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Paul Stoffels left his perch as J&J’s chief scientific officer in 2022 to replace Galapagos’ founding CEO Onno van de Stolpe, inheriting a company that had suffered a series of clinical failures since its 1999 creation.
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Mirador debuted last year with a massive $400 million and the goal of developing game-changing therapies for inflammatory and fibrotic diseases. The company aims to enter the clinic this year.
As obesity drug developers compete for the highest weight-loss efficacy, experts contend that overall health outcomes—evidenced by successful studies in therapeutic areas like cardiovascular and sleep apnea—may prove a greater market advantage.
Having established success in cancer, biopharma is now looking to leverage CAR T therapies against a new target, autoimmune disorders, with several early- to mid-stage readouts expected this year.
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Bristol Myers Squibb announced that the U.S. Food and Drug Administration has granted accelerated approval for KRAZATI® in combination with cetuximab as a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
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As the Trump administration—including HHS Secretary Robert F. Kennedy Jr.—plays fast and loose with scientific studies and facts, there may be a more sinister force at play: censorship.
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Novartis plans to build seven new facilities in the U.S., touting the creation of up to 1,000 new jobs at the company. The new facilities will include a biomedical research hub in California, two radioligand plants, and four manufacturing sites.
Analysts at William Blair expect drug developers will continue to perform “at least some animal testing” on their investigational products. Though the process to phase out animal testing will begin “immediately,” no specific timetable was given.
Biotech companies are already seeing regulatory delays and plenty of uncertainty after around 3,500 FDA employees were cut by the Trump administration.
Pharma stocks went on a wild ride Wednesday amid whiplashing tariff threats from the U.S. president.
The number of employees laid off dropped year over year during the first quarter. BioSpace recaps the five largest layoffs, which included BMS and Novartis cuts.
According to Tempest, its options include a partnership or licensing deal, as well as a merger or an acquisition.
In this episode presented by DIA, BioSpace’s head of insights Lori Ellis discusses the underrepresentation of women in clinical trials with Martin Hodosi, partner at Kearney and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine.
Experts express concern that last week’s unprecedented FDA layoffs will trigger a little-known mechanism that could result in a “disaster” the Trump administration doesn’t see coming.
Jefferies analysts predict Annexon’s tanruprubart could be approved by mid-2026.
Leerink analysts noted, however, that Uplizna’s slow onset of therapeutic efficacy compares unfavorably to would-be competitors in generalized myasthenia gravis.