News and views from day four of the BIO International Convention: emerging company M&A deals nearly double in 2018; former FDA official Amy McKee said "everything worked right" with accelerated approval and removal of Lilly's Lartruvo; and the ASCO effect on the 3-6 June BIO meeting.
The accelerated approval and withdrawal of Eli Lilly & Co.’s soft tissue sarcoma drug Lartruvo (olaratumab) is “an example of everything going right in the regulatory world,” a former deputy director of the US Food and Drug Administration’s Oncology Center of Excellence believes.
Amy McKee, who left the agency in February to join Parexel International Corp. as VP of regulatory consulting services,...
The world’s biggest pharmaceutical companies mostly saw growth in 2024 but 2025 promises to be more of a mixed bag with headwinds including losses of exclusivity, Medicare Part D redesign and challenges in the Chinese market.
The nod will help unlock a national market for the partners’ Dupert (fulzerasib) in which roughly 50,000 people are expected to be newly diagnosed with lung cancer harboring the KRAS G12C mutation in 2025. Meanwhile, two other homegrown rivals are also closing in on marketing clearances in China.
2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.
Tarsus Pharmaceuticals is putting more sales and marketing heft behind its novel eyelid disease therapy, Xdemvy, to capitalize on a solid start in a previously untapped market.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
