Biologics
In what may be one of the last actions by FDA commissioner Robert Califf before he resigns his post ahead of the incoming Trump administration’s start date next Monday, the commissioner has posted a comprehensive essay and personal reflection on the safety and effectiveness of Covid-19 vaccines. Califf’
Drugs
FDA has accepted for priority review an AstraZeneca and Daiichi Sankyo BLA for datopotamab deruxtecan for treating adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer who have received prior systemic therapies. The user fee review action date is expected during the
Devices
Philips and its subsidiary Braemar Manufacturing are recalling (Class 1 device correction) their Monitoring Service Application concerning the Mobile Cardiac Telemetry Monitoring (BTPS-1000) system after identifying that some electrocardiogram (ECG) events received were not properly routed. “As a result, these events were not reviewed by a cardiology technician for
Devices
FDA has posted a guidance entitled “Premarket Approval Application (PMA) and Humanitarian Device Exemption (HDE) Modular Review.” The document provides information regarding the modular review program and outlines the procedures for submitting or reviewing a modular PMA or HDE. Unlike a traditional PMA or HDE when an applicant submits all
Drugs
FDA has granted Rigel Pharmaceuticals an orphan drug designation for R289 and its use in treating myelodysplastic syndromes (MDS). The “potent and selective” dual inhibitor of IRAK1 and IRAK4 is being studied in an ongoing Phase 1b study evaluating the safety, tolerability, pharmacokinetics and preliminary activity in patients with lower-
Drugs
CDER’s senior leadership is in turmoil ahead of president-elect Donald Trump’s 1/20 inauguration as director Patrizia Cavazzoni unexpectedly announces her early retirement effective two days before the new administration takes hold. “Leaving CDER was an extremely difficult decision, but the time has come for me to
FDA Policy/General
Over 18,000 physicians have recently signed an open letter urging the U.S. Senate to reject incoming president Donald Trump’s nomination of Robert F. Kennedy Jr. to serve as HHS secretary. “As physicians who care deeply about the health and safety of our patients and communities, we are
Drugs
FDA has accepted for review a Fortress Biotech NDA for CUTX-101 (copper histidinate) for treating Menkes disease, a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A. The submission has been granted priority review and a user fee action date of 6/30.
Drugs
Tenpoint Therapeutics is reporting positive topline results from BRIO-II, the company’s second Phase 3 pivotal trial evaluating Brimochol PF (brimonidine), a pupil-modulating therapeutic designed to correct the loss of near vision associated with presbyopia. BRIO-II met its pre-specified primary endpoints, demonstrating statistically significant improvements in
Devices
FDA has cleared a CapsoVision 510(k) for its CapsoCam Plus capsule endoscopy system for remote ingestion. The action clears the path for patients to “conveniently ingest the CapsoCam Plus capsule from the comfort of their homes under virtual medical supervision, representing a transformative step in enhancing patient accessibility and
Drugs
Pfizer is announcing positive topline results from its pivotal Phase 3 CREST trial evaluating sasanlimab, an investigational anti-PD-1 monoclonal antibody, for combination use with Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer. The
FDA Policy/General
Federal Register notice: FDA announces that a priority review voucher was used with the agency’s 12/20/2024 approval of Vertex Pharmaceuticals’ Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a once-daily next-in-class triple combination cystic fibrosis transmembrane conductance regulator modulator for treating cystic fibrosis in people six years and
Drugs
FDA has accepted for review an Agios Pharmaceuticals sNDA for Pyrukynd (mitapivat) to treat adults with non-transfusion-dependent alpha- or beta-thalassemia. The agency set a PDUFA review goal date of 9/7. A company statement says the sNDA is based on results from the ENERGIZE and ENERGIZE-T
Drugs
FDA has granted fast track designation for Marengo Therapeutics’ invikafusp alfa to treat unresectable, locally advanced, or metastatic colorectal cancers with high tumor mutational burden. A company statement says the designation was informed by encouraging results from Marengo’s first-in-human clinical study of invikafusp alfa in heavily pretreated
Devices
FDA has cleared a ZuriMED Technologies 510(k) for the FiberLocker System for rotator cuff repair reinforcement. Traditional repair techniques often fail at the suture-tendon interface, which leads to retears that require further surgeries and longer recovery times, according to the company. Its FiberLocker system is designed to reinforce
FDA Policy/General
Federal Register notice: The FDA is announcing it has issued a priority review voucher to Neurocrine Biosciences because its 12/13 NDA approval for Crenessity (crinecerfont) was a qualifying action. The drug was approved to be used together with glucocorticoids (steroids) to control androgen (a testosterone-like hormone) levels in
Devices
Fresenius Kabi has recalled (Class 1) its Ivenix Infusion System and Large Volume Pump due to potential pneumatic valve failures that may cause the pump to stop an active infusion or could prevent the pump from being used. FDA has determined that the cause of the failures is related to
Devices
Johnson & Johnson says it has paused the U.S. external evaluation and all U.S. Varipulse cases while it investigates the root cause of four reported neurovascular events in the U.S. external evaluation. A company statement says that since beginning the external evaluation cases with the Varipulse platform
Devices
FDA has granted Alleviant Medical a breakthrough designation for its no-implant atrial shunt technology for treating heart failure with reduced ejection fraction (HFrEF). The agency also approved the company’s investigational device exemption application for it to begin a pivotal trial focused on (HFrEF) patients, according to the company.
Drugs
A Federation of American Scientists online report calls on FDA to create a dedicated regulatory pathway for non-manufacturers to seek approval of new indications for repurposed generic drugs. Written by three RebootRx executives, the report says one possible approach would be an extension of the existing 510(b)(2)
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Developing Drugs for Optical Imaging.” The document provides recommendations on clinical trial design features that support development and approval of optical imaging drugs that are used in conjunction with imaging devices and intended as intraoperative aids for detecting tumors
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction.” The document provides recommendations on developing drugs/biological products intended for reduction and long-term maintenance of body weight in obese/overweight patients. To view the notice, click