Clinical Trials: Page 2
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Permission granted by Takeda
Takeda says $4B TYK2 drug succeeds in large psoriasis studies
The results position Takeda, which acquired its therapy in one of the industry’s larger single-drug acquisitions, to challenge Bristol Myers Squibb’s Sotyktu.
By Ben Fidler • Dec. 18, 2025 -
Permission granted by Pfizer
Sponsored by PfizerDeveloping a path forward in cancer cachexia
Pfizer scientists have been working to advance understanding of – and potential treatments for – cachexia.
Dec. 16, 2025 -
Explore the Trendline➔
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TrendlineNeuroscience drug development
Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.
By BioPharma Dive staff -
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Nektar sees silver lining as autoimmune drug ‘narrowly’ misses in alopecia study
Despite being unable to declare statistical success, the company claimed its therapy showed enough promise to support moving into late-stage testing.
By Kristin Jensen • Dec. 16, 2025 -
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Argenx falters in effort to expand immune drug’s use
The company will stop two trials testing its blockbuster therapy Vyvgart in thyroid eye disease after treatment was judged to be ineffective at an interim checkpoint.
By Jonathan Gardner • Dec. 15, 2025 -
Courtesy of Sanofi
Sanofi MS drug hits two setbacks
Tolebrutinib, which Sanofi acquired in a $3.7 billion buyout, failed a Phase 3 study in “primary progressive” multiple sclerosis and is facing a delayed U.S. approval decision in another form of the disease.
By Jacob Bell • Dec. 15, 2025 -
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Immune resetKyverna to seek first clearance of a CAR-T therapy for autoimmune disease
The company intends to file a U.S. application in the first half of 2026 following positive study results in a condition called stiff person syndrome that has no approved therapies.
By Ben Fidler • Dec. 15, 2025 -
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Sponsored by PearsonHow rare-disease teams can fine-tune COAs to bridge meaningful change and measurable progress
Discover why refining COAs is essential to capturing subtle, meaningful patient change—and how teams can close the sensitivity gap.
Dec. 15, 2025 -
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Arcus cancels work on Gilead-partnered cancer combo after trial setback
A study using TIGIT and PD-1 drugs for gastrointestinal disease was canceled for “futility” at an early checkpoint, another blow to research on a once-promising target.
By Jonathan Gardner • Dec. 12, 2025 -
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Brain drug revivalAC Immune posts positive data for Parkinson’s immunotherapy
Shares of AC Immune rose by double-digits on news that the company, encouraged by new data, now intends to ask drug regulators for feedback to “potentially accelerate” the time to an approval filing.
By Jacob Bell • Dec. 11, 2025 -
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Obesity drugsLilly’s three-pronged drug puts obesity field ‘on notice’
Lilly’s closely watched retatrutide spurred as much as 29% weight loss in a Phase 3 study, a finding that is “raising the bar” for future obesity drug competitors, one analyst wrote.
By Kristin Jensen • Dec. 11, 2025 -
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Novartis notches another win for drug acquired in MorphoSys deal
Ianalumab, which has already succeeded in testing against Sjogren’s syndrome, proved impactful in a condition that causes low platelet counts.
By Jonathan Gardner • Dec. 9, 2025 -
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News roundupFDA raises CAR-T approval standards; Novartis bets on an AI startup
CAR-T cancer therapies now need to succeed in randomized, controlled trials to earn approvals. Elsewhere, a drug from Bristol Myers Squibb and BioNTech proved effective in breast cancer patients.
By BioPharma Dive staff • Dec. 9, 2025 -
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J&J’s ‘remarkable’ Tecvayli data support earlier use in multiple myeloma
In a step forward for bispecific antibodies, study results presented at ASH suggest a Tecvayli-based combination could have curative potential early in a patient’s disease course.
By Jonathan Gardner • Dec. 9, 2025 -
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Terns drug shows potential to challenge Novartis’ blockbuster leukemia treatment
While early, study results presented at ASH show Tern’s drug could surpass Novartis’ Scemblix and “raise the bar in efficacy” for chronic myeloid leukemia medicines, the company’s CEO said.
By Jonathan Gardner • Dec. 8, 2025 -
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At ASH, Lilly makes case to widen Jaypirca use in leukemia, lymphoma
In a head-to-head trial, Lilly’s drug was as effective as Imbruvica at inducing responses and displayed certain safety advantages that could make it a preferred treatment in early lines of care.
By Jonathan Gardner • Dec. 7, 2025 -
Courtesy of Vertex Pharmaceuticals
Vertex CRISPR therapy hits early goal in children with blood disorders
Casgevy, now a "national priority" drug, helped kids with sickle cell and beta thalassemia, results which may help toward a label expansion and stronger commercial uptake.
By Jonathan Gardner • Dec. 6, 2025 -
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Vaccines12 former FDA chiefs blast Prasad’s move to toughen vaccine standards
In an article published in NEJM, nearly all living ex-FDA commissioners lambasted the CBER head’s plans to use a probe into COVID vaccine safety to upend longstanding regulatory protocols.
By Jonathan Gardner • Dec. 4, 2025 -
Permission granted by Bristol Myers Squibb
After finding ‘irregularities,’ Bristol Myers to extend key trial of Cobenfy in Alzheimer’s psychosis
Data from the "ADEPT-2" study, which analysts had hoped would arrive before year's end, are now expected sometime in 2026.
By Jacob Bell • Dec. 3, 2025 -
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Capricor soars on positive results for Duchenne cell therapy
Shares quadrupled now that the company appears on track to reverse an earlier FDA rejection of what could be the first treatment for heart-related complications of Duchenne.
By Kristin Jensen • Dec. 3, 2025 -
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Pharvaris’ pill succeeds in late-stage trial for rare swelling disorder
Phase 3 data could make the Dutch biotech's drug competitive in the increasingly crowded market of hereditary angioedema treatments.
By Jonathan Gardner • Dec. 3, 2025 -
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FDA details plan to scale back animal tests for some antibody drugs
The draft guidance issued Tuesday comes as regulators and policymakers have looked for ways to aid U.S. drugmakers amid fast progress by their China-based counterparts.
By Jonathan Gardner • Dec. 2, 2025 -
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Belite continues ascent as Stargardt drug hits mark in late-stage trial
The results position Belite, one of the sector’s top-performing companies since 2022, to seek approval of what could be the first marketed medicine for the rare eye condition.
By Ben Fidler • Dec. 1, 2025 -
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Sponsored by LabcorpExpanding access in oncology trials: The case for a paired tissue-plasma approach
Paired tissue-liquid biopsy: A smarter path to faster enrollment and better trial outcomes.
Dec. 1, 2025 -
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Novartis cuts hundreds of jobs; Novo’s dual-acting diabetes drug heading to Phase 3
The layoffs affect Swiss manufacturing facilities. Elsewhere, the FDA pushed back an approval deadline and a mid-stage study showed Novo’s amycretin helps regulate blood sugar.
By BioPharma Dive staff • Nov. 26, 2025 -
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Kelun, Merck tout ADC as potential first-line treatment in lung cancer
The partners said a TROP2-targeting antibody drug conjugate succeeded in a late-stage trial, paving the way for potential approval in the first-line setting.
By Delilah Alvarado • Nov. 25, 2025
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