Clinical Trials
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Ultragenyx close to learning whether gene therapy gamble will pay off
Two therapies acquired in a 2017 buyout of Dimension are poised to enter late-stage testing, if results due soon look good.
By Jonathan Gardner • July 19, 2019 -
Neon to advance cancer vaccine after early results suggest added benefit
The Cambridge biotech aims to prove that adding its personalized vaccine to drugs like Opdivo can improve responses across several solid tumors.
By Ned Pagliarulo • July 15, 2019 -
GSK poses challenge to rival AstraZeneca with positive PARP data
Results from the PRIMA study show GSK's Zejula improved progression free survival when used as a frontline maintenance treatment for ovarian cancer.
By Jacob Bell • July 15, 2019 -
Gilead forges closer ties with Galapagos in $5.1B deal
Eschewing a buyout, Gilead head Daniel O'Day instead opted for a partnership approach in his first major development deal as the biotech's CEO.
By Ned Pagliarulo • UPDATED: July 15, 2019 at 12:28 a.m. -
Amgen and Novartis halt Alzheimer's studies as faith in amyloid hypothesis dims
The setback in high-risk pre-symptomatic patients raises questions over use of anti-beta amyloid agents, even in a preventive setting.
By Jonathan Gardner • July 12, 2019 -
Amgen's KRAS success has other drugmakers eager to follow
Novartis, for one, will partner on a combination study with Mirati Therapeutics, which awaits the first clinical readout for its closely watched KRAS inhibitor.
By Ned Pagliarulo • July 10, 2019 -
New GSK data raises threat to Gilead's star HIV drug
Dovato, GSK's two-drug HIV treatment, maintained viral suppression about as well as three-drug regimens with a similar makeup to Gilead's Biktarvy.
By Jacob Bell • July 10, 2019 -
Intra-Cellular's depression drug goes 1 for 2 in Phase 3 studies
The biotech's stock dropped more than 20% on news of a failed study in bipolar disorder, which company execs attributed to a high placebo rate.
By Andrew Dunn • July 08, 2019 -
Sangamo backs up early success for hemophilia gene therapy
Updated results show the highest dose of Sangamo's gene therapy boosted blood-clotting protein levels for hemophilia A patients to normal levels.
By Andrew Dunn • July 05, 2019 -
BioPharma Dive's 10 biggest stories of the spring
Developments in gene therapy, cancer treatments, drug pricing and dealmaking kept the industry in the headlines.
By Jacob Bell • July 03, 2019 -
Gilead firms up path to market for key arthritis drug
Filing filgotinib with the FDA this year, as Gilead now plans to do, would shorten the lead held by competitor AbbVie.
By Ned Pagliarulo • July 02, 2019 -
Deep DiveOnce 'bodies for hire,' CROs are finding a new role as data specialists
Drugmakers and regulators are paying more attention to what real-world data can prove — driving demand for CROs to help keep up.
By Jacob Bell • June 28, 2019 -
Q&ADigital is bringing the change clinical trials need, DIA head says
Barbara Kunz, DIA's global chief executive, noted that when it comes to new technology, "there's a pretty big mountain that we'll be climbing. Some of the early successes will seem trivial a year from now."
By Jacob Bell • June 28, 2019 -
Pfizer muscular dystrophy gene therapy stumbles on safety
Study results presented Friday, which were the first significant look at Pfizer's DMD candidate, spurred shares in rival Sarepta to climb higher.
By Jonathan Gardner • June 28, 2019 -
Zogenix boosted on FDA about-face for seizure drug application
The regulator agreed to permit resubmission of Zogenix's drug with a corrected dataset, while waving off a potentially time-consuming toxicology study.
By Jonathan Gardner • June 27, 2019 -
AstraZeneca gets immuno-oncology win in a disease that Merck doesn't rule
Imfinzi's success in small-cell lung cancer pits it against Roche's Tecentriq, as both are now ahead of Merck's Keytruda.
By Jonathan Gardner • June 27, 2019 -
FDA officials see 'missed opportunity' with patient outcomes in clinical trials
The information is viewed as a valuable tool for improving trial design, guiding drug approvals and supporting label decisions, but its reach has been limited.
By Jacob Bell • June 26, 2019 -
FDA lifts hold on AbbVie multiple myeloma study
However, nine other studies for Venclexta remain suspended for safety concerns.
By Andrew Dunn • June 24, 2019 -
Beating Keytruda a big task, Exelixis and Roche find
A combination of Cotellic and Tecentriq didn't beat Merck's immunotherapy as a single agent in melanoma.
By Jonathan Gardner • June 21, 2019 -
Regeneron, Sanofi antibody works in asthma, but not as well as Dupixent
Phase 2 data fueled analyst speculation over how the companies' drug, REGN3500, as well as one from AnaptysBio, would stack up to Dupixent.
By Andrew Dunn • June 21, 2019 -
Despite late-stage win, investors not sold on Global Blood sickle cell drug
Patients taking voxelotor had significant increases in hemoglobin, but a miss on a "very important" secondary endpoint may hinder the drug down the line.
By Jacob Bell • June 14, 2019 -
Savara lung disease trial misses, but execs vow to press on
Patients did show a quality of life improvement, however, which the company hopes will be met favorably by the FDA.
By Jonathan Gardner • June 13, 2019 -
NASH trial miss halves CymaBay's market value
None of the three doses CymaBay tested performed better than placebo in cutting liver fat, a result that dims prospects for the biotech's drug.
By Jacob Bell • June 11, 2019 -
Novo Nordisk goes for broke on semaglutide heart data
The diabetes giant is asking the FDA for permission to market cardiovascular claims before a long-term outcomes study is complete.
By Jonathan Gardner • June 11, 2019 -
Experimental drug delays Type 1 diabetes in research first
The findings suggest progression of the chronic condition could be slowed with therapy, and sent shares in the drug's biotech owner soaring.
By Ned Pagliarulo • June 10, 2019
