Drug Development
One way Takeda lives out its values is by striving to ensure that patients are aware of and can access the company’s clinical trials. Two employees from its research and development organization discuss why representation matters and the work their team is doing to benefit patients now and in the future.
FEATURED STORIES
Of all the stories we published this year, these deep dives by BioSpace editors stand out as relevant re-reads going into the New Year.
After 27 years in business, Cytokinetics hopes to pit its own cardiac myosin inhibitor against one it initially developed—now owned by Bristol Myers Squibb—in a market worth billions. Aficamten has a PDUFA date of Dec. 26.
In the midst of regulatory and political upheaval, biopharma’s R&D engine kept running, churning out highs and lows in equal parts. Here are some of this year’s most glorious clinical trial victories.
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The patient, who died on December 14, was originally enrolled in a Phase III study in 2022 and transitioned into an extension phase in 2023.
Ceralasertib is part of AstraZeneca’s ambitious plan to hit $80 billion in revenue by 2030.
Pfizer and Metsera, Sarepta and uniQure made the list with dramatic tales. The other two spots went to the regulatory challenges facing biopharma under the new administration, especially in the vaccines sector.
Insmed pointed to a strong placebo response as the reason for the trial’s failure.
The fatalities were attributed to interstitial lung disease, a known side effect of Daiichi Sankyo’s DXd-based antibody-drug conjugates. A spokesperson declined to say how many patients died.
With zasocitinib, Takeda is looking to challenge Bristol Myers Squibb’s kinase inhibitor Sotyktu, for which the Japanese pharma is running a head-to-head study in plaque psoriasis. Takeda expects to file for zasocitinib’s FDA approval next year.
In this episode of Denatured, Jennifer Smith-Parker speaks to Kenneth Galbraith, CEO of Zymeworks and Josh Smiley, president and COO of Zai Lab, about how renewed confidence is driving biotech entering 2026.
Participants in a Phase III trial who switched to Eli Lilly’s orforglipron after 72 weeks of treatment with Wegovy or Zepbound largely maintained their weight loss for up to a year.
Despite falling short of its primary Phase II objective, Nektar plans to push its T cell stimulator rezpeg into Phase III development.
Eli Lilly’s retatrutide exceeds expectations in Phase III, capping off a sparkling 2025 for the obesity titan; an internal FDA safety review finds no confirmed pediatric deaths caused by COVID-19 vaccines, and Commissioner Marty Makary says no black box warning will be attached to the shots; and BioSpace looks at six biotechs that could be pharma’s next buy.