Clinical Trials: Page 141
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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 -
Explore the Trendline➔
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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 -
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 -
UPDATED: Novartis cancer hopeful panobinostat not on track for FDA approval
Panobinostat, which Novartis developed as part of a combo therapy for multiple myeloma, did not show superiority in clinical trials—and it was associated with an increased risk of death.
By Nicole Gray • Nov. 6, 2014 -
Why GSK's promising hep C vaccine is good news for its Ebola drug
Glaxo is using the same technology to develop vaccines against Ebola and hep C. And the hepatitis drug has produced the best results ever seen from a hep C vaccine-in-development.
By Nicole Gray • Nov. 6, 2014 -
FDA presents novel plan for testing and fast-tracking Ebola drugs
In light of the Ebola crisis, the FDA is adopting an umbrella testing system that supports clinical trial flexibility and an analyze-as-you-go approach.
By Nicole Gray • Nov. 6, 2014 -
Lundbeck's schizophrenia drug wallops competition in novel head-to-head trial
The QUALIFY trial pitting injectable aripiprazole against injectable paliperidone palmitate is the first head-to-head study comparing atypical antipsychotics in a close-to-real-world setting.
By Nicole Gray • Nov. 4, 2014 -
Most UK diabetes patients fall short of evidence-based treatment goals
Two-thirds of UK diabetics fail to meet treatment targets related to control of blood pressure, blood sugar, and cholesterol. Does this represent a failure of the NHS?
By Nicole Gray • Nov. 3, 2014 -
BMS's novel Opdivo exceeds expectations in late-stage lung cancer trials
41% of late-stage lung cancer patients treated with Opdivo (nivolmumab) survived, versus a historical one-year survival rate of 5.5% to 18%.
By Nicole Gray • Oct. 31, 2014 -
US senators propose FDA vouchers to expedite Ebola drug development
Lawmakers have proposed a voucher system that would give drug developers an expedited review in order to encourage the creation of as many Ebola treatments as possible.
By Nicole Gray • Oct. 30, 2014 -
Cost-effectiveness: Treat prisoners with Sovaldi now, save money later
A new cost-effectiveness study shows that treating prisoners with Sovaldi can not only help offset long-term Medicaid costs, but prevent released prisoners from spreading hep C.
By Nicole Gray • Oct. 29, 2014 -
Sarepta's mega-orphan Duchenne's drug faces more roadblocks
The FDA's demand for yet more data means eteplirsen approval is not likely before 2016. Sarepta's stock was down 35% on the news.
By Nicole Gray • Oct. 28, 2014 -
Anti-inflammatories may boost the effects of antidepressants
In a meta-analysis, researchers found that anti-inflammatory drugs can be used to personalize treatment of depressed patients and enhance the effects of various antidepressants.
By Nicole Gray • Oct. 23, 2014 -
Study: Parkinson's disease drugs make some patients want to party
The dopamine agonists used to treat Parkinson's patients can sometimes lead to an obsession with gambling and pornography, research finds.
By Nicole Gray • Oct. 22, 2014 -
UPDATED: GSK, NewLink Ebola vaccine trials could launch this January in Africa
But the World Health Organization (WHO) still doesn't know precisely how the trials will be constructed.
By Sy Mukherjee • Oct. 21, 2014 -
Study: Viagra could be used to protect against heart disease
New research published in BMC Medicine shows that long-term, daily use of Viagra (sildenafil) may provide cardiovascular protection.
By Nicole Gray • Oct. 21, 2014 -
These anti-inflammatories may enhance the effects of schizophrenia treatment
A meta-analysis of 26 gold-standard trials suggest that aspirin, estrogen, and other anti-inflammatories may significantly enhance the effects of schizophrenia meds.
By Nicole Gray • Oct. 20, 2014 -
FDA
Fearing creation of deadlier viruses, US tells scientists to halt bird flu research
Federal officials have decreed that certain studies involving mutant forms of the SARS, MERS, and influenza viruses be halted pending a thorough review of risks and benefits.
By Nicole Gray • Oct. 20, 2014 -
Deep Dive
How new FDA flexibility in breast cancer trials can help high-risk patients
Although the death rate from breast cancer has been decreasing since 2000, high-risk women still face daunting odds. New guidance issued by the FDA this month will help them.
By Nicole Gray • Oct. 17, 2014
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