Biologics
FDA has granted ImmunoGen an accelerated approval for Elahere (mirvetuximab soravtansine-gynx) for treating adult patients with folate receptor alpha (FRa)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Approval was based on objective response rate (ORR)
Devices
Insulet has announced a Medical Device Correction for the Omnipod 5 Automated Insulin Delivery System because of an issue with the Omnipod 5 Controller charging port and cable. The correction follows 24 reports the company says it received about the Omnipod 5 Controller charging port (USB-C port) or cable
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Merck’s Prevymis (letermovir), indicated for prophylaxis of cytomegalovirus (CMV) infections and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant. The regulatory review period is 3,157 days, of which
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Data to Support Social and Behavioral Research as Used by the Food and Drug Administration” (OMB Control Number 0910-0847). The collection supports agency-conducted research intended to understand the perceptions and behaviors of patients, consumers and
FDA Policy/General
Federal Register notice: FDA is extending by two months the comment period on two proposed rules (see earlier story) that appeared in the 9/28 Federal Register. One proposed rule would replace current requirements for FDA-regulated cooperative research with new requirements that would require any institution located in the
Drugs
GSK says it has complied with an FDA request to restrict the second-line maintenance indication for Zejula (niraparib) to only the patient population with deleterious or suspected deleterious germline BRCA mutations (gBRCAmut). The first-line indication remains unchanged for maintenance treatment of adult patients with advanced epithelial ovarian, fallopian
Drugs
The Federal Trade Commission has filed an amicus brief with the Delaware federal court in the case of Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals, taking issue with a Jazz patent for Xyrem (sodium oxybate) listed in FDA’s Orange Book that it says improperly blocks generic competition. The brief discusses
Drugs
FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) plus platinum-based chemotherapy for treating adult patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC). The approval was based on data from the POSEIDON Phase 3 trial, which showed that patients treated with the combination
Devices
FDA has cleared a DiaSorin 510(k) for its Simplexa Congenital CMV Direct kit, a molecular diagnostic test that detects cytomegalovirus (CMV) DNA in saliva swab and urine specimens from infants that are 21 days old or younger. Saliva swab specimens are easy to collect for screening purposes and urine
Devices
FDA has published a guidance, Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents, to promote clarity regarding references to the terms “device” and “counterfeit device.” The document says the Safeguarding Therapeutics Act redesignated the definition of
Drugs
FDA is seeking comments on a draft guidance entitled “Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin Q5A(R2).” The International Council for Harmonization document addresses the testing and evaluation of the viral safety of biotechnology products, and it outlines what data should
Drugs
The CDER Office of Pharmaceutical Quality (OPQ) has issued a Manual of Policies and Procedures, Quality Assessment for Products in Expedited Programs, outlining policies and procedures that are intended to facilitate and expedite the development, time to submission, assessment, and marketing approval of NDAs and BLAs for products that address
FDA Policy/General
Federal Register notice: FDA has determined for patent term extension purposes the regulatory review period for SK Biopharmaceuticals’ Xcopri (cenobamate), indicated for treating partial-onset seizures in adult patients. The regulatory review period is 5,326 days, of which 4,850 days occurred during the testing phase and 476 days
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Dutch Ophthalmic’s Tissueblue (brilliant blue g ophthalmic solution), a disclosing agent indicated to selectively stain the internal limiting membrane. The regulatory review period is 4,631 days, of which 4,395 days occurred during
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Nexletol (bempedoic acid), indicated as an adjunct to diet and maximally tolerated statin therapy for treating adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL–C. The regulatory
Devices
AdvaMed is proposing a change to an FDA draft guidance on ethical considerations for clinical investigations of medical products involving children. The association says that to promote the development of pediatric medical devices, the guidance should include relevant information on when adult data can be extrapolated for pediatric use from
Devices
Bristol Myers Squibb commends FDA for publishing a draft guidance on computer software assurance for production and quality system software, but finds several aspects of it that appear contrary to the agency’s stated objectives or are not fully developed. In a comment letter, BMS says the items needing clarification
Drugs
FDA has approved Seagen’s Adcetris (brentuximab vedotin) for treating pediatric patients two years and older with previously untreated high risk classical Hodgkin lymphoma (cHL). The drug is intended for use in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide. The approval is based on data from a Phase 3
Drugs
FDA has issued a refusal to file letter to BrainStorm Cell Therapeutics for its BLA for NurOwn to treat ALS (amyotrophic lateral sclerosis). The company says FDA said it could request a Type A meeting with the agency to discuss the content of the letter. Company officials said they plan
Devices
Yale University researchers say that with the role of artificial intelligence (AI) in breast cancer screening likely to grow in the next decade, it is important that FDA increase evidentiary regulatory standards, develop improved postmarketing surveillance and trials, and engage key stakeholders to help ensure that new AI products meet
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Sameness Evaluations in an ANDA — Active Ingredients.” The document provides recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug. To view the notice, click here.
Drugs
FDA’s Pulmonary-Allergy Drugs Advisory Committee has voted 16 to 1 to support approval of an AstraZeneca NDA for PT027 (albuterol/budesonide) for treating asthma in those aged 18 years and older, but it did not support (16 to 1 vote against) the product’s use in children and