02-04-2025
Leqembi's EU review drags on; Sanofi gets a new development head
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Today, a brief rundown of news involving Eisai, Biogen and Sanofi, as well as updates from Opthea, Novartis, and PTC Therapeutics.
The saga to get Eisai and Biogen's newer drug for Alzheimer's disease approved in Europe continues. On Tuesday, the partners disclosed that the European Commission, which makes the final call on what medicines are cleared for market in European Union, referred the Leqembi case to an 'appeal committee.' These committees offer representatives from member countries a forum to further discuss proposed actions, such as the approval of a drug marketing application. A key regulatory committee sided against Leqembi's approval last summer, but reversed course after Eisai appealed that decision. — Jacob Bell
Sanofi has made former GSK executive Chris Corsico its new head of development, according to an internal company communication obtained by BioPharma Dive. Corsico, whose new position is effective immediately, will report to Sanofi's global head of R&D Houman Ashrafian. At GSK, Corsico led development of the company's drug portfolio. He spent more than two decades at Boehringer Ingelheim previously. — Ned Pagliarulo
Eye drug maker Opthea has scrapped plans to develop a treatment for a form of age-related macular degeneration, and warned investors it could run out of funding. In a Monday announcement, the company said it would terminate its Phase 3 trial of sozinibercept, which was tested as a combination with Lucentis. There 'remains material uncertainty as to Opthea's ability to continue as a going concern,' said the company, which had $100 million in cash and equivalents as of the end of March. — Gwendolyn Wu
Novartis appointed Karen Hale as its new chief legal and compliance officer, the Swiss pharma said Sunday, replacing Klaus Moosmayer. Hale, who joined Novartis in 2021 from AbbVie to become its chief legal officer, will now also oversee the company's ethics and risk compliance policies. 'Strengthening enterprise-wide risk alignment and ensuring our commitment to ethics, compliance, and integrity remains a guiding force in everything we do,' Hale wrote in a LinkedIn post. — Gwendolyn Wu
After years of regulatory back-and-forth, the European Commission will not renew the marketing authorization of PTC Therapeutics' drug Translarna to treat Duchenne muscular dystrophy. Effectively, Translarna is no longer approved in Europe, although individual countries can use certain pathways to allow continued use. Translarna was initially authorized in Europe in 2014, but in 2022 failed a confirmatory testing. European regulators have repeatedly recommended against the drug's continued availability, but those decisions went through several appeals. PTC is still working to win approval of Translarna in the U.S., where it has been rejected multiple times, too. — Ned Pagliarulo
