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FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the medicine, which was acquired in the $3.7 billion buyout of ChemoCentryx.
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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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Days after backing out of two Ionis-partnered neuro programs, Biogen has inked a potential $1.8 billion buy of Human Immunology Biosciences and boosting its late-stage immunology pipeline.
Patent cliffs and other factors may lead other large drugmakers to embrace similar cost-cutting measures, experts tell BioSpace.
As part of an ongoing Senate investigation into pharma companies’ tax rates, Sen. Ron Wyden (D-Ore.) has asked Pfizer CEO Albert Bourla to explain irregularities in its reported revenues, losses and taxes paid.
Johnson & Johnson on Tuesday released Phase II/III results showing its monoclonal antibody Tremfya is better than its blockbuster Stelara in terms of endoscopic outcomes in Crohn’s disease.
Approaches and targets for depression and other mental health illnesses have remained stagnant for decades. With several readouts for novel therapies on the horizon, that could be changing.
Odds are, you won’t love every job. Is that OK? And what should you do if you’re struggling to find happiness at work?
Participants experienced fewer asthma attacks when receiving the antibody every six months, GSK said Tuesday, positioning the company to file for approval of the potential blockbuster.
Formerly known as AbGenomics Holding, AltruBio on Tuesday said it will use the funds to push its ulcerative colitis asset into a Phase IIb trial with an anticipated readout in 2026.
Eli Lilly is paying $60 million upfront to Aktis Oncology to discover and develop novel tumor-targeting radiopharmaceuticals, as radiopharma dealmaking continues to heat up in 2024.
The PR departments of Chinese CDMOs affected by the BIOSECURE Act and their U.S. partners must step up to ensure proposed legislation doesn’t squash innovation.