Clinical Trials: Page 73
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Deep Dive
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 -
Explore the Trendline➔
Getty Images
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 -
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 -
Dive Awards
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: 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: 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: 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 -
Alex Ritter, Jennifer Lippincott Schwartz and Gillian Griffiths, National Institutes of Health. (2015). "Killer T cells surround a cancer cell" [Image]. Retrieved from Flickr.
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 • Nov. 29, 2018 -
Sponsored by Medidata
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 -
Sponsored by PAREXEL
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 -
Q&A
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 -
Deep Dive
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