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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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Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
Early-stage financing rounds are on track to hit their lowest dollar value in years as funders continue to eschew risky investments, experts told BioSpace.
A mostly black box since emerging with more than a billion dollars in hand, Xaira Therapeutics is slowly pulling back the curtain, revealing plans to find partners and validate its pipeline.
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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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New data from Novo Nordisk’s Phase IIIa ONWARD 2 trial studying insulin icodec shows it is effective as a once-weekly treatment for Type 2 diabetes.
Rivus raised $132 million in a Series B financing round that will be used in developing HU6, a new drug class designed to treat cardio-metabolic disease by addressing obesity.
Carisma Therapeutics is merging with Sesen Bio to advance Carisma’s cell therapy platform - in particular, its chimeric antigen receptor macrophage (CAR-M) therapies.
Celltrion agreed Wednesday to jointly develop Abpro’s cancer molecule ABP-102 in a deal that could net as much as $1.75 billion. See inside for more cancer collaborations.
Novo Nordisk and Octagon Therapeutics announced that they forged a research collaboration focused on inflammatory diseases.
After enduring nine months of clinical holds, Merck announced that it is restarting the Phase III clinical program for islatravir, its candidate for people with HIV-1 infection.
A 3-judge panel questioned the legitimacy of Johnson & Johnson’s plan to form a subsidiary company with the purpose of absorbing legal liabilities from talc-related lawsuits.
Poxel presented positive histology data from its Phase II DESTINY-1 trial in non-alcoholic steatohepatitis (NASH), with its primary efficacy endpoint of liver fat decrease at 36 weeks.
This week’s money flowed into various therapeutic areas like cancer and inflammatory disorders, while government and philanthropic grants fund the fight against infectious diseases.
The FDA granted rare pediatric disease designation to AVR-RD-04, an experimental gene therapy treatment for the lysosomal storage disease cystinosis, AVROBIO announced Tuesday.