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The company is trying to increase doctor awareness of and testing for a rare lung cancer mutation to help boost use of its drug Braftovi, which the pharmaceutical maker anticipates could grow to become the standard of care.
Yesterday the FDA issued an alert about Astellas’ Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, stating that it can cause rare but serious liver injury. The agency stated that if there are signs and symptoms suggesting liver injury, halting use of the medicine could prevent worsening liver injury and potentially return liver function to normal.
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.
The groundbreaking event aims to address the significant funding gap faced by women entrepreneurs in healthcare and life sciences, where only three percent of venture capital funding goes to female founders, and an even smaller percentage to women of color.
A review of the latest biopharma job cuts thus far in September and beyond.
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