Need 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. 

Dec. 12, 2018

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

Explore the Trendline➔

Oncology's research boom

More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

By BioPharma Dive staff

Replacement 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.   

Dec. 10, 2018

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. 7, 2018

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. 7, 2018

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. 7, 2018

Six practices of high performing clinical research sites

How are high-performing clinical research sites getting sponsors to return to them again and again?

Dec. 7, 2018

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. 6, 2018

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. 6, 2018

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. 6, 2018

3 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. 5, 2018

At 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. 5, 2018

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. 4, 2018

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. 4, 2018

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. 3, 2018

Innovation 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. 3, 2018

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. 2, 2018

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. 2, 2018

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. 1, 2018

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. 1, 2018

An 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 • Nov. 29, 2018

Demystifying analytics and machine learning in clinical trials

Experts discuss what you should know about advanced analytics and machine learning in clinical trials.

Nov. 29, 2018

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

Bristol-Myers' Opdivo falls short again in small cell lung cancer

Although the pharma holds an approval for Opdivo in third-line SCLC, chances of expanding use of the immunotherapy look slim after a second trial miss.

By Suzanne Elvidge • Nov. 27, 2018

Vertex's first CF triplet shows early success in late-stage trials

Positive data reinforced investor beliefs that a three-drug regimen will be a boon to the biotech's bottom line.

By Jacob Bell • Nov. 27, 2018