Drugs
Capricor Therapeutics says it has completed an FDA mid-cycle review meeting for a BLA seeking approval for deramiocel and its use in treating Duchenne muscular dystrophy (DMD) cardiomyopathy. “During the meeting, FDA stated that no significant deficiencies have been identified by the review committee and that the package is
FDA Policy/General
FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissuing them in draft form that makes modifications based on undisclosed comments made by stakeholders. The guidances are “Recommendations To Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells,
Devices
A citizen petition from Harmed Americans for Reform in Medical-Device Safety is asking FDA to restrict the off-label use of the Da Vinci Robotic System and video-assisted thoracoscopy (VATS) devices to perform the “hybrid convergent cardiac ablation” protocol in patients with isolated atrial fibrillation. It also urges
Devices
FDA has denied a CytoSorbents de novo marketing request for its DrugSorb-ATR antithrombotic removal system, an agency-designated breakthrough device intended for reducing the severity of bleeding in patients undergoing coronary artery bypass grafting surgery within two days of stopping the antiplatelet drug Brilinta (AstraZeneca’s ticagrelor). In its
Devices
FDA has cleared a GE HealthCare 510(k) for its MR Contour DL, an artificial intelligence (AI) model that uses deep learning for organs-at-risk (OAR) segmentation. The device “leverages the soft-tissue detail of MR [magnetic resonance] images to create precise organ contours of OAR during radiation therapy
Drugs
FDA has accepted for review a Novo Nordisk NDA for a once-daily, 25 mg oral formulation of Wegovy (semaglutide) for chronic weight management in obese adults or those who are or overweight with one or more comorbid conditions, and to reduce the risk of major adverse cardiovascular events (MACE)
FDA Policy/General
FDA has begun rehiring some Freedom of Information office workers who were terminated under White House-mandated reduction-in-force cuts. The move was expected after HHS secretary Robert F. Kennedy Jr said 4/21 that the many employees would see their positions restored at FDA and other health agencies’
Drugs
FDA Office of Scientific Integrity director George Warren has issued a scheduling order on Vanda Pharmaceuticals’ request for a hearing on CDER’s proposal to refuse to approve the company’s NDA for its gastroparesis drug tradipitant. In the order, Warren notes that CDER had requested until 9/12 to
FDA Policy/General
FDA is working to rehire about one-third of the 60 travel support staff who were fired as part of an agency-wide reduction in force. The Associated Press reports the agency also plans to recall food scientists who were fired, but they have not yet received formal written notification
Devices
FDA has approved Element Science’s PMA for the Jewel Patch Wearable Cardioverter Defibrillator. A company statement says the product “combines the principles of human-centered design with the latest advancements in machine learning.” The Jewel Patch is described as a novel, water-resistant wearable cardioverter defibrillator designed to detect
Devices
FDA has approved Edwards Lifesciences' SAPIEN 3 transcatheter aortic valve replacement (TAVR) platform for patients with severe aortic stenosis who show no symptoms. The approval extends the use of the platform, including the SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA valves, to a broader patient population
Drugs
In a Phase 3 trial funded by Novo Nordisk, patients receiving a weekly dose of 2.4 mg of semaglutide (the company’s Ozempic and Wegovy), a glucagon-like peptide-1 receptor agonist, had better results regarding steatohepatitis and fibrosis in metabolic dysfunction-associated steatohepatitis than patients receiving placebo. The
FDA Policy/General
FDA staff reductions in force appear to be hurting programs that track drug safety, according to anonymous sources who spoke with Chemical & Engineering News. A fired employee told the newsletter that “there’s a handful of employees desperately keeping the lights on.” The report says the CDER Division of
Biologics
FDA will soon require all new vaccines be evaluated in placebo-controlled trials before they’re licensed for use, and this could also apply to some seasonal vaccines for the flu and Covid-19, which are tweaked each year to provide protection against strains circulating around the world. “Under HHS
Drugs
FDA has extended by three months its review of a Cytokinetics NDA for aficamten for treating patients with obstructive hypertrophic cardiomyopathy (oHCM). The agency said the review extension is required to conduct a full review of the company’s proposed Risk Evaluation and Mitigation Strategy (REMS), according to the company.
Drugs
FDA has approved a Satsuma Pharmaceuticals 505(b)(2) NDA for Atzumi (dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine with or without aura in adults. The NDA was resubmitted 11/2024 after addressing chemistry, manufacturing, and controls considerations cited in a 1/2024 complete response letter, according
Drugs
Reps. Alexandria Ocasio-Cortez (D-NY) and Nydia Velázquez (D-NY) are calling on HHS secretary Robert F. Kennedy, Jr., to reverse the reduction in force that forced the FDA San Juan, Puerto Rico, medical products laboratory to close. In a statement (contains a link to their letter to Kennedy)
Drugs
Immunic says “positive” data from the Phase 2 CALLIPER trial of nuclear receptor related 1 (Nurr1) activator vidofludimus calcium (IMU-838) in patients with progressive multiple sclerosis (PMS) showed the therapy reduced the relative risk of 24-week confirmed disability worsening (24wCDW) events by 20% compared to placebo. “Further analyses
Drugs
Gilead Sciences has agreed to pay $202 million to settle a U.S. government civil fraud lawsuit and resolve claims that the company offered and paid kickbacks (e.g., honoraria payments, meals, and travel expenses) to healthcare practitioners who spoke at or attended Gilead speaker events to induce them to
Biologics
FDA commissioner Marty Makary continues to suggest that the bar is moving for Covid-19 vaccine boosters, telling CBS News in a 4/29 interview that the last study Novavax had conducted to demonstrate clinical benefit was from 2021 “and it excluded people with prior Covid infection. Now, essentially everyone
FDA Policy/General
A new poll finds that 44% of the U.S. public says that having new leaders in charge of federal public health agencies will make them trust recommendations coming from the organizations less than they used to (30% a “lot less” and 14% a “little less).” The poll was published
FDA Policy/General
Four Skadden attorneys say the 4/1 layoff of 3,500 FDA employees will likely have the greatest impact on products in development because the agency may not be able to issue as much guidance as it had previously or provide feedback and updates on applications. Writing in an online