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

Explore the Trendline➔

Radiopharmaceuticals

A series of technological advances have led to an explosion of scientific progress — and dealmaking — involving medicines that can precisely deliver radioactive materials into tumors.   

By BioPharma Dive staff

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

Drug development innovations that work: Adaptive trial design

Adaptive trials can increase the potential of a drug launch by 13%. So why is this method still underutilized by the industry?

Nov. 27, 2018

5 rheumatologists discuss the evolving landscape of RA treatment

Drug pricing, JAK inhibitors and more personalized therapies are top of mind for many rheumatoid arthritis doctors.

By Jacob Bell • Nov. 26, 2018

Could Gilead and Galapagos' JAK inhibitor lead the class? Wall Street thinks it has a chance.

The therapy lags its competitors in getting to market, but clinical data could make filgotinib stand out. How much would a late arrival hurt its prospects?

By Andrew Dunn • Nov. 26, 2018

Vectura asthma drug fails in Phase 3 study

As a result, the pharma will abandon VR475 but carry on with another candidate and three early-stage nebulization programs.

By Andrew Dunn • Nov. 26, 2018

ASH data helps cement Darzalex's place in multiple myeloma standard of care

Adding the J&J drug to Revlimid and dexamethasone cut risk of death or cancer progression 45% for newly diagnosed patients ineligible for transplants.

By Jacob Bell • Nov. 21, 2018

Sobi's late-breaking ASH data also spurs an approval

Emapalumab, to be branded as Gamifant, is now OK'd in the U.S. for patients with a rare inflammatory disease known as primary HLH.

By Jacob Bell • Nov. 20, 2018

FDA's Woodcock: 'The clinical trial system is broken'

The CDER director said the current system doesn't serve the interests of patients and noted support for trials capable of answering multiple clinical questions at once. 

By Andrew Dunn • Nov. 20, 2018

Bavencio falls short in ovarian cancer study

The setback is the third miss for Pfizer and Merck KGaA's checkpoint inhibitor, which is being tested in three other late-stage studies of the tumor type.

By Suzanne Elvidge • Nov. 20, 2018

Aimmune's peanut allergy drug draws mixed reactions

Publication in NEJM of the PALISADE data reinforced analysts' confidence in AR101, but also may have stoked some safety concerns among investors.

By Jacob Bell • Nov. 19, 2018

MYSTIC deals another blow to AstraZeneca as Imfinzi misses on OS

Analysts said "statistical issues" could be behind Imfinzi monotherapy not delivering on overall survival in the first-line non-small cell lung cancer setting.

By Jacob Bell • Nov. 16, 2018

Blueprint posts 'impressive' data for lead candidate, but investor response tepid

One Wall Street analyst said Blueprint's lead drug candidate is shaping up to have a best-in-class profile after reviewing fresh clinical trial results.

By Suzanne Elvidge • Nov. 16, 2018

3 hemophilia patients lift uniQure's value more than $450M

After six weeks, hemophilia B patients who received the biotech's gene therapy had Factor IX levels thought to significantly reduce the risk of bleeding events.

By Jacob Bell • Nov. 15, 2018

A look at risk-based monitoring, 12 months later

The implementation of risk-based monitoring is moving forward, but it is not without its challenges.

By Kirill Soldatov, Director of Process Improvement • Nov. 15, 2018