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 (REMS). No additional efficacy or safety data has been requested. The NDA is under review for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed acute myeloid leukemia that is FMS-like tyrosine kinase 3-internal tandem duplication positive.

Vaxxinity to detail novel migraine vaccine in AAN session

Although many migraine agents have become available over the years, their cost, efficacy, and toxic effects are factors that have hobbled some therapies. Working on a vaccine in the space is Vaxxinity Inc. with UB-313, which is undergoing a phase I trial that began in September 2022. Data are due on safety and tolerability, and immunogenicity in the first half of this year. The product is designed to teach the body to produce antibodies that target and suppress calcitonin gene-related peptide. Cape Canaveral, Fla.-based Vaxxinity will discuss the vaccine April 24 during the American Academy of Neurology (AAN) annual meeting in Boston.

Insulin pricing bill requires PBMs to pass through rebates

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 those with diabetes can access the life-saving medicine without the excess costs associated with drug rebates and stymied competition. The bill updates one introduced last year, but it now includes the advice of advocates, lawmakers and experts, requiring pharmacy benefit managers (PBMs) to pass through to health plan sponsors all insulin rebates and other discounts that they receive from manufacturers, thereby reducing what the senators call “perverse incentives in the insulin market that encourage high list prices.” It also provides for a new expedited FDA approval pathway for generic biologics lacking biosimilar competition, and it extends price caps beyond Medicare patients to those with private insurance.

European Commission to ‘cut red tape’ for merging pharma firms

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. It first introduced in 2000 a simplified procedure for “unproblematic mergers,” but has been trying to streamline the merger review process further ever since.

Radiopharmaceuticals: The next big disrupter

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.

Also in the news

Achieve, Allogene, Apex Labs, Aquestive, Beigene, Bioinvent, Boehringer Ingelheim, Cantargia, Cantex, Carsgen, Cyclo, Daré, DBV, Dermata, Emergent, Genentech, Genmab, GRI, Immvira, Innocare, Innovent, Janssen, Lianbio, Maia, Pharmaessentia, Phio, Promore, Retinai, Sanofi, Sellas, Sensei, Sirona, Therapeutic Solutions, Tiziana, Vallon, Visus