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
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…
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…
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
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may use patient-level data from other trials and/or real-world data (RWD) sources as an external control arm in a new draft guidance.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:…
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…
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…
Sen. Elizabeth Warren (D-Mass.) has asked the Federal Trade Commission (FTC) to take a hard look at two pending pharmaceutical mergers she believes could impact drug prices. Source: Drug Industry…
A bipartisan group of senators has re-introduced proposed legislation to establish a task force between the U.S. Patent and Trademark Office (USPTO) and the FDA to improve coordination in implementing…
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…