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Roche said the Phase II results help build the case for advancing CT-388 into late-stage testing, which is set to get underway this quarter.
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Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
From opening new therapeutic mechanisms to repairing neuronal damage, investigational molecules from Ventyx Therapeutics, AC Immune, Gain Therapeutics and more could shape the future of Parkinson’s disease treatment.
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The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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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.
AstraZeneca on Tuesday laid out an ambitious plan to boost growth in its existing oncology, biopharma and rare disease portfolios, as well as launch 20 new medicines before the end of the decade.
Late-stage results from the NOTUS trial showed Sanofi and Regeneron’s Dupixent lowered moderate to severe chronic obstructive pulmonary disease exacerbations by 34% and led to significantly better lung function.
Following its recent about-face on the BIOSECURE Act, designed to combat China’s influence in the biopharma industry, lobbying group Biotechnology Innovation Organization in a realignment is laying off 30 employees.
The regulator on Monday approved two interchangeable biosimilars to Regeneron’s Eylea, providing additional competition for the pharma’s blockbuster as key patent protections are set to expire.
Despite weathering a difficult year, biopharma continues to see massive pay gaps between CEOs and their median employees, with top executives often earning hundreds of times more.
Until compelling surface targets for lung cancer are developed, antibody-drug conjugates will fail to treat most patients with lung cancer, experts told BioSpace.
Following a series of clinical failures, optimism builds for the first disease-modifying treatment.
Seladelpar, which Gilead acquired when it bought CymaBay in February for $4.3 billion, showed positive results for reducing pruritus in primary biliary cholangitis patients and reducing inflammation.