Drugs
A 2/18-2/20 FDA inspection at Gussyup, doing business as Private Label Grooming in Henderson, NV, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 7/9 Warning Letter says the specific violations were: * failure of the firm’s quality control
Drugs
Novartis is reporting that its experimental antibody ianalumab, when combined with eltrombopag, significantly extended the time to treatment failure in patients with primary immune thrombocytopenia (ITP) who had previously received corticosteroids. The finding comes from the Phase 3 VAYHIT2 trial and marks another late-stage success for the drug in
FDA Policy/General
Infactory CEO Brooke Hartley Moy says she was not surprised when FDA’s internal artificial intelligence tool Elsa started producing fake research data. Interviewed for an online Cybernews report, Moy says AI models are still far from perfect and are known to hallucinate facts, oversimplify nuance, and generate confident nonsense.
Drugs
FDA has approved an Insmed NDA for Brinsupri (brensocatib) tablets as the first treatment for non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 and older. “There have been no approved therapies for NCFB,” an FDA release says. “Before today’s action, patients relied on antibiotics and symptom management, such
Drugs
Merck says the combination of Keytruda (pembrolizumab) and Pfizer’s Padcev (enfortumab vedotin-ejfv), given before and after surgery, significantly improved survival outcomes in patients with muscle-invasive bladder cancer who cannot receive cisplatin-based chemotherapy. In the Phase 3 KEYNOTE-905 (EV-303) trial, the regimen achieved statistically significant
Drugs
Less than two weeks after abruptly resigning, Vinay Prasad has returned to FDA to continue leading CBER at the request of commissioner Marty Makary and HHS secretary Robert F. Kennedy Jr. Prasad, who had come under attack from right-wing activist and commentator Laura Loomer, former Sen. Rick Santorum (R-
Drugs
Novartis says that it will seek FDA approval of its investigational drug ianalumab after it met the primary endpoint in two Phase 3 trials for Sjögren’s disease, a chronic autoimmune condition that can damage glands, skin, joints, kidneys, lungs, and other organs. Most patients experience dry eyes and mouth,
Drugs
FDA has accepted for priority review a GSK supplemental NDA for gepotidacin as an oral treatment for uncomplicated urogenital gonorrhoea in patients aged 12 and older. The agency has set a user fee review action target date of 12/11. If approved, gepotidacin would become the first oral option for
Drugs
FDA has issued Dr. Reddy's Laboratories a seven-item Form FDA-483 after inspecting the firm’s sterile drug manufacturing facility in Andhra Pradesh, India. According to the FDA-483, the agency cited the following: * Procedures designed to prevent microbiological contamination of drug products purporting to be sterile
Drugs
FDA has accepted for review an Arvinas and Pfizer NDA for vepdegestrant, a first-in-class oral PROteolysis TArgeting Chimera (PROTAC) therapy for treating estrogen receptor–positive/HER2-negative, ESR1-mutated advanced or metastatic breast cancer in patients who have previously received endocrine-based therapy. The agency has set a
Drugs
FDA has approved PharmaTher’s KETARx (ketamine), indicated for use in treating surgical pain. The company says the approval of KETARx “provides a strong foundation for expanding the development of ketamine across diverse therapeutic areas within the company's product pipeline.” It says. Tthese include mental health conditions like
Drugs
FDA says a nationwide shortage of sodium chloride 0.9% injection products has officially ended. “This success is the result of close collaboration between the FDA, the Administration for Strategic Preparedness and Response, and our industry partners, who worked swiftly and strategically to expand manufacturing capacity and restore stability to
Drugs
FDA has granted Boehringer Ingelheim accelerated approval for Hernexeos (zongertinib), a kinase inhibitor for treating adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations. The approval applies to patients whose disease has progressed following prior systemic therapy
Drugs
FDA has sharply expanded its drug quality enforcement efforts since the end of the Covid-19 Public Health Emergency, with foreign oversight reaching all-time highs, according to the agency’s latest State of Pharmaceutical Quality report. FDA investigators conducted 972 drug quality assurance inspections in fiscal year 2024 — nearly
Drugs
FDA says it plans to take action against unapproved animal-derived thyroid medications. An online statement outlines the agency’s concerns with the unapproved medications, saying tablets made from the same manufacturing batches may not always provide the same thyroid hormone levels, and thyroid medications derived from animal thyroid glands
Drugs
Eli Lilly plans to file an NDA by the end of the year for its investigational obesity treatment orforglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist, based on just-announced Phase 3 data showing the drug demonstrated significant weight loss. The ATTAIN-1 study enrolled 3,127
Drugs
FDA has lifted its recommended pause on the use of Valneva’s Ixchiq for chikungunya virus. The agency also has approved updates to the vaccine’s Prescribing Information (PI) to reflect new safety data, particularly in older individuals with chronic health conditions. Ixchiq remains approved in the U.S. for
Drugs
FDA is launching FDA PreCheck, a new program it says will “strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of manufacturing sites in the U.S.” An agency announcement says more than half of the drugs distributed in the U.S. are manufactured overseas,
Drugs
FibroGen and FDA have reached an agreement on important design elements for a pivotal Phase 3 trial of the company’s roxadustat to treat anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS) and high red blood cell burden. A company statement says it will submit the Phase 3
Drugs
FDA has published the draft International Council for Harmonization (ICH) Q3E Guideline for Extractables and Leachables to receive public comment. The document “provides a holistic framework and process for the assessment and control of leachable impurities to further expand the existing ICH guidelines on impurities….” It says it applies to
Drugs
FDA has issued Johnson & Johnson a complete response letter (CRL) for its supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) in a quadruplet regimen in patients with newly diagnosed, transplant-ineligible multiple myeloma. The CRL is based on observations from facility inspections and is not related to any
Drugs
FDA has accepted a Lantheus NDA for a new formulation of its Pylarify F 18 prostate-specific membrane antigen (PSMA) imaging agent, submitted by its affiliate, Aphelion. The agency has set a user fee review action target date of 3/6/2026. The new formulation builds on Lantheus’ current prostate