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The failure of AstraZeneca and Ionis’ Wainua in a late-stage study of ATTR-CM casts doubt on Alnylam’s next-generation candidate but is good news for others in the space, including BridgeBio and Intellia Therapeutics.
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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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Roivant Sciences launches new subsidiary Hemavant that will develop Eisai-licensed asset for transfusion-dependent anemia in patients with low-risk MDS.
With EVADER, the Chameleon team hopes to make one-and-done treatments a relic of the past.
Six months after the one-time treatment, 47% of patients in Cohort 1 demonstrated a promising two-step or greater improvement in their diabetic retinopathy.
Since 2016 the state has offered more than $70 million in tax credits to 114 different entities and has generated about $140 million in investments into the state’s life sciences ecosystem.
CMS says it would only cover the cost of Biogen’s Aduhelm and any required scans “if they are enrolled in qualifying clinical trials.”
ProQR Therapeutics has reported that their drug sepofarsen failed to meet its primary and secondary endpoints in recent Phase II/III clinical trials.
Stoughton, Mass.-based Collegium Pharmaceutical is expanding its pain-treating portfolio with a $604 million buyout of Raleigh’s BioDelivery Sciences International (BDSI).
The planned testing for DNL919 was held back pending additional documentation required to initiate the studies and information on the preclinical toxicology assessment.
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Moderna is reportedly in talks with the UK government to establish mRNA manufacturing facilities in the country, as well as collaborating with health authorities on clinical trials.