The European Commission has escalated its review of Leqembi, an Alzheimer’s treatment developed by Eisai and Biogen, by referring the case to an appeal committee. This latest development continues the medication’s complex journey toward potential approval in the European Union. The appeal committee will provide member states’
representatives an opportunity to further examine the proposed drug authorization. This follows a significant turn of events last summer when a key regulatory committee initially opposed Leqembi’s approval before reversing their stance following an appeal from Eisai.
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 GSK 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, a company specializing in eye treatments, has announced the discontinuation of its Phase 3 trial for sozinibercept, a drug being tested in combination with Lucentis for age-related macular degeneration. The company has expressed serious 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.
Novartis has made changes to its executive leadership, promoting Karen Hale to the position of chief legal and compliance officer. Hale, who joined Novartis in 2021 from AbbVie, will replace Klaus Moosmayer and expand her previous role as chief legal officer to include oversight of the company’s ethics and risk compliance policies. In a LinkedIn statement, Hale 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. This decision effectively ends the drug’s approval status in Europe, although individual countries may still permit its use through specific pathways. Translarna’s European journey began with its initial authorization in 2014, but the drug failed a confirmatory test in 2022, leading to multiple regulatory
recommendations against its continued availability. Despite these setbacks in Europe, PTC Therapeutics continues its efforts to secure approval in the United States, where the drug has faced multiple rejections from regulators.
These developments reflect ongoing challenges and changes in the pharmaceutical industry, from regulatory hurdles and clinical trial setbacks to executive leadership transitions and financial
sustainability concerns. The industry continues to navigate complex approval processes, particularly for innovative treatments, while companies adapt their organizational structures and development strategies to meet evolving market demands and regulatory
requirements.
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