Devices
Philips has issued an urgent field safety notice about its Azurion and Allura Xper systems installed with the FlexMove option, which could pose a risk for patients and bystanders. It says that “due to the forces applied during the movement of the C-Arc of the Azurion and Allura systems,
Drugs
A just-posted, four-item Form FDA-483 provides more detail on medical device reporting (MDR) and other violations cited in a 2022 inspection of iRhythm’s Cypress, CA manufacturing facility that led to a recent Warning Letter on its ZIO AT arrhythmia monitoring system. The inspection form cited the
Drugs
Eli Lilly says a head-to-head clinical trial comparing its migraine drug Emgality (galcanezumab-gnlm) to Pfizer’s Nurtec ODT (Rimegepant) did not meet the primary endpoint — Emgality’s statistical superiority to Nurtec. Lilly says the drugs’ response rates were similar, but Emgality “performed numerically better on key secondary
Devices
FDA has approved Premia Spine’s TOPS System as an alternative to spinal fusion for treating certain patients with degenerative spondylolisthesis with moderate to severe lumbar spinal stenosis. The implant is designed to attach to the spine, and unlike a spinal fusion procedure, the TOPS System allows motion in the
Drugs
Reps. Adam Schiff (D-CA) and Ann McLane Kuster (D-NH) have introduced the Updated Drug Labeling for Patient Safety Act to ensure that patients are made aware of all potential risks and side effects of prescription drugs, including generics. In a statement (includes a link to the bill text)
Biologics
FDA’s Vaccines and Related Biological Products Advisory Committee 6/15 voted 21 to 0 that the Covid-19 vaccination program for the 2023-2024 season should contain a monovalent vaccine comprising the XBB-lineage variant. Panel members essentially agreed with an FDA briefing document released in advance of the
Drugs
Researchers from FDA, PharmaLex, and Quinten Health say there remain challenges to address before artificial intelligence/machine learning (AI/ML) has an increased impact on precision medicine. Writing in Therapeutic Innovation & Regulatory Science, the researchers summarize the topics discussed at a 2022 panel of FDA and industry experts about
Drugs
Corvus Pharmaceuticals says it plans to meet with FDA officials in the third quarter to discuss a potential registration Phase 3 trial of its CPI-818 ITK inhibitor in T cell lymphoma. In a statement announcing updated CPI-818 Phase 1/1b results, the company says it is beginning to
Drugs
Harvard Medical School professor Jerry Avorn says the current FDA drug approval process under which a drug either gets full approval or is rejected should be changed. Writing in a Washington Post opinion piece, Avorn says that under the “pass-fail” system, a drug that FDA disapproves remains mostly unavailable,
Drugs
FDA has cleared the addition of a protocol amendment to the Phase 3 trial of GlycoMimetics’ uproleselan for relapsed/refractory acute myeloid leukemia. The company says the amendment will allow a time-based analysis of the overall survival primary endpoint to be conducted following a defined cutoff date if the
Biologics
Public Citizen’s Health Research Group is urging FDA to not grant accelerated approval to Sarepta Therapeutics’ gene therapy SRP-9001 for treating ambulatory Duchenne muscular dystrophy (DMD) because the data do not justify approval. In a 6/15 letter to the agency, the advocacy group says the data failed
Devices
FDA has cleared an American Laboratory Products 510(k) for its Calprotectin Immunoturbidimetric Assay and its in vitro diagnostic use as an aid in diagnosing inflammatory bowel disease (IBD), specifically Crohn’s disease and ulcerative colitis. It also aids in the differentiation of IBD from irritable bowel syndrome when used
Drugs
FDA has issued a partial clinical hold against Mersana Therapeutics’ clinical trials of UpRi (upifitamab rilsodotin) in platinum-sensitive ovarian cancer after the company submitted a safety report that evaluated bleeding events. The hold affects the UP-NEXT and UPGRADE-A clinical trials, and patients who are already enrolled may
Drugs
Aldeyra Therapeutics says the Phase 3 INVIGORATE-2 Clinical Trial of 0.25% reproxalap ophthalmic solution in patients with allergic conjunctivitis “achieved statistical significance for the primary endpoint and all secondary endpoints.” The trial enrolled 131 allergic conjunctivitis patients and the primary efficacy endpoint was change from baseline in patient-
Drugs
FDA has told a Florida federal court that it expects to decide by 10/31 whether to approve a Florida plan to import some drugs from Canada. Public radio station WUSF reports the agency statement led the federal judge to stay key parts of a state lawsuit against the agency
Drugs
In a 6/12 letter to customers, Pfizer advises there is a “limited supply and impending stock out” for selected Bicillin L-A (penicillin G benzathine injectable suspension) and Bicillin C-R (penicillin G benzathine and penicillin G procaine injectable suspension) prefilled syringes. The letter estimates that all Bicillin C-
Devices
FDA has cleared a Surmodics 510(k) for its Pounce LP (Low Profile) Thrombectomy System. The device was originally cleared in 2021 for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 3.5 mm to 6 mm in diameter, according to the company.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Content of Premarket Submissions for Device Software Functions.” The document provides information about the recommended documentation sponsors should include in premarket submissions for device software functions. To view the notice, click here.
Drugs
The CDER Biomarker Qualification Program has issued a Biomarker Letter of Support for four pancreatic injury safety biomarkers identified and evaluated by the Critical Path Institute (C-Path)’s Predictive Safety Testing Consortium (PSTC). C-Path says the biomarkers will help increase the ability to detect and monitor drug-induced
Drugs
Attorneys Dominick DiSabatino and Cortney Inman (SheppardMullin) say FDA appears to have two goals for its recently announced proposed rule to require manufacturers to provide a one-page Patient Medication Information (PMI) for each drug prescribed. The goals, they say, are: * standardization of patient-facing prescription drug product labeling; and
Drugs
2seventy bio says Seattle Children’s has paused the Phase 1 trial of the PLAT-08 study of SC-DARIC33 in acute myeloid leukemia following a fatal adverse event. A company statement says the study couples 2seventy bio’s DARIC T cell platform with Seattle Children’s expertise in oncology
Drugs
FDA has approved an Amneal Pharmaceuticals 505(b)(2) for Pemrydi RTU, a ready-to-use formulation of pemetrexed for injection that does not require reconstitution, dilution, or refrigeration. The injectable will be available in three vial sizes: 100mg/10mL; 500 mg/50mL; and 1,000mg/100mL. “By eliminating formulation