Clinical Trials
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Biogen backs away from AGTC after gene therapy failure
The smaller biotech lost a main revenue source and about half its market cap as one of its candidates proved safe but ineffective in a rare eye disorder.
By Jacob Bell • Dec. 13, 2018
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J&J's Tremfya beats out Novartis' Cosentyx in psoriasis study
Tremfya's success could boost J&J as both drugmakers jockey to carve out a leading position in the hotly competitive market for psoriasis drugs.
By Andrew Dunn • Dec. 12, 2018
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SponsoredNeed to accelerate study execution in the face of trial complexity? Consider a unified data strategy
Need to accelerate study execution in the face of trial complexity? Consider a unified data strategy.
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Axovant drops small molecule development after dementia drug failure
The company will shift its focus to gene therapies after a Phase 2 trial setback for nelotanserin in patients with Lewy body dementia.
By Suzanne Elvidge • Dec. 11, 2018
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SponsoredReplacement of in vivo Draize test with alternative in vitro methods
Regulatory pressure and technological advancements have led to ethical in vitro-based evaluations of skin irritants and corrosives.
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Roche's Tecentriq gets first-line lung cancer approval
While a positive step for Roche's I/O ambitions, it will likely run into trouble differentiating Tecentriq from the first-line regimen of Keytruda plus chemo.
By Andrew Dunn • Dec. 07, 2018
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Novartis sheds light on liquid biopsies with SOLAR-1 analysis
Tying together a targeted drug and a companion diagnostic could give Novartis an edge in advanced breast cancer.
By Suzanne Elvidge • Dec. 07, 2018
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Supernus ADHD data doesn't win back investor optimism
An "odd data point" may have overshadowed otherwise positive Phase 3 readouts. Still, analysts see potential in SPN-812.
By Suzanne Elvidge • Dec. 07, 2018
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SponsoredSix practices of high performing clinical research sites
How are high-performing clinical research sites getting sponsors to return to them again and again?
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Conatus unsuccessful in spinning NASH failure
The pharma's share value almost halved Thursday morning despite what it described as "clinically meaningful" results for its drug, emricasan.
By Jacob Bell • Dec. 06, 2018
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AbbVie's Rova-T hits yet another setback
The cancer drug's prospects look dim after its latest clinical failure, casting further negative light on AbbVie's nearly $6 billion Stemcentrx acquisition.
By Suzanne Elvidge • Dec. 06, 2018
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ASH successes set to lift Imbruvica in CLL
Positive data from three studies might be a commercial boon for AbbVie and J&J's drug. Yet high expectations could leave room for investor disappointment.
By Ned Pagliarulo • Dec. 06, 2018
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Deep Dive3 questions leaving ASH
Like many a medical meeting, ASH showcased data that — while promising — also offers as many questions as answers.
By Jacob Bell • Dec. 05, 2018
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Deep DiveAt ASH, bispecific cancer therapies make a mark
The therapies work to guide tumor-fighting immune cells to target cancerous invaders. Research at ASH suggests they could be another avenue of attack in immuno-oncology.
By Ned Pagliarulo , Jacob Bell • Dec. 05, 2018
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Eli Lilly's former drug yields Phase 2 win for Vanda Pharma
Shares in the biotech jumped more than 25% Monday on the news, which should support advancement of the therapeutic candidate.
By Andrew Dunn • Dec. 04, 2018
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ASH18: Bluebird's gene therapy progress shadowed by MDS case
Changes made by the biotech to its Lentiglobin treatment look to be bearing fruit, but a new case of myelodysplasia syndrome has raised old concerns.
By Ned Pagliarulo • Dec. 04, 2018
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ASH18: Legend's CAR-T brought back to reality
Though strong, updated data on LCAR-B38M was a notch below the almost unbelievable efficacy and safety the biotech showed at ASCO last year.
By Jacob Bell • Dec. 03, 2018
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Dive AwardsInnovation of the Year: RNA-targeting therapies
The arrival of Onpattro and Tegsedi cap decades of progress in the field, which has once again drawn the eye of big pharma.
By Ned Pagliarulo • Dec. 03, 2018
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ASH18: Bluebird's follow-on CAR-T finds initial success, but durability will be key test
Phase 1 data on a dozen patients hint that bb21217 may deliver the efficacy and persistence that Bluebird and partner Celgene have been vying for.
By Jacob Bell • Dec. 02, 2018
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ASH18: CAR-T shows up in early CLL test
Data at ASH suggest JCAR017, the CAR-T therapy Celgene acquired in its deal for Juno, may have a path forward in chronic lymphocytic leukemia.
By Ned Pagliarulo • Dec. 02, 2018
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ASH18: Cancer drug trials in need of modernization, NCI director says
Targeted therapies have made large strides across a number of cancer types and are changing how clinical trials are conducted in the process, the head of the National Cancer Institute told BioPharma Dive.
By Ned Pagliarulo • Dec. 01, 2018
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ASH18: Trial successes back Celgene belief in luspatercept
At ASH, updated results from the Believe and Medalist studies showcased the drug in beta-thalassemia and myelodysplastic syndromes.
By Ned Pagliarulo • Dec. 01, 2018
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Q&AAn interview with Nobel Prize-winning cancer immunologist Jim Allison
Allison, an immunologist at MD Anderson, won the Nobel Prize in Medicine this year. BioPharma Dive caught up with him to talk about immunotherapy.
By Rebecca Ritzel
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SponsoredDemystifying analytics and machine learning in clinical trials
Experts discuss what you should know about advanced analytics and machine learning in clinical trials.
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Alkermes' schizophrenia drug succeeds in needed trial win
Positive results for ALKS 3831 could help offset some of the disappointment from a recent setback with another Alkermes' drug candidate.
By Ned Pagliarulo • Nov. 29, 2018