Business briefs: Glaxo, Teva, Johnson & Johnson
Herve Gisserot is the new head of GlaxoSmithKline's China business unit, reports the Wall Street Journal, which notes that Mark Reilly, whom Gisserot has replaced, will remain with the drug maker. A spokesman told the WSJ that Reilly will help shape the company's response to allegations of misconduct. The company has been accused of bribing doctors, hospitals and government officials.
Teva and Lonza have parted ways. The companies said in a joint statement Thursday that they are dissolving their 2009 biosimilars joint venture, called TL-JV. “In our assessment those investments in biosimilars will require more capital than initially planned and will also take more time until they reach the market,” is how Lonza's COO Stephen Kutzer explained the move.
Breakthrough therapy status is helping the pharmaceutical industry in the US, but Reuters notes that the accelerated approval pathway does not necessarily guarantee approvals abroad. Two examples of the local benefit are Johnson & Johnson's ibrutinib, which the drug maker and its partner Pharmacyclics expect to get to the approval stage two years earlier than it would have through regular channels, as well as Vertex's cystic fibrosis medication Kalydeco, which sped through the approval process. Vertex's CEO Jeffrey Leiden told a Washington, DC, conference that was aimed at raising review process awareness, that the designation makes talks with the regulator go swiftly. It also helps conversations that would typically take weeks or months happen at a faster clip. International regulators aren't the only ones resistant to breakthrough status. Reuters notes that payers are also reticent to go along with a drug that's been reviewed and approved on an expedited basis if the “data do not show improved survival or other clear benefit they are used to seeing when drugs are approved.”