Clinical Trials: Page 67
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NASH trial miss halves CymaBay's market value
None of the three doses CymaBay tested performed better than placebo in cutting liver fat, a result that dims prospects for the biotech's drug.
By Jacob Bell • June 11, 2019 -
Novo Nordisk goes for broke on semaglutide heart data
The diabetes giant is asking the FDA for permission to market cardiovascular claims before a long-term outcomes study is complete.
By Jonathan Gardner • June 11, 2019 -
Explore the Trendline➔
Getty Images
TrendlineOncology's research boom
More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.
By BioPharma Dive staff -
Experimental drug delays Type 1 diabetes in research first
The findings suggest progression of the chronic condition could be slowed with therapy, and sent shares in the drug's biotech owner soaring.
By Ned Pagliarulo • June 10, 2019 -
Courtesy of Eli Lilly
Trulicity heart data falls short for Lilly investors
Results from REWIND show Trulicity's heart benefit as similar to that of Novo Nordisk's Victoza, intensifying competition between the rival drugmakers.
By Jonathan Gardner • June 10, 2019 -
Sponsored by Parexel
Drug development innovations that work: Precision medicine (Part 3 in a series)
Precision medicine development offers great promise for good patient outcomes, particularly in oncology.
June 7, 2019 -
Biotechs dive deeper into targeted cancer research, despite costs
Finding patients for clinical trials is expensive, but the challenge appears worth it as biotechs move quickly to advance targeted drugs toward approval.
By Jacob Bell • June 5, 2019 -
3 takeaways from cancer's biggest conference
Investors think biotech can go two for two on a target thought to be "undruggable," accelerated approval becomes every biotech's plan and new data underscore immunotherapy's benefit.
By Ned Pagliarulo • June 5, 2019 -
FDA 'open for business' in considering real-world evidence, Sharpless says
Still, the acting agency chief warned clinical trial expense won't cut it as an excuse for relying on unorthodox data sources.
By Kim Dixon • June 5, 2019 -
MacroGenics dives as breast cancer drug shows small improvement
While researchers said more study is needed, the relative benefit seen from margetuximab didn't instill investor confidence.
By Jacob Bell • June 5, 2019 -
Q&A
Pfizer, late on immunotherapy, charts faster course for targeted drugs
Four approvals last fall gave Pfizer a new slate of cancer medicines that should help it catch up in the competitive field.
By Jacob Bell • June 4, 2019 -
Biotech, pharma stocks climb higher after cancer meeting
Investors (mostly) cheered clinical results released over the past four days at ASCO, although the largest gains were made by a company that didn't even present.
By Ned Pagliarulo • Updated June 5, 2019 -
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 -
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 -
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 -
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
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
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