Drugs
Roche says it is withdrawing a Tecentriq (atezolizumab) accelerated approval indication for treating adults with locally advanced or metastatic urothelial carcinoma (bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1
Drugs
Researchers from Harvard University and West Virginia University College of Law say the use of so-called skinny labels “led to years of earlier competition for five biologics through 2021, with estimated savings to Medicare of $1.5 billion through 2020.” Writing in JAMA Internal Medicine, the researchers say that
Drugs
Sen. Richard Burr (R-NC), ranking member of the Senate HELP Committee, says there is no chance of action on legislation to reform FDA oversight of dietary supplements during the lame-duck session of Congress now underway. Axios reports that despite Burr’s definitive statement, a GOP committee aide said
Drugs
FDA has granted Caribou Biosciences a Regenerative Medicine Advanced Therapy designation for CB-010 and its use in treating relapsed or refractory large B cell lymphoma (LBCL), and a Fast Track designation for relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). CB-010 is described by
Drugs
FDA has posted a final guidance entitled “Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridioides difficile Infection Not Responsive to Standard Therapies.” The document outlines the agency’s intended enforcement discretion with respect to IND requirements under limited circumstances. The
Drugs
In approving 11/22 Behring’s Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy to treat adults with Hemophilia B (congenital Factor IX deficiency), FDA simultaneously denied a citizen petition from the National Hemophilia Foundation (NHF) that sought restrictive Risk Evaluation and Mitigation Strategies (REMS) for the
Drugs
FDA has issued Spectrum Pharmaceuticals a complete response letter rejecting the company’s poziotinib and its use in treating patients with previously treated locally advanced or metastatic non-small cell lung cancer that harbors HER2 exon 20 insertion mutations. The letter requested additional data including a randomized controlled study before
Drugs
Janssen says results of the Phase 3b ESCAPE-TRD trial demonstrated that its Spravato (eskeamine nasal spray) had superior efficacy compared to Seroquel XR (quetiapine extended-release) in treatment-resistant major depressive disorder. A company announcement says that Spravato met its primary endpoint, demonstrating a superior efficacy in achieving remission
Drugs
FDA says it is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with Amgen’s osteoporosis drug Prolia (denosumab). “Our review of interim results from an ongoing safety study of Prolia suggests an increased risk of
Drugs
GSK says that at FDA’s request it is withdrawing the accelerated approval for Blenrep (belantamab mafodotin-blmf) due to the therapy’s poor showing in progression-free survival (PFS) in a Phase 3 confirmatory study. The monotherapy treatment was granted accelerated approval in 2020 for adult patients with relapsed
Drugs
FDA has approved Behring’s Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy to treat adults with Hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current of historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes. An agency
Biologics
A 3/1-3/22 FDA inspection at Invitrx Therapeutics, Lake Forest, CA, found multiple violations in the firm’s manufacturing of cellular and acellular products for allogeneic use. An 11/9 Warning Letter says the products are intended to be administered by injection, ophthalmically, or by nebulization and purport
Drugs
FDA has announced a 1/26/2023 Webinar entitled FDA’s Labeling Resources for Human Prescription Drugs that will discuss new resources available for the pharmaceutical industry. The resources are listed on an agency-maintained Webpage and include: * Prescribing Information Resources, which includes a sample template for the prescribing information
Drugs
FDA has approved a Jazz Pharmaceuticals supplemental BLA to add a Monday/Wednesday/Friday (MWF) intramuscular dosing schedule for Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn). The therapy is approved for use as a component of a multi-agent chemotherapeutic regimen for treating acute lymphoblastic leukemia and lymphoblastic lymphoma in adult
Drugs
FDA has approved a Provention Bio BLA for Tzield (teplizumab-mzwv) injection and its use in delaying onset of Stage 3 Type 1 diabetes in adults and pediatric patients eight years of age and older who currently have Stage 2 Type 1 diabetes. “The drug’s potential to delay clinical
Drugs
FDA inspections of drug manufacturing operations are going to be geared to increased scrutiny of management’s responsibility and risk management operations, according to FDA Office of Regulatory Affairs (ORA) Division of Pharmaceutical Quality Operations III program director Jeffrey Meng. He provided an ORA compliance update during an online PharmaLink
Drugs
Pfizer and BioNTech have announced results showing that their current authorized bivalent booster vaccine provides a greater increase in neutralizing antibody titers than their original Covid-19 vaccine against emerging Omicron sublineages. “Based on these findings, the Omicron BA.4/BA.5-adapted bivalent booster may help to provide improved
Drugs
Due to increased demand for amoxicillin oral powder and subsequent shortages, FDA 11/18 issued an immediately in effect guidance on the preparation of beta-lactam oral antibiotic suspension products compounded by pharmacists. The agency says it has received requests for clarification about preparation of compounded versions of the products
Drugs
Comments are due by 11/22 on an FDA proposal published 7/25 to expand the National Drug Code (NDC) from 10 to 12 digits. An 11/17 CDER Small Business and Industry Assistance Webinar explains the reasons for the proposed change and describes the five-year implementation period that
Drugs
FDA has warned seven dietary supplement manufacturers that they are illegally selling products that claim to cure, treat, mitigate, or prevent cardiovascular disease or related conditions such as atherosclerosis, stroke, or heart failure. An agency notice says FDA is urging consumers not to use these or similar products because they
Drugs
FDA has approved Lilly’s Rezvoglar (insulin glargine-aglr) as an interchangeable biosimilar insulin product to Sanofi’s Lantus (insulin glargine). The agency says Rezvoglar is a long-acting human insulin analog indicated to approve glycemic control in adults and pediatric patients with diabetes mellitus. FDA previously approved Rezvoglar as
Drugs
Nine Democratic senators led by Sen. Elizabeth Warren (D-MA) are asking FDA to take three specific steps to protect and expand access to medication abortion. In an 11/17 letter to FDA commissioner Robert Califf, the senators ask that the agency: * finalize the updated Risk Evaluation and Mitigation Strategy