Clinical Trials: Page
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New poll finds widespread support for cancer research funding
According to the STAT-Harvard poll, over 80% of Americans believe a 20% increase in federal research funding would be appropriate or not enough.
By Nicole Gray • March 28, 2016 -
Amid safety concerns, FDA adcomm set to review Acadia's Parkinson's drug
Acadia's Nuplazid is forecast for over $1 billion in 2020 sales, but has to clear regulatory hurdles in Tuesday's advisory committee review.
By Nicole Gray • March 28, 2016 -
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 -
In major stroke study, AstraZeneca's Brilinta fails to beat aspirin
The global trial measured the reduction in recurrent events after a patient first suffers a stroke.
By Ned Pagliarulo • March 23, 2016 -
BioMarin's PKU drug meets primary goal in phase 3, but falls short on secondary endpoints
The company hopes to file for approval with the FDA by the end of the year.
By Nicole Gray • March 22, 2016 -
Biden names corporate exec Greg Simon to lead Cancer Moonshot
Simon has previously worked with the charity FasterCures, as well as at Pfizer and as CEO of the life sciences finance company Poliwogg.
By Nicole Gray • March 21, 2016 -
Johnson & Johnson's psoriasis drug Stelara succeeds in Phase 3
The blockbuster treatment proved effective against a placebo in treating Crohn's disease.
By Ned Pagliarulo • March 18, 2016 -
In new deal, Kite Pharma partnering with Roche on cancer immunotherapy
The collaboration will explore combining Kite's leading CAR-T therapy with Roche's atezolizumab.
By Ned Pagliarulo • March 18, 2016 -
Top Gilead cancer researcher has left company
The news of the departure comes as Gilead has halted six trials for its cancer drug Zydelig after an increased number of adverse events.
By Nicole Gray • March 18, 2016 -
In limited study, NIH-developed dengue vaccine proves 100% effective
Researchers hope their work can help inform development of a vaccine for Zika virus, which shares similarities with dengue.
By Nicole Gray • March 17, 2016 -
EMA finalizes clinical trial redaction guidelines
Pharmaceutical companies claim publication of all clinical trial data would compromise trade secrets. Advocates for transparency, on the other hand, argue more information is need to enhance the ability to replicate important findings.
By Nicole Gray • March 16, 2016 -
Lilly changes endpoint for phase 3 Alzheimer's trial
The endpoint change for solanezumab will affect data analysis, but not the actual conduct of the trial.
By Nicole Gray • March 16, 2016 -
As EMA investigates, Gilead halts six clinical trials of cancer drug
Gilead has been working to expand the indications of Zydelig, hoping to break into oncology.
By Ned Pagliarulo • March 15, 2016 -
Roche signs potential $1 billion cancer immunotherapy deal with Cambridge biotech
Separately, the FDA boosted the prospects of Roche's bladder cancer drug atezolizumab, granting the immunotherapy priority review status.
By Ned Pagliarulo • March 15, 2016 -
GW Pharma stock doubles after positive phase 3 cannabis drug results
In a trial involving 120 patients, treatment with Epidiolex resulted in a median 39% reduction in seizures, compared with 13% in placebo-treated patients.
By Nicole Gray • March 15, 2016 -
EU regulators investigating Gilead's Zydelig after infection deaths
Higher rates of adverse events were seen in three clinical trials involving Zydelig and other cancer drugs.
By Nicole Gray • March 14, 2016 -
Sanofi's sarilumab bests blockbuster Humira in Phase 3 study
The IL-6 antibody is slated for a regulatory decision from the FDA by Q4 2016.
By Ned Pagliarulo • March 11, 2016 -
Death from French drug trial likely due to high doses of compound
The drug trial left one man dead and five others in the hospital in January. Portuguese drugmaker Bial had been testing an FAAH-enzyme inhibitor for the treatment of pain and mood disorders.
By Ned Pagliarulo • March 10, 2016 -
French regulator halts manufacturing at HIV-focused biotech
A November inspection by ANSM turned up 45 manufacturing deficiencies, including five critical flaws.
By Nicole Gray • March 10, 2016 -
Novartis' Cosentyx proves superior to Janssen's Stelara in head-to-head comparison
The efficacy data further bolsters the profile of Cosentyx, which recently had its label expanded to include indications for ankylosing spondylitis and psoriatic arthritis.
By Nicole Gray • March 7, 2016 -
In high-profile failure, Celldex's cancer vaccine crashes in phase 3
The biotech ended its study early after an interim analysis showed patients treated with the gliobastoma drug fared slightly worse than the control group.
By Ned Pagliarulo • March 7, 2016 -
AbbVie paying Boehringer $595M upfront to gain access to psoriasis drug
The compound, an anti-IL23 antibody, is currently in phase 3 development for the treatment of psoriasis. Two other phase 2 studies are evaluating the drug against Crohn's disease, asthma, and psoriatic arthritis.
By Ned Pagliarulo • March 7, 2016 -
New study strengthens link between Zika and serious birth defects
Published in NEJM, the small study found 29% of pregnant women infected by Zika had fetuses showing serious abnormalities in ultrasound readings.
By Nicole Gray • March 7, 2016 -
GSK's asthma drug Nucala boosted by long-term safety study
The company also published post-marketing safety results for its Advair Diskus product, showing comparable safety results to a common corticosteroid.
By Nicole Gray • March 7, 2016 -
Much-anticipated trial shows Novo's Victoza reduces CV risk
The results could help keep Victoza competitive with Eli Lilly/Boehringer Ingelheim's Jardiance, which became the first diabetes drug to demonstrate a cardiovascular benefit.
By Ned Pagliarulo • March 4, 2016 -
Merck forges ahead with phase 3 trial of Humira biosimilar
A number of other companies, including Amgen, Novartis, and Boehringer Ingelheim, are developing other biosim versions, hoping to wrest away some of Humira's $14 billion in 2015 sales.
By Nicole Gray • March 3, 2016