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Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
FDA
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Year-over-year BioSpace data show there were fewer job postings live on the website in the fourth quarter of 2024, and the decrease was higher than the third quarter’s drop.
Biogen and Eisai have spent much of Leqembi’s launch convincing physicians and patients that it’s safe to treat Alzheimer’s disease. With patients now hitting the 18-month mark of treatment, the conversation is finally shifting to efficacy.
The pharma giant inked its third T cell engager deal of 2025 Wednesday—this time with Xilio Therapeutics for tumor-activated immunotherapies.
The Boston-area company’s previous raises were also aimed at getting its investigational antibody treatment for inclusion body myositis through clinical trials. Now, Abcuro is eyeing a regulatory submission and potential launch.
The funding agreement comes as Biogen revealed a modest Q4 sales beat, which analysts expect will be “overshadowed” by the company’s forecasted dip in 2025 revenues.
The approval comes days after Germany’s Merck KGaA confirmed it was in advanced talks to acquire SpringWorks.
Just a few months after Vir Biotechnology lost an emergency authorization for its COVID-19 antibody, Marianne de Backer stepped in as CEO to answer a critical question: What’s next?
The partnership dates back to 2015, when Incyte paid $60 million upfront for access to four checkpoint programs, including TIM-3, LAG-3, OX40 and GITR.
Gilead beat consensus estimates in Q4 with $7.6 billion in revenue, driven largely by its HIV drug Biktarvy and CAR T therapies Trodelvy and Yescarta.
As the Q4 2024 pharma earnings period rolls on through the first month of President Donald Trump’s second term, executives find themselves faced with policy questions ranging from the Inflation Reduction Act to RFK Jr.