Clinical Trials: Page
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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 -
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 -
Explore the Trendline➔
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TrendlineRadiopharmaceuticals
A series of technological advances have led to an explosion of scientific progress — and dealmaking — involving medicines that can precisely deliver radioactive materials into tumors.
By BioPharma Dive staff -
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 -
Drug co-invented by Martin Shkreli fails, pressuring his former biotech
While the ex-CEO serves a seven-year prison sentence, one of his former companies said a drug he helped develop fell short in Phase 3 testing.
By Andrew Dunn • Aug. 22, 2019 -
GSK's ViiV reports positive data for long-acting two-drug HIV therapy
Topline results showed the cabotegravir-based treatment can hold the virus in check with just six injections a year, GSK said.
By Kristin Jensen • Aug. 22, 2019 -
AstraZeneca lung cancer miss is Merck's gain
While Imfinzi is well established in early treatment, showing benefit in the metastatic setting has proven difficult, with survival data from NEPTUNE the latest stumble.
By Ned Pagliarulo • Aug. 21, 2019 -
Getty / Edited by BioPharma Dive
Sarepta now needs flawless progress for gene therapy
An unexpected rejection for the biotech's Vyondys 53 puts investor focus even more tightly on the biotech's earlier-stage muscular dystrophy pipeline.
By Jonathan Gardner • Aug. 20, 2019 -
AstraZeneca diabetes drug posts more positive heart data
Fewer patients with a history of heart issues died from a cardiovascular event or experienced worsening heart failure when taking Farxiga.
By Jacob Bell • Aug. 20, 2019 -
Sponsored by PSI
The quest for patient centricity: The travel conundrum
Patient enrollment is a central part of a clinical trial. But without proper transport, how can trials enroll?
By Alistair Neally, PSI CRO – Director, Vendor Management • Aug. 20, 2019 -
Price, safety will test blockbuster billing for AbbVie's new arthritis drug
Rinvoq adds another oral option to rheumatologists' tool kits, but at a list price of $59,000 per year.
By Jacob Bell • Aug. 16, 2019 -
Roche cancer drug the 3rd approved for pan-tumor use
Entrectinib, which will be sold as Rozlytrek, joins Bayer's Vitrakvi as a treatment for solid cancers featuring a rare genetic fusion.
By Ned Pagliarulo • Updated Aug. 15, 2019 -
Study success strengthens case for Lynparza in ovarian cancer
Lynparza, approved since December as a first-line maintenance therapy in the tumor type, is now supported by positive results from a second trial in that setting.
By Ned Pagliarulo • Aug. 14, 2019 -
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 -
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
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