Clinical Trials: Page 58
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Regeneron gets cholesterol drug win where Praluent won't go
The experimental therapy cut "bad" cholesterol levels almost 50% compared to placebo in patients with a hard-to-treat metabolic disorder.
By Jonathan Gardner • Aug. 14, 2019 -
Lilly bests J&J, with implications for AbbVie's new immunology star
A study of psoriasis patients found Lilly's Taltz outperformed J&J's Tremfya, which works the same way as AbbVie's new-to-market offering, Skyrizi.
By Jacob Bell • Aug. 13, 2019 -
Explore the Trendline➔
National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
TrendlineCell therapy
The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.
By BioPharma Dive staff -
Elizabeth Regan/BioPharma Dive
Deciphera success sets up 2-horse race in gastrointestinal cancer
The small biotech rejoined the billion-dollar club after trial results for its experimental drug look to have bested those of a rival from Blueprint.
By Jonathan Gardner • Aug. 13, 2019 -
Sponsored by Veradigm
Adapting the research model for the real world – A case for change?
The widespread adoption of electronic health record systems provides an opportunity to reimagine the traditional clinical research model.
Aug. 13, 2019 -
As Ebola outbreak rages, researchers find promise in Regeneron drug
The antibody-based therapy yielded higher survival rates than standard of care in a large clinical trial, which is now advancing to an expansion stage.
By Jacob Bell • Aug. 12, 2019 -
Jacob Bell/BioPharma Dive
AstraZeneca cancer drugs build as primary care shrinks
Top-seller Tagrisso shined in the front-line lung cancer setting, which should help offset declines to respiratory and cardiovascular drugs.
By Jonathan Gardner • Aug. 12, 2019 -
Nektar battered over manufacturing issues and Bristol-Myers pullback
A study of skin, kidney and bladder cancer found disease progressed faster after patients received inactive doses of a Nektar drug paired with Opdivo.
By Jonathan Gardner • Aug. 9, 2019 -
Hospitalized gene therapy patient triggers Sarepta sell off
An erroneous report of rhabdomyolysis in a patient enrolled in a Duchenne trial was the latest safety worry to send shares in a gene therapy biotech spiraling.
By Jonathan Gardner • Aug. 8, 2019 -
Permission granted by Novartis
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 -
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 -
Getty / Edited by BioPharma Dive
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 -
Getty / Edited by BioPharma Dive
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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