Clinical Trials

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
Sponsored
The 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
Amgen 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
AbbVie ends Rova-T research after another study setback

A string of clinical failures derailed AbbVie's ambitions for the cancer drug, which was once predicted to earn billions of dollars in peak sales.
By Andrew Dunn • Aug. 29, 2019
Deep Dive
Amyloid's last hope? Prevention studies next big test for Alzheimer's research

The DIAN-TU trial, studying patients genetically predisposed to Alzheimer's, could help decide the fate of what's been the dominant hypothesis of the disease's cause.
By Jonathan Gardner • Aug. 29, 2019
Biopharma jobs boom in Massachusetts, though challenges still exist

Many more jobs have opened up in R&D than in manufacturing, which saw growth of just 1% between 2017 and 2018.
By Jacob Bell • Aug. 27, 2019
Lilly's case for Taltz helped by expanded approval

By prescription numbers, Taltz trails Novartis' rival drug Cosentyx. An approval for use in ankylosing spondylitis will go some ways to level the playing field.
By Ned Pagliarulo • Aug. 26, 2019
Medicines Co.'s PCSK9 drug succeeds in first Phase 3 test

Positive results are a "major milestone," said one Wall Street analyst, easing safety concerns and setting up the biotech to file for approval this year.
By Andrew Dunn • Aug. 26, 2019
Moving quickly, GSK to advance myeloma drug on new data

Positive Phase 2 results are early validation of GSK R&D chief Hal Barron's decision to bet heavily on the BCMA-targeting therapy.
By Ned Pagliarulo • Aug. 23, 2019