Drugs
FDA has converted from accelerated approval to full approval Eisai’s Alzheimer’s disease drug Leqembi (lecanemab-irmb). The drug received accelerated approval in January. FDA says it was converted to traditional approval following a determination that a confirmatory trial verified clinical benefit, making it the first drug in its
Drugs
A long-awaited new FDA guidance explains how the agency interprets and intends to enforce the prohibition of wholesaling against facilities that compound drugs under Section 503B of the Federal Food, Drug, and Cosmetic Act. Six Reed Smith attorneys write in an online post that the guidance first describes FDA’
Drugs
FDA has issued a complete response letter (CRL) to Regeneron Pharmaceuticals for its BLA for aflibercept 8 mg to treat patients with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. The company says the issuance of the CRL was due solely to an ongoing review of inspection
Devices
Four Sidley Austin attorneys say FDA expects to issue in August a notice of proposed rulemaking to amend agency regulations to make explicit that laboratory-developed tests (LDTs) are medical devices under the Federal Food, Drug, and Cosmetic Act. In an online post, the attorneys say the agency decided to
Drugs
FDA has authorized SystImmune to proceed with a planned study of its BL-B01D1 in an IND for subjects with metastatic or unresectable non-small cell lung cancer. The company says BL-B01D1 is a first-in-class bispecific antibody-drug conjugate developed by SystImmune that targets both EGFR and
Drugs
Harvard Medical School researchers say that for the 409 human drug advisory committee meetings held from 2010-2021, FDA regulatory actions followed the committees’ recommendations 88% of the time. Writing in JAMA Health Forum, the researchers also say the agency called fewer committee meetings as the years progressed (50 meetings
Drugs
FDA has released the form FDA-483 issued following a 6/15-6/23 inspection at an Ipca Laboratories drug manufacturing facility in Dhar, Madhya Pradesh, India. The eight inspection observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components
Drugs
FDA has issued a complete response letter for an Amneal Pharmaceuticals drug intended to help control Parkinson’s symptoms for a longer duration. The agency letter cited safety concerns, Reuters reports. The company said FDA requested additional data as it was not convinced of the safety of carbidopa, one of
Drugs
CDER has published a Manual of Policies and Procedures, Understanding CDER’s Risk-Based Site Selection Model, outlining how the Office of Pharmaceutical Quality manages the site selection model used by Center staff to prioritize manufacturing sites for routine quality-related (current good manufacturing practice) surveillance inspections. The document says
FDA Policy/General
Here the health product-related Federal Register notices published by the agency during FDA Webview’s 7/3-10 annual break for Independence Day: July 10 Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Human Cells, Tissues, and Cellular and Tissue-Based Products — 21 CFR
Devices
CDRH says it is transitioning from paper export documents for medical devices to electronic export documents starting 1/2/2024. The documents that will be issued electronically include: * Certificate to Foreign Government, * Certificate of Exportability Section 801(e)(1) or 802, * Non-Clinical Research Use Only Certificate, * Certificate to Foreign
Drugs
FDA has approved a labeling update for Novartis’ Leqvio (inclisiran) to allow earlier use in patients with elevated LDL-C who have an increased risk of heart disease, as an adjunct to diet and statin therapy. “High LDL-C is one of the most readily modifiable risk factors for heart
Drugs
FDA has released the 29-page form FDA-483 with 16 observations from a 5/1-5/12 inspection at an Intas Pharmaceuticals drug manufacturing facility in Ahmedabad, Gujarat, India. News accounts have cited the company as being involved in the current shortage of the oncology drug cisplatin. The specific
Devices
Outset Medical says FDA sent it a 7/5 Warning Letter with six observations from a 2/10 inspection involving the firm’s Tablo Hemodialysis System. Outset released the information in a Securities and Exchange Commission filing. The company says the letter does not request any restriction on the manufacture,
Biologics
Sarepta Therapeutics has sold for $102 million its Rare Pediatric Disease Priority Review Voucher that was awarded last month after gaining accelerated approval for Elevidys (delandistrogene moxeparvovec-rokl) for treating ambulatory pediatric patients aged four through five years with Duchenne muscular dystrophy. The company did not disclose the buyer of
Drugs
FDA has issued Hemogenyx Pharmaceuticals a clinical hold on an IND for the company’s chimeric antigen receptor T-cells (CAR-T) therapy for treating acute myeloid leukemia. The company says the hold is related to a “splicing that occurs during the manufacturing process of the lentivirus that is used
Devices
New York University researchers say there can be discrepancies between the marketing and 510(k) clearance of artificial intelligence (AI)- or machine learning (ML)-enabled devices, with some devices marketed as having such capabilities not approved by FDA for AI or ML. Writing in an online JAMA Network article, the
Drugs
FDA has granted Theriva Biologics an orphan drug designation for VCN-01, a systemic, selective, stroma-degrading oncolytic adenovirus for treating pancreatic cancer. In the Phase 2b VIRAGE study, intravenous VCN-01 is being evaluated in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel) as a first line
Drugs
Madrigal Pharmaceuticals has begun a rolling NDA submission seeking accelerated approval of resmetirom for treating nonalcoholic steatohepatitis with liver fibrosis. Madrigal says it has submitted the majority of the NDA and plans to submit the rest by 7/30. “In the MAESTRO-NASH biopsy trial, resmetirom achieved both liver histological
Devices
Teleflex has recalled (Class 1) its Slick Set Uncuffed Endotracheal Tube and Stylet Set (oral/nasal) due to reports about the 15mm connector disconnecting from the endotracheal tube. The company recently sent an “urgent medical device recall” notice to users that advised to stop using affected products and immediately quarantine
Drugs
A group of bipartisan House members are reintroducing the Promising Pathway Act that would provide a provisional approval pathway for promising drugs that treat life-threatening conditions. “Although other expedited pathways exist, this bill allows for more innovative clinical trials and encourages FDA review of applications on a rolling basis,
FDA Policy/General
Federal Register notice: FDA is announcing an information collection revision entitled “New Animal Drugs for Minor Use and Minor Species.” The collection supports regulations that establish an index of legally marketed unapproved new animal drugs for minor species and requirements for the designation of minor use or minor species new