→ Teva $TEVA upped its profit outlook for the year today, but nevertheless saw its share price drop by about 5% as analysts highlighted the continued erosion of generic drug revenue. The Israeli company also noted that it expects to see a decision from the FDA on its migraine drug fremanezumab in mid-September after regulators delayed their review over manufacturing issues.
→ Akcea $AKCA, the growing Ionis $IONS spinout, is rolling out two of its drugs in Latin America with the help of a new partner. PTC Therapeutics $PTC, the Duchenne company that’s recently been nabbing up gene therapies, will sell Akcea’s Tegsedi and Waylivra in the region. Tegsedi has been approved by the European Commission to treat polyneuropathy in hATTR amyloidosis patients, and Waylivra is under regulatory review in the US, Europe, and Canada to treat familial chylomicronemia syndrome. “One of the key mutations that leads to hATTR amyloidosis occurs more frequently in individuals of Portuguese descent,” said Marcio Souza, chief operating officer at PTC, in a statement. “There are approximately 6,000 patients with polyneuropathic hATTR amyloidosis in Latin America, making it a strategically important region for Tegsedi. We are well positioned to file for registration in key Latin American countries in the short term.”
→ Hong Kong-based EdiGene has appointed former Shire R&D exec Dong Wei to serve as the company’s new CEO. The company, which has a US presence in Cambridge, MA, is developing a pipeline in genetic diseases and cancer, along with CRISPR/Cas 9-based drug discovery services.
“Genome editing is revolutionizing drug development in multiple aspects,” Wei said in a statement. “With its deep science and proprietary platforms, EdiGene is uniquely positioned in this rapid advancing field. It is a privilege to work with such an excellent team to develop innovative options for patients in China and the world.”
Wei comes from Treos Bio, where he was COO. Before that, he was the global development leader of late-stage development programs at Shire, senior director of business operation and program management at Johnson & Johnson Innovation Center and held various R&D and business positions at companies including BioMarin, Elan, and Janssen.
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