Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it “strongly agrees with the potential benefits of artificial intelligence (AI) and machine learning (MI) in drug development, including the potential to bring safe and effective drugs to patients faster; provide broader access to drugs and thereby improve health equity; increase the
Drugs
Novartis says top-line data from two Phase 3 studies evaluating remibrutinib 25 mg in patients with chronic spontaneous urticaria (CSU) met their primary endpoint of absolute change from baseline in weekly urticaria activity score (UAS7) at Week 12, “demonstrating clinically meaningful and statistically significant improvements in disease activity.” Remibrutinib
Drugs
FDA has cleared an Aspen Neuroscience IND for its ANPD001, described as an autologous cell therapy to treat Parkinson’s disease by replacing lost dopamine neurons. The company says it plans to start a Phase 1/2a clinical trial for people with moderate to severe Parkinson’s disease. Aspen says
Drugs
FDA has accepted for review a Vitaris/Mapi Pharma NDA for GA Depot 40 mg, a long-acting glatiramer acetate being investigated as a once-monthly injection to treat relapsing forms of multiple sclerosis. The companies say the agency has assigned a PDUFA action date of 3/8/24 for
Drugs
Physicians and health systems can take steps to identify substandard generic medicines and minimize the risk to patients from them. That’s the view of two authors of a Health Affairs article. “Because generic drugs sold in the U.S. must be FDA-approved,” the authors write, “healthcare providers and
Drugs
A Congressional Research Service paper says Congress adopted 4/23/2021 legislation that generally codified FDA’s long-standing approach to evaluating new chemical entity (NCE) exclusivity. The paper, Defining Active Ingredient: The U.S. Food and Drug Administration’s Legal Interpretation of Regulatory Exclusivities, reviews the history of the
Drugs
Shire, Baxter International, Baxalta, Viropharma and Takeda Pharmaceuticals have agreed to pay $42 million to settle an enforcement action brought under the Texas Medicaid Fraud Prevention Act (TMFPA) involving allegedly improper reimbursements for certain pharmaceuticals. The alleged violations were first brought in a lawsuit filed by a whistleblower under the
Drugs
FDA has granted HuidaGene Therapeutics a rare pediatric disease designation (RPDD) for HG004 and its use in treating inherited retinal disease caused by RPE65 mutations. Inherited retinal disease is described by the company as a group of rare blinding conditions caused by mutations in any 1 of more than 250
Drugs
FDA has granted traditional approval for Genentech’s Gavreto (pralsetinib) for treating adult patients with metastatic RET (rearranged during transfection) fusion-positive non-small cell lung cancer (NSCLC) as confirmed by an FDA-approved test. Pralsetinib had previously been granted accelerated approval 9/2020 for the NSCLC indication based on
Drugs
FDA has issued Galera Therapeutics a complete response letter (CRL) on an NDA for avasopasem manganese for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment. “In the CRL, the FDA communicated that the results from the Phase 3 ROMAN trial together
Drugs
Researchers at three universities who evaluated the evidence in 413 studies supporting 37 novel drugs approved by FDA in 2022 say the results “highlight a trend toward less rigorous standards for novel drug approvals that has evolved over the past few decades.” Writing in an open-access JAMA Network Open
Drugs
Three Morgan Lewis attorneys say an updated FDA draft guidance to implement the International Council for Harmonizations good clinical practice (GCP) guidelines is part of a series of agency documents demonstrating its interest in modernizing the guidelines to account for emerging technologies. An online post says FDA’s receptivity to
Drugs
FDA has warned six overseas over-the-counter drug manufacturers about significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished drugs. In each instance, based on a review of records requested from the companies and other information, the 8/3 Warning Letters cited these violations: * failing to conduct
Drugs
The Biotechnology Innovation Organization (BIO) says it “applauds FDA for the issuance of a comprehensive and clear discussion paper on the use of artificial intelligence/machine learning (AI/ML) in drug development and supports FDA’s risk-based approach to the review, assessment, and regulation.” In a comment letter, BIO
Drugs
Novo Nordisk says its Wegovy (once-weekly subcutaneous semaglutide 2.4 mg) reduced the risk of major adverse cardiovascular events (MACE) by 20% in overweight or obese adults in the SELECT trial. A company statement says Wegovy met the trial’s primary objective by demonstrating a statistically significant and superior
Drugs
FDA has published a draft guidance, QTc Information in Human Prescription Drug and Biological Product Labeling, to assist applicants to incorporate QTc interval prolongation-related information in the labeling of non-antiarrhythmic human prescription drug and biological products. The document provides illustrative examples of the content and format of QTc
Drugs
Drägerwerk has recalled its Dräger Carina Sub-Acute Care Ventilators due to the potential for contamination of the breathing gas with 1,3- Dichloropropan-2-ol, a constituent of the PE-PUR foam used for sound insulation. The company says testing “measured concentrations of 1,3-Dichloropropan- 2-ol above
Drugs
FDA has granted ABM Therapeutics an orphan drug designation for ABM-1310, a novel small molecule BRAF inhibitor for treating patients with glioblastoma (GBM) who have the BRAF V600 mutation. The company says the drug has BRAF-mutation selectivity, high water solubility, and high blood-brain barrier permeability. ABM-1310
Drugs
FDA has approved a Sage Therapeutics NDA for Zurzuvae (zuranolone), an oral drug for treating postpartum depression (PPD) in adults. “Until now, treatment for PPD was only available as an IV injection given by a health care provider in certain health care facilities,” an agency release says. The daily recommended
Drugs
FDA has issued a draft guidance entitled “Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry.” The agency was given authority under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) to require manufacturers to submit cosmetic product listings, including a list of ingredients used in these
Drugs
FDA has approved Astellas Pharma’s Izervay (avacincaptad pegol intravitreal solution) for treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). As AMD progresses, retinal cell loss and the underlying blood vessels in the macula results in “marked thinning and atrophy of retinal tissue,” the company says. “Geographic
Drugs
FDA has cleared an Abbott 510(k)for its Alinity h-series hematology system for use by laboratories to run complete blood counts (CBC). The device includes Alinity hq, an automated hematology analyzer, and Alinity hs, an integrated slide maker and stainer, according to the company. It also leverages Abbott’