Clinical Trials: Page 66
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Sponsored by Covance
Listening to – and learning from – the voice of the patient
Patient recruitment and retention represent the biggest challenges in clinical trials. See how Covance leverages their global patient intelligence to design protocols that improve both.
By Greg Kline, Executive Director, Market and Patient Intelligence • June 4, 2019 -
Getty / Edited by BioPharma Dive
Bluebird gene therapy approved in Europe in first for severe blood disorder
Zynteglo is intended as a one-time, lifelong treatment for patients with transfusion-dependent beta thalassemia.
By Ned Pagliarulo • June 3, 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 -
Blueprint keeps pressure on Lilly with RET-targeted cancer therapy
No drugs are approved specifically for RET-driven cancers. Two experimental drugs from Blueprint and Eli Lilly could soon change that.
By Ned Pagliarulo • June 3, 2019 -
At cancer conference, debate over speedy drug approvals in the spotlight
An unsuccessful Phase 3 study of Eli Lilly's Lartruvo made for an unusual feature in the ASCO annual meeting's top trial showcase.
By Ned Pagliarulo • June 3, 2019 -
Jacob Bell/BioPharma Dive
Seattle Genetics drug could provide new option for bladder cancer patients
Enfortumab vedotin, an antibody-drug conjugate, proved effective in patients whose cancers had progressed despite chemo and immunotherapy.
By Jacob Bell • June 3, 2019 -
Jacob Bell/BioPharma Dive
Early cancer drug data give Amgen hope it has 'cracked KRAS code'
Considered "undruggable," KRAS for decades eluded researchers' efforts to target the oncogene. Encouraging results from a early study hint at an answer.
By Ned Pagliarulo • June 3, 2019 -
Jacob Bell/BioPharma Dive
AstraZeneca, Merck make case for PARP's place in pancreatic cancer
When given as maintenance therapy, Lynparza doubled the time to disease progression versus placebo. An early look at survival, though, showed no clear advantage.
By Jacob Bell • June 2, 2019 -
Jacob Bell/BioPharma Dive
For some lung cancer patients, Keytruda provides lasting benefit
Five-year survival rates from an early Merck study were notably higher than the extremely low historical mark, but also illustrate immunotherapy's limits.
By Ned Pagliarulo • June 1, 2019 -
Novartis breast cancer drug shows survival benefit in younger women
The results are a first for the CDK 4/6 inhibitor class and give Kisqali an advantage over rival drugs made by Pfizer and Eli Lilly.
By Ned Pagliarulo • June 1, 2019 -
Elizabeth Regan/BioPharma Dive
As ASCO begins, Iovance shows progress with cancer cell therapy
The biotech's therapy, which uses tumor-infiltrating lymphocytes, has spurred responses in some patients with advanced melanoma and cervical cancer.
By Andrew Dunn • May 31, 2019 -
Turning Point makes push to outdo Pfizer, Roche in targeted cancer therapy
Fresh off an IPO, the San Diego biotech unveiled data on ASCO's first day for repotrectinib, its challenger to Xalkori and entrectinib in a rare type of lung cancer.
By Ned Pagliarulo • May 31, 2019 -
Follow-up studies often lacking for cancer drugs approved early
New findings published in JAMA "raise several doubts about the success of the accelerated approval process," researchers wrote.
By Ned Pagliarulo • May 29, 2019 -
BioMarin readies hemophilia gene therapy for FDA submission
But the debate over valrox's durability has not dissipated, as factor expression continued to decline in clinical trial patients.
By Jonathan Gardner • May 28, 2019 -
Novartis gene therapy approved, but will come at cost of more than $2M
Zolgensma is designed to be a cure for spinal muscular atrophy, but its steep price will pose difficulties for a system designed for chronic therapy rather than one-time treatments.
By Ned Pagliarulo • Updated May 24, 2019 -
Yujin Kim/BioPharma Dive
Could Novartis' gene therapy have more than one price?
Indication-based pricing may be possible for less severe patients, who would receive a smaller dose. Lower manufacturing costs would lessen the blow to Novartis too.
By Jonathan Gardner • May 23, 2019 -
No news is bad news for Tocagen
A brain cancer trial of the biotech's combination therapy will continue to final analysis, but investors predict failure as the stock fell to a record low.
By Jonathan Gardner • May 22, 2019 -
Courtesy of Eli Lilly
Lilly drug scores in Phase 2 Crohn's study
After 12 weeks of treatment, three doses of Lilly's mirikizumab beat placebo on the study's primary endpoint, setting it up for late-stage testing.
By Jacob Bell • May 22, 2019 -
Array gets a win in colorectal cancer
Data for the biotech's triple combination missed expectations, but investors drove shares up to a near record high.
By Jonathan Gardner • May 21, 2019 -
BioCryst meets late-stage study goal, but falls short of competition
The biotech's stock tumbled 50% when markets opened Tuesday, as BioCryst's Phase 3 results failed to stack up to rival therapies.
By Andrew Dunn • May 21, 2019 -
Long-term heart data reassures for Medicines Co.
Inclisiran maintained cholesterol-lowering benefit with fewer side effects than competing Amgen and Sanofi/Regeneron products.
By Jonathan Gardner • May 20, 2019 -
Kendall Davis/BioPharma Dive
The NASH dash runs into some early hurdles
In a trio of articles, BioPharma Dive explored the key problems the NASH field faces and what's being done to solve them.
By Jacob Bell • May 17, 2019 -
AbbVie brain cancer drug fails late-stage study in another oncology setback
An interim review found the glioblastoma drug didn't improve survival, leading the biotech to end the trial early and halt enrollment for other studies.
By Andrew Dunn • May 17, 2019 -
Breast cancer survival data buoys Macrogenics and Puma
Macrogenics touts signs of an overall survival benefit over Herceptin for margetuximab, while Puma's new Nerlynx study points to a delay in progression, for a price.
By Jonathan Gardner • May 16, 2019 -
Biotech in the spotlight at ASCO as pharma takes back seat
Few major data sets are expected from immunotherapy leaders like Merck, Roche and Bristol-Myers. Instead, studies by Amgen, Macrogenics, Blueprint and Seattle Genetics are drawing attention.
By Ned Pagliarulo • May 16, 2019 -
Pfizer touts late-stage win for JAK drug that could duel with Dupixent
While a thin top-line readout leaves questions on safety, Pfizer says its experimental drug succeeded in a pivotal atopic dermatitis trial.
By Andrew Dunn • May 15, 2019
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