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Clinical trial setbacks have limited the near-term opportunities for some of Daiichi Sankyo’s ADCs but the drug developer is betting near-term readouts will catapult it into the top tier of oncology companies in the coming years.
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Biotech is increasingly financed, governed and regulated as though it were a mature pharmaceutical industry rather than a discovery system built around scientific uncertainty. Structural changes are needed to sustain the sector’s strategic innovation.
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Biogen, and partner Denali, are discontinuing the Phase III LIGHTHOUSE study of BIIB122 in Parkinson’s disease due to the trial’s long timeline and complexity.
Neurologist David Weisman, with financial ties to the companies, was removed from the FDA’s upcoming advisory committee meeting slated to consider Leqembi’s traditional approval.
A Kenilworth, NJ, R&D campus that formerly served as Merck’s global headquarters is now set to reopen and become the Northeast Science and Technology (NEST) Center.
The combination therapy was added to standard chemotherapy and lowered the risk of progression or death by 37% in newly diagnosed patients with advanced ovarian cancer without BRCA mutations.
Non-alcoholic steatohepatitis patients treated with the company’s efruxifermin saw significant improvements in liver fat and biomarkers of liver damage, fibrosis and cardiometabolic health.
Data from a new head-to-head study showed BMS’ Opdivo induced better progression-free survival among Hodgkin’s lymphoma patients than Seagen’s Adcetris.
After five years of follow-up, AstraZeneca’s Tagrisso reduces the risk of death by 51% as compared with placebo in EGFR-mutated NSCLC patients, according to Phase III ADAURA trial results.
Servier Pharmaceuticals’ Vorasidenib, acquired from Agios in a $1.8 billion deal, slowed the growth of a certain type of low-grade glioma by 61% in a Phase III trial.
Combined with chemotherapy, Keytruda in KEYSTONE-671 significantly improved EFS and reduced the risk of disease recurrence, progression or death by 42%, beating Imfinzi’s EFS in the AEGEAN trial.
Follow news from the American Society of Clinical Oncology 2023 annual meeting—BioSpace will be tracking key updates here throughout the conference.