Clinical Trials: Page 125
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ACC 2016: Novartis' Entresto reduces risk of hospitalization in HF patients
The data will likely help Novartis as it builds out recent pay-for-performance deals with Aetna and Cigna, two major insurers.
By Nicole Gray • April 3, 2016 -
Lilly's arthritis drug baricitinib notches another success
The drug will have significant competition however, as a number of companies are also lining up new rheumatoid arthritis treatments.
By Nicole Gray • April 1, 2016 -
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 -
FDA panel says benefits outweigh risks for Acadia's Parkinson's drug
The advisory committee voted 12-2 in favor of the Parkinson's disease psychosis drug, setting the stage for a FDA decision May 1.
By Ned Pagliarulo • March 29, 2016 -
Theranos blood testing inconsistent with other labs, study shows
Compared to testing by LabCorp and Quest Diagnostics, Theranos' technology was 1.6 times more likely to yield abnormal results.
By Nicole Gray • March 29, 2016 -
New phase 2 data boosts prospects for Alder's migraine drug
The company hopes to stay abreast of competing companies, such as Amgen and Lilly, which are developing drugs using the same mechanism as Alder's ALD403.
By Ned Pagliarulo • March 28, 2016 -
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 -
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