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While GSK did not provide a specific reason for returning Wave Life Sciences’ WVE-006, the decision comes after the asset in September 2025 came below analyst expectations in a Phase Ib/IIa AATD study.
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AstraZeneca’s $15 billion pledge to its China operations highlights the country’s advantages. But other regions are also hoping to host more clinical studies.
With Lykos’ regulatory failure now squarely in the rearview mirror, Compass Pathways and Definium are leading what one analyst suspects will be “a very big year for psychedelics.”
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
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Phacilitate’s annual event dawns as cell and gene therapies reach a new tipping point: the science has hit new heights just as regulatory and government policies spark momentum and frustration.
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In addition to missing the mark in overall survival, Gilead reported Thursday a higher number of deaths in the Trodelvy arm of the confirmatory metastatic urothelial cancer study.
Novartis’ Scemblix posted stronger results with fewer discontinuation rates than both its own Gleevec and a stronger second-generation TKI, positioning it for a potential first-line indication in chronic myeloid leukemia.
As evidenced by this week’s buyouts by J&J and Merck, Big Pharma appears to have found a sweet spot favoring smaller deals over megabillion-dollar acquisitions.
The American Society of Clinical Oncology annual meeting kicks off today in Chicago, with highly anticipated presentations that include reports on a bispecific antibody, an ADC and a BCMA-targeted CAR-T cell therapy.
The Roivant spinout is shifting its attention away from batoclimab to anti-FcRn candidate IMVT-1402, which will target autoimmune disorders, while allowing argenx’s Myasthenia Gravis drug Vyvgart to maintain its lead position for now.
Tempting as it may be to turn to full automation to meet burdensome requirements, the potential for hallucination and other issues means biopharma companies must proceed with caution.
Additional analyses from BridgeBio Pharma’s late-stage study show the oral drug candidate improved clinical outcomes in transthyretin amyloid cardiomyopathy patients.
As BioNTech struggles to establish its footing in a post-pandemic world, the biotech has secured $145 million from the Coalition for Epidemic Preparedness Innovations to expand its mRNA operations in Rwanda.
Despite Biohaven’s bispecific protein degrader cutting autoantibody IgG levels by up to 37% in an early-stage study, investors saw it as “below the high bar” of 60%, according to William Blair analysts.
FDA
Tris Pharma on Wednesday secured the FDA’s green light for Onyda XR, the first liquid non-stimulant nighttime treatment for attention deficit hyperactivity disorder in pediatric patients.