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FDA
FDA decisions lack majority consensus, experts agree, possibly leading to less nuanced verdicts on new drug applications. This type of “fiat” decision-making, as multiple regulatory experts have called it, is also bleeding into the agency’s policymaking.
IPO
Generate:Biomedicines has hit the public markets as the world begins to question the usefulness of AI technology. CEO Mike Nally says biology is the key to unlocking the technology’s full potential.
The CDC’s changes threaten to cut vaccine sales for makers including Pfizer, Moderna, Merck and more, but a legal expert suspects affected manufacturers will stay on the sidelines rather than back a push to declare the revised schedule unlawful.
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Eli Lilly’s win in a head-to-head trial drove Novo Nordisk’s market cap to pre-Wegovy levels not long after the victor became the first pharma company to top a $1 trillion valuation. It seems one company can do no right, while the other can do no wrong.
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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.
Novartis, Eli Lilly and more put on their deal-making caps, Bristol Myers Squibb targets $2 billion in savings through 2027, sales continue to soar for Lilly and Novo Nordisk’s GLP-1s and Regeneron sues Sanofi over an alleged failure to provide adequate information about Dupixent sales.
From revenue to R&D investment, Novo and Lilly and their mega-blockbuster weight loss drugs Zepbound and Wegovy have moved into a new pharma stratosphere, far eclipsing their rivals.