Daiichi Sankyo Co Ltd. has experienced yet another setback with its quizartinib NDA submission, as the U.S. FDA has now extended the review period by three months to July 24, 2023, to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies. No additional efficacy or safety data has been requested. Read More
The U.S. FDA’s green light April 17 for Abbvie Inc. to expand the label of Qulipta (atogepant) – the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist for migraine, with language that includes prevention of such headaches chronically in adults – provided a welcome addition to the arsenal, but sufferers are still waiting for an improved remedy. Vaxxinity Inc. just might have it. And with a vaccine, no less. Read More
Following up on a bipartisan effort to keep down the costs of insulin, U.S. Sens. Susan Collins (R-Maine) and Jeanne Shaheen (D-N.H.) reintroduced a bill on April 20 to ensure patients with diabetes can access the life-saving medicine without the excess costs associated with drug rebates and stymied competition. Read More
The European Commission is bringing out rules designed to further simplify and streamline procedures for pharmaceutical companies planning on merging under EU Merger Regulation rules. The commission assesses mergers and acquisitions of companies whose turnover exceeds certain thresholds to prevent concentrations that would significantly impede effective competition in the European Economic Area or in a substantial part of it. Read More
Radiopharmaceuticals have been used for a long time for diagnostics, but radiopharma therapies are entering a new era in which they are becoming widely accepted as a key tool in the oncology armamentarium potentially providing patients with a big bump in efficacy with fewer side effects and less damage to healthy tissue. In this eight-part series, BioWorld takes a deep dive into this new treatment modality to explore what the new uses or alternatives are and what the future of radiopharmaceutical therapy might look like. Part one sets the stage and outlines the beginnings of the industry and some of the challenges drugmakers will need to overcome. The series takes a closer look at the different radiopharmaceutical moieties, the science behind them, the patient journey, the therapies in the pipeline, the regulatory landscape, and the supply chain vulnerabilities. Read More
New and updated clinical data presented by biopharma firms at the American Association for Cancer Research annual meeting, including: Innovent, Primmune. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Achieve, Beigene, Bioinvent, Cantex, Dare, Maia, Promore, Sellas, Visus. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Boehringer Ingelheim, Emergent, Genmab, GRI, Janssen, Retinai, Vallon, Ventus. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apex, Aquestive, Cantargia, Carsgen, DBV, Dermata, Genentech, Innocare, Regeneron, Sanofi, Sensei, Therapeutic Solutions, Tiziana. Read More
