Archive for January 2023
Industry Nonprofit Issues Standards for Data-Sharing
In the latest push for data interoperability in drug research, the Pistoia Alliance, a nonprofit aimed at encouraging collaboration among industry stakeholders, has published a guide for data standards that would make research data shareable among sponsors, clinical trial sites and regulators. Source: Drug Industry Daily
Read MoreFDA Seeks Comments on ICH Draft Guideline on Bioequivalence Testing for Solid Oral Drugs
The FDA has asked for feedback on an International Council for Harmonization (ICH) draft guideline on bioequivalence (BE) studies for immediate-release solid oral drugs. Source: Drug Industry Daily
Read MoreICER Questions Benefit of Astellas Pharma’s Hot Flash Candidate
Fezolinetant, Astellas Pharma’s potential first-in-class treatment for menopausal hot flashes, shouldn’t cost more than $2,600 per year if approved, according to a cost-benefit analysis by the Institute for Clinical and Economic Review (ICER) based on the available trial data. Source: Drug Industry Daily
Read MoreICH Finalizes Revised Quality Risk Management Guideline
The International Council for Harmonization (ICH) has issued the final version of its revised guideline on quality risk management ICH Q9(R1), adding information on risk management methodology, such as assessing the degree of risk analysis required, risk-based decision-making and managing subjectivity. Source: Drug Industry Daily
Read MoreAppeals Court Decides in Favor of Pharma in 340B Battle
A federal appeals court has ruled that companies participating in the 340B drug pricing program may restrict discounts to hospitals that use multiple contract pharmacies, handing appellants Sanofi, Novo Nordisk and AstraZeneca a major win in their ongoing fight with HHS. Source: Drug Industry Daily
Read MoreLGM Pharma Enters Consent Decree Following Allegations of Adulterated Drugs
A federal court in Florida has issued a consent decree against LGM Pharma, a Boca Raton-based active pharmaceutical ingredient (API) importer and distributor, prohibiting the company from distributing APIs that don’t comply with current good manufacturing practices (cGMP). Source: Drug Industry Daily
Read MoreFDA Issues Draft Guidance on Externally Controlled Trials
The FDA says trial sponsors and investigators may use patient-level data from other trials and/or real-world data (RWD) sources as an external control arm in a new draft guidance. Source: Drug Industry Daily
Read MoreAmgen Launches Long-Approved Humira Biosimilar Amjevita
Amgen finally launched Amjevita (adalimumab-atto) in the U.S. yesterday, releasing the first rival to AbbVie’s mega-blockbuster anti-inflammatory drug, Humira. Source: Drug Industry Daily
Read MoreDozens of Pediatric Trials Failed to Properly Report Results, Study Finds
Nearly four dozen pediatric clinical trials involving more than 3,600 children failed to publish their findings on ClinicalTrials.gov or in scientific literature, according to a new analysis by U.K.-based trial transparency advocacy group TranspariMED and other non-U.S. researchers. Source: Drug Industry Daily
Read MoreFDA Pulls Evusheld EUA, But AstraZeneca Has Another Antibody in The Wings
The FDA has pulled the Emergency Use Authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab/cilgavimab) because, the agency says, more than 90 percent of the circulating SARS-CoV-2 variants in the U.S. are now resistant to it. Source: Drug Industry Daily
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