Clinical Trials
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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 -
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 -
SponsoredThe 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 at 6:15 p.m. -
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 -
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 -
SponsoredAdapting 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.
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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 -
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. 09, 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. 08, 2019 -
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. 07, 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 • UPDATED: Aug. 6, 2019 at 6:33 p.m. -
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. 05, 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. 05, 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. 05, 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. 01, 2019 -
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. 01, 2019
