Clinical Trials: Page 139
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Montgomery County Planning Commission
GSK shingles vax shows major promise, could challenge Merck's Zostavax
GSK's phase III clinical trials have been going on for four long years. But the efforts are paying off in a big way.
By Nicole Gray • Dec. 19, 2014 -
Will this Pfizer orphan drug emerge as the Duchenne victor?
Pfizer, BioMarin, and Sarepta are all working on drugs to treat Duchenne muscular dystrophy (DMD), which overwhelmingly affects boys.
By Nicole Gray • Dec. 18, 2014 -
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 -
Abbott closes Veropharm deal amidst US-Russia political tension
Abbott has completed a deal to buy Veropharma from billionaire Roman Avdeev for $305 million, in spite of ongoing political tensions between the West and Russia.
By Nicole Gray • Dec. 15, 2014 -
Novartis psoriasis drug bests J&J's Stelara in head-to-head trial
After 16 weeks, patients treated with Cosentyx (secukinumab) achieved clear or almost clear skin
By Nicole Gray • Dec. 15, 2014 -
Deep Dive
ICYMI: 3 charts that show why 2014 was a milestone year for US novel drug approvals
"What really matters is that many of these new products offer significant clinical value to the care of thousands of patients with serious and life-threatening disease," said FDA Commissioner Maggie Hamburg.
By Sy Mukherjee • Dec. 12, 2014 -
Merck, NewLink Ebola vax trial suspended over joint pain complaints
4 participants out of 59 complained of joint pain in their hands and feet, prompting the University of Geneva Hospital to take temporary precautions.
By Sy Mukherjee • Dec. 11, 2014 -
Bluebird shares skyrocket on promising gene therapy-blood disorder data
Investors flocked to bluebird bio inc. after the company presented data at the American Society of Hematology showing a 100% cure rate of patients with beta-thalassemia.
By Nicole Gray • Dec. 10, 2014 -
Montgomery County Planning Commission
Merck, BMS PD-1 drugs continue to roll, show promise for Hodgkin's lymphoma
Big news out of the American Society of Hematology meeting: Keytruda (pembrolizumab) and Opdivo (nivolumab) showed significant response in Hodgkin's patients. But one performed better than the other.
By Nicole Gray • Dec. 8, 2014 -
FDA
Why CRO employee turnover is still so high
In a global survey of public and private contract research organizations, HR+ Survey Solutions found that overall employee turnover is still high despite being slashed in recent years.
By Nicole Gray • Dec. 8, 2014 -
Promising Biogen Alzheimer's drug leapfrogs from phase I to phase III
In the last 15 years, more than 100 investigational Alzheimer's therapies have failed. Could Biogen Idec finally break through the AD development morass?
By Nicole Gray • Dec. 3, 2014 -
Puma Biotech plummets in after hours trading after delaying breast cancer NDA
Neratinib (PB272), Puma's investigational breast cancer drug for metastatic HER-2 positive breast cancer, has performed exceptionally well in phase III clinical trials.
By Nicole Gray • Dec. 3, 2014 -
The key to successful clinical trial recruitment? Patient empowerment
Researchers at the University of Sussex have produced a white paper linking patient empowerment and a streamlined recruitment process with clinical recruitment success.
By Nicole Gray • Dec. 1, 2014 -
Glaxo/NIH Ebola vaccine elicits immune response in human trials
GSK and the National Institute of Allergy and Infectious Diseases have been developing a preventive Ebola vaccine since September. The preliminary results are promising.
By Nicole Gray • Dec. 1, 2014 -
Trouble for J&J? Amgen/AZ plaque psoriasis drug bests Stelara in phase III
In a 12-week head-to-head trial, brodalumab, for the treatment of moderate-to-severe plaque psoriasis, outperformed both J&J's Stelara (ustekinumab) and placebo.
By Nicole Gray • Nov. 26, 2014 -
Deep Dive
A lead investigator reveals how Baxter's Hyqvia got its hard-won approval
When Hyqvia was denied FDA approval in 2012, Baxter's clinical research team took a step back and found a way forward. BioPharma Dive spoke to its lead investigator to learn more.
By Nicole Gray • Nov. 25, 2014 -
UK life sciences minister: Hospitals must aid in clinical trial process
George Freeman, like many other opinion leaders, believes the era of the blockbuster has come and gone. Up next: Making hospitals a key part of the drug-development ecosystem.
By Nicole Gray • Nov. 24, 2014 -
GSK, Clovis team up to study treamtents for mutant form of lung cancer
NSCLC is already difficult to treat, and epidermal growth factor receptor NSCLC is especially hard to treat. But Clovis, which is developing a promising oncologic agent, is teaming up with GSK to take it on.
By Nicole Gray • Nov. 19, 2014 -
FDA
Has the price of developing drugs really doubled in the last 11 years?
A Tufts study finds that the cost of drug development has doubled to $2.56 billion over the last 11 years. But some groups remain highly skeptical.
By Nicole Gray • Nov. 19, 2014 -
Plot twist: Controversial Merck cholesterol drugs Zetia, Vytorin work
After years of controversy, IMPROVE-IT investigators have solid data showing that Zetia (ezetimbe) and Vytorin (simvastatin/ezetimbe) work.
By Nicole Gray • Nov. 18, 2014 -
Montgomery County Planning Commission
Merck dances: Keytruda more than doubles PFS in some melanoma patients
Merck's Keytruda (pembrolizumab) continues to shine as an up-and-coming oncology treatment.
By Nicole Gray • Nov. 18, 2014 -
AstraZeneca in preclinical development for Brilinta reversal agent
As Brilinta, AZ's novel oral anticoagulant for secondary prevention of acute coronary syndromes (ACS), struggles to consolidate its rank among second-generation platelet inhibitors, its quest to develop a reversal antidote could make it the winner in a growing market.
By Nicole Gray • Nov. 14, 2014 -
Swing and a miss: Merck's ambitious 4-week hep C regimen fails
Researchers have pushed down hep C treatment times from 48 weeks to 12 weeks, and even 8 weeks. But when Merck tried a 4-week regimen, there were high levels of relapse.
By Nicole Gray • Nov. 11, 2014 -
Isis Pharma wins $10M neurodegeneration treatment milestone from Biogen
The development deal between Biogen Idec and Isis Pharmaceuticals is bearing fruit as Isis begins clinical trials for its third drug for Biogen.
By Nicole Gray • Nov. 10, 2014 -
The cost of a cure: $188B to treat all US hep C patients with pricey new drugs
MD Anderson specialists found that treating all 1.6 million U.S. hep C patients (including those who remain undiagnosed) with Sovaldi or Olysio could cost $188 billion over the next five years.
By Nicole Gray • Nov. 10, 2014 -
AZ's $2B ovarian cancer drug-in-development could be a 2-for-1 deal
Olaparib, which AstraZeneca is developing for treatment of ovarian cancer, is also being tested to evaluate its potential in prostate cancer. The early results look good.
By Nicole Gray • Nov. 6, 2014
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