Drugs
FDA has approved Axsome Therapeutics’ Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. Approval was based on data from the Phase 3 MOMENTUM trial which treated moderate and severe migraine pain, the Phase 3 INTERCEPT trial which treated mild migraine pain, and
Drugs
FDA has cleared a Roche 510(k) for its Tina-quant Lipoprotein (a) Gen.2 Molarity assay that measures lipoprotein (a), or Lp(a), in nanomoles per liter. The company says Lp(a) is an “under-recognized, potential risk factor for cardiovascular disease due to its ability to promote the
Drugs
FDA has granted orphan drug designation to Marsh Biosciences’ MB-105, described as a first-in-class CD5 CAR-T cell therapy to treat relapsed/refractory CD5-positive T-cell lymphoma. The company says it is developing MB-105 for several CD5-positive hematologic malignancies. It says the therapy employs
Drugs
Adial Pharmaceuticals says it has completed with positive results its pharmacokinetic study of AD04 (ondansetron) for treating alcohol use disorder and will work with FDA on designing a Phase 3 trial. A company statement says the formulation “exhibited predictable bioavailability relative to the reference standard; near-micro doses exhibited dose
Drugs
A bipartisan group of nine senators has reintroduced the FDA Modernization Act (FDAMA) 3.0 directing the agency to implement the FDA Modernization Act 2.0 legislation intended to modernize drug testing protocols and improve patient outcomes. A statement issued by Sen. Cory Booker (D-NJ), one of the sponsors,
Drugs
FDA has approved a new indication for Novo Nordisk’s Ozempic (semaglutide), which the company says makes it the only GLP-1 receptor agonist to reduce the risk of worsening kidney disease and cardiovascular death in adults with Type 2 diabetes and chronic kidney disease. The company says the approval
Drugs
FDA has approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for treating adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer that has progressed on one or more endocrine therapies. Approval was based on data from the DESTINY-Breast06 Phase 3
Drugs
FDA says a Bioresearch Monitoring Program inspection at a clinical trial site maintained by Dr. Americo Padilla/Miami Dade Medical Research Institute determined that the site did not follow laws and regulations governing the conduct of clinical investigations and the protection of human subjects. A 1/17 Warning Letter says
Drugs
FDA has accepted for priority review a Merck sNDA for a new indication for its Welireg (belzutifan) to treat adults and pediatric patients over age 12 with advanced pheochromocytoma and paraganglioma. A company statement says the sNDA was based on objective response rate and duration of response data from the
Drugs
TerSera Therapeutics is petitioning FDA to require that ANDAs citing the company’s Prialt (ziconotide) as the reference-listed drug/device combination to meet compatibility testing requirements to support product labeling for use with the Medtronic SynchroMed II and SynchroMed III infusion system. The company’s petition says Prialt is
Drugs
FDA has approved a Supernus Pharmaceuticals label update for attention-deficit/hyperactivity disorder (ADHD) drug Qelbree (viloxazine extended-release capsules) to include new pharmacodynamic data. The updated label (Section 12.2) describes the drug’s “partial agonist activity at the serotonin 5-HT2C receptor and inhibition of the norepinephrine transporter,
Drugs
Provepharm is recalling (Class 1) one lot of phenylephrine hydrochloride injection, USP, 10 mg/mL (pharmacy bulk package) due to a customer complaint about visible black particulate matter found in a single sealed vial. “Administration of an injectable product containing particulate matter may cause local irritation or swelling as a
Drugs
FDA has approved an Eisai/Biogen supplemental BLA for Leqembi (lecanemab-irmb) and its intravenous use once every four weeks as maintenance dosing in Alzheimer’s disease patients with mild cognitive impairment or mild dementia. “After 18 months of once every two weeks initiation phase, a transition to the maintenance
Drugs
Pfizer has agreed to pay $59.7 million to resolve allegations that its subsidiary, Biohaven Pharmaceutical, engaged in illegal kickback schemes before being acquired by Pfizer. The settlement resolves claims that Biohaven provided improper financial incentives to healthcare providers to encourage prescriptions of its migraine drug Nurtec ODT, in violation
Drugs
Vanda Pharmaceuticals has submitted an NDA for tradipitant for treating motion sickness. The submission is based on data from the Phase 3 Motion Serifos study of 316 participants who went on boat trips under varied sea conditions and received tradipitant 170 mg, tradipitant 85 mg, or placebo. “Both 170 mg
Drugs
FDA has granted Clarity Pharmaceuticals a fast track designation for 64Cu-SAR-bisPSMA for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive prostate cancer lesions in patients with biochemical recurrence of prostate cancer following definitive therapy. The designation is based on data the company submitted that
Drugs
Caranx Medical has submitted a PMA for its TAVIpilot AI Software for real-time intra-operative guidance of transcatheter heart valve implantation. The software is designed to assist surgeons in their positioning of a prosthetic heart valve, according to the company. Preoperative CT-scan images are used to plan the
Drugs
ALX Oncology says it plans to discuss with FDA its path for seeking accelerated approval for its investigational CD47-blocker evorpacept based on “positive updated data” from the ASPEN-06 Phase 2 clinical trial demonstrating the therapy generates a durable clinical response with a well-tolerated safety profile among patients
Drugs
FDA has approved a Medexus NDA for Grafapex (treosulfan), an injectable alkylating agent for use with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients with acute myeloid leukemia (AML) or myelodysplastic syndrome. Approval was based on data from Phase 3 MC-
Drugs
As part of the Trump Administration’s regulatory freeze while it reviews pending FDA actions, the effective date of a recent final rule entitled “Nonprescription Drug Product With an Additional Condition for Nonprescription Use (ACNU)” is delayed from 1/27 to 3/21. The final rule establishes requirements for a
Drugs
CDRH associate director for medical affairs and chief medical officer for in vitro diagnostics Sara Brenner has been elevated to FDA acting commissioner under the Trump Administration. She previously served in the first Trump administration’s White House Office of Science and Technology Policy as a senior policy advisor for
Drugs
Merck and Eisai are announcing disappointing results from the Phase 3 LEAP-015 trial evaluating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, plus Lenvima (lenvatinib), a multiple receptor tyrosine kinase inhibitor discovered by Eisai, in combination with chemotherapy for the first-line treatment of patients with locally advanced unresectable