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Many drug developers could improve the alignment of their quality units and their business units — and potentially avoid Form 483 inspection observations — if they dusted off and applied the International Council on Harmonization’s ICH Q10 Pharmaceutical Quality System guidance, according to one pharma quality expert. Read More
Most cancer drugs that gain an Accelerated Approval don’t end up showing any clinical benefit in their confirmatory trials, exposing thousands of patients to ineffective therapeutics that may linger on the market for years until postmarketing studies show their true clinical impact, a new analysis has shown. Read More
Following through on a 2023 pledge from its CEO, Amylyx is voluntarily pulling its controversial amyotrophic lateral sclerosis drug Relyvrio/Albrioza (AMX0035; ursodoxicoltaurine) after the drug failed its confirmatory phase 3 study. Read More
The FDA’s guidance on the quantity of bioavailability (BA) and bioequivalence (BE) testing samples to be retained by NDA applicants and contract research organizations (CRO) contains both draft and final language focusing on both the test article and reference standard. Read More
Closing on May 31, the European Medicines Agency (EMA) has opened a second consultation for its guideline on requirements for investigational advanced therapy medicinal products (ATMP) in clinical trials. Read More
In a nod to the increasing potential of demonstrating drug/biologic safety and/or effectiveness through noninterventional studies, the FDA has published long-awaited draft guidance on designing and analyzing such studies with real-world data (RWD) in mind. Read More
Last month, signs that magrolimab increases the risk of death prompted Gilead to shelve the drug for blood cancer, Vertex’s second-gen cystic fibrosis combo leaves the company’s first-gen efforts in the dust, a new drug combo looks promising for multiple myeloma, and Regenxbio hopes to snag an Accelerated Approval for a new rare disease gene therapy. Also, Astra Zeneca is touting “major advance” in treating one type of non-small cell lung cancer. Read More
AI models developed by GE HealthCare used readily available clinical data to forecast cancer immunotherapy outcomes and adverse reactions with 70-80 percent accuracy, according to an article published in the Journal of Clinical Oncology Clinical Cancer Informatics. Read More