AstraZeneca’s perioperative Imfinzi ‘significantly extends survival’ in type of bladder cancer
The result comes months after an FDA advisory committee flagged the risk of potential overtreatment with perioperative regimens.
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Lilly secures FDA nod for eczema therapy, eyes launch in ‘coming weeks’
Friday’s approval comes after a previous rejection in October 2023 due to manufacturing concerns.
Gilead touts 96 percent HIV risk reduction with twice-yearly PrEP, eyes regulatory filings
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.
Sanofi dips into red-hot radiopharma space with $110M licensing deal
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.
J&J positions Tremfya as Stelara successor with FDA nod for ulcerative colitis
Tremfya’s ulcerative colitis approval on Wednesday comes as Johnson & Johnson’s blockbuster immunotherapy Stelara continues to face growing competition from biosimilars.
Intercept’s Ocaliva in jeopardy as FDA questions efficacy, safety ahead of Adcomm
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.
Biopharma layoff tracker 2024: Charles River Laboratories, Vesigen, Connect Biopharma and more cut staff
A review of the latest biopharma job cuts thus far in September and beyond.
Vertex, CRISPR’s Casgevy faces complex path to profitability
No patients have received Casgevy, CRISPR Therapeutics and Vertex Pharmeceuticals’ recently approved sickle cell gene therapy. Experts weigh in on the path to profit for the treatment and the therapeutic class in general.
Lilly continues once-weekly insulin rally with two Phase III diabetes readouts
The late-stage clinical trial results showed that Eli Lilly’s once-weekly insulin efsitora matched daily injections for patients with type 1 and 2 diabetes, respectively.
Novo’s Saxenda effectively, safely lowers BMI in children: NEJM study
A study published Tuesday in The New England Journal of Medicine showed that children between the ages of six and 12 who took liraglutide for just over a year experienced a significant reduction in body mass index compared to placebo.