Clinical Trials
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Tecvayli tops standard drugs in early multiple myeloma, J&J says
The results build on evidence U.S. regulators found so compelling last year they proactively awarded J&J a new kind of drug review voucher.
By Jonathan Gardner • Jan. 15, 2026 -
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What Sanofi’s multiple sclerosis troubles could mean for the space
Regulatory and clinical roadblocks have set back its oral BTK inhibitor tolebrutinib, but the drug class still has many opportunities to make an impact.
By Kelly Bilodeau • Jan. 13, 2026 -
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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Sponsored by PearsonBest practices for COA selection: Building a stronger foundation for clinical trials
In a time when COAs are more nuanced, critical and complex than ever, researchers can turn to best practices to move forward efficiently while maintaining scientific and regulatory rigor.
Jan. 12, 2026 -
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GSK, Ionis claim study success for RNA-based hepatitis B drug
The companies didn’t provide details, but said global regulatory filings are now planned for the therapy, an oligonucleotide meant to provide “functional cures” for chronic hepatitis B infections.
By Kristin Jensen • Jan. 7, 2026 -
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Alumis soars as TYK2 drug hits mark in psoriasis trials
Shares more than doubled in value after Phase 3 results suggested Alumis’ pill may compare favorably with other emerging oral options for psoriasis, among them drugs from Takeda and Johnson & Johnson.
By Jonathan Gardner • Jan. 6, 2026 -
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Zenas shares crash after top drug misses expectations in immune disease study
While the company’s bispecific medication obexelimab met its objectives in a trial in IgG4-related disease, it didn’t appear to match the effectiveness of a recently approved Amgen drug.
By Jonathan Gardner • Jan. 5, 2026 -
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Sponsored by LifeLabsStrategic diagnostic testing partnerships are accelerating clinical research
With the rise of biologics, precision medicine and AI-driven drug discovery, clinical research has entered a new and complex era.
Jan. 5, 2026 -
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Tracker10 clinical trials to watch in the first half of 2026
After a lengthy downturn, the biotech industry finally gathered momentum in 2025. Key readouts in obesity, infectious disease and many rare conditions could help it continue.
By BioPharma Dive staff • Jan. 5, 2026 -
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Patient deaths put Merck, Daiichi’s ADC trial on partial hold
The FDA placed the hold after researchers recorded a “higher than anticipated” incidence of deaths in a study testing “I-DXd” in people with small cell lung cancer.
By Delilah Alvarado • Dec. 19, 2025 -
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News roundupNovo files for CagriSema approval; Merck and Pfizer’s trial win
Novo Nordisk's application for CagriSema comes at the same time as competitor Eli Lilly's ask for its obesity drug orforglipron. Elsewhere, Merck & Co. and Pfizer succeeded in a bladder cancer study.
By BioPharma Dive staff • Dec. 19, 2025 -
Courtesy of Galapagos
Galapagos TYK2 drug hits goal in one trial, misses in another
The Belgian biotech is still on the hunt for partners after reporting that its drug succeeded against an inflammatory skin and muscle disorder but missed in a lupus study.
By Jonathan Gardner • Dec. 19, 2025 -
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Obesity drugsLilly obesity pill, headed for quick FDA review, hits mark in ‘maintenance’ trial
Orforglipron helped keep weight down when used after initial therapy with an injectable, a new treatment strategy that could broaden its use in obesity.
By Jonathan Gardner • Dec. 18, 2025 -
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Insmed’s ‘win streak’ ends as top drug fails study in chronic nasal condition
The company’s valuation, which surged past $40 billion this year, fell by almost a fifth on a dimmer outlook for its closely followed lung disease medicine.
By Kristin Jensen • Dec. 18, 2025 -
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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 -
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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 -
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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 -
Permission granted by Kyverna Therapeutics
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 roundup
FDA 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
