Drugs
The FDA Oncology Drugs Advisory Committee meets 9/26 to discuss the risk/benefit assessment of using immune checkpoint inhibitors (ICIs) with chemotherapy for the first-line treatment of patients with (1) unresectable or metastatic esophageal squamous cell carcinoma at different levels of programmed death ligand 1 (PD-L1) protein
Drugs
A 2023 inspection at C&T Dream Co. (Cheonan, Korea) resulted in a nine-observation FDA Form-483 that cites significant GMP deviations. For example, the FDA investigator said the laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
Drugs
Gilead Sciences has recalled one lot of Veklury (remdesivir) for injection 100 mg/vial, after it received a customer complaint and confirmed the presence of a glass particle in the product’s vial. “The administration of an injectable product that contains glass particles may result in local irritation or swelling
Drugs
Ideaya Biosciences says it is advancing darovasertib, an investigational therapy for neoadjuvant uveal melanoma (UM), into a Phase 3 trial following “positive interim” Phase 2 clinical trial data and a successful FDA Type C meeting on the registrational trial design for seeking regulatory approval. “Darovasertib has demonstrated compelling preliminary clinical
Drugs
FDA has approved UCB’s Bimzelx (bimekizumab-bkzx) for treating adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS). The therapy is designed to selectively inhibit two key cytokines driving inflammatory processes
Drugs
FDA has approved Zevra Therapeutics’ Miplyffa (arimoclomol) for treating Niemann-Pick disease, Type C (NPC) in adults and children aged two and older. The rare genetic disorder is characterized by progressive neurological deterioration and organ dysfunction, an agency release says. The disease is caused by changes in either the NPC1
Drugs
Vanda Pharmaceuticals is criticizing FDA for failing to approve the company’s NDA for tradipitant to treat the symptoms of gastroparesis. A company statement says FDA issued a complete response letter that “was conclusory in nature, generally disregarded the evidence provided and instead suggested that Vanda conduct additional studies with
Drugs
Bionpharma has recalled (Class 1) a single Batch (#2310083) of atovaquone oral suspension, 750mg per mL, due to contamination with Cohnella bacteria. The product was manufactured by CoreRx in Clearwater, FL and distributed by Bionpharma, a recall notice says. The quinone antimicrobial drug is indicated for preventing pneumocycstis jirovecii pneumonia
Drugs
CDER director Patrizia Cavazzoni and Office of Therapeutic Biologics and Biosimilars director Sarah Yim say a new guidance indicates that a clinical switching study is generally no longer needed to demonstrate interchangeability between a biosimilar and its reference product. Writing in a JAMA Viewpoint, the two say that as the
Drugs
FDA has issued Laboratorios Farmaceuticos Rovi a four-item Form FDA-483 after inspecting the company’s Madrid, Spain manufacturing facility and documenting significant GMP deficiencies. For example, the agency cited the firm over its written records about its investigations into unexplained discrepancies because they do not always include the
Drugs
FDA has just released the forms FDA-483 issued following an 8/26-9/6 inspection at Granules India Limited in Telangana, India, and a 7/25-8/2 inspection at Gland Pharma Limited Units I&II, also in Telangana. Both companies are listed as manufacturing human drugs. The
Drugs
Joint comments from AbbVie, Genentech, and Johnson & Johnson on a draft guidance about pediatric inflammatory bowel disease (IBD) drug development question why FDA does not allow broader use of extrapolating adult data to determine an appropriate dose for pediatric patients. “We recommend that the agency re-evaluate the need
Drugs
Sens. Marco Rubio (R-FL) and Angus King (I-ME) are urging FDA to develop clear regulatory guidelines for advanced manufacturing technologies (AMT) for drugs. In a statement (contains the text of their letter to FDA commissioner Robert Califf), the senators say that with “insufficient levels of domestic pharmaceutical manufacturing,
Biologics
The Institute for Clinical and Economic Review (ICER), a private, independent, nonprofit research institute, says that while it applauds FDA’s continued effort to create policies and guidance to enhance greater diversity in clinical trials, it is concerned about the stated intended goal of a draft guidance on diversity action
Drugs
FDA has approved a new indication for Merck’s Keytruda (pembrolizumab) with pemetrexed (Lilly’s Alimta) and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM). An agency statement says efficacy was investigated in the KEYNOTE-483 trial with the primary outcome measure of
Drugs
Congresswoman Nanette Barragán (D-CA) has reintroduced the Prompt Approval of Safe Generic Drugs Act, legislation that would expand access to lower-cost generic drugs by removing hurdles in the drug approval process. “These barriers otherwise prevent the Food and Drug Administration (FDA) from approving certain follow-on products that
Drugs
Applied Therapeutics says that following a late-cycle review meeting with FDA on the company’s NDA for govorestat to treat classic galactosemia, the agency no longer sees a need for a 10/2024 advisory committee meeting that had been scheduled and is moving forward with its priority review toward
Biologics
FDA has published a guidance, Conducting Clinical Trials with Decentralized Elements, with recommendations for sponsors, investigators, and other interested parties about implementing decentralized elements in clinical trials. The document says decentralized elements can include telehealth, visits with trial personnel, in-home visits with remote trial personnel, or visits with local
Drugs
A 1/25-1/29 FDA inspection at the TJA Health drug manufacturing facility in Joliet, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 7/17 Warning Letter says the specific violations were: * failure to test samples of each component for
Drugs
A 6/12-6/16/2023 FDA inspection at the Quality CDMO drug manufacturing facility in Fort Worth, TX, found the company produces drug products that are legally considered to be unapproved new drugs. A 9/11 Warning Letter reviews claims made for five drug products that are not generally
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) is asking FDA to consider a phased approach to enforcing the Drug Supply Chain Security Act (DSCSA) in light of the mutual dependence among trading partners in the supply chain. The association’s 9/12 comment letter says its members have been working
Drugs
FDA has approved Novartis’ Kisqali (ribociclib) for combination use with an aromatase inhibitor for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) Stage II and III early breast cancer (EBC) at high risk of recurrence, including those with node-negative