Armed with readouts from the PURPOSE 1 and 2 trials, Gilead Sciences is now gearing up for global regulatory submissions for lenacapavir as a pre-exposure prophylactic option for human immunodeficiency virus.
The approval, known as a prequalification, comes as a new type of the virus spreads from the Democratic Republic of Congo, where the current outbreak began in early 2023, to several neighboring countries.
Sanofi will join Big Pharma peers Novartis, BMS and Eli Lilly in radioligands, striking a $110 million licensing deal with RadioMedix and Orano Med to develop AlphaMedix for neuroendocrine tumors.
Tremfya’s ulcerative colitis approval on Wednesday comes as Johnson & Johnson’s blockbuster immunotherapy Stelara continues to face growing competition from biosimilars.
With today’s advisory committee meeting looming, the sole indication for Intercept Pharmaceuticals’ Ocaliva appears to be at risk as the regulator flags issues regarding its post-marketing results.
Yesterday the company announced it will halt the development of its experimental drug, aimed at improving cognitive function in patients with schizophrenia, after it did not achieve the primary goal in a mid-stage trial.