Clinical Trials: Page 2
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With eye to competition, Biogen explores higher doses of Spinraza
A Phase 2/3 trial appears aimed at seeing whether a greater dose of the spinal muscular atrophy treatment could deliver better efficacy in adults.
By Ned Pagliarulo • Sept. 20, 2019 -
Cancer drug trials often at risk of bias, study finds
Randomized controlled studies are not all alike, as researchers determined about half of pivotal studies supporting recent cancer drug approvals in Europe had potential flaws.
By Andrew Dunn • Sept. 19, 2019 -
Novartis, shadowed by data scandal, renews case for Zolgensma
Presymptomatic infants treated with the gene therapy reached motor milestones consistent with normal development, updated study results showed.
By Ned Pagliarulo • Sept. 19, 2019 -
Acceleron dealt pipeline setback
The biotech's muscular dystrophy drug ACE-083 failed a Phase 2 trial, putting the spotlight for Acceleron more firmly on Celgene-partnered luspatercept.
By Jonathan Gardner • Sept. 17, 2019 -
Biogen stops Phase 2 study in another hit to 'high-risk' pipeline
The biotech halted testing of an experimental drug for idiopathic pulmonary fibrosis less than a week after discontinuing its Alzheimer's drug elenbecestat.
By Andrew Dunn • Sept. 17, 2019 -
Ebola vaccine from Merck takes step toward US approval
As DRC's outbreak persists, Merck plans to increase supply of its experimental V920 drug, aiming to produce 650,000 doses over the next six to 18 months.
By Ned Pagliarulo • Sept. 17, 2019 -
5 questions ESMO cancer drug data might answer
Can Bristol-Myers convince doctors of Opdivo's potential in lung cancer? Will AstraZeneca remain the king of PARPs? Data set to be unveiled could offer some indication.
By Ned Pagliarulo , Jonathan Gardner • Sept. 16, 2019 -
Another BACE dropped as Biogen and Eisai halt elenbecestat trials
Data monitors cited an "unfavorable risk-benefit ratio" in deciding to stop the trials, dealing another blow to a drug class that's come up short before.
By Jonathan Gardner • Sept. 13, 2019 -
Novartis' strong MS results could pose challenge to Roche
Little used in cancer, ofatumumab could find a second life as a multiple sclerosis drug, posting data that show it convincingly beat out Aubagio.
By Ned Pagliarulo • Sept. 13, 2019 -
Adverum sinks on first gene therapy data for eye disease
A decline in eyesight post-treatment reflects poorly on the therapy's potential, lengthening the company's odds of catching rival Regenxbio.
By Jonathan Gardner • Sept. 12, 2019 -
In a 'make or break' moment, Tocagen falls short
The San Diego biotech's lead drug failed to extend survival in a pivotal study for an aggressive type of brain tumor, setting back the company's plans.
By Andrew Dunn • Sept. 12, 2019 -
Moderna marks progress toward goal of coaxing medicine from body's cells
Preliminary data suggest Moderna could reach its lofty ambitions for mRNA. "Any protein under the sun we can make," CEO Stéphane Bancel told BioPharma Dive.
By Ned Pagliarulo • Sept. 12, 2019 -
BioMarin talks down worries on gene therapy data differences
BioMarin's R&D head said timing of steroid treatment impacted interim Phase 3 data, which had spurred questions on valrox's durability.
By Andrew Dunn • Sept. 10, 2019 -
Biomarker data help Merck case for wide use of Keytruda combo
"In the setting of chemo combinations, it does not appear that PD-L1 or TMB influences the outcome," said Merck development head Roy Baynes.
By Ned Pagliarulo • Sept. 10, 2019 -
SponsoredThe evolution of the patient experience
With the healthcare business model constantly evolving the pharmaceutical landscape, the role of healthcare providers is sure to look radically different in a few decades.
By Ian Wilcox • Sept. 10, 2019 -
Trial win could drive Acadia's Nuplazid to new use
A data monitoring board stopped study of dementia-related psychosis patients early due to positive efficacy, setting Nuplazid up for another FDA filing.
By Jonathan Gardner • Sept. 09, 2019 -
Pfizer touts successor to Prevnar 13
Phase 2 data showed Pfizer's experimental pneumococcal vaccine to be safe, boosting confidence in what Pfizer hopes will be a follow-on to Prevnar 13.
By Andrew Dunn • Sept. 09, 2019 -
Cancer drug data back up Lilly's Loxo buyout
Updated study results show striking efficacy for LOXO-292 in an uncommon form of lung cancer, clearing the path for Lilly to file for approval this year.
By Ned Pagliarulo • Sept. 09, 2019 -
Amgen update shows promise, limits of KRAS cancer drug
A 54% response rate among lung cancer patients will encourage, but several relapses could temper sky-high expectations for AMG 510.
By Ned Pagliarulo • Sept. 08, 2019 -
Ultragenyx gene therapy data disappoints investors
The biotech said the current dose of DTX401 will be taken into Phase 3 testing, although a less potent dosage level showed similar efficacy.
By Jonathan Gardner • Sept. 05, 2019 -
UniQure stays a step ahead in hemophilia B
Seeing high interest from patients and study investigators, uniQure is enrolling six more participants than planned in its Phase 3 gene therapy study.
By Ned Pagliarulo • Sept. 03, 2019 -
Medicines Co.'s cholesterol drug looks good to take on PCSK9 rivals
Data show inclisiran more or less matched Repatha and Praluent on cholesterol lowering, but the drug will need a smart launch, and possibly a partner, to compete.
By Jonathan Gardner • UPDATED: Sept. 3, 2019 at 10:07 a.m. -
Novartis vies for multiple sclerosis dominance with Arzerra trial
The repurposed cancer drug is aiming at Roche's Ocrevus, but an upcoming full data presentation will tell MS specialists more about its promise.
By Jonathan Gardner • Aug. 30, 2019 -
Deep DiveAmgen puts its KRAS hopes on 'Navy Seals' team of drug hunters
Found in many solid tumors, mutant KRAS is cancer research's white whale. Amgen's drug looks the most promising to emerge from decades of failed efforts, but others are close behind.
By Ned Pagliarulo • Aug. 30, 2019 -
AstraZeneca gets lupus win but past failure could slow progress
A miss in anifrolumab's first Phase 3 trial a year ago raises questions over whether regulators will need a third study to see the drug through to market.
By Jonathan Gardner • Aug. 29, 2019
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