Drugs
Six FDA researchers say alternative trial designs and analytical methods with an iterative process that leverages nonclinical data and clinical observations beyond short-term safety data are needed to identify optimized dosages for newer oncology drugs, given that targeted therapies and immunotherapies often do not demonstrate traditional dose-limiting toxicities
Drugs
Texas has approved legislation creating a Wholesale Prescription Drug Importation Program that would contract with Canadian drug wholesalers and suppliers to bring cheaper prescription drugs into the state. The plan would require HHS approval to be implemented. The Texas Tribune reports the program will not be fully designed until next
Drugs
Senator Elizabeth Warren (D-MA) and Rep. Pramila Jayapal (D-WA) have written FDA commissioner Robert Califf urging him to restrict patents that are listed in the Orange Book to curb loopholes in the patent system that drug companies have “exploited to rake in billions in profits.” The lawmakers complain
Drugs
FDA has approved 15 ANDAs representing the first generics of Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets, Takeda’s attention-deficit/hyperactivity disorder drug. Vyvanse is also approved for treating moderate to severe binge-eating disorder in adults. Companies receiving approval were: Teva Pharmaceuticals, Sun Pharmaceutical, Ascent Pharmaceuticals, Specgx, Rhodes
Drugs
Janssen Pharmaceutical has submitted a supplemental BLA seeking an expanded approval for Rybrevant (amivantamab-vmjw) — combination use with chemotherapy (carboplatin-pemetrexed) as a first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The
Drugs
A Flag Pharma citizen petition is asking FDA to revisit the therapeutic equivalence ratings for generic drugs that relied on bioequivalence studies performed by Maharashtra, India-based Synapse Labs between 2009 and 2023 after Spanish regulatory authorities inspected the facility and documented data integrity and pharmacokinetic anomalies. “Such findings raise
Drugs
Novocure says its Phase 3 ENGOT-ov50/GOG-3029/INNOVATE-3 clinical trial of Tumor Treating Fields (TTFields) together with paclitaxel in patients with platinum-resistant ovarian cancer did not meet its primary endpoint of overall survival (OS) at the final analysis. “Patients randomized to receive TTFields therapy plus paclitaxel
Drugs
FDA has released a new guidance entitled “Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies” that spells out the agency’s intention to not take enforcement actions pursuant to the security requirements until after 11/27/2024. The
Drugs
CDER is seeking comments on its proposal to withdraw Oncopeptides’ accelerated-approved multiple myeloma drug Pepaxto (melphalan flufenamide). The proposal came after a confirmatory trial (OCEAN) demonstrated a worse overall survival and failed to verify clinical benefit. Pepaxto was originally approved 2/2021, and at FDA’s request, Oncopeptides ceased
Drugs
FDA has granted Redx an orphan drug designation for zelasudil (RXC007), an oral, selective Rho-associated coiled-coil containing protein kinase 2 (ROCK2) inhibitor for treating idiopathic pulmonary fibrosis (IPF). Zelasudil is currently in a Phase 2a trial in IPF patients, with topline data expected early next year. Zelasudil works
Drugs
Merck and Eisai have terminated the Phase 3 LEAP-010 trial evaluating Merck’s Keytruda (pembrolizumab), an anti-PD-1 therapy, plus Eisai’s Lenvima (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor (TKI), as a first-line treatment for patients with recurrent or metastatic head and neck squamous
Drugs
FDA has approved a Gilead sNDA for the use of Veklury (remdesivir) with no dose adjustments to treat Covid-19 in people with mild, moderate, and severe hepatic impairment. A company statement says the approval supports Veklury’s position as the only approved antiviral Covid-19 treatment that can be
Drugs
Akebia Therapeutics says it expects to resubmit an NDA to FDA in the third quarter for its vadadustat to treat anemia due to chronic kidney disease in patients on dialysis. The company says the resubmission follows its receipt of minutes summarizing an End of Dispute Type A meeting with FDA
Drugs
FDA has granted Nectero Medical a fast track designation for its Endovascular Aneurysm Stabilization Treatment (EAST) combination product to treat patients with infrarenal abdominal aortic aneurysms (AAAs) with a maximum diameter of 3.5 – 5.0 cm. According to the company, EAST is a single-use endovascular product comprising a
Drugs
Two Oregon State University (OSU) studies indicate that FDA is approving more novel pharmaceutical drugs on single clinical trials and with less public disclosure about those trials than was the norm a few years ago. A university statement says researchers agree it is important to minimize delays in making treatments
Drugs
FDA has granted Taysha Gene Therapies a fast track designation for TSHA-102, an intrathecally delivered AAV9 gene transfer therapy for treating Rett syndrome. The therapy uses the company’s miRNA-Responsive Auto-Regulatory Element (miRARE) technology, which is designed to mediate levels of the MECP2 gene in the central
Drugs
Three Ropes & Gray attorneys say an FDA 8/15 final guidance on informed consent “illustrates a continuing trend toward modernization of clinical research through adoption of risk-based positions that attempt to reduce administrative burden while maintaining protections for human subjects.” Their online Alert also says FDA gives increased
Drugs
FDA says its 9/1-9/29/22 inspection at a clinical trial site maintained by Angela Stupi in Cranberry Twp., PA, found objectionable conditions for two trials of investigational drugs. The inspection was part of the agency’s Bioresearch Monitoring Program and found that Stupi did not comply with
Drugs
FDA says its Endocrinologic and Metabolic Drugs Advisory Committee will meet 9/21 to review and vote on an Intarcia Therapeutics NDA for ITCA 650 (exenatide in Duros device), a drug/device combination product that was rejected by CDER in 2021 as an adjunct to diet and exercise to improve
Drugs
The industry-based Council for Federal Cannabis Regulation (CFCR) says FDA can and should regulate cannabidiol (CBD) and cannabinoid products through its enforcement discretion powers and enforcement policy. In a response to a request for input on cannabis regulation from the Senate HELP Committee and the House Committee on Energy
Drugs
FDA has issued a warning against using Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair due to bacterial or fungal contamination. “Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection,” the
Drugs
AstraZeneca says an FDA draft guidance on efficacy endpoints for clinical trials investigating antidiabetic drugs and biological products, when combined with a 2020 guidance, appears to cover substantially less material than the 2008 guidance it replaces. In a comment letter, the company suggests that the agency consider including in the