Clinical Trials: Page 144
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Amgen's multiple myeloma drug meets phase III targets
Kyprolis (carfilzomib), used in combination with other medications, increased progression-free survival by 8.7 months in relapsed multiple myeloma patients.
By Nicole Gray • Aug. 5, 2014 -
Postdoctoral fellow admits to faking Novartis brain tumor study results
A paper was published in the journal Cancer Research in 2013 based on the false data, which documented prolonged survival times in mice treated with an investigational compound.
By Nicole Gray • Aug. 4, 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 -
High-dose estrogen birth control may increase breast cancer risk, study finds
The new data, published in the latest issue of Cancer Research, relies on electronic pharmacy records instead of self-reporting and is consequently considered more reliable than previous studies.
By Nicole Gray • Aug. 4, 2014 -
WHO plans $100 million emergency response as Ebola deaths top 700
“The scale of the Ebola outbreak, and the persistent threat it poses, requires WHO and Guinea, Liberia and Sierra Leone to take the response to a new level,” said WHO Director-General Dr. Margaret Chan.
By Sy Mukherjee • July 31, 2014 -
Bad news for Bayer/Amgen's blockbuster Nexavar in late-stage breast cancer trials
Using Nexavar in conjunction with chemotherapy did not improve progression-free survival in women with advanced breast cancer.
By Nicole Gray • July 28, 2014 -
Investigation raises new questions about Boehringer's blood thinner
Boehringer Ingelheim goes on the defensive as British Medical Journal investigators express concerns about the drug's clinical study design and data calculations.
By Nicole Gray • July 25, 2014 -
Puma stock soars nearly 300% on positive breast cancer drug trial results
Puma’s stock was up more than 275% on news that neratinib hit its target for improving disease-free survival rates in breast cancer patients.
By Nicole Gray • July 23, 2014 -
Could evolocumab become the gold-standard in cholesterol reduction?
Many in the clinical community say ‘yes’ based on extensive data published in NEJM.
By Nicole Gray • July 23, 2014 -
EMD Serono's Egrifta effective against drug-induced fatty liver disease in trial
Up to 40% of HIV-infected patients receiving antiretroviral (ARV) treatment have fatty liver disease.
By Nicole Gray • July 22, 2014 -
Regeneron and Bayer's DME drug shows promise in phase III trials
Regeneron Pharmaceuticals and Bayer's Eylea led to significant improvements in patients' eyesight in a phase III clinical trial.
By Nicole Gray • July 22, 2014 -
Deep Dive
Niacin: the poster child for post-marketing drug surveillance
More than ever, long-term post-marketing surveillance matters.
By Nicole Gray • July 21, 2014 -
Could Gilead's Sovaldi also treat Hep C in HIV patients?
The results of a new clinical trial were excellent news for Gilead, but women and patients with cirrhosis were underrepresented in the study.
By Nicole Gray • July 21, 2014 -
Study: GSK's combo melanoma drug bests Roche's Zelboraf
Interim analysis shows improved overall survival rates in patients with metastatic melanoma -- one of the most serious forms of the cancer.
By Nicole Gray • July 21, 2014 -
FDA fast-tracks review of Avastin as supplemental cancer drug
Encouraging phase III data in cervical cancer trials bodes well for the drug's chances of approval.
By Nicole Gray • July 17, 2014 -
GSK, Theravance's new COPD drug moves to Phase III testing
Can a newly formulated triple combo inhaled medication reduce exacerbations more than existing once-daily COPD treatments?
By Nicole Gray • July 16, 2014 -
FDA tackles informed consent concerns with new guidance
In clinical trials, informed consent ensures the rights and the well-being of subjects. This guidance presents the latest updates.
By Nicole Gray • July 16, 2014 -
How electronic records can cut clinical trial costs, yield more reliable results
A study of 300 people with COPD or at high risk for cardiovascular disease underscores the clinical advantages of EMRs.
By Nicole Gray • July 16, 2014 -
Otsuka and Lundbeck file application for schizophrenia and depression drug
The new drug application is a sign of Lundbeck's continued commitment to developing treatments for depressive disorders.
By Nicole Gray • July 16, 2014 -
Sanofi's dengue vaccine shows progress in trials
This is the first vaccine to demonstrate true efficacy against the complex virus.
By Nicole Gray • July 14, 2014 -
Phase III trial of Regado's antithrombotic system placed on hold
A data review by the FDA is expected to take five to seven weeks.
By Nicole Gray • July 11, 2014 -
Lilly, Yabao develop, market diabetes drug
The combined capabilities will give the two a presence in China and global reach.
By Nicole Gray • July 8, 2014 -
Study: Partial stem-cell transplant reverses sickle cell disease
The study, published Wednesday in the Journal of the American Medical Association, suggests a major shift in treatment.
By Nicole Gray • July 2, 2014 -
GSK/Theravance apply for U.S. approval of once-daily asthma treatment
This two-drug, fixed-combo is designed to be used in various pulmonary conditions.
By Nicole Gray • July 1, 2014 -
Lundbeck's stroke drug fails in advanced clinical trials
There was no statistically significant difference between placebo-treated patients and patients treated with drug.
By Nicole Gray • June 30, 2014 -
NICE changes its position on Glivec use
The agency is liberalizing its previous stance even though the drug costs more than $35,000 per year.
By Nicole Gray • June 30, 2014