Clinical Trials: Page
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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 -
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 -
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 -
Viiv's HIV combo drug recommended for approval by EMA advisers
It's likely the drug will become a formidable competitor to Gilead's Atripla.
By Nicole Gray • June 30, 2014 -
EU advisors recommend Avastin for refractory ovarian cancer
The drug will be used in combination with chemotherapy to improve outcomes.
By Nicole Gray • June 27, 2014 -
Boehringer's Pradaxa reversal drug gets breakthrough therapy status
The ability to reverse anticoagulation could help Pradaxa become the leading anticoagulant.
By Nicole Gray • June 27, 2014 -
Eisai files NDA for lenvatinib in Japan
Thyroid cancer affects up to 29,000 people in Japan.
By Nicole Gray • June 27, 2014 -
NICE recommends Invokana for diabetes
This is the 10th drug that NICE has recommended for treatment of type 2 diabetes.
By Nicole Gray • June 26, 2014 -
FDA requests additional information on AstraZeneca's ovarian cancer drug
The agency has concerns related to efficacy and safety.
By Nicole Gray • June 26, 2014