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
Biologics
FDA is hosting a one-day public workshop 10/23 to explore new approaches for approving patch test allergens used in diagnosing allergic contact dermatitis (ACD) — a common inflammatory skin condition affecting millions of Americans. The virtual workshop is intended to bring together regulators, clinicians, academic researchers, and industry stakeholders
Devices
A 4/7-4/9 FDA inspection at Levo AG in Wohlen, Switzerland, found multiple violations in the firm’s manufacturing of several models of Class 2 stand-up wheelchairs. A just-released 7/18 Warning Letter says the specific violations were: * failure to establish and maintain a quality system
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
Biologics
Attorneys at Hyman, Phelps & McNamara say they are encouraged by an FDA draft guidance outlining a roadmap for postapproval monitoring of cell and gene therapies (CGT). Writing in the law firm’s online FDALawBlog, the attorneys acknowledge that FDA and industry are in the early stage of commercial CGT
Devices
In a recent submission to the Trump administration, the Advanced Medical Technology Association (AdvaMed) outlined a series of recommendations aimed at strengthening U.S. leadership in medical technology and safeguarding national security amid reliance on imported devices, personal protective equipment and medical consumables. AdvaMed proposed the creation of a new
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
Drugs
FDA has announced the first nine voucher recipients under the recently launched Commissioner’s National Priority Voucher (CNPV) pilot program. Each recipient has a product with significant potential to address a major national priority, such as meeting a large unmet medical need, reducing downstream health care utilization, addressing a public
Drugs
FDA has approved Azurity Pharmaceuticals’ Ferabright (ferumoxytol injection), an iron-based contrast agent for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant brain tumors. The product is designed to help radiologists visualize lesions with a disrupted blood-brain barrier, enhancing the detection and delineation
FDA Policy/General
Sen. Jim Banks (R-IN) is urging FDA to step up inspections of pharmaceutical manufacturing facilities abroad, citing persistent quality lapses and lagging oversight in countries that supply the majority of U.S. drug ingredients. In a 10/16 letter to FDA commissioner Marty Makary, Banks warned that “shoddy foreign
Drugs
A controversial FDA safety communication on acetaminophen and autism — issued immediately after a 9/22 press conference featuring president Donald Trump, HHS secretary Robert F. Kennedy Jr., and FDA commissioner Marty Makary — has drawn sharp concern from legal experts who say the agency appears to be moving away from long-