Clinical Trials: Page 2
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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
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SponsoredDrug 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?
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Deep DiveCould 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
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Q&A5 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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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SponsoredA 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
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Solid's manufacturing work allows trial to restart
After a challenging year, it looks as though Solid Biosciences' gene therapy for Duchenne muscular dystrophy is back on track.
By Suzanne Elvidge • Nov. 14, 2018
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AbbVie showcases Mavyret's curative power with shorter regimen
The aim of EXPEDITION-8, a Phase 3b study, was to see if 8-week dosing would work in treatment-naive hep C patients with compensated cirrhosis.
By Suzanne Elvidge • Nov. 14, 2018
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'Super'-responder analysis gives more power to Viking's fatty liver drug
VK2809 reduced liver fat content by 50% or more in 67% of patients, the analysis found, further supporting Viking's view that its drug could help with both NAFLD and NASH.
By Kristin Jensen
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Ionis, Akcea succeed in heart drug trial, setting up Novartis decision
The Phase 2 trial achieved all primary and secondary endpoints, helping lower lipoprotein(a) levels with a solid safety profile. Now, Novartis can choose to lead a Phase 3 trial or back out.
By Andrew Dunn • Nov. 13, 2018
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Novartis' Entresto offers superior benefit to enalapril in heart study
Results from the PIONEER-HF trial reinforce the Swiss pharma's confidence that its drug can be a foundational therapy for certain heart failure patients.
By Suzanne Elvidge • Nov. 13, 2018
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AstraZeneca calls victory in CV study, but will payers feel the same?
A large cardiovascular study found the British pharma's Farxiga offers heart health benefits, yet the diabetes drug still faces stiff competition.
By Jacob Bell • Nov. 12, 2018
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Amarin's Vascepa trial stirs data debate as stock drops 10%
A five-year clinical trial showed strong heart benefits for the fish oil-based pill, but questions on the placebo used in the study have raised doubts as well.
By Andrew Dunn • Nov. 12, 2018
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At SITC, clear wins for immunotherapy combos remain elusive
Findings presented over the weekend illustrate the challenge drugmakers face in their quest to improve on the success of Keytruda and Opdivo.
By Ned Pagliarulo • Nov. 12, 2018
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NASH drugs come into focus as field awaits late-stage data
This year's Liver Meeting could shift the fortunes for a second wave of NASH-focused biotechs advancing behind the four drugmakers currently out in front.
By Ned Pagliarulo • Nov. 09, 2018
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Gilead's search for the next great liver drug won't end with its FXR agonist
GS-9674 scored in clinical trials across multiple indications, but the drug is having difficulty standing out against rival therapies.
By Jacob Bell • Nov. 09, 2018
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Mallinckrodt's rare disease drug set back by confusing trial result
Study results were supposed to show the drugmaker's treatment slowed disease progression more than placebo. Instead, both active and placebo groups showed no disease progression.
By Suzanne Elvidge • Nov. 08, 2018