Biologics
FDA has published a draft guidance, Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment, to assist sponsors who are developing medical products to treat the underlying pathophysiology and structural progression of osteoarthritis. The document says that approvals for osteoarthritis to date have been based
Biologics
FDA has sent untitled letters to registrants of two Web sites that promote the iCare HIV 1&2 Rapid Screen Test and the iCare One-Step HIV 1/2 Oral Fluid Test cautioning that the tests are not approved for sale in the U.S. and have not received
Biologics
Evolus has resubmitted a BLA for DWP-450 (prabotulinumtoxinA) for treating glabellar lines, also known as frown lines, in adult patients. If approved, DWP-450 would be a competitor to Allergan’s Botox. The resubmission follows a May complete response letter that requested the submission of additional data to complete
Biologics
FDA has issued a draft guidance, Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis, with the agency’s assessment of babesiosis as a relevant transfusion-transmitted infection. The document, directed to blood establishments that collect blood and blood components, contains recommendations for donor screening, donation testing, donor deferral, and
Biologics
FDA has told ADMA Biologics that it has closed out an April Establishment Inspection Report (EIR) issued after a compliance inspection at the firm’s Boca Raton, FL production facility. The EIR cited requests for clarification and information, as well as a summary of potential next steps for the review
Biologics
FDA has accepted for priority review an Immunomedics BLA for sacituzumab govitecan and its use in treating patients with metastatic triple-negative breast cancer who previously received at least two prior therapies for metastatic disease. Sacituzumab govitecan is described by the company as a novel, first-in-class antibody-drug
Biologics
FDA has accepted for review a Genentech BLA for a subcutaneous formulation of Herceptin (trastuzumab) and its use in FDA-approved breast cancer indications. This is a co-formulation with Halozyme’s proprietary recombinant human hyaluronidase enzyme (ENHANZE technology), which is approved and marketed under the Herceptin subcutaneous brand in
Biologics
FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), an anti-PD-1 therapy for treating previously treated patients with advanced hepatocellular carcinoma. The submission is based on data from the Phase 2 KEYNOTE-224 trial, which were recently presented at the 2018 American Society of
Biologics
CBER says it is planning to develop 15 guidances during calendar year 2018. The guidances are grouped under two categories — blood and blood components and tissues and advanced therapies.
Biologics
CBER says that as of 10/1, it will increase the use of secure e-mail for regulatory communications in an effort to streamline and facilitate communication with sponsors and protect proprietary and company confidential information. After 10/1, the notice says, outgoing e-mail communications containing regulatory information will
Biologics
Public Citizen says HHS has made substantive changes to the protocol and consent forms for a National Institutes of Health clinical trial that the advocacy group said had potentially serious ethical violations. In an 8/1/17 letter, Public Citizen called for immediate suspension of the Myocardial Ischemia and Transfusion
Biologics
FDA has accepted for review a Bio Products Laboratory supplemental BLA for Coagadex (coagulation factor X, human) for prophylactic treatment of hereditary factor X deficiency. The submission is based on data from TEN02, a Phase 3 prospective study. The primary endpoint was the investigator’s assessment of overall efficacy, “which
Biologics
FDA has approved a Hospira BLA for Retacrit (epoetin alfa-epbx), the first biosimilar version of Amgen’s Epogen/Procrit (epoetin alfa) for treating anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery
Biologics
FDA has approved a Janssen supplemental BLA to use Darzalex (daratumumab) in combination with bortezomib, melphalan and prednisone for treating patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. The agency’s decision came a few weeks ahead of the scheduled 5/21 user fee
Biologics
FDA has released two charts showing the number of HCT/P (human cells, tissues, and cellular and tissue-based products) inspections performed in fiscal years 2013-2017. They ranged from 598 in FY 2015 to 671 in FY 2013. There were 621 inspections in FY 2017. The number of inspections
Biologics
FDA has accepted for review a Sanofi Pasteur supplemental BLA to expand the age indication of its Fluzone Quadrivalent (influenza vaccine) 0.5 mL dose to include children aged six through 35 months. The agency has set a user fee review action target of 1/28/2019. If approved, physicians
Biologics
Reacting to an incident in which a south Florida clinic performed unproven stem cell treatments that left three female patients blind, Sen. Charles Grassley (R-IA) has asked HHS and FDA for additional information. Grassley’s letter to the agencies cited a Washington Post report indicating that the three women
Biologics
FDA has accepted for review a Bristol-Myers Squibb supplemental BLA for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for treating adults with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan. The agency has set a user fee
Biologics
FDA commissioner Scott Gottlieb says the agency is working on about a dozen new policies to help the fledgling biosimilar market grow and gain acceptance. “We are going to be advancing new policies to try to stimulate more biosimilar development,” Gottlieb said during a 3/28 keynote address at CNBC’
Biologics
CBER has released a list of 12 guidance documents in three categories it plans to publish during the 2018 calendar year. The document says the list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CBER has already
Biologics
FDA has accepted for review a Merz North America supplemental BLA for Xeomin (incobotulinumtoxinA) for treating chronic sialorrhea (excessive drooling) due to Parkinson’s Disease or other neurologic disorders in adult patients. The submission is based on a Phase 3 study, which Merz says met both of its co-primary
Biologics
FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) for treating patients with advanced cervical cancer that is progressing on or after chemotherapy. This is the first submission for an anti-PD-1 therapy in cervical cancer, and the agency has set a user fee review