Drugs
Teleflex has recalled its Arrow-Trerotola Over-The-Wire Percutaneous Thrombolytic Device (PTD) Kit, 7FR, after receiving reports about the inner lumen becoming detached from the device’s basket. The PTD catheter is used with the Arrow Rotator Drive Unit to permit mechanical declotting of native arterio-venous fistulae and
Drugs
FDA has accepted for priority review an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) for the adjuvant treatment of patients with BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery. The
Drugs
An FDA advisory committee briefing document says data show that Merck’s oral antiviral molnupiravir (MOV) was associated with a relative risk reduction of 52% in hospitalization or death compared to placebo in adults with mild-to-moderate Covid-19 and at high risk for progression to severe disease. Committee
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Pharma Mar’s Zepzelca (lurbinectedin), indicated for treating adult patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy. The review period is 4,170 days, which includes 3,
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Prescription Drug User Fee Program” (OMB Control Number 0910-0297). The collection is being revised to include the agency’s current commitment goals outlined in the document “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through
Drugs
FDA has issued a draft guidance on Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products. The document provides sponsors with considerations about designing a registry or proposing to use an existing registry to support a regulatory decision about a drug’s effectiveness or
Devices
FDA has cleared a Hyperfine 510(k) for its advanced image reconstruction technology that uses deep learning to improve magnetic resonance imaging (MRI) on its Swoop MRI device. “The image quality resulting from this innovative approach elevates the diagnostic value of portable MRI,” the company says. The artificial intelligence application
Drugs
FDA has approved an On Target Laboratories NDA for Cytalux (pafolacianine), an imaging drug to assist surgeons in identifying ovarian cancer lesions. “The drug is designed to improve the ability to locate additional ovarian cancerous tissue that is normally difficult to detect during surgery,” FDA says in a news release.
FDA Policy/General
DEVICES FDA has approved an expanded indication for the Concentric Medical Trevo clot retrieval device to allow treatment of certain stroke patients up to 24 hours after symptom onset, expanding the use to a broader group of patients. An agency news release says the device is cleared for use as
FDA Policy/General
FDA Reclassifying HIV Viral Load Tests 11/24/2021 Federal Register notice: FDA is proposing to reclassify human immunodeficiency virus viral load monitoring tests, a postamendments Class 3 device with the product code MZF, into Class 2 (special controls), subject to premarket notification. To view the notice, click here. Info
FDA Policy/General
Astellas Pharma has agreed to acquire Ganymed Pharmaceuticals AG for $1.4 billion. The transaction will give Astellas rights to IMAB362, which recently was shown to significantly extend median survival when added to standard chemotherapy for patients with advanced gastric cancer. Startup Unity Biotechnology has raised $116 million in a
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Immunomedics’ Trodelvy (sacituzumab govitecan-hziy), indicated for treating adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. The review period is 2,856 days, which
Devices
A 2/23-3/30 FDA inspection at Smiths Medical ASD, Minneapolis, MN, determined that the firm is a specification developer and manufacturer for a variety of medical devices including blood warmers and infusion pumps. A just-released 10/1 Warning Letter says the inspection found that the firm’s
Devices
FDA has scheduled a 12/14 Webinar for stakeholders interested in learning about the final rule Medical Device De Novo Classification Process and associated guidance document updates. An online notice says the Webinar will: * describe the background and history of the de novo program; * describe the de novo regulations and
Drugs
The Department of Justice says Alain Bouaziz, a French national who lives in the United Arab Emirates, has been charged with making false statements to FDA to fraudulently obtain control of Sanorex, a weight-loss drug owned by an unidentified major pharmaceutical company. A department statement says Bouaziz was arrested
Devices
FDA has granted Pear Therapeutics a breakthrough device designation for its reSET-A PDT (Prescription Digital Therapeutic) product candidate designed for treating alcohol use disorder. PDTs are designed to collect real world data for use by prescribing clinicians and for population health management by payors and health systems, according to
Biologics
A 4/5-4/16 FDA inspection at Surgenex, Scottsdale, AZ, determined that it manufactures cellular products for allogenic use that are distributed to third-party distributors, some under private label, and directly to healthcare professionals and medical facilities. An 11/15 Warning Letter says the products are intended for
FDA Policy/General
Federal Register notice: FDA is proposing to reclassify human immunodeficiency virus viral load monitoring tests, a postamendments Class 3 device with the product code MZF, into Class 2 (special controls), subject to premarket notification. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Investigational New Drug Applications — 21 CFR Part 312” (OMB Control Number 0910-0014). The collection supports Section 505 of the Federal Food, Drug, and Cosmetic Act and the licensing provisions of the Public Health Service Act that
Drugs
FDA has approved Takeda’s Livtencity (maribavir), the first treatment approved by the agency for adults and pediatric patients with post-transplant cytomegalovirus infection that does not respond to available antiviral treatment for the infection. The approval was announced by the Brand Institute, which partnered with Takeda in naming the
Drugs
FDA has approved an Aadi Bioscience NDA for Fyarro (sirolimus protein-bound particles for injectable suspension) (albumin-bound) for treating adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). Approval was based on efficacy data from the AMPECT multicenter, single-arm clinical trial in 31
Biologics
Pfizer has asked a California federal court for an injunction against former employee Chun Xiao (Sherry) Li, claiming she uploaded over 12,000 files from her company laptop to a personal account and/or device. In its court filing, Pfizer says Li resigned effective 11/24 and reportedly accepted a