Clinical Trials: Page 64
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Novartis CEO on defense as data scandal clouds gene therapy approval
"We tried to do all of the right things," said company chief Vas Narasimhan, after the FDA disclosed manipulated testing data was included in Novartis' application for Zolgensma.
By Ned Pagliarulo • Aug. 7, 2019 -
Novartis used manipulated data in winning Zolgensma approval, FDA says
AveXis, the Novartis unit which developed Zolgensma, knew of the data issue more than two months before the therapy's landmark OK, the FDA said.
By Ned Pagliarulo • Aug. 6, 2019 -
Explore the Trendline➔
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TrendlineNeuroscience drug development
Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.
By BioPharma Dive staff -
Regulators, Gilead at odds over HIV drug's use in women
An expert panel today will discuss Gilead's application for Descovy's use as a preventive treatment for HIV.
By Jacob Bell • Aug. 5, 2019 -
Sickle-cell setback triggers share slide at GlycoMimetics
Hospitalized patients were not ready for discharge any sooner after taking rivipansel, a result that will force the biotech to rely on earlier-stage projects.
By Jonathan Gardner • Aug. 5, 2019 -
Roche trial win for Tecentriq leaves questions unanswered
Combining the immunotherapy with chemo extended progression-free survival in bladder cancer patients, but the Phase 3 study hasn't yet proven a survival benefit.
By Ned Pagliarulo • Aug. 5, 2019 -
Medicines Co. awaits its date with destiny
After slimming down to focus on one big R&D bet, the company needs inclisiran to match or outperform on-market PCSK9 drugs Repatha and Praluent.
By Jonathan Gardner • Aug. 1, 2019 -
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Amicus gives early look at Batten disease gene therapy
"It's important to treat these children as soon as we can and to halt the progression of the disease," Amicus CEO John Crowley told BioPharma Dive.
By Andrew Dunn • Aug. 1, 2019 -
Courtesy of Eli Lilly
Lilly cancer push boosted by survival benefit to key drug
While the pharma's breast cancer drug Verzenio was third to market in its class, a study finding it lengthened survival could help encourage greater use.
By Ned Pagliarulo • July 30, 2019 -
Novartis heart drug misses on potentially billion-dollar market
Entresto didn't outperform valsartan in a late-stage study of patients who had heart failure with preserved ejection fraction, sending Novartis shares down.
By Jacob Bell • July 29, 2019 -
J&J advances MS drug candidate toward US, EU markets
Ponesimod, a drug the pharma giant acquired via its $30 billion buyout of Actelion, succeeded in a Phase 3 head-to-head trial against Sanofi's Aubagio.
By Ned Pagliarulo • July 26, 2019 -
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Editas, Allergan launch first in vivo study of CRISPR-based medicine
The Phase 1/2 trial will test Editas' genome editing approach in a form of inherited blindness known as Leber congenital amaurosis.
By Ned Pagliarulo • July 25, 2019 -
Sponsored by PAREXEL
Patient-centric or site-centric clinical trials: Can you have both?
Improving patient recruitment is one of the top challenges drug developers, research sites and CROs face when managing clinical trials.
July 25, 2019 -
Bristol-Myers hits snag in plan to catch Merck in lung cancer
Pairing Opdivo with Yervoy extended survival in previously untreated lung cancer patients, but a combination with chemo — Merck's calling card with Keytruda — came up short.
By Ned Pagliarulo • Updated July 25, 2019 -
Merck advancing 2-drug HIV hopeful
Islatravir represents a new type of HIV drug and, if Merck's plans pan out, could offer less frequent dosing than competitor pills from Gilead and GSK.
By Jacob Bell • July 24, 2019 -
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 -
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 -
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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 -
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
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