The European Commission has escalated its review of Leqembi, an Alzheimer’s treatment developed by Eisai and Biogen, by referring the case to an appeals committee. This latest development comes as part of an ongoing approval process that has seen multiple twists and turns in the European Union. The appeals committee will provide representatives from EU member states an opportunity to further evaluate the proposed marketing application. This referral follows a complex regulatory journey where an important regulatory committee initially opposed Leqembi’s approval before reversing its stance after Eisai’s appeal.
In other pharmaceutical industry news, Sanofi has appointed Chris Corsico as its new head of development, according to internal communications reviewed by BioPharma Dive. Corsico, who previously served at GlaxoSmithKline where he managed the company’s drug portfolio development, will report directly to Houman Ashrafian, Sanofi’s global R&D head. Before his tenure at GSK, Corsico spent over 20 years at Boehringer Ingelheim.
Meanwhile, Opthea, an eye drug developer, has announced the
discontinuation of its Phase 3 trial for sozinibercept, a treatment being tested in combination with Lucentis for age-related macular degeneration. The company has raised concerns about its financial stability, noting “material uncertainty” regarding its ability to continue operations, despite holding $100 million in cash and equivalents at the end of March.
In executive movements, Novartis has named Karen Hale as its new chief legal and compliance officer, replacing Klaus Moosmayer. Hale, who joined Novartis in 2021 from AbbVie, will expand her current role as chief legal officer to oversee the company’s ethics and risk compliance policies. In a LinkedIn post, she emphasized her commitment to strengthening enterprise-wide risk alignment and maintaining ethical standards throughout the organization.
In a significant regulatory development, PTC Therapeutics has faced a setback as the European Commission has decided not to renew the marketing authorization for Translarna, its treatment for Duchenne muscular dystrophy. While the drug can still be accessed through certain country-specific pathways, it effectively loses its European approval, which had been in place since 2014. The decision follows the drug’s failure in confirmatory testing in 2022 and multiple regulatory recommendations against its continued availability. Despite these challenges in Europe, PTC continues its efforts to secure approval in the United States, where the drug has faced multiple rejections but persists in seeking authorization.
The pharmaceutical landscape continues to evolve with these
developments, reflecting the complex nature of drug development, regulatory approval processes, and corporate leadership changes. These events highlight the ongoing challenges and dynamics within the industry, from regulatory hurdles and clinical trial outcomes to executive appointments and financial sustainability concerns. The situations faced by companies like Eisai, Biogen, Sanofi, Opthea, Novartis, and PTC Therapeutics demonstrate the diverse challenges and opportunities present in the current biopharmaceutical environment.
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