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TOP STORIES
The acquisition of Tubulis GmbH—Gilead Sciences’ latest of the year after buying Arcells and Ouro Medicines—brings into the fold a novel ovarian cancer candidate that has demonstrated promising mid-stage data.
Humira will be available on TrumpRx at an 86% discount, according to media reports, as part of AbbVie’s deal with the White House to avoid tariffs. The news comes less than a week after the president announced up to 100% levies on pharma products.
FDA
Aiming to protect patients, the FDA sent lawmakers a wish list of legislative proposals intended to clarify and expand its oversight of updates to approved drug production processes.
Sanofi has faced questions about the potential of lunsekimig in eczema, with executives calling the clinical trial a “measured risk.”
Sales of Amgen’s thyroid eye disease drug Tepezza have slowed, dipping 1% to $457 million in the fourth quarter of 2025.
If the Trump administration’s proposal passes, the FDA’s budget will be more than $200 million bigger in 2027, with plans to launch new programs that expedite drug development, boost national security and promote “radical transparency.”
Follow along as BioSpace tracks job cuts and restructuring initiatives.
While an acquisition is a good exit for Soleno Therapeutics, the company’s acceptance of Neurocrine Biosciences’ $53-per-share offer came as a surprise to Stifel analysts given the potential growth of Vykat XR, approved last year for extreme hunger in patients with Prader-Willi syndrome.
Some disease areas bucked the trend of shrinking pipelines, however, with immune and cardiovascular indications seeing an upward trend in investigational assets.
Anthropic in October last year iterated its Claude AI model to better cater to biopharma purposes. Sanofi, Novo Nordisk, AbbVie and others already use Claude in their operations.
Takeda and Denali Therapeutics first partnered in early 2018 to advance drugs for neurodegenerative diseases. One asset, for Alzheimer’s disease, was previously discontinued after an FDA hold and disappointing early data.
The upcoming FDA decision for Replimune’s advanced melanoma drug could be a litmus test for the agency’s future regulatory decision-making, analysts say, with implications stretching well beyond one company.
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