Clinical Trials: Page 66
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In pivot, Sage turns focus to treatment-resistant depression
An R&D event Wednesday showcased the biotech's plans for SAGE-217, an experimental therapy central to Sage's roughly $9 billion valuation.
By Ned Pagliarulo • July 24, 2019 -
Elizabeth Regan/BioPharma Dive
Myovant set to battle AbbVie after second Phase 3 success for key drug
Both the small biotech and the industry giant expect to file for approval this year for competing treatments of uterine fibroids.
By Andrew Dunn • July 23, 2019 -
Explore the Trendline➔
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TrendlineOncology's research boom
More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.
By BioPharma Dive staff -
Acadia schizophrenia trial misses goal, setting back pipeline hopes
Adding pimavanserin to drugs like Abilify yielded no greater improvement than using antipsychotic treatment alone, results from a Phase 3 study showed.
By Ned Pagliarulo • July 23, 2019 -
Getty / Edited by BioPharma Dive
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 -
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 -
Elizabeth Regan/BioPharma Dive
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 8, 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 5, 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 3, 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 2, 2019 -
Deep Dive
Once '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&A
Digital 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 -
Courtesy of AbbVie
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 -
Courtesy of Merck & Co.
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
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