Drugs
FDA researchers say 99.7% of good clinical practice (GCP) inspections conducted from 2017 to 2023 were classified as either NAI (no action indicated) or VAI (voluntary action indicated), and their recommendations and final classifications remained highly congruent. Writing in the open-source Therapeutic Innovation & Regulatory Science, the researchers
Drugs
A 2/3-2/14 FDA inspection at the Glenmark Pharmaceuticals Limited drug manufacturing facility in Pithampur, Madhya Pradesh, India, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 7/11 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexplained discrepancy
Drugs
A Center for Medicine in the Public Interest (CMPI) report says FDA regulatory failures in enforcing limits on GLP-1 compounding put patients at risk. The report was written by former FDA associate commissioner Peter Pitts, CMPI president. Pitts says a temporary shortage of the GLP-1 drugs that have
Drugs
FDA has named Stanford pediatrics (neonatology) adjunct professor George Tidmarsh, an industry veteran for over 30 years, as the new CDER director. Tidmarsh is replacing former Center director Patrizia Cavazzoni, who left the agency in the early days of the Trump administration and has since returned to her industry roots
Drugs
Sarepta is brushing off a 7/18 “informal” request from FDA to voluntarily halt shipment of Elevidys (delandistrogene moxeparvovec), a gene therapy for Duchenne muscular dystrophy. The request was in response to two reports of fatal acute liver failure following treatment of non-ambulatory pediatric male Duchenne patients with the
Drugs
Roche says its investigational chronic obstructive pulmonary disease (COPD) drug astegolimab showed mixed results in two key late-stage clinical trials evaluating its effectiveness in reducing patient exacerbations in those with moderate to very severe chronic conditions. The company’s Phase 2B ALIENTO trial met its primary endpoint, with astegolimab
Drugs
Johnson & Johnson has submitted an NDA for icotrokinra, which it describes as a first-in-class oral therapy for moderate to severe plaque psoriasis. If approved, icotrokinra would be the first targeted oral peptide to block the interleukin-23 (IL-23) receptor for both adults and adolescents aged 12
Drugs
FDA has posted an International Conference on Harmonization draft guidance entitled E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials. The document provides recommendations for the appropriate inclusion and retention of pregnant or breastfeeding women in clinical trials. The agency says the scope of the guidance includes pre- and
Drugs
FDA has rejected Genentech’s move to broaden the use of its lymphoma drug Columvi (glofitamab-gxbm). The agency issued the company a complete response letter rejecting its supplemental BLA to expand Columvi’s use in combination with chemotherapy for patients with relapsed or refractory diffuse large B-cell lymphoma
Drugs
FDA’s Psychopharmacologic Drugs Advisory Committee 7/18 voted 10 to 1 against approving an Otsuka Pharma NDA for Rexulti (brexpiprazole) when used in combination with Zoloft (sertraline) for treating adults with post-traumatic stress disorder (PTSD). The panel members said available data do not establish the efficacy of the
Drugs
FDA’s Oncologic Drugs Advisory Committee 7/17 voted against approving GSK’s BLA for Blenrep (belantamab mafodotin) for treating adults with multiple myeloma in combination with other therapies in patients who have received at least one prior line of therapy. Panel members voted five to three against the risk-
Drugs
Dexcom is recalling (Class 1) certain Dexcom G6, G7, ONE, and ONE+ glucose monitoring receivers because a speaker problem may prevent an alert from sounding when blood sugar is dangerously low or high. “The use of affected product may cause serious adverse health consequences, including seizures, vomiting, loss of consciousness,
Drugs
Sen. Marsha Blackburn (R-TN) and Tennessee attorney general Jonathan Skrmetti are calling on the Federal Trade Commission to investigate what they say are “shady online marketing practices of GLP-1 receptor agonists.” In a 7/17 letter, Blackburn and Skrmetti say the drugs, which are promoted as alternatives to
FDA Policy/General
In the first six months of this year, CDER lost 385 employees and only added 18, according to an online BioSpace post. That contrasts with the situation in 2024, when CDER had lost just under 130 employees and had hired nearly 250 new staff. The post says staff statistics for
Drugs
FDA says B. Braun Medical has notified customers recommending that certain microbore extension sets be removed from the market because their labels show incorrect information about the device’s filter. Specifically, the product label shows that the device contains an air-eliminating filter, but an FDA alert says the filter
Drugs
FDA has granted priority review to Johnson & Johnson’s NDA for TAR-200 for treating patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ, with or without papillary tumors. The intravesical drug-releasing system is designed to provide sustained
Drugs
A study raises questions about the ability of an FDA-approved surrogate endpoint — pathologic complete response (pCR) — to reliably predict improvement in long-term survival in patients diagnosed with rectal cancer. The study, by Tulane University researcher Kavin Sugumar in association with Mayo Arizona and other medical centers, was published
Drugs
FDA Oncology Center of Excellence (OCE) director Richard Pazdur says the agency and its international partners are considering expanding Project Orbis from exclusively oncology products to other therapeutic areas. Project Orbis is a collaborative program led by OCE that facilitates the concurrent submission and review of oncology products among international
Drugs
A Phase 3 clinical trial evaluating Alexion’s anselamimab for light chain (AL) amyloidosis failed to meet its primary endpoint in the overall study population, but showed significant clinical benefit in a predefined subgroup of patients, according to just-released topline results. The Cardiac Amyloid Reaching for Extended Survival (CARES)
Drugs
FDA says it will accept applications until 2/10/2026 for the Office of Orphan Products Development’s Natural History Studies Grant Program. A grant notice says the funding opportunity is intended to support prospective or retrospective, efficient, and innovative natural history studies with a focus on collaborative and standardized
Drugs
FDA has released the form FDA-483 issued following a 6/9-6/19 inspection at Natco Pharma Limited, a Rangareddy, Telangana, India, sterile and non-sterile drug manufacturer. The seven inspection observations were: * aseptic processing areas are deficient regarding the system for monitoring environmental conditions; * failure to maintain equipment
Drugs
FDA has published a draft guidance, Development of Cancer Drugs for Use in Novel Combination—Determining the Contribution of the Individual Drugs’ Effects, with recommendations for characterizing the safety and effectiveness of individual drugs for use in a novel combination regimen in treating cancer. The document says the guidance is