Drugs
Revance Therapeutics has resubmitted its BLA for DaxibotulinumtoxinA for Injection, indicated for treating moderate to severe glabellar lines, in response to a 10/21 Complete Response Letter. The company says the submission adheres to input it received 12/2021 during a Type A meeting. Specifically, it says it contains information
Drugs
FDA has accepted for priority review a Servier supplemental NDA for Tibsovo (ivosidenib tablets) as a potential treatment for patients with previously untreated IDH1-mutated acute myeloid leukemia (AML). The submission is based on data from the AGILE study, a global Phase 3 trial in patients with previously untreated IDH1-
Drugs
Gilead Sciences says results from its Phase 3 TROPiCS-02 study evaluating Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2-metastatic breast cancer showed that the therapy met its primary endpoint with a statistically significant improvement in progression-free survival (PFS) versus physician’s choice of chemotherapy. Patients on
Drugs
FDA has placed a partial clinical hold on Alpine Immune Sciences’ NEON-2 trial evaluating davoceticept (ALPN-202) in combination with pembrolizumab (Merck’s Keytruda) in adults with advanced malignancies. The regulatory hold was the result of Alpine’s report of a Grade 5 serious adverse event (patient death) in
Drugs
House Energy and Commerce Committee chairman Frank Pallone (D-NJ) has introduced the Accelerated Approval Integrity Act that would revamp FDA’s accelerated approval program. Accelerated approval reform has been under a microscope lately following FDA’s controversial approval for Biogen's Alzheimer’s therapy Aduhelm (aducanumab). It has
Drugs
FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) 360 mg (injection for intravenous use) for adult patients with resectable non-small cell lung cancer (NSCLC). The approval came five days after the company said the submission was accepted for priority review and having a 7/13 user fee review
Drugs
CDER says it has multiple efforts underway to support rare disease drug development, particularly through data sharing initiatives that are important to advance development in this area. For example, the Center is working with the Critical Path Institute to develop the Rare Disease Cures Accelerator-Data and Analytics Platform, which
Drugs
FDA has issued South Korea-based GC Pharma a complete response letter on its BLA for GC5107 (immune globulin intravenous (human), 10% Liquid) because the agency could not conduct a pre-license inspection of its Ochang facility. “We will continue to communicate with the FDA to coordinate the required onsite
Drugs
Sens. Susan Collins (R-ME) and Shelley Capito (R-WV) are asking the Centers for Medicare and Medicaid Services (CMS) to ensure that its national coverage determination on Biogen’s Aduhelm (aducanumab) and other monoclonal antibody Alzheimer’s drugs does not restrict access and impede research into the disease. In
Drugs
FDA has extended by three months its review of a TG Therapeutics BLA and supplemental NDA for ublituximab in combination with Ukoniq (umbralisib) as a treatment for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The agency told the company that updated overall survival analyses, which were
Drugs
Median Technologies has filed a 513(g) submission seeking FDA guidance on the best path to market for its iBiopsy Lung Cancer Screening Artificial Intelligence/Machine Learning technology-based end-to-end CADe/CADx Software as Medical Device. The submission should give Median information to determine the best product classification
Drugs
Civica says it will manufacture and distribute as early as 2024 three insulins that, once approved, will be available to patients with diabetes at significantly lower prices than products currently on the market. A company statement says it will produce glargine, lispro, and aspart, which are biologics that are interchangeable
Drugs
FDA has published a guidance, Initiation of Voluntary Recalls Under 21 CFD Part 7, Subpart C, to clarify agency recommendations on timely initiation of voluntary recalls and help companies to be “recall ready.” The document discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making
Drugs
A Los Angeles Times analysis is joining the chorus of those raising questions about FDA’s use of accelerated approval pathways for drugs whose benefit has not been shown in clinical trials. The newspaper’s report, reprinted by Yahoo! Finance, says that 14 of the 50 (28%) new drugs approved
Drugs
The 837 medical device recalls in 2021 were 20.2% lower than the 10-year annual average of 1,049 recalls, according to the Sedgwick recall index for 2021. The report shows that software issues remained the top cause for recalls, accounting for 162 events (19.4%). The number of
Drugs
A recent Personalized Medicine Coalition report lists six milestones for 2021 in terms of personalized medicine at FDA. The report says that despite the Covid-19 pandemic, the pace of progress in personalized medicine continues to accelerate as FDA more regularly and rapidly approves diagnostic tools and treatments that expand
Drugs
Karyopharm Therapeutics says that during a recent meeting with FDA officials, the officials expressed doubt that the results of the SIENDO trial would support approval of an sNDA for the company’s selinexor (Xpovio) as front-line maintenance therapy following chemotherapy in patients with advanced or recurrent endometrial cancer. “Karyopharm
Drugs
Attorney Nick Oberheiden (Oberheiden PC) gives a step-by-step approach for responding to an FDA Warning Letter. In his online post, Oberheiden says FDA enforcement actions can have substantial ramifications, and manufacturers who receive Warning Letters must respond appropriately. “However,” he adds, “this does not necessarily mean jumping into
Drugs
FDA has told Finch Therapeutics that a clinical hold remains in place on its Phase 3 trial of CP101 in recurrent C. difficile infection. The company says an agency 2/24 letter said it needed additional information about Finch’s SARA-CoV-2 donor screening protocols. Since 3/2020 FDA
Drugs
FDA has published a guidance, Pre-Launch Activities Importation Requests (PLAIR), finalizing a 7/2013 draft guidance with the same name. The document describes agency policy on requests for the importation of unapproved finished drug products by an applicant preparing the product for U.S. market launch based on anticipated
Drugs
FDA has told Belgium’s Celyad Oncology that it has placed a clinical hold on the company’s CYAD-101-002 (KEYNOTE-B79) Phase 1b trial due to insufficient information to assess the risk to study subjects. The company says it announced on 2/28 that it was voluntarily pausing
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says using registries as part of real-world data (RWD) to support drug and biologic regulatory decision-making “leverages unique, available, and important RWD to understand more about patients and their medical history and can characterize potential benefits and risks in diverse patient