with chemotherapy, significantly reduced the risk of disease progression or death by 40% compared with tislelizumab (BeiGene’s Tevimbra) plus chemotherapy in the Phase 3 HARMONi-6 trial for first-line treatment of patients with advanced squamous non-
Drugs
FDA has approved a new indication for Novo Nordisk’s Rybelsus (oral semaglutide) tablets to reduce the risk of major adverse cardiovascular events (MACE) — including cardiovascular death, heart attack, or stroke — in adults with Type 2 diabetes who are at high risk for such events, with or without a prior
Drugs
Kenvue is urging FDA to deny a recent citizen petition requesting updates to the pregnancy warning on acetaminophen products. The 9/22 petition sought to add labeling linking acetaminophen use during pregnancy to neurodevelopmental disorders, including autism. It also proposed limits on dose, frequency, and duration for both consumer and
Drugs
A new report by RBC Capital Markets analyzing FDA approval trends finds a slowdown in drug approvals, a rise in rejected applications, and an increase in delayed reviews during the third quarter. Financial analysts found that the drug approval rate dropped to 73% in the third quarter, a significant decrease
Drugs
FDA has approved expanded indications for Celltrion’s Yuflyma (adalimumab-aaty) and its unbranded version to include the treatment of hidradenitis suppurativa (HS) in adolescent patients aged 12 years and older, and uveitis (UV) in pediatric patients aged two years and older. HS and UV are currently approved in adult